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ORGANIC SPECTROSCOPY

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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PF-07321332


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PF-07321332

https://clinicaltrials.gov/ct2/show/NCT04756531

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PFIZER INITIATES PHASE 1 STUDY OF NOVEL ORAL ANTIVIRAL THERAPEUTIC AGENT AGAINST SARS-COV-2

Tuesday, March 23, 2021 – 11:00am

  • In-vitro studies conducted to date show that the clinical candidate PF-07321332 is a potent protease inhibitor with potent anti-viral activity against SARS-CoV-2
  • This is the first orally administered coronavirus-specific investigational protease inhibitor to be evaluated in clinical studies, and follows Pfizer’s intravenously administered investigational protease inhibitor, which is currently being evaluated in a Phase 1b multi-dose study in hospitalized clinical trial participants with COVID-19

NEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) announced today that it is progressing to multiple ascending doses after completing the dosing of single ascending doses in a Phase 1 study in healthy adults to evaluate the safety and tolerability of an investigational, novel oral antiviral therapeutic for SARS-CoV-2, the virus that causes COVID-19. This Phase 1 trial is being conducted in the United States. The oral antiviral clinical candidate PF-07321332, a SARS-CoV2-3CL protease inhibitor, has demonstrated potent in vitro anti-viral activity against SARS-CoV-2, as well as activity against other coronaviruses, suggesting potential for use in the treatment of COVID-19 as well as potential use to address future coronavirus threats.

“Tackling the COVID-19 pandemic requires both prevention via vaccine and targeted treatment for those who contract the virus. Given the way that SARS-CoV-2 is mutating and the continued global impact of COVID-19, it appears likely that it will be critical to have access to therapeutic options both now and beyond the pandemic,” said Mikael Dolsten, MD, PhD., Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer. “We have designed PF-07321332 as a potential oral therapy that could be prescribed at the first sign of infection, without requiring that patients are hospitalized or in critical care. At the same time, Pfizer’s intravenous antiviral candidate is a potential novel treatment option for hospitalized patients. Together, the two have the potential to create an end to end treatment paradigm that complements vaccination in cases where disease still occurs.”

Protease inhibitors bind to a viral enzyme (called a protease), preventing the virus from replicating in the cell. Protease inhibitors have been effective at treating other viral pathogens such as HIV and hepatitis C virus, both alone and in combination with other antivirals. Currently marketed therapeutics that target viral proteases are not generally associated with toxicity and as such, this class of molecules may potentially provide well-tolerated treatments against COVID-19.

The Phase 1 trial is a randomized, double-blind, sponsor-open, placebo-controlled, single- and multiple-dose escalation study in healthy adults evaluating the safety, tolerability and pharmacokinetics of PF-07321332.

Initiation of this study is supported by preclinical studies that demonstrated the antiviral activity of this potential first-in-class SARS-CoV-2 therapeutic designed specifically to inhibit replication of the SARS-CoV2 virus. The structure of PF-07321332, together with the pre-clinical data, will be shared in a COVID-19 session of the Spring American Chemical Society meeting on April 6.

Pfizer is also investigating an intravenously administered investigational protease inhibitor, PF-07304814, which is currently in a Phase 1b multi-dose trial in hospitalized clinical trial participants with COVID-19.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer NewsLinkedInYouTube and like us on Facebook at Facebook.com/Pfizer.

.CLIP

https://cen.acs.org/content/cen/articles/99/i13/Pfizer-unveils-oral-SARS-CoV.html

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Drugmaker Pfizer revealed its oral COVID-19 antiviral clinical candidate PF-07321332 on Tuesday at the American Chemical Society Spring 2021 meeting. The compound, which is currently in Phase 1 clinical trials, is the first orally administered compound in the clinic that targets the main protease (also called the 3CL protease) of SARS-CoV-2, the virus that causes COVID-19. By inhibiting the main protease, PF-07321332 prevents the virus from cleaving long protein chains into the parts it needs to reproduce itself. Dafydd Owen, director of medicinal chemistry at Pfizer, presented the compound in a symposium of the Division of Medicinal Chemistry.

Last year, Pfizer reported PF-07304814, a different small molecule inhibitor of SARS-CoV-2’s main protease. The work to develop that compound began during the 2002-2003 outbreak of SARS-CoV, severe acute respiratory syndrome. But that molecule can only be given intravenously, which limits its use to hospital settings.

Because PF-07321332 can be taken orally, as a pill or capsule, it could be given outside of hospitals if it proves to be safe and effective. People who have been exposed to SARS-CoV-2 could take it as a preventative measure, for example.

“For the foreseeable future, we will expect to see continued outbreaks from COVID-19. And therefore, as with all viral pandemics, it’s important we have a full toolbox on how to address it,” Charlotte Allerton, Pfizer’s head of medicine design, told C&EN.

PF-07321332 was developed from scratch during the current pandemic. It’s a reversible covalent inhibitor that reacts with one of the main protease’s cysteine residues. Owen also discussed the chemistry involved in scaling up the compound. The first 7 mg of the compound were synthesized in late July 2020. Encouraged by the early biological data, the Pfizer team aimed to scale up the synthesis. By late October, they’d made 100 g of the compound. Just two weeks later, the chemists had scaled up the synthesis to more than 1 kg. Owen said 210 researchers had worked on the project. Ana Martinez, who studies COVID-19 treatments at the Spanish National Research Council CSIC and also presented during the symposium, told C&EN that having a COVID-19 antiviral is of critical importance. She eagerly anticipates the safety and efficacy data from the trials of PF-07321332. “Hopefully we will have a new drug to fight against COVID-19,” Martinez said. And because the molecule targets the main protease, she said that it might be useful for fighting other coronaviruses and preventing future pandemics.Chemical & Engineering News 

./////////////////PF-07321332, PF 07321332, COVID 19, CORONA VIRUS, SARS-CoV-2 inhibitor, PHASE 1

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Sinovac COVID-19 vaccine, CoronaVac,


sinovac
File:SINOVAC COVID-19 vaccine.jpg

Sinovac COVID-19 vaccine, CoronaVac,

  • PiCoVacc

CoronaVac, also known as the Sinovac COVID-19 vaccine,[1] is an inactivated virus COVID-19 vaccine developed by the Chinese company Sinovac Biotech.[2] It has been in Phase III clinical trials in Brazil,[3] Chile,[4] Indonesia,[5] the Philippines,[6] and Turkey.[7]

It relies on traditional technology similar to BBIBP-CorV and BBV152, other inactivated-virus COVID-19 vaccines in Phase III trials.[8] CoronaVac does not need to be frozen, and both the vaccine and raw material for formulating the new doses could be transported and refrigerated at 2–8 °C (36–46 °F), temperatures at which flu vaccines are kept.[9]

Brazil announced results on 13 January 2021 showing 50.4% effective at preventing symptomatic infections, 78% effective in preventing mild cases needing treatment, and 100% effective in preventing severe cases.[10] Final Phase III results from Turkey announced on 3 March 2021 showed an efficacy of 83.5%.[11] Interim results in Indonesia were announced on 11 January 2021 with an efficacy of 65.3%.[12] A detailed report containing confidence intervals, efficacy by age and side effects has not yet been released.

CoronaVac is being used in vaccination campaigns by certain countries in Asia,[13][14][15] South America,[16][17][18] North America,[19][20] and Europe.[21] In March, a Sinovac spokesman told Reuters production capacity for CoronaVac could reach 2 billion doses a year by June 2021.[22] As of March 21, 70 million doses of CoronaVac had been administered worldwide.[23

Technology

CoronaVac is an inactivated vaccine. It uses a similar, more traditional technology as in BBIBP-CorV and BBV152, other inactivated-virus vaccines for COVID-19 in Phase III trials.[24][25] CoronaVac does not need to be frozen, and both the vaccine and raw material for formulating the new doses could be transported and refrigerated at 2–8 °C (36–46 °F), temperatures at which flu vaccines are kept.[26] CoronaVac could remain stable for up to three years in storage, which might offer some advantage in vaccine distribution to regions where cold chains are not developed.[27]

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Efficacy

Empty bottle of CoronaVac

On 7 January 2021, results from Phase III trials in Brazil among 13,000 volunteers revealed the vaccine was 78% effective in preventing symptomatic cases of COVID-19 requiring medical assistance (grade 3 on the WHO Clinical Progression Scale[28]) and 100% effective against moderate and severe infections.[29] After mounting pressure from scientists, Butantan said on 12 January that these rates only included volunteers who had mild to severe cases of COVID-19.[30] The overall efficacy, including asymptomatic cases and symptomatic cases not requiring medical assistance (WHO grade 2), was 50.38%.[31] Of the 220 participants infected, 160 cases were in the placebo group and 60 cases in the group that received CoronaVac.[32]

On 3 March 2021, final Phase III results from Turkey showed an efficacy of 83.5%. The final efficacy rate was based on 41 infections, 32 of which had received a placebo, said Murat Akova, head of the Phase III trials in Turkey. He added the vaccine prevented hospitalization and severe illness in 100% of cases, saying six people who were hospitalized were all in the placebo group. The final results were based on a 10,216 participants, 6,648 of whom received the vaccine as part of the Phase III study that began mid-September. Turkey had announced an interim result with 29 infections in December, which placed the efficacy at 91.25%.[33][34]

On 11 January, Indonesia released Phase III results from an interim analysis of 25 cases which showed an efficacy rate of 65.3% based on data of 1,600 participants in the trial.[35] The trial was conducted in the city of Bandung, and it was not clear how Indonesian scientists made their calculations.[30]

Variability in results

Officials said the lowered figure of 50.4% included “very light” cases of COVID-19 among participants omitted in the earlier analysis. Ricardo Palácios, Medical Director of Instituto Butantan said Sinovac’s relatively low efficacy rate of 50% was due to more rigorous standards for what counts as an infection among trial participants. The Institute included six types of cases in its results: asymptomatic, very mild, mild, two levels of moderate, and severe, while western vaccine makers generally included only mild, moderate, and severe categories. Brazil’s trial was also largely made up of frontline health care workers. “They are more exposed to the virus and may explain the relatively low efficacy rate,” said Yanzhong Huang, a senior fellow for global health at the Council on Foreign Relations.[36]

The release of more definitive data on CoronaVac’s efficacy was delayed because Sinovac needed to reconcile results from different trials using varying protocols.[32] According to Instituto Butantan director Dimas Covas, the Brazilian group was considered more vulnerable to infection and exposure to higher viral loads. In Turkish and Indonesian Phase III trials, the composition of volunteers was similar to that of the general population.[37]

COVID-19 variants

On March 10, Instituto Butantan Director Dimas Covas said CoronaVac was efficient against three variants of COVID-19 in the country; British B.1.1.7, South African 501.V2, and Brazil’s P.1, of which are derived variants P.1 from Manaus state, and P.2 from Rio de Janeiro.[38]

CoronaVac and other inactivated virus vaccines have all parts of the virus. Butantan said this may generate a more comprehensive immune response compared to other vaccines using only a part of the spike protein used by COVID-19 to infect cells. Tests run by Butantan used the serum of vaccinated people, which are placed in a cell culture and subsequently infected with the variants. The neutralization consists of determining whether antibodies generated from the vaccine will neutralize the virus in the culture.[38]

Clinical trials

For broader coverage of this topic, see COVID-19 vaccine.

Phase I–II

In a Phase II clinical trial completed in July 2020 and published in The Lancet, CoronaVac showed seroconversion of neutralising antibodies for 109 (92%) of 118 participants in the 3 μg group, 117 (98%) of 119 in the 6 μg group, after the days 0 and 14 schedule; whereas at day 28 after the days 0 and 28 schedule, seroconversion was seen in 114 (97%) of 117 in the 3 μg group, 118 (100%) of 118 in the 6 μg group.[39]

In May, CoronaVac began Phase I–II trials in China on adults over the age 60, and in September CoronaVac began Phase I–II trials in China on children ages 3–17.[40] Phase II results for older adults published in The Lancet showed CoronaVac was safe and well tolerated in older adults, with neutralising antibody induced by a 3 μg dose were similar to those of a 6 μg dose.[41]

Phase III

Latin America

In late July 2020, Sinovac began conducting a Phase III vaccine trial to evaluate efficacy and safety on 9,000 volunteer healthcare professionals in Brazil, collaborating with Butantan Institute.[42][43] On 19 October, São Paulo Governor João Doria said the first results of the clinical study conducted in Brazil proved that among the vaccines being tested in the country, CoronaVac is the safest, the one with the best and most promising immunization rates.[44] On 23 October, São Paulo announced the creation of six new centers for trials of CoronaVac, increasing the number of volunteers in the trials to 13,000.[45]

Brazil briefly paused Phase III trials on 10 November after the suicide of a volunteer before resuming on 11 November. Instituto Butantan said the suicide had no relation to the vaccine trial.[46][47]

In August, a Phase III trial was started in Chile, headed by Pontifical Catholic University of Chile, which was expected to include 3,000 volunteers between the ages of 18 and 65.[48]

Europe

In September, Turkey began Phase III trials with 13,000 volunteers on a two-dose 14-day interval.[49] The monitoring process for CoronaVac is underway at 25 centers in 12 cities across the country.[50]

The Governor of West Java Ridwan Kamil participating in phase 3 trial of the Sinovac COVID-19 vaccine in Indonesia.

Asia

In August, Sinovac began Phase III trials in Indonesia with Bio Farma in Bandung involving 1,620 volunteers.[51] In November, Padjadjaran University Medical School provided an update that the trials were running smoothly and that “at most, they found a slight body fever which disappeared within two days”.[52]

In October, Saudi Arabia signed an agreement with Sinovac to distribute CoronaVac to 7,000 healthcare workers, after conducting Phase III trials with the Saudi Arabian National Guard.[53]

Manufacturing

Brazilian version of CoronaVac, manufactured by Butantan

In March, a Sinovac spokesman told Reuters production capacity for CoronaVac could reach 2 billion doses a year by June. The figure is double the capacity of 1 billion doses in bulk ingredients the firm said it could reach by February.[22]

After Indonesia’s Phase III trials, Bio Farma plans to ramp up production to 250 million doses a year.[54]

On 9 November, São Paulo began building a facility to produce 100 million doses a year.[55] On 10 December, João Doria said Butantan aimed to fill and finish 1 million doses per day on its production line for a vaccination campaign starting 25 January. Doria said 11 Brazilian states have contacted Butantan seeking doses of CoronaVac.[56]

In Malaysia, Pharmaniaga will manufacture, fill, and finish CoronaVac. Pharmaniaga signed a deal to obtain bulk supply of the vaccine as well as technology transfer from Sinovac.[57]

In Egypt, the government was in “advanced stage” discussions with Sinovac to manufacture CoronaVac for local use and export to African countries.[58]

Market and deployment

As of March 21, 70 million doses of CoronaVac had been administered worldwide.[23]

 
show  Full authorizationshow  Emergency authorization  Eligible COVAX recipient (assessment in progress)[80]

South America

São Paulo State Secretary of Health Jean Gorinchteyn (left) and Instituto Butantan chairman Dimas Covas (right) holding single-dose prefilled syringes of CoronaVac, part of the fourth shipment of Sinovac-manufactured vaccine to arrive in Brazil

In Brazil, São Paulo governor João Doria signed a $90 million contract with Sinovac in September to receive the initial 46 million doses of CoronaVac.[81] The price for CoronaVac was announced to be US$10.3 (about R$59).[82] In January, Brazil announced it would obtain 100 million total doses.[83] On 17 January, ANVISA approved emergency use of CoronaVac, with a 54-year-old nurse in São Paulo being the first to receive a vaccine outside of clinical trials in the country.[16] In early February, Brazil said it intends to buy an additional 30 million doses to be produced locally on top of the existing 100 million doses.[84]

In January, Bolivia authorized use of CoronaVac. Butantan Institute had opened negotiations with South American countries to sell the vaccine, which would be produced in São Paulo.[85]

In October, Chile signed an agreement to purchase 20 million doses of CoronaVac[86] which was approved for emergency use on 20 January.[87] By early March, the country had received 10 million doses of CoronaVac and had vaccinated 4.1 million people.[88]

In February, Colombia had purchased 5 million doses of CoronaVac and was in talks for an additional 5 million doses,[89] which had been approved for emergency use on February 5.[90]

In February, Ecuador signed a deal for 2 million doses of CoronaVac which had been approved for emergency use.[91] Chile donated 20,000 doses of CoronaVac to Ecuador on March 6.[92]

In March, Paraguay received a donation of 20,000 doses of CoronaVac from Chile.[92] Paraguay began vaccinations with CoronaVac on March 10.[93]

In January, Uruguay announced the purchased of 1.75 million doses of CoronaVac.[94] The first 192,000 doses arrived on 25 February and vaccinations started on 1 March.[18]

Europe

In March, Albania received 192,000 doses of a first batch of 1 million doses purchased through Turkey.[95]

In November, Turkey signed a contract to buy 50 million doses of CoronaVac.[96] Turkey approved emergency use on 13 January[97] and President Recep Tayyip Erdoğan received his first dose at Ankara City Hospital.[98] In February, Turkey signed a deal for another 50 million doses for a total of 100 million doses.[21] By March 10.7 million doses had been administered, and 852 of the 1.3 million people who had received both doses were later diagnosed with the disease. 53 were hospitalized, but none of those hospitalized were intubated or died.[99]

In December, Ukraine signed a contract to purchase 1.8 million doses of CoronaVac. One dose of CoronaVac would cost 504 hryvnias (around $18).[100] On March 9, Ukraine granted approval for use of CoronaVac.[101]

Asia

On 19 January, Azerbaijan launched its vaccination campaign with CoronaVac. Azerbaijan plans to receive 4 million doses of the vaccine and aims to vaccinate 40% of the population.[102]

In February, Cambodia approved Coronavac[103] for emergency use and later ordered 1.5 million doses to arrive on March 26.[104]

In late August, China approved CoronaVac for emergency use to vaccinate high-risk groups such as medical staff.[105] In early February, China approved CoronaVac for general use.[15]

In December, Hong Kong ordered 7.5 million doses of CoronaVac.[106] The vaccination campaign with CoronaVac began on 26 February.[107]

In August, Indonesia’s Foreign Minister Retno Marsudi said an agreement was signed with Sinovac for 50 million doses,[108] which later increased to 140 million doses.[109] Indonesia approved emergency use authorization on 11 January and[35] President Joko Widodo received the first shot of the vaccine, which would be free for all Indonesian citizens.[13] By March, Indonesia had received 53.5 million doses of CoronaVac.[110]

On 26 January, Malaysia ordered 12 million doses.[57] CoronaVac was approved for emergency use on 2 March.[111] Malaysian Science, Technology and Innovation Minister Khairy Jamaluddin received the first dose with CoronaVac on 18 March as part of the vaccination campaign.[112]

In January, the Philippine’s announced the country had secured 25 million doses.[113] The vaccine was approved on 22 February but not for all health workers as it had lower efficacy when used with health workers compared to healthy individuals aged 18-59. The first 600,000 doses of CoronaVac arrived on 28 February.[114]

Singapore has signed advance purchase agreements for CoronaVac.[115] In February, the first doses arrived in the country.[116]

In early January, Thailand’s Ministry of Public Health announced an order for 2 million doses of CoronaVac,[117] which was approved for emergency use on 22 February.[118] Thailand started its vaccination program on 27 February.[14] In March, Thailand was in talks to purchase an additional 5 million doses.[119]

North America

By March 8, Dominican Republic had vaccinated 400,000 people and had reserved delivery for 10 million additional doses of CoronaVac.[19]

In February, Mexico approved emergency use of CoronaVac.[120] The country has ordered 20 million doses,[121] of which the first 200,000 doses arrived on 20 February.[122] It is currently used as part of the national vaccination campaign.[20]

Africa

In March, Benin received 203,000 doses of CoronaVac with vaccinations to start with health workers and the medically vulnerable.[123]

In March, South Africa’s drug regulator began assessing CoronaVac for use in the country.[124] South African firm Numolux said it could supply 5 million doses once it secured regulatory clearances.[125]

In March, Tunisia’s Ministry of Health approved marketing authorization of CoronaVac in the country.[126]

In March, Zimbabwe approved CoronaVac for emergency use.[127]

Oceania

In March, Fiji said it would be receiving a donation of CoronaVac.[128]

Controversies

Politicization

CoronaVac has been championed by the governor of São PauloJoão Doria, who many believe will challenge Jair Bolsonaro for the presidency in 2022.[129] A political showdown began in October 2020, when Bolsonaro vetoed a deal between the Brazilian health ministry and the São Paulo government for the purchase of 46 million doses of the vaccine.[130] After Instituto Butantan announced CoronaVac’s efficacy rate, Bolsonaro mocked the vaccine’s effectiveness against COVID-19.[131] Critics against the politicization of vaccines have warned that failure to follow international testing and safety protocols risks undermining public trust and can increase people’s hesitancy to inoculation.[129] Doctors in São Paulo said they were struggling to convince patients that CoronaVac would be safe.[132]

In March 2021, the Paraná Pesquisas opinion polling institute found that the vaccines preferred by Brazilians are CoronaVac and the Oxford–AstraZeneca vaccine, chosen by 23.6% and 21.2% of Brazilians interviewed, respectively, against 11.3% of those who would prefer the Pfizer–BioNTech vaccine.[133]

Delays in releasing results

On 23 December 2020, researchers in Brazil said the vaccine was more than 50% effective, but withheld full results at Sinovac’s request, raising questions again about transparency as it was the third delay in releasing results from the trials.[134] São Paulo Health Secretary Jean Gorinchteyn later said the vaccine didn’t reach 90% efficacy. Turkey said its trial showed an estimated efficacy rate of 91.25%, though that was based on only 29 infected cases.[32] When São Paulo state officials announced the protection rate, they declined to provide a more detailed breakdown of the trial, such as information about age groups and side effects of the vaccine.[32] Scientists said the lack of transparency about the data ran the risk of damaging CoronaVac’s credibility, with Brazilians and others world-wide already reluctant to take it.[30] Nikolai Petrovsky, a professor at the College of Medicine and Public Health at Flinders University said, “There is enormous financial and prestige pressure for these trials to massively overstate their results.”[135]

References

  1. ^ Corum, Jonathan; Zimmer, Carl. “How the Sinovac Vaccine Works”The New York TimesISSN 0362-4331. Retrieved 1 March 2021.
  2. ^ Nidhi Parekh (22 July 2020). “CoronaVac: A COVID-19 Vaccine Made From Inactivated SARS-CoV-2 Virus”. Retrieved 25 July2020.
  3. ^ “New coronavirus vaccine trials start in Brazil”AP News. 21 July 2020. Retrieved 7 October 2020.
  4. ^ “Chile initiates clinical study for COVID-19 vaccine”Chile Reports. 4 August 2020. Retrieved 7 October 2020.
  5. ^ “248 volunteers have received Sinovac vaccine injections in Bandung”Antara News. 30 August 2020. Retrieved 7 October2020.
  6. ^ “DOH eyes 5 hospitals for Sinovac vaccine Phase 3 clinical trial”PTV News. 16 September 2020. Retrieved 7 October 2020.
  7. ^ “Turkey begins phase three trials of Chinese Covid-19 vaccine”TRT World News. 1 September 2020. Retrieved 7 October 2020.
  8. ^ Zimmer, Carl; Corum, Jonathan; Wee, Sui-Lee. “Coronavirus Vaccine Tracker”The New York TimesISSN 0362-4331. Retrieved 12 February 2021.
  9. ^ “CoronaVac: Doses will come from China on nine flights and can…” AlKhaleej Today (in Arabic). 1 November 2020. Retrieved 12 February 2021.
  10. ^ “Sinovac: Brazil results show Chinese vaccine 50.4% effective”BBC News. 13 January 2021. Retrieved 12 February 2021.
  11. ^ AGENCIES, DAILY SABAH WITH (25 December 2020). “Turkey set to receive ‘effective’ COVID-19 vaccine amid calls for inoculation”Daily Sabah. Retrieved 12 February 2021.
  12. ^ hermesauto (11 January 2021). “Indonesia grants emergency use approval to Sinovac’s vaccine, local trials show 65% efficacy”The Straits Times. Retrieved 12 February 2021.
  13. Jump up to:a b TARIGAN, EDNA; MILKO, VICTORIA (13 January 2021). “Indonesia starts mass COVID vaccinations over vast territory”Associated Press. Retrieved 15 January 2021.
  14. Jump up to:a b “Thailand Kicks Off Covid-19 Vaccine Program With Sinovac Shots”Bloomberg.com. Retrieved 28 February 2021.
  15. Jump up to:a b “China approves Sinovac vaccines for general public use”South China Morning Post. 6 February 2021. Retrieved 6 February2021.
  16. Jump up to:a b Fonseca, Jamie McGeever, Pedro (17 January 2021). “Brazil clears emergency use of Sinovac, AstraZeneca vaccines, shots begin”Reuters. Retrieved 17 January 2021.
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External links

Vaccine description
TargetSARS-CoV-2
Vaccine typeInactivated
Clinical data
Routes of
administration
Intramuscular injection
ATC codeNone
Legal status
Legal statusEmergency authorization for use in China, Indonesia, Brazil and Turkey
Identifiers
DrugBankDB15806
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COVID-19 pandemic
SARS-CoV-2 (virus)COVID-19 (disease)
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 COVID-19 Portal
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Sinovac Biotech Ltd. (Chinese: 北京科兴生物制品有限公司, NasdaqSVA) is a Chinese biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases. The company is based in Haidian DistrictBeijing.[2] The company is listed on the NASDAQ but the exchange halted Sinovac’s trading in February 2019 due to a proxy fight.[3][4]

Vaccines

Sinovac’s commercialized vaccines include Healive (hepatitis A), Bilive (combined hepatitis A and B), Anflu (influenza), Panflu (H5N1) and PANFLU.1 (H1N1). Sinovac is currently developing a Universal Pandemic Influenza vaccine and a Japanese encephalitis vaccine.[5][better source needed]

Sinovac is also developing vaccines for enterovirus 71 and human rabies. Its wholly owned subsidiary, Tangshan Yian, is conducting field trials for independently developed inactivated animal rabies vaccines.[citation needed]

COVID-19 vaccine development

Main article: CoronaVac

CoronaVac is an inactivated virus COVID-19 vaccine developed by Sinovac.[6] It has been in Phase III clinical trials in Brazil,[7] Chile,[8] Indonesia,[9] Malaysia,[10] Philippines,[11] and Turkey.[12]

It relies on traditional technology similar to BBIBP-CorV and BBV152, other inactivated-virus COVID-19 vaccines in Phase III trials.[13] CoronaVac does not need to be frozen, and both the vaccine and raw material for formulating the new doses could be transported and refrigerated at 2–8 °C (36–46 °F), temperatures at which flu vaccines are kept.[14]

Brazil announced results on January 13, 2021 showing 50.4% effective at preventing symptomatic infections, 78% effective in preventing mild cases needing treatment, and 100% effective in preventing severe cases.[15] Final Phase III results from Turkey announced on 3 March 2021 showed an efficacy of 83.5%.[16] Interim results in Indonesia were announced on 11 January 2021 with an efficacy of 65.3%.[17]

CoronaVac is being used in vaccination campaigns by certain countries in Asia,[18][19][20] South America,[21][22] and Europe.[23] In March, a Sinovac spokesman told Reuters production capacity for CoronaVac could reach 2 billion doses a year by June 2021.[24] As of 27 February 36 million doses had been administered in total.[25]

See also

References

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  22. ^ Miranda, Natalia A. Ramos (28 January 2021). “Chile receives two million-dose first delivery of Sinovac COVID-19 vaccine”Reuters. Retrieved 30 January 2021.
  23. ^ “Turkey aims to vaccinate 60 percent of population: Minister – Turkey News”Hürriyet Daily News. Retrieved 12 February 2021.
  24. ^ Liu, Roxanne (2021-03-03). “Sinovac eyes two billion doses in annual capacity of virus vaccine by June”Reuters. Retrieved 2021-03-03.
  25. ^ “Malaysia receives first batch of Sinovac Covid-19 vaccine today”. Bernama. 27 February 2021. Retrieved 27 February 2021– via The Malay Mail.

External links

TypePublic
Traded asNasdaqSVA
(American Depository Receipts)
Founded1999; 22 years ago
FounderYin Weidong[1]
HeadquartersBeijing,China
Websitehttp://www.sinovac.com/
Sinovac Biotech
Simplified Chinese北京科兴生物制品有限公司
Traditional Chinese北京科興生物製品有限公司
hideTranscriptionsStandard MandarinHanyu PinyinBěijīng Kē Xìng Shēngwù Zhìpǐn Yǒuxiàn Gōngsī

/////////Sinovac COVID-19 vaccine, CoronaVac, corona virus, covid 19, vaccine, china, Sinovac Biotech, PiCoVacc

#Sinovac COVID-19 vaccine, #CoronaVac, #corona virus, #covid 19, #vaccine, #china, #Sinovac Biotech, #PiCoVacc

Sputnik V, Gam-COVID-Vac, Gamaleya


sputnik-5

Sputnik V 

Gam-COVID-Vac

Gamaleya

SARS-CoV-2

  • Gam-COVID-Vac Lyo
Chart: How Effective Are The Covid-19 Vaccines? | Statista

Gam-COVID-Vac was created by Gamaleya Research Institute of Epidemiology and MIcrobiology in Russia. The vaccine candidate is a heterologous COVID-19 vaccine containing two components, recombinant adenovirus type 26 (rAd26) vector and recombinant adenovirus type 5 (rAd5) vector which both carry the SARS-CoV-2 spike glycoprotein. The vaccine is offered in both a frozen (Gam-COVID-Vac) and freeze-dried formulation (lyophilizate; Gam-COVID-Vac Lyo). Phase 1/2 human trials with 76 participants evaluated the safety, tolerability, and immunogenicity of both frozen (Gam-COVID-Vac;NCT04436471) and freeze-dried (Gam-COVID-Vac Lyo;NCT04437875) vaccine candidates in June 2020, and were completed in early August 2020. Preliminary results suggested that all participants developed antibodies to the SARS-CoV-2 glycoproteins with a good safety profile in both trials.

Sputnik V (Russian: Спутник V, literally Traveler V) is a COVID-19 vaccine developed by the Gamaleya Research Institute of Epidemiology and Microbiology. Registered on 11 August 2020 by the Russian Ministry of Health as Gam-COVID-Vac (Russian: Гам-КОВИД-Вак, romanizedGam-KOVID-Vak),[2][3] Sputnik V is an adenovirus viral vector vaccine. The “V” in the name is the letter V, not the Roman numeral for five.[4]

Gam-COVID-Vac was initially approved for distribution in Russia on the preliminary results of Phase III studies eventually published on 4 September 2020.[5] The quick approval in early August of Gam-COVID-Vac was met with criticism in mass media and precipitated discussions in the scientific community whether this decision was justified in the absence of robust scientific research confirming the safety and efficacy of the vaccine.[2][3][6][7][8] On 2 February 2021, an interim analysis from the trial was published in The Lancet, indicating 91.6% efficacy without unusual side effects.[9]

Emergency mass-distribution of the vaccine began in December 2020 in multiple countries including RussiaArgentinaBelarusHungarySerbia and the United Arab Emirates. As of February 2021, over a billion doses of the vaccine were ordered for immediate distribution globally.[10]

Infographic: What we know about Russia's Sputnik-V vaccine | Dhaka Tribune

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Technology

 President Putin‘s meeting with government members, on 11 August 2020 via videoconference, at which he announced a conditionally registered vaccine against COVID-19.[2][3] Medical worker in Moscow with the vaccineSee also: COVID-19 vaccine

Gam-COVID-Vac is a viral two-vector vaccine based on two human adenoviruses – a common cold virus – containing the gene that encodes the full-length spike protein (S) of SARS-CoV-2 to stimulate an immune response.[5][11][12] The Gam-COVID-Vac vaccine was developed by a cellular microbiologists team of the government-backed Gamaleya Research Institute of Epidemiology and Microbiology. The group was led by MD and RAS associate member Denis Logunov, who also worked on vaccines for the Ebolavirus and the MERS-coronavirus.[13]

The recombinant adenovirus types 26 and 5 are both used as vectors in the vaccine. They were biotechnology-derived and contain the SARS-CoV-2 S protein cDNA. Both of them are administered into the deltoid muscle: the Ad26-based vaccine is used on the first day and the Ad5 vaccine is used on the 21st day to boost immune response.[11][14][15]

The vaccine can be formulated as frozen (storage temperature must be −18 °C or 0 °F or lower) and freeze-dried (“Gam-COVID-Vac-Lyo”, storage temperature is 2–8 °C or 36–46 °F) dosage forms.[16] The first formulation was developed for large-scale use, it is cheaper and easier to manufacture. The production of a lyophilized formulation takes much more time and resources, although it is more convenient for storage and transportation. Gam-COVID-Vac-Lyo was developed especially for vaccine delivery to hard-to-reach regions of Russia.[17] The head of the Gamaleya Research Institute Alexander Ginzburg estimates that it will take 9–12 months to vaccinate the vast majority of the Russian population, assuming in-country resources are adequate.[18][19] A single-dose version is also being developed to speed up vaccination outside Russia. It will offer less protection than the two-dose versions, but it is still expected to reach an efficacy of 85%.[20][21]

COVID-19 vaccines: where we stand and challenges ahead | Cell Death &  Differentiation

Clinical research

Phase I–II

A phase I safety trial began on 18 June.[2] On 4 September, data on 76 participants in a phase I–II trial were published, indicating preliminary evidence of safety and an immune response.[5] The results were challenged by international vaccine scientists as being incomplete, suspicious, and unreliable when identical data were reported for many of the trial participants,[22] but the authors responded that there was a small sample size of nine, and the measured results of titration could only take discrete values (800, 1600, 3200, 6400). Coupled with the observation that values tended to reach a plateau after three to four weeks, they contend that it is not unlikely that several participants would show identical results for days 21 to 28.[23]

Phase III

 Sputnik V, efficacy for different conditions. The error bars indicate the confidence interval containing the efficacy with 95% probability

In early November 2020, Israel Hadassah Medical Center director-general Prof. Zeev Rotstein stated that Hadassah’s branch in Moscow’s Skolkovo Innovation Center was collaborating on a phase III clinical trial.[24]

The ongoing phase III study is a randomised, double-blind, placebo-controlled, multi-centre clinical trial involving 40,000 volunteers in Moscow, and is scheduled to run until May 2021.[25] In 2020–2021, phase III clinical studies were also being conducted in Belarus,[26] UAE,[27] India[28] and Venezuela.[29]

On 2 February 2021, an interim analysis from the Moscow trial was published in The Lancet, indicating 91.6% efficacy (95% CI 85.6–95.2) after the second vaccination, without unusual side effects.[30] The trial started on 7 September 2020 using the frozen liquid form of the vaccine, and data was analysed up to the second database lock on 24 November 2020. The over-60-years-old group in the trial (oldest participant was 87) had essentially the same efficacy (91.8%) as for all ages. The lowest age participants were 18 years old.[9][31]

SARS-CoV-2 vaccines strategies: a comprehensive review of phase 3  candidates | npj Vaccines

Sputnik–AstraZeneca COVID-19 vaccine trials

On 21 December 2020 the Russian Direct Investment Fund (RDIF), the Gamaleya National Center, AstraZeneca and R-Pharm have signed an agreement aimed at the development and implementation of a clinical research program to assess the immunogenicity and safety of the combined use of one of the components of the Sputnik V vaccine developed by the Gamaleya Center, and one of the components of the AZD1222 vaccine, developed by AstraZeneca and the University of Oxford.[32] The study program will last 6 months in several countries, and it is planned to involve 100 volunteers in each study program. On 9 February 2021, the Ministry of Health of the Republic of Azerbaijan allowed clinical studies in the country for the combined use of the Sputnik V vaccine and the vaccine developed by AstraZeneca, stating that the trials would begin before the end of February 2021.[33][34]

Composition

The Gam-COVID-Vac is a two-vector vaccine.[1] The active component for both vectors is a modified (recombinant) replication-defective adenovirus of a different serotype (Serotype 26 for the first vaccination and serotype 5 for the second vaccination), which has been modified to include the protein S-expressing gene of SARS-CoV-2.[1]

The other ingredients (excipients) are the same, both quantitatively and qualitatively, in the two components.[35]

As per the official datasheet, no further components or ingredients, including other adjuvants, should be included in the vaccine.[1]

History

In May 2020, the Gamaleya Research Institute of Epidemiology and Microbiology announced that it had developed the vaccine without serious side effects. By August 2020, phases I and II of two clinical trials (involving 38 patients each) were completed. Only one of them used the formulation which later obtained marketing authorization under limited conditions.[36][37] This vaccine was given the trade name “Sputnik V”, after the world’s first artificial satellite.[3][7][38]

During preclinical and clinical trials, 38 participants who received one or two doses of the Gam-COVID-Vac vaccine had produced antibodies against SARS-CoV-2’s spike protein, including potent neutralizing antibodies that inactivate viral particles.[2] On 11 August 2020, the Russian minister of Health Mikhail Murashko announced at a government briefing with the participation of President Vladimir Putin regulatory approval of the vaccine for widespread use. The state registration of the vaccine was carried out “conditionally” with post-marketing measures according to the decree of the Government of the Russian Federation. The registration certificate for the vaccine stated that it could not be used widely in Russia until 1 January 2021, and before that, it may be provided to “a small number of citizens from vulnerable groups”, such as medical staff and the elderly, according to a Ministry of Health spokesperson.[3] The license under register number No. ЛП-006395 (LP-006395) was issued on 11 August by the Russian Ministry of Health. Although the announcement was made even before the vaccine candidate had been entered into Phase III trials, the practice of marketing authorization “on conditions” also exists in other countries.[39][40] On 26 August, certificate No. ЛП-006423 (LP-006423) was issued for the lyophilized formulation “Gam-COVID-Vac-Lyo”.[2][3][7][41][5]

The commercial release of the Gam-COVID-Vac was first scheduled for September 2020. In October, Mikhail Murashko said that the Gam-COVID-Vac will be free for all Russian citizens after the launching of mass production.[42][43] Later on, Russian Ministry of Health registered maximum ex-factory price equal to 1,942 rubles for two components and included them into The National List of Essential medicines.[44] There were also suggestions to include the vaccine in the National Immunisation Calendar of Russia.[44]

According to Russian media, the mass production of the Gam-COVID-Vac was launched by 15 August. By that moment, the Russian Federation has already received applications from 20 countries for the supply of 1 billion doses of vaccine. Three facilities were able to produce about a million doses per month at each with a potential doubling of capacity by winter. By the end of 2020, Gamaleya Research Institute’s production, according to an interview with the organization’s spokesperson, was planned to produce 3–5 million doses.[45][46]

On 9 March 2021, an agreement was signed by the RDIF sovereign wealth fund and Swiss-based pharmaceutical company Adienne to produce the vaccine in Italy. Kirill Dmitriev, RDIF’s head, told Russian state TV his fund had also struck deals with production facilities in Spain, France and Germany for local manufacturing of the vaccine.[47]

Scientific assessment

Balram Bhargava, director of the Indian Council of Medical Research, said that Russia had managed to fast-track a COVID-19 vaccine candidate through its early phases.[48]

On 11 August 2020, a World Health Organization (WHO) spokesperson said, “… prequalification of any vaccine includes the rigorous review and assessment of all required safety and efficacy data”.[8]

  • A WHO assistant director said, “You cannot use a vaccine or drugs or medicines without following through all of these stages, having complied with all of these stages”.[49]
  • Francois Balloux, a geneticist at University College London, called the Russian government’s approval of Gam-COVID-Vac a “reckless and foolish decision”.[2] Professor Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, characterized the announcement was a “political stunt”, and stated that the untested vaccine could be very harmful.[8]

Stephen Griffin, Associate Professor in the School of Medicine, University of Leeds, said “that we can be cautiously optimistic that SARS-CoV2 vaccines targeting the spike protein are effective.” Moreover, as the Sputnik antigen is delivered via a different modality, namely using a disabled Adenovirus rather than formulated RNA, this provides flexibility in terms of perhaps one or other method providing better responses in certain age-groups, ethnicities, etc., plus the storage of this vaccine ought to be more straightforward.[50][failed verification][51]

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said “the data [is] compatible with the vaccine being reasonably effective … These results are consistent with what we see with other vaccines, because the really big message for global health scientists is that this disease [COVID-19] is able to be addressed by vaccines.”[50]

Julian Tang, clinical virologist at the University of Leicester, said: “Despite the earlier misgivings about the way this Russian Sputnik V vaccine was rolled out more widely – ahead of sufficient Phase 3 trial data – this approach has been justified to some extent now.”[52]

Ian Jones, a professor of virology at the University of Reading, and Polly Roy, professor and Chair of Virology at The London School of Hygiene and Tropical Medicine, commenting on phase III results published in the Lancet in February 2021, said “The development of the Sputnik V vaccine has been criticised for unseemly haste, corner cutting, and an absence of transparency. But the outcome reported here is clear and the scientific principle of vaccination is demonstrated, which means another vaccine can now join the fight to reduce the incidence of COVID-19.”[53]

Hildegund C. J. Ertl, a vaccine scientist at the Wistar Institute, called the phase-III results published on 2 February 2021 “great”: “Good safety profile, more than 90% efficacy across all age groups, 100% efficacy against severe disease or death, can be stored in the fridge and low cost. What more would we want?”[54]

According to preliminary review by experts,[who?] the lyophilized formulation of Gam-COVID-Vac is similar to the smallpox vaccine, circumventing the need for continuous “colder chain” or cold-chain storage – as required for the Pfizer–BioNTech and Moderna vaccines respectively – and allowing transportation to remote locations with reduced risk of vaccine spoilage.[55][56]

On 6 March 2021, Director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), Anthony Fauci, said that the data from Sputnik V “looked pretty good” to him.[57]

Distribution, vaccination and public perception

Early perception

An opinion poll of Canadians conducted by Léger in August 2020 found that a majority (68%) would not take the Russian vaccine if offered a free dose, compared to 14% who said they would take it. When Americans were asked the same question, 59% would not take the Russian vaccine if offered a free dose, compared to 24% who said they would take it.[58][59]

  • At that time, British and American officials stated that the Gam-COVID-Vac vaccine would likely be rejected due to concerns that the normally rigorous process of vaccine clinical testing was not followed.[60] One public health expert said the quick approval of Gam-COVID-Vac by the Russian government was “cutting corners”, and may harm public confidence if the vaccine proves to be unsafe or ineffective.[7] “There is a huge risk that confidence in vaccines would be damaged by a vaccine that received approval and was then shown to be harmful”, said immunologist Peter Openshaw.[7]


As for early September 2020, according to public opinion polls, only half of the Russian population would take the vaccine voluntarily.[61]

In Russia

 Vaccination of military personnel and civilian specialists of the Northern Fleet with the second component of the drug “Gam-COVID-Vac” (“Sputnik V”).

In the beginning of December 2020, Russian authorities announced the start of a large-scale free of charge vaccination with Gam-COVID-Vac for Russian citizens: the “immunization” program was launched on 5 December 2020 (with 70 Moscow-based medical centers providing vaccinations).[62]

Doctors and other medical workers, teachers, and social workers were given priority due to their highest risk of exposure to the disease.[63] The age for those receiving shots was initially capped at 60, later this restriction was lifted.[64]

Potential recipients were notified via text messaging, which says “You are working at an educational institution and have top-priority for the COVID-19 vaccine, free of charge”. Patients are asked a few general health questions before getting the vaccine. Program’s leaflet is handed to the patient, which warns of possible side effects, suggesting those are most likely to be mild and last a couple of days at most.[65][66][67] People with certain underlying health conditions, pregnant women, and those who have had a respiratory illness for the past two weeks are barred from vaccination.[63] Vaccine vial is removed from medical centre’s freezer about 15 minutes before use.

In early December 2020, the Minister of HealthMikhail Murashko, said that Russia had already vaccinated more than 100,000 high-risk people.[68] Forty thousand of those are volunteers in Sputnik V’s Phase 3 trials, another 60,000 medics and doctors have also taken the vaccine.[69] The head of the Russian Direct Investment Fund, Kirill Dmitriev, said in an interview with the BBC that Russian medics expect to give about 2 million people coronavirus vaccinations in December.[70]

Up to the beginning of December 2020, Generium (which is supervised by Pharmstandard) and Binnopharm (which is supervised by AFK Sistema) companies produced Gam-COVID-Vac on a large scale.

On 10 December, Deputy Prime Minister Tatyana Golikova announced that approximately 6.9 million doses of the Sputnik V vaccine will enter civilian circulation in Russia before the end of February 2021.[71] Moscow Mayor Sergei Sobyanin announced that the newly-opened Moscow-based “R-Pharm” will become a leading manufacturer of Russia’s Sputnik V coronavirus vaccine. Working at full capacity, the factory will produce up to 10 million doses a month.[72]

Outside of Russia

 In dark green are the countries that ordered (Russian or licensed domestic production; China also plans to produce Sputnik V on its territory.) or approved Sputnik V vaccine against COVID-19 (w/disputed Crimea). In light green are the countries that have shown interest in obtaining the vaccine.

According to the Russian Direct Investment Fund, they had received orders for more than 1.2 billion doses of the vaccine as of December 2020. Over 50 countries had made requests for doses, with supplies for the global market being produced by partners in IndiaBrazilChinaSouth KoreaHungary, and other countries.[73][74] In August 2020, according to the Russian authorities, there were at least 20 countries that wanted to obtain the vaccine.[75]

While free in Russia, the cost per dose would be less than US$10 (or less than US$20 for the two doses needed to vaccinate one person) on international markets, which makes it much more affordable compared to mRNA vaccines from other manufacturers. Kirill Dmitriev, head of the fund, told reporters that over 1 billion doses of the vaccine are expected to be produced in 2021 outside of Russia.[76][77]

The Israeli Hadassah Medical Center has signed a commercial memorandum of understanding to obtain 1.5–3 million doses.[78]

  • According to The New York Times’ sources,[79] to secure the release of an Israeli civilian held in Syria, Israel agreed to finance a supply of Russian-made Covid-19 vaccines for Damascus.

Argentina had agreed to buy 25 million doses of Russia’s Covid-19 vaccine.[80] The vaccine was registered and approved in Argentina in late December 2020.[81] The Brazilian state of Bahia has also signed an agreement to conduct Phase III clinical trials of the Sputnik V vaccine and plans to buy 50 million doses to market in northeastern Brazil.[82]

On 21 January 2021, the Argentine president Alberto Fernández became the first Latin American leader to be inoculated against the disease via the then recently approved Sputnik V.[83][84]

Due to the delay in shipping of doses from Italy and the European Union, San Marino imported doses of the Sputnik V vaccine (not approved by the E.M.A.) and started a mass vaccination on 28 February of its healthcare workers.[85]

EMA’s human medicines committee (CHMP) has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology. [86] Asked about the prospect of Austria taking the same step (as some other European countries chose to do), EMA management board chair Christa Wirthumer-Hoche told Austria’s ORF broadcaster: “It’s somewhat comparable to Russian roulette. I would strongly advise against a national emergency authorisation,” she said, pointing to the fact that there was not yet sufficient safety data about those who had already been given the vaccine. “We could have Sputnik V on the market in future, when we’ve examined the necessary data,” she said, adding that the vaccine needed to match up to European criteria on quality control and efficacy.[87]

Although vaccination rates in Russia are below those of other developed nations (as of March 2021),[88] Russia is pursuing deals to supply its vaccine abroad.[89]

Emergency use authorization

 show  Full authorizationshow  Emergency authorizationshow  Ordered doses  Eligible COVAX recipient (assessment in progress)[143]  EMA review in progress[144]

As of December 2020, Belarus and Argentina granted emergency use authorization for the vector-based vaccine.[145] On 21 January 2021, Hungary became the first European Union country to register the shot for emergency use, as well as the United Arab Emirates in the Gulf region.[146][147][148][149][150]

On 19 January 2021, the Russian authorities applied for the registration of Sputnik V in the European Union, according to the RDIF.[151] On 10 February, the European Medicines Agency (EMA) said that they had “not received an application for a rolling review or a marketing authorisation for the vaccine”. The developers have only expressed their interest that the vaccine be considered for a rolling review, but EMA’s Human Medicines Committee (CHMP) and the COVID-19 EMA pandemic Task Force (COVID-ETF) need to give their agreement first before developers can submit their application for initiation of the rolling review process.[152] On 4 March 2021, the Committee for Medicinal Products for Human Use (CHMP) of the EMA started a rolling review of Sputnik V.[153] The EU applicant is R-Pharm Germany GmbH.[153]

Emergency use has also been authorized in Algeria, Bolivia, Serbia, the Palestinian territories,[154] and Mexico.[155]

On 25 January 2021, Iran approved the vaccine, with Foreign Minister Mohammad Javad Zarif saying the country hopes to begin purchases and start joint production of the shot “in the near future”, after Supreme Leader Ayatollah Ali Khamenei banned the government from importing vaccines from the United States and United Kingdom.[156][157]

On 1 March 2021, Slovakia bought two million Sputnik V vaccines. Slovakia received the first batch of 200,000 vaccines, and expects to receive another 800,000 doses in March and April. Another 1 million vaccines are set to arrive in May and June.[158] The Czech Republic is also considering buying Sputnik V.[159]

On 18 March 2021, German regional leaders including State Premiers and the major of Berlin called for the swift approval of the Russian vaccine by the European Medicines Agency to counteract the acute shortages of effective vaccines in Europe. German medical experts have recommended its approval also, and consider the Sputnik Vaccine “clever” and “highly safe”.[160]

On 19 March 2021, the Philippine Food and Drug Administration granted emergency use authorization for Sputnik V, the fourth COVID-19 vaccine to be given authorization. The Philippine government is planning to buy 20 million doses of the vaccine.[161][162]

As of March 23, 2021, 56 countries have granted Sputnik V emergency use authorization.[163]

Production

As of March 2021, RDIF has licensed production in India, China, South Korea and Brazil. In the EU, RDIF has signed production agreements, subject to European Medicines Agency approval, with companies in Germany, Spain and France, and is in negotiations with a Swiss/Italian company. By the end of March 2021 RDIF anticipates 33 million doses will have been manufactured in Russia, less than 5% of which will have been exported.[164]

An agreement for the production of over 100 million doses of vaccine in India has been made with Dr. Reddy’s Laboratories, who on 11 January 2021 submitted mid-stage trial data to the Indian regulator and recommended moving onto late-stage trials.[154] The RDIF announced plans to sell 100 million doses to India, 35 million to Uzbekistan, and 32 million to Mexico, as well as 25 million each to Nepal and Egypt.[165]

In March 2021, the Italian-Russian Chamber of Commerce announced that Italy would be the first EU country to manufacture the two-dose COVID-19 vaccine under license. From July to the end of 2021, the Italian-Swiss pharmaceutical company Adienne in Caponago will manufacture 10 million doses. The announcement came in a time of acute vaccine shortages in Europe while the Sputnik V vaccine was still under review by the European Medicines Agency. Russian authorities said they would be able to provide a total of 50 million doses to European countries beginning in June 2021.[166]

The Sputnik V doses to be manufactured in South Korea are not for domestic use. The vaccine is to be exported to Russia, Algeria, Argentina, Hungary, Iran and the United Arab Emirates.[167]

References

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  2. Jump up to:a b c d e f g Callaway E (August 2020). “Russia’s fast-track coronavirus vaccine draws outrage over safety”Nature584(7821): 334–335. doi:10.1038/d41586-020-02386-2PMID 32782400
  3. Jump up to:a b c d e f Cohen J (11 August 2020). “Russia’s approval of a COVID-19 vaccine is less than meets the press release”Science. Retrieved 13 August 2020.
  4. ^ How Sputnik V worksGamaleya Research Institute of Epidemiology and Microbiology, 11 January 2021, retrieved 18 March 2021
  5. Jump up to:a b c d Logunov DY, Dolzhikova IV, Zubkova OV, Tukhvatullin AI, Shcheblyakov DV, Dzharullaeva AS, et al. (September 2020). “Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia”Lancet396 (10255): 887–897. doi:10.1016/S0140-6736(20)31866-3PMC 7471804PMID 32896291.
  6. ^ Mahase E (August 2020). “Covid-19: Russia approves vaccine without large scale testing or published results”BMJ370: m3205. doi:10.1136/bmj.m3205PMID 32816758.
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  8. Jump up to:a b c Berkeley Jr L (11 August 2020). “Scientists worry whether Russia’s Sputnik V’ coronavirus vaccine is safe and effective”CNBC. Retrieved 11 August 2020.
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  29. ^ Clinical trial number NCT04642339 for “Clinical Trial of the Immunogenicity, Safety, and Efficacy of the Gam-COVID-Vac Vaccine Against COVID-19 in Venezuela” at ClinicalTrials.gov
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  34. ^ “Study in Adults to Determine the Safety and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, Given in Combination With rAd26-S, Recombinant Adenovirus Type 26 Component of Gam-COVID-Vac Vaccine, for the Prevention of COVID-19”ClinicalTrials.gov. U.S. National Library of Medicine. 14 January 2021. NCT04686773. Retrieved 9 February 2021.
  35. ^ “ИНСТРУКЦИЯ ПО МЕДИЦИНСКОМУ ПРИМЕНЕНИЮ ЛЕКАРСТВЕННОГО ПРЕПАРАТА Гам-КОВИД-Вак, Комбинированная векторная вакцина для профилактики коронавирусной инфекции, вызываемой вирусом SARS-CoV-2” (PDF). МИНИСТЕРСТВО ЗДРАВООХРАНЕНИЯ РОССИЙСКОЙ ФЕДЕРАЦИИ.
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External links

Scholia has a profile for Gam-COVID-Vac (Q98270627).
Russian Ministry of Health image of Gam-COVID-Vac vials
Vaccine description
TargetSARS-CoV-2
Vaccine typeViral vector
Clinical data
Trade namesSputnik V[1]Спутник V
Other namesGam-COVID-VacГам-КОВИД-Вак
Routes of
administration
Intramuscular
ATC codeNone
Legal status
Legal statusRegistered in Russia on 11 August 2020
AEAGDZBOBYHUIRPSRS: EUA only
Identifiers
DrugBankDB15848

////////SARS-CoV-2, corona virus, covid 19, Gam-COVID-Vac Lyo, Sputnik V, Gam-COVID-Vac, Gamaleya, russia

#SARS-CoV-2, #corona virus, #covid 19, #Gam-COVID-Vac Lyo, #Sputnik V, #Gam-COVID-Vac, #Gamaleya, #russia, #vaccine

Johnson & Johnson COVID-19 vaccine, JNJ 78436735


j-j

Johnson & Johnson COVID-19 vaccine, JNJ 78436735

  • Ad26.COV2.S
  • JNJ-78436735
  • Ad26COVS1
  • VAC31518
  •  UNII: JT2NS6183B
NAMEDOSAGESTRENGTHROUTELABELLERMARKETING STARTMARKETING END  
Covid-19 Vaccine JanssenInjection, suspension0.95 Inf. UIntramuscularJanssen Cilag International Nv2021-03-17Not applicableEU flag 
Janssen COVID-19 VaccineInjection, suspension50000000000 {VP}/0.5mLIntramuscularJanssen Products, LP2021-01-04Not applicableUS flag 
NAMEINGREDIENTSDOSAGEROUTELABELLERMARKETING STARTMARKETING END  
Janssen COVID-19 VaccineAd26.COV2.S (50000000000 {VP}/0.5mL)Injection, suspensionIntramuscularJanssen Products, LP2021-01-04Not applicableUS flag 
FORMROUTESTRENGTH
Injection, suspensionIntramuscular0.95 Inf. U
Injection, suspensionIntramuscular50000000000 {VP}/0.5mL

The Johnson & Johnson COVID-19 vaccine is a human adenovirus viral vector COVID-19 vaccine[12] developed by Janssen Vaccines in Leiden in The Netherlands,[13] and its Belgian parent company Janssen Pharmaceuticals,[14] subsidiary of American company Johnson & Johnson (J&J).[15][16]

The vaccine is based on a human adenovirus that has been modified to contain the gene for making the spike protein of the SARS-CoV-2 virus that causes COVID-19.[3] The vaccine requires only one dose and does not need to be stored frozen.[17]

The vaccine started clinical trials in June 2020, with Phase III trials involving around 43,000 people.[18] On 29 January 2021, Janssen announced that the vaccine was 66% effective in a one-dose regimen in preventing symptomatic COVID-19, with an 85% efficacy in preventing severe COVID-19.[19][20][21] The most common side effects were pain at the injection site, headache, fatigue, muscle aches and nausea.[22] Most of these side effects were mild to moderate in severity and lasted one or two days.

The vaccine has been granted an Emergency Use Authorization by the US Food and Drug Administration[23] and a conditional marketing authorisation by the European Medicines Agency.[11][24][25]

Ad26.COV2.S is a lead recombinant vaccine candidate that contains an adenovirus serotype 26 (Ad26) vector expressing a stabilized SARS-CoV-2 spike protein. The vaccine was created in collaboration with Johnson and Johnson (J&J), Janssen Pharmaceutical, and the Beth Israel Deaconess Medical Center. This vaccine lead candidate uses Janssen’s AdVac® and PER.C6® technologies. A preclinical study in hamsters infected with SARS-COV-2 infection1 showed a single immunization with the vaccine elicited neutralizing responses and protected against SARS-CoV-2 induced pneumonia and mortality, providing protection against the disease progression. Follow up preclinical studies in rhesus monkeys2 showed that the Ad26 vaccine produced a robust response and provided near perfect protection in nasal swabs and bronchoalveolar lavage following SARS-COV-2 challenge. As of June 2020, a Phase 1/2 clinical trial in adult humans was announced to evaluate the safety, immunogenicity, and efficacy of the ad26.COV.S vaccine in 1045 healthy adults between the ages of 18-55 (NCT04436276).

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Description

The Johnson & Johnson COVID-19 vaccine consists of a replication-incompetent recombinant adenovirus type 26 (Ad26) vector expressing the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein in a stabilized conformation.[26][4] The stabilized version of the spike protein – that includes two mutations in which the regular amino acids are replaced with prolines – was developed by researchers at the National Institute of Allergy and Infectious Diseases‘ Vaccine Research Center and the University of Texas at Austin.[27][28][29] The vaccine also contains the following inactive ingredients: citric acid monohydratetrisodium citrate dihydrateethanol (alcohol), 2-hydroxypropyl-β-cyclodextrin (HBCD) (hydroxypropyl betadex), polysorbate 80sodium chloridesodium hydroxide, and hydrochloric acid.[26][1]

Characteristics

The Johnson & Johnson COVID-19 vaccine can remain viable for months in a standard refrigerator.[30][31][32] Unlike the Pfizer–BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine, the Johnson & Johnson COVID-19 vaccine is administered as a single dose instead of two separate doses and it is not shipped frozen.[33][17]

The storage and handling information in the Fact Sheet supersedes the storage and handling information on the carton and vial labels.[17] The vaccine should not be stored frozen.[17] Unpunctured vials may be stored between 9 to 25 °C (48 to 77 °F) for up to twelve hours.[26][17]

Development

During the COVID-19 pandemic, Johnson & Johnson committed over US$1 billion toward the development of a not-for-profit COVID-19 vaccine in partnership with the Biomedical Advanced Research and Development Authority (BARDA) Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS).[34][35] Johnson & Johnson stated that its vaccine project would be “at a not-for-profit level” as the company viewed it as “the fastest and the best way to find all the collaborations in the world to make this happen”.[36]

Inside of an Emergent BioSolutions facility where, in collaboration with Johnson & Johnson, vaccines are produced.

Janssen Vaccines, in partnership with Beth Israel Deaconess Medical Center (BIDMC), is responsible for developing the vaccine candidate, based on the same technology used to make its Ebola vaccine.[16][37][38]

Clinical trials

Phase I-II

In June 2020, Johnson & Johnson and the National Institute of Allergy and Infectious Diseases (NIAID) confirmed its intention to start a clinical trials of the Ad26.COV2.S vaccine in September 2020, with the possibility of Phase I/IIa human clinical trials starting at an accelerated pace in the second half of July.[39][40][41]

A Phase I/IIa clinical trial started with the recruitment of the first subject on 15 July 2020, and enrolled study participants in Belgium and the US.[42] Interim results from the Phase I/IIa trial established the safety, reactogenicity, and immunogenicity of Ad26.COV2.S.[43][44]

Phase III

A Phase III clinical trial called ENSEMBLE started enrollment in September 2020, and completed enrollment on 17 December 2020. It was designed as a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a single-dose vaccine versus placebo in adults aged 18 years and older. Study participants received a single intramuscular injection of Ad26.COV2.S at a dose level of 5×1010 virus particles on day one.[45] The trial was paused on 12 October 2020, because a volunteer became ill,[46] but the company said it found no evidence that the vaccine had caused the illness and announced on 23 October 2020, that it would resume the trial.[47][48] On 29 January 2021, Janssen announced safety and efficacy data from an interim analysis of ENSEMBLE trial data, which demonstrated the vaccine was 66% effective at preventing the combined endpoints of moderate and severe COVID-19 at 28 days post-vaccination among all volunteers. The interim analysis was based on 468 cases of symptomatic COVID-19 among 43,783 adult volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. No deaths related to COVID-19 were reported in the vaccine group, while five deaths in the placebo group were related to COVID-19.[49] During the trial, no anaphylaxis was observed in participants.[49]

A second Phase III clinical trial called ENSEMBLE 2 started enrollment on 12 November 2020. ENSEMBLE 2 differs from ENSEMBLE in that its study participants will receive two intramuscular (IM) injections of Ad26.COV2.S, one on day 1 and the next on day 57.[50]

Manufacturing

In April 2020, Johnson & Johnson entered a partnership with Catalent who will provide large-scale manufacturing of the Johnson & Johnson vaccine at Catalent’s Bloomington, Indiana facility.[51] In July 2020, the partnership was expanded to include Catalent’s Anagni, Italy facility.[52]

In July 2020, Johnson & Johnson pledged to deliver up to 300 million doses of its vaccine to the U.S., with 100 million upfront and an option for 200 million more. The deal, worth more than $1 billion, will be funded by the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Defense Department.[53][54] The deal was confirmed on 5 August.[55]

In September 2020, Grand River Aseptic Manufacturing agreed with Johnson & Johnson to support the manufacture of the vaccine, including technology transfer and fill and finish manufacture, at its Grand Rapids, Michigan facility.[56]

In December 2020, Johnson & Johnson and Reig Jofre, a Spanish pharmaceutical company, entered into an agreement to manufacture the vaccine at Reig Jofre’s Barcelona facility.[57] If the European Medicines Agency (EMA) grants approval to the vaccine by March 2021, a European Union regulator said that Johnson & Johnson could start supplying vaccines to EU states starting on April 2021.[58][59]

In August 2020, Johnson & Johnson signed a contract with the U.S. federal government for US$1 billion, agreeing to deliver 100 million doses of the vaccine to the U.S. following the U.S. Food and Drug Administration (FDA) grant of approval or emergency use authorization (EUA) for the vaccine.[54] Under its agreement with the U.S. government, Johnson & Johnson was targeted to produce 12 million doses by the end of February 2021, more than 60 million doses by the end of April 2021, and more than 100 million doses by the end of June 2021. However, in January 2021, Johnson & Johnson acknowledged manufacturing delays would likely prevent it from meeting its contract of 12 million doses delivered to the U.S. by the end of February.[60] In late February 2021 congressional testimony by a company executive, however, Johnson & Johnson indicated that the company could deliver 20 million doses to the U.S. government by the end of March, and 100 million doses in the first half of 2021.[61]

In February 2021, Sanofi and Johnson & Johnson struck a deal for Sanofi to provide support and infrastructure at Sanofi’s Marcy-l’Étoile, France facility to manufacture approximately 12 million doses of the Johnson & Johnson vaccine per month once authorized.[62]

In March 2021, Merck & Co and Johnson & Johnson struck a deal for Merck to manufacture the Johnson & Johnson vaccine at two facilities in the United States to help expand the manufacturing capacity of the vaccine using provisions of the Defense Production Act.[63]

Regulatory approval process

 
show  Full authorizationshow  Emergency authorization  Eligible COVAX recipient

Europe

Beginning on 1 December 2020, clinical trial of the vaccine candidate has been undergoing a “rolling review” process by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA), a step to expedite EMA consideration of an expected conditional Marketing Authorisation Application.[58][78] On 16 February 2021, Janssen applied to the EMA for conditional marketing authorization of the vaccine.[3][79] The Committee for Medicinal Products for Human Use (CHMP) approved the COVID-19 Vaccine Janssen on 11 March.[11][25] Shipments of the vaccine are scheduled to start in the second half of April, with a commitment to deliver at least 200 million doses to the EU in 2021.[80]

United States

On 4 February 2021, Janssen Biotech applied to the U.S. Food and Drug Administration (FDA) for an EUA, and the FDA announced that its Vaccines and Related Biological Products Advisory Committee (VRBPAC) would meet on 26 February to consider the application.[30][33][81][82] Johnson & Johnson announced that it planned to ship the vaccine immediately following authorization.[49] On 24 February, ahead of the VRBPAC meeting, briefing documents from Janssen and the FDA were issued; the FDA document recommends granting the EUA, concluding that the results of the clinical trials and safety data are consistent with FDA EUA guidance for COVID-19 vaccines.[83][84][26][85] At the 26 February meeting, VRBPAC voted unanimously (22–0) to recommend that a EUA for the vaccine be issued.[86] The FDA granted the EUA for the vaccine the following day.[9][10][87] On 28 February, the CDC Advisory Committee on Immunization Practices (ACIP) recommended the use of the vaccine for those aged 18 and older.[88][23]

Elsewhere

On 11 February 2021, Saint Vincent and the Grenadines issued an EUA for the Johnson & Johnson vaccine, as well as the Moderna vaccine, the Pfizer–BioNTech vaccine, the Sputnik V vaccine, and the Oxford–AstraZeneca vaccine.[89]

In December 2020, Johnson & Johnson entered into an agreement in principle with Gavi, the Vaccine Alliance to support the COVAX Facility. On 19 February 2021, Johnson & Johnson submitted its formal request and data package to the World Health Organization for an Emergency Use Listing (EUL); an EUL is a requirement for participation in COVAX. Johnson & Johnson anticipates providing up to 500 million doses through 2022 for COVAX.[90][31][91]

On 25 February 2021, Bahrain authorized the vaccine for emergency use.[92][93]

On 26 February 2021, the South Korean Ministry of Food and Drug Safety began a review of Johnson & Johnson’s application for approval of its vaccine.[94]

In late November 2020, Johnson & Johnson submitted a rolling review application to Health Canada for approval of its vaccine.[95] The Canadian government has placed an order with Johnson & Johnson for 10 million doses, with an option to purchase up to 28 million additional doses; on 5 March, the vaccine became the fourth to receive Health Canada approval.[96]

In February 2021, the vaccine received emergency authorization in South Africa.[97][98][99]

Deployment and impact

Given the Johnson & Johnson vaccine is a single dose and has a lower cost, it is expected that it will play an important role in low and middle-income countries.[100] With lower costs and lower requirements of storage and distribution in comparison to the COVID-19 vaccines by Pfizer and Moderna, the Johnson & Johnson vaccine will be more easily transported, stored, and administered.[101] South African health minister Zweli Mkhize announced on 9 February 2021 that the country would sell or swap its one million doses of AstraZeneca vaccine.[102] Once it did so, South Africa began vaccination using the Johnson & Johnson vaccine on 17 February 2021,[99] marking the vaccine’s first use outside of a clinical trial.[103]

Ethical concerns

The United States Conference of Catholic Bishops has expressed ethical concerns about the vaccine due to the use of tissue from aborted fetuses in the 1980s.[104]

See also

Notes

  1. ^ US authorization also includes the three sovereign nations in the Compact of Free AssociationPalau, the Marshall Islands, and Micronesia.[75][76]

References

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  100. ^ Grady D (29 January 2021). “Which Covid Vaccine Should You Get? Experts Cite the Effect Against Severe Disease”The New York Times. Retrieved 9 February 2021.
  101. ^ Brueck H. “Moderna vaccine creator calls Johnson & Johnson’s competing shot a ‘darn good’ tool to fight the pandemic”Business Insider. Retrieved 9 February 2021.
  102. ^ Winning A, Roelf W (9 February 2021). “South Africa may sell AstraZeneca shots as it switches to J&J vaccine to fight variant”Yahoo!. Reuters. Retrieved 11 February 2021.
  103. ^ “Johnson & Johnson applies to WHO for emergency use listing of COVID-19 vaccine”. Reuters. 19 February 2021. Retrieved 19 March 2021.
  104. ^ “Some US bishops discourage Catholics from getting Johnson & Johnson vaccine if others are available”. CNN. 3 March 2021. Retrieved 20 March 2021.

External links

Scholia has a profile for Ad26.COV2.S (Q98655215).
A vial of Janssen COVID-19 Vaccine
Vaccine description
TargetSARS-CoV-2
Vaccine typeViral vector
Clinical data
Trade namesJanssen COVID-19 Vaccine,[1][2] COVID-19 Vaccine Janssen[3]
Other namesAd26.COV2.S[4][5][6]JNJ-78436735[4][5][6]Ad26COVS1[4][5]VAC31518[4][5]
License dataUS DailyMedJanssen_COVID-19_Vaccine
Routes of
administration
Intramuscular
ATC codeNone
Legal status
Legal statusCA: Schedule D; Authorized by interim order [7][8]US: Unapproved (Emergency Use Authorization)[9][1][10]EU: Conditional marketing authorization granted [11]
Identifiers
DrugBankDB15857
UNIIJT2NS6183B
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 COVID-19 Portal
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////////////////Johnson & Johnson,  COVID-19 vaccine, JNJ 78436735, Ad26.COV2.S, JNJ-78436735, Ad26COVS1, VAC31518, vaccine, corona virus, covid 19

#Johnson & Johnson,  #COVID-19 vaccine, #JNJ 78436735, #Ad26.COV2.S, #JNJ-78436735, #Ad26COVS1, VAC31518, #vaccine, #corona virus, #covid 19

NOVAWAX, NVX-CoV2373,


Novavax COVID-19 vaccine reports 89.3% efficacy; protection against UK/South Africa strains

NOVAWAX

NVX-CoV2373

SARS-CoV-2 rS Nanoparticle Vaccine

MCDC OTA agreement number W15QKN-16-9-1002

Novavax COVID-19 vaccine, Coronavirus disease 19 infection

SARS-CoV-2 rS,  TAK 019

Novavax, Inc. is an American vaccine development company headquartered in Gaithersburg, Maryland, with additional facilities in Rockville, Maryland and Uppsala, Sweden. As of 2020, it had an ongoing Phase III clinical trial in older adults for its candidate vaccine for seasonal influenzaNanoFlu and a candidate vaccine (NVX-CoV2373) for prevention of COVID-19.

NVX-CoV2373 is a SARS-CoV-2 rS vaccine candidate and was shown to have high immunogenicity in studies. The vaccine is created from the genetic sequence of COVID-19 and the antigen derived from the virus spike protein is generated using recombinant nanoparticle technology. The vaccine was developed and tested by Novavax. As of May 2020, the company is pursuing a Phase 1 clinical trial (NCT04368988) to test the vaccine.

History

Novavax was founded in 1987. It focused principally on experimental vaccine development, but did not achieve a successful launch up to 2021.[4]

In June 2013, Novavax acquired the Matrix-M adjuvant platform with the purchase of Swedish company Isconova AB and renamed its new subsidiary Novavax AB.[5]

In 2015, the company received an $89 million grant from the Bill & Melinda Gates Foundation to support the development of a vaccine against human respiratory syncytial virus for infants via maternal immunization.[6][7][8][9]

In March 2015 the company completed a Phase I trial for its Ebola vaccine candidate,[10] as well as a phase II study in adults for its RSV vaccine, which would become ResVax.[11] The ResVax trial was encouraging as it showed significant efficacy against RSV infection.[11]

2016 saw the company’s first phase III trial, the 12,000 adult Resolve trial,[11] for its respiratory syncytial virus vaccine, which would come to be known as ResVax, fail in September.[3] This triggered an eighty-five percent dive in the company’s stock price.[3] Phase II adult trial results also released in 2016 showed a stimulation of antigencity, but failure in efficacy.[11] Evaluation of these results suggested that an alternative dosing strategy might lead to success, leading to plans to run new phase II trials.[3] The company’s difficulties in 2016 led to a three part strategy for 2017: cost reduction through restructuring and the termination of 30% of their workforce; pouring more effort into getting ResVax to market; and beginning clinical trials on a Zika virus vaccine.[3]

Alongside the adult studies of ResVax, the vaccine was also in 2016 being tested against infant RSV infection through the route of maternal immunization.[11]

In 2019, late-stage clinical testing of ResVax, failed for a second time, which resulted in a major downturn in investor confidence and a seventy percent reduction in capital value for the firm.[12][13] As a secondary result, the company was forced to conduct a reverse stock split in order to maintain Nasdaq minimum qualification, meaning it was in risk of being delisted.[13]

The company positions NanoFlu for the unmet need for a more effective vaccine against influenza, particularly in the elderly who often experience serious and sometimes life-threatening complications. In January 2020, it was granted fast track status by the U.S. Food and Drug Administration (FDA) for NanoFlu.

External sponsorships

In 2018, Novavax received a US$89 million research grant from the Bill and Melinda Gates Foundation for development of vaccines for maternal immunization.[14]

In May 2020, Novavax received US$384 million from the Coalition for Epidemic Preparedness Innovations to fund early-stage evaluation in healthy adults of the company’s COVID-19 vaccine candidate NVX-CoV2373 and to develop resources in preparation for large-scale manufacturing, if the vaccine proves successful.[15] CEPI had already invested $4 million in March.[15]

Drugs in development

ResVax is a nanoparticle-based treatment using a recombinant F lipoprotein or saponin, “extracted from the Quillaja saponaria [or?] Molina bark together with cholesterol and phospholipid.”[16] It is aimed at stimulating resistance to respiratory syncytial virus infection, targeting both adult and infant populations.[11]

In January 2020, Novavax was given Fast Track status by the FDA to expedite the review process for NanoFlu, a candidate influenze vaccine undergoing a Phase III clinical trial scheduled for completion by mid-2020.[17]

COVID-19 vaccine candidate

See also: NVX-CoV2373 and COVID-19 vaccine

In January 2020, Novavax announced development of a vaccine candidate, named NVX-CoV2373, to establish immunity to SARS-CoV-2.[18] NVX-CoV2373 is a protein subunit vaccine that contains the spike protein of the SARS-CoV-2 virus.[19] Novavax’s work is in competition for vaccine development among dozens of other companies.

In January 2021, the company released phase 3 trials showing that it has 89% efficacy against Covid-19, and also provides strong immunity against new variants.[20] It has applied for emergency use in the US and UK but will be distributed in the UK first.Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 TrialJan 28, 2021 at 4:05 PM ESTDownload PDF

First to Demonstrate Clinical Efficacy Against COVID-19 and Both UK and South Africa Variants

  • Strong efficacy in Phase 3 UK trial with over 50% of cases attributable to the now-predominant UK variant and the remainder attributable to COVID-19 virus
  • Clinical efficacy demonstrated in Phase 2b South Africa trial with over 90% of sequenced cases attributable to prevalent South Africa escape variant
  • Company to host investor conference call today at 4:30pm ET

GAITHERSBURG, Md., Jan. 28, 2021 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3%, in its Phase 3 clinical trial conducted in the United Kingdom (UK). The study assessed efficacy during a period with high transmission and with a new UK variant strain of the virus emerging and circulating widely. It was conducted in partnership with the UK Government’s Vaccines Taskforce. Novavax also announced successful results of its Phase 2b study conducted in South Africa.

“With today’s results from our UK Phase 3 and South Africa Phase 2b clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2 and 3 trials involving over 20,000 participants. In addition, our PREVENT-19 US and Mexico clinical trial has randomized over 16,000 participants toward our enrollment goal of 30,000. NVX-CoV2373 is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging UK and South Africa variants,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “NVX-CoV2373 has the potential to play an important role in solving this global public health crisis. We look forward to continuing to work with our partners, collaborators, investigators and regulators around the world to make the vaccine available as quickly as possible.”

NVX-CoV2373 contains a full-length, prefusion spike protein made using Novavax’ recombinant nanoparticle technology and the company’s proprietary saponin-based Matrix-M™ adjuvant. The purified protein is encoded by the genetic sequence of the SARS-CoV-2 spike (S) protein and is produced in insect cells. It can neither cause COVID-19 nor can it replicate, is stable at 2°C to 8°C (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.

UK Phase 3 Results: 89.3% Efficacy

The study enrolled more than 15,000 participants between 18-84 years of age, including 27% over the age of 65. The primary endpoint of the UK Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.

The first interim analysis is based on 62 cases, of which 56 cases of COVID-19 were observed in the placebo group versus 6 cases observed in the NVX-CoV2373 group, resulting in a point estimate of vaccine efficacy of 89.3% (95% CI: 75.2 – 95.4). Of the 62 cases, 61 were mild or moderate, and 1 was severe (in placebo group).

Preliminary analysis indicates that the UK variant strain that was increasingly prevalent was detected in over 50% of the PCR-confirmed symptomatic cases (32 UK variant, 24 non-variant, 6 unknown). Based on PCR performed on strains from 56 of the 62 cases, efficacy by strain was calculated to be 95.6% against the original COVID-19 strain and 85.6% against the UK variant strain [post hoc].

The interim analysis included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups.

“These are spectacular results, and we are very pleased to have helped Novavax with the development of this vaccine. The efficacy shown against the emerging variants is also extremely encouraging. This is an incredible achievement that will ensure we can protect individuals in the UK and the rest of the world from this virus,” said Clive Dix, Chair, UK Vaccine Taskforce.

Novavax expects to share further details of the UK trial results as additional data become available. Additional analysis on both trials is ongoing and will be shared via prepublication servers as well as submitted to a peer-reviewed journal for publication. The company initiated a rolling submission to the United Kingdom’s regulatory agency, the MHRA, in mid-January.

South Africa Results:   Approximately 90% of COVID-19 cases attributed to South Africa escape variant

In the South Africa Phase 2b clinical trial, 60% efficacy (95% CI: 19.9 – 80.1) for the prevention of mild, moderate and severe COVID-19 disease was observed in the 94% of the study population that was HIV-negative. Twenty-nine cases were observed in the placebo group and 15 in the vaccine group. One severe case occurred in the placebo group and all other cases were mild or moderate. The clinical trial also achieved its primary efficacy endpoint in the overall trial population, including HIV-positive and HIV-negative subjects (efficacy of 49.4%; 95% CI: 6.1 – 72.8).

This study enrolled over 4,400 patients beginning in August 2020, with COVID-19 cases counted from September through mid-January. During this time, the triple mutant variant, which contains three critical mutations in the receptor binding domain (RBD) and multiple mutations outside the RBD, was widely circulating in South Africa. Preliminary sequencing data is available for 27 of 44 COVID-19 events; of these, 92.6% (25 out of 27 cases) were the South Africa escape variant.

Importantly in this trial, approximately 1/3 of the patients enrolled (but not included in the primary analyses described above) were seropositive, demonstrating prior COVID-19 infection at baseline. Based on temporal epidemiology data in the region, the pre-trial infections are thought to have been caused by the original COVID-19 strain (i.e., non-variant), while the subsequent infections during the study were largely variant virus. These data suggest that prior infection with COVID-19 may not completely protect against subsequent infection by the South Africa escape variant, however, vaccination with NVX-CoV2373 provided significant protection.

“The 60% reduced risk against COVID-19 illness in vaccinated individuals in South Africans underscores the value of this vaccine to prevent illness from the highly worrisome variant currently circulating in South Africa, and which is spreading globally. This is the first COVID-19 vaccine for which we now have objective evidence that it protects against the variant dominating in South Africa,” says Professor Shabir Maddi, Executive Director of the Vaccines and Infectious Diseases Analytics Research Unit (VIDA) at Wits, and principal investigator in the Novavax COVID-19 vaccine trial in South Africa. “I am encouraged to see that Novavax plans to immediately begin clinical development on a vaccine specifically targeted to the variant, which together with the current vaccine is likely to form the cornerstone of the fight against COVID-19.”

Novavax initiated development of new constructs against the emerging strains in early January and expects to select ideal candidates for a booster and/or combination bivalent vaccine for the new strains in the coming days. The company plans to initiate clinical testing of these new vaccines in the second quarter of this year.

“A primary benefit of our adjuvanted platform is that it uses a very small amount of antigen, enabling the rapid creation and large-scale production of combination vaccine candidates that could potentially address multiple circulating strains of COVID-19,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “Combined with the safety profile that has been observed in our studies to-date with our COVID-19 vaccine, as well as prior studies in influenza, we are optimistic about our ability to rapidly adapt to evolving conditions.”

The Coalition for Epidemic Preparedness Innovations (CEPI) funded the manufacturing of doses of NVX-CoV2373 for this Phase 2b clinical trial, which was supported in part by a $15 million grant from the Bill & Melinda Gates Foundation.

Significant progress on PREVENT-19 Clinical Trial in US and Mexico

To date, PREVENT-19 has randomized over 16,000 participants and expects to complete our targeted enrollment of 30,000 patients in the first half of February.  PREVENT-19 is being conducted with support from the U.S. government partnership formerly known as Operation Warp Speed, which includes the Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at HHS. BARDA is also providing up to $1.75 billion under a Department of Defense agreement.

PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial | COVID-19) is a Phase 3, randomized, placebo-controlled, observer-blinded study in the US and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in up to 30,000 subjects 18 years of age and older compared with placebo. The trial design has been harmonized to align with other Phase 3 trials conducted under the auspices of Operation Warp Speed, including the use of a single external independent Data and Safety Monitoring Board to evaluate safety and conduct an unblinded review when predetermined interim analysis events are reached.

The trial’s primary endpoint is the prevention of PCR-confirmed, symptomatic COVID-19. The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints will be assessed at least seven days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2.

Conference Call

Novavax will host a conference call today at 4:30pm ET. The dial-in numbers for the conference call are (877) 212-6076 (Domestic) or (707) 287-9331 (International), passcode 7470222. A replay of the conference call will be available starting at 7:30 p.m. ET on January 28, 2021 until 7:30 p.m. ET on February 4, 2021. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 7470222.

A webcast of the conference call can also be accessed on the Novavax website at novavax.com/events. A replay of the webcast will be available on the Novavax website until April 28, 2021.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax’ patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. Over 37,000 participants have participated to date across four different clinical studies in five countries. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that completed enrollment in November and the PREVENT-19 trial in the U.S. and Mexico that began in December.

About Matrix-M™

Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

Candidate: NVX-CoV2373

Category: VAX

Type: Stable, prefusion protein made using Novavax’ proprietary nanoparticle technology, and incorporating its proprietary saponin-based Matrix-M™ adjuvant.

2021 Status: Novavax on March 11 announced final efficacy of 96.4% against mild, moderate and severe disease caused by the original COVID-19 strain in a pivotal Phase III trial in the U.K. of NVX–CoV2373. The study enrolled more than 15,000 participants between 18-84 years of age, including 27% over the age of 65.

The company also announced the complete analysis of its Phase IIb trial in South Africa, showing the vaccine had an efficacy of 55.4% among a cohort of HIV-negative trial participants, and an overall efficacy of 48.6% against predominantly variant strains of SARS-CoV-2 among 147 PCR-positive cases (51 cases in the vaccine group and 96 in the placebo group). Across both trials, NVX-CoV2373 demonstrated 100% protection against severe disease, including all hospitalization and death.

Philippines officials said March 10 that they secured 30 million doses of NVX-CoV2373 through an agreement with the Serum Institute of India, the second vaccine deal signed by the national government, according to Agence France-Presse. The first was with AstraZeneca for 2.6 million doses of its vaccine, developed with Oxford University.

The Novavax vaccine will be available from the third quarter, at a price that has yet to be finalized. The government hopes to secure 148 million doses this year from seven companies—enough for around 70% of its population.

In announcing fourth quarter and full-year 2020 results on March 1, Novavax said it could file for an emergency use authorization with the FDA in the second quarter of 2021. Novavax hopes it can use data from its Phase III U.K. clinical trial in its FDA submission, and expects the FDA to examine data in May, a month after they are reviewed by regulators in the U.K., President and CEO Stanley C. Erck said on CNBC. Should the FDA insist on waiting for U.S. data, the agency may push the review timeline by one or two months, he added.

The company also said that NVX-CoV2373 showed 95.6% efficacy against the original strain of COVID-19 and 85.6% against the UK variant strain, and re-stated an earlier finding that its vaccine met the Phase III trial’s primary endpoint met with an efficacy rate of 89.3%.

Novavax said February 26 that it signed an exclusive license agreement with Takeda Pharmaceutical for Takeda to develop, manufacture, and commercialize NVX-CoV2373 in Japan.

Novavax agreed to transfer the technology for manufacturing of the vaccine antigen and will supply its Matrix-M™ adjuvant to Takeda. Takeda anticipated the capacity to manufacture over 250 million doses of the COVID-19 vaccine per year. Takeda agreed in return to pay Novavax undisclosed payments tied to achieving development and commercial milestones, plus a portion of proceeds from the vaccine.

Takeda also disclosed that it dosed the first participants in a Phase II clinical trial to test the immunogenicity and safety of Novavax’ vaccine candidate in Japanese participants.

Novavax on February 18 announced a memorandum of understanding with Gavi, the Vaccine Alliance (Gavi), to provide 1.1 billion cumulative doses of NVX-CoV2373 for the COVAX Facility. Gavi leads the design and implementation of the COVAX Facility, created to supply vaccines globally, and has committed to working with Novavax to finalize an advance purchase agreement for vaccine supply and global distribution allocation via the COVAX Facility and its partners.

The doses will be manufactured and distributed globally by Novavax and Serum Institute of India (SII), the latter under an existing agreement between Gavi and SII.

Novavax and SK Bioscience said February 15 that they expanded their collaboration and license agreement, with SK finalizing an agreement to supply 40 million doses of NVX-CoV2373 to the government of South Korea beginning in 2021, for an undisclosed price. SK also obtained a license to manufacture and commercialize NVX-CoV2373 for sale to South Korea, as a result of which SK said it will add significant production capacity.

The agreement also calls on Novavax to facilitate technology transfer related to the manufacturing of its protein antigen, its Matrix M adjuvant, and support to SK Bioscience as needed to secure regulatory approval.

Rolling review begins—On February 4, Novavax announced it had begun a rolling review process for authorization of NVX-CoV2373 with several regulatory agencies worldwide, including the FDA, the European Medicines Agency, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada. The reviews will continue while the company completes its pivotal Phase III trials in the U.S. and U.K., and through initial authorization for emergency use granted under country-specific regulations, and through initial authorization for emergency use.

A day earlier, Novavax executed a binding Heads of Terms agreement with the government of Switzerland to supply 6 million doses of NVX-CoV2373, to the country. Novavax and Switzerland plan to negotiate a final agreement, with initial delivery of vaccine doses slated to ship following successful clinical development and regulatory review.

On January 28, Novavax electrified investors by announcing that its COVID-19 vaccine NVX-CoV2373 showed efficacy of 89.3% in the company’s first analysis of data from a Phase III trial in the U.K., where a variant strain (B.1.1.7) accounted for about half of all positive cases.

However, NVX-CoV2373 achieved only 60% efficacy in a Phase IIb trial in South Africa, where that country’s escape variant of the virus (B.1.351, also known as 20H/501Y.V2) was seen in 90% of cases, Novavax said.

Novavax said January 7 it executed an Advance Purchase Agreement with the Commonwealth of Australia for 51 million doses of NVX-CoV2373 for an undisclosed price, with an option to purchase an additional 10 million doses—finalizing an agreement in principle announced in November 2020. Novavax said it will work with Australia’s Therapeutics Goods Administration (TGA), to obtain approvals upon showing efficacy in clinical studies. The company aims to deliver initial doses by mid-2021.

2020 Status: Phase III trial launched—Novavax said December 28 that it launched the pivotal Phase III PREVENT-19 trial (NCT04611802) in the U.S. and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373. The randomized, placebo-controlled, observer-blinded study will assess the efficacy, safety and immunogenicity of NVX-CoV2373 in up to 30,000 participants 18 years of age and older compared with placebo. The trial’s primary endpoint is the prevention of PCR-confirmed, symptomatic COVID-19. The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints will be assessed at least seven days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2.

Two thirds of the participants will be assigned to randomly receive two intramuscular injections of the vaccine, administered 21 days apart, while one third of the trial participants will receive placebo. Trial sites were selected in locations where transmission rates are currently high, to accelerate the accumulation of positive cases that could show efficacy. Participants will be followed for 24 months following the second injection

PREVENT-19 is being conducted with support from federal agencies involved in Operation Warp Speed, the Trump administration’s effort to promote development and distribution of COVID-19 vaccines and drugs. Those agencies include the Department of Defense (DoD), the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA)—which has committed up to $1.6 billion to Novavax under a DoD agreement (identifier MCDC OTA agreement number W15QKN-16-9-1002).

Novavax is also conducting a pivotal Phase III study in the United Kingdom, a Phase IIb safety and efficacy study in South Africa, and an ongoing Phase I/II trial in the U.S. and Australia. Data from these trials are expected as soon as early first quarter 2021, though timing will depend on transmission rates in the regions, the company said.

Novavax said November 9 that the FDA granted its Fast Track designation for NVX-CoV2373. By the end of November, the company expected to finish enrollment in its Phase III U.K. trial, with interim data in that study expected as soon as early first quarter 2021.

Five days earlier, Novavax signed a non-binding Heads of Terms document with the Australian government to supply 40 million doses of NVX-CoV2373 to Australia starting as early as the first half of 2021, subject to the successful completion of Phase III clinical development and approval of the vaccine by Australia’s Therapeutic Goods Administration (TGA). The vaccine regimen is expected to require two doses per individual, administered 21 days apart.

Australia joins the U.S., the U.K., and Canada in signing direct supply agreements with Novavax. The company is supplying doses in Japan, South Korea, and India through partnerships. Australian clinical researchers led the global Phase I clinical trial in August, which involved 131 Australians across two trial sites (Melbourne and Brisbane). Also, approximately 690 Australians have participated in the Phase II arm of the clinical trial, which has been conducted across up to 40 sites in Australia and the U.S.

Novavax joined officials in its headquarters city of Gaithersburg, MD, on November 2 to announce expansion plans. The company plans to take 122,000 square feet of space at 700 Quince Orchard Road, and has committed to adding at least 400 local jobs, nearly doubling its current workforce of 450 worldwide. Most of the new jobs are expected to be added b March 2021.

Maryland’s Department of Commerce—which has prioritized assistance to life sciences companies—approved a $2 million conditional loan tied to job creation and capital investment. The state has also approved a $200,000 Partnership for Workforce Quality training grant, and the company is eligible for several tax credits, including the Job Creation Tax Credit and More Jobs for Marylanders.

Additionally, Montgomery County has approved a $500,000 grant tied to job creation and capital investment, while the City of Gaithersburg said it will approve a grant of up to $50,000 from its Economic Development Opportunity Fund. The city accelerated its planning approval process to accommodate Novavax’ timeline, given the company’s role in fighting COVID-19 and resulting assistance from Operation Warp Speed, the Trump administration’s effort to accelerate development of COVID-19 vaccines.

On October 27, Novavax said that it had enrolled 5,500 volunteers in the Phase III U.K. trial, which has been expanded from 10,000 to 15,000 volunteers. The increased enrollment “is likely to facilitate assessment of safety and efficacy in a shorter time period,” according to the company.

The trial, which is being conducted with the U.K. Government’s Vaccines Taskforce, was launched in September and is expected to be fully enrolled by the end of November, with interim data expected by early first quarter 2021, depending on the overall COVID-19 attack rate. Novavax has posted the protocol for the Phase III U.K. trial online. The protocol calls for unblinding of data once 152 participants have achieved mild, moderate or severe endpoints. Two interim analyses are planned upon occurrence of 66 and 110 endpoints.

Novavax also said it expects to launch a second Phase III trial designed to enroll up to 30,000 participants in the U.S. and Mexico by the end of November—a study funded through the U.S. government’s Operation Warp Speed program. The patient population will reflect proportional representation of diverse populations most vulnerable to COVID-19, across race/ethnicity, age, and co-morbidities.

The company cited progress toward large-scale manufacturing while acknowledging delays from original timeframe estimates. Novavax said it will use its contract manufacturing site at FUJIFILM Diosynth Biotechnologies’ Morrisville, NC facility to produce material for the U.S. trial.

On September 25, Novavax entered into a non-exclusive agreement with Endo International subsidiary Par Sterile Products to provide fill-finish manufacturing services at its plant in Rochester, MI, for NVX-CoV2373. Under the agreement, whose value was not disclosed, the Rochester facility has begun production of NVX-CoV2373 final drug product, with initial batches to be used in Novavax’ Phase III clinical trial in the U.S. Par Sterile will also fill-finish NVX-CoV2373 vaccine intended for commercial distribution in the U.S.

A day earlier, Novavax launched the U.K. trial. The randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in up to 10,000 subjects 18-84 years of age, with and without “relevant” comorbidities, over the following four to six weeks, Novavax said. Half the participants will receive two intramuscular injections of vaccine comprising 5 µg of protein antigen with 50 µg Matrix‑M adjuvant, 21 days apart, while half of the trial participants will receive placebo. At least 25% of the study population will be over age 65.

The trial’s first primary endpoint is first occurrence of PCR-confirmed symptomatic COVID-19 with onset at least seven days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2. The second primary endpoint is first occurrence of PCR-confirmed symptomatic moderate or severe COVID-19 with onset at least seven days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2

“The data from this trial is expected to support regulatory submissions for licensure in the UK, EU and other countries,” stated Gregory M. Glenn, M.D., President, Research and Development at Novavax.

Maryland Gov. Larry Hogan joined state Secretary of Commerce Kelly M. Schulz and local officials in marking the launch of Phase III studies with a tour of the company’s facilities in Gaithersburg: “The coronavirus vaccine candidate that’s been developed by Novavax is one of the most promising in the country, if not the world.”

On August 31, Novavax reached an agreement in principle with the government of Canada to supply up to 76 million doses of NVX-CoV2373. The value was not disclosed. Novavax and Canada did say that they expect to finalize an advance purchase agreement under which Novavax will agree to supply doses of NVX-CoV2373 to Canada beginning as early as the second quarter of 2021.

The purchase arrangement will be subject to licensure of the NVX-CoV2373 by Health Canada, Novavax said. The vaccine is in multiple Phase II clinical trials: On August 24, Novavax said the first volunteers had been enrolled in the Phase II portion of its ongoing Phase I/II clinical trial (NCT04368988), designed to evaluate the immunogenicity and safety of two doses of of NVX-CoV2373 (5 and 25 µg) with and without 50 µg of Matrix‑M™ adjuvant in up to 1,500 volunteers ages 18-84.

The randomized, placebo-controlled, observer-blinded study is designed to assess two dose sizes (5 and 25 µg) of NVX-CoV2373, each with 50 µg of Matrix‑M. Unlike the Phase I portion, the Phase II portion will include older adults 60-84 years of age as approximately half of the trial’s population. Secondary objectives include preliminary evaluation of efficacy. The trial will be conducted at up to 40 sites in the U.S. and Australia, Novovax said.

NVX-CoV2373 is in a pair of Phase II trials launched in August—including a Phase IIb study in South Africa to assess efficacy, and a Phase II safety and immunogenicity study in the U.S. and Australia.

On August 14, the U.K. government agreed to purchase 60 million doses of NVX-CoV2373 from the company, and support its planned Phase III clinical trial in the U.K., through an agreement whose value was not disclosed. The doses are set to be manufactured as early as the first quarter of 2021.

The trial will be designed to evaluate the ability of NVX-CoV2373 to protect against symptomatic COVID-19 disease as well as evaluate antibody and T-cell responses. The randomized, double-blind, placebo-controlled efficacy study will enroll approximately 9,000 adults 18-85 years of age in the U.K., and is expected to start in the third quarter.

Novavax also said it will expand its collaboration with FUJIFILM Diosynth Biotechnologies (FDB), which will manufacture the antigen component of NVX-CoV2373 from its Billingham, Stockton-on-Tees site in the U.K., as well as at U.S. sites in Morrisville, NC, and College Station, TX. FDB’s U.K. sitevis expected to produce up to 180 million doses annually.

On August 13, Novavax said it signed a development and supply agreement for the antigen component of NVX-CoV2373 with Seoul-based SK bioscience, a vaccine business subsidiary of SK Group. The agreement calls for supply to global markets that include the COVAX Facility, co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization.

Novavax and SK signed a letter of intent with South Korea’s Ministry of Health and Welfare to work toward broad and equitable access to NVX-CoV2373 worldwide, as well as to make the vaccine available in South Korea. SK bioscience agreed to manufacture the vaccine antigen component for use in the final drug product globally during the pandemic, at its vaccine facility in Andong L-house, South Korea, beginning in August. The value of the agreement was not disclosed.

On August 7, Novavax licensed its COVID-19 vaccine technology to Takeda Pharmaceutical through a partnership by which Takeda will develop, manufacture, and commercialize NVX‑CoV2373 in Japan, using Matrix-M adjuvant to be supplied by Novavax. Takeda will also be responsible for regulatory submission to Japan’s Ministry of Health, Labour and Welfare (MHLW).

MHLW agreed to provide funding to Takeda—the amount was not disclosed in the companies’ announcement—for technology transfer, establishment of infrastructure, and scale-up of manufacturing. Takeda said it anticipated the capacity to manufacture over 250 million doses of NVX‑CoV2373 per year.

Five days earlier, Serum Institute of India agreed to license rights from Novavax to NVX‑CoV2373 for development and commercialization in India as well as low- and middle-income countries (LMIC), through an agreement whose value was not disclosed. Novavax retains rights to NVX-CoV2373 elsewhere in the world.

Novavax and Serum Institute of India agreed to partner on clinical development, co-formulation, filling and finishing and commercialization of NVX-CoV2373. Serum Institute will oversee regulatory submissions and marketing authorizations in regions covered by the collaboration. Novavax agreed to provide both vaccine antigen and Matrix‑M adjuvant, while the partners said they were in talks to have the Serum Institute manufacture vaccine antigen in India. Novavax and Seerum Institute plan to split the revenue from the sale of product, net of agreed costs.

A day earlier, Novavax announced positive results from the Phase I portion of its Phase I/II clinical trial (NCT04368988), designed to evaluate two doses of NVX-CoV2373 (5 and 25 µg) with and without Matrix‑M™ adjuvant in 131 healthy adults ages 18-59. NVX-CoV2373, adjuvanted with Matrix-M, elicited robust antibody responses numerically superior to human convalescent sera, according to data submitted for peer-review to a scientific journal.

All participants developed anti-spike IgG antibodies after a single dose of vaccine, Novavax said, many also developing wild-type virus neutralizing antibody responses. After the second dose, all participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease, the company said—adding that IgG antibody response was highly correlated with neutralization titers, showing that a significant proportion of antibodies were functional.

For both dosages of NVX‑CoV2373 with adjuvant, the 5 µg dose performed “comparably” with the 25 µg dose, Novavax said. NVX‑CoV2373 also induced antigen-specific polyfunctional CD4+ T cell responses with a strong bias toward the Th1 phenotype (IFN-g, IL-2, and TNF-a).

Based on an interim analysis of Phase I safety and immunogenicity data, the trial was expanded to Phase II clinical trials in multiple countries, including the U.S. The trial—which began in Australia in May—is being funded by up-to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI). If the Phase I/II trial is successful, CEPI said, it anticipates supporting further clinical development that would advance NVX-CoV2373 through to licensure.

On July 23, Novavax joined FDB to announce that FDB will manufacture bulk drug substance for NVX-CoV2373, under an agreement whose value was not disclosed. FDB’s site in Morrisville, NC has begun production of the first batch of NVX-CoV2373. Batches produced at FDB’s Morrisville site will be used in Novavax’s planned pivotal Phase III clinical trial, designed to assess NVX-CoV2373 in up to 30,000 participants, and set to start this fall.

The Phase III trial is among R&D efforts to be funded through the $1.6 billion awarded in July to Novavax through President Donald Trump’s “Operation Warp Speed” program toward late-stage clinical trials and large-scale manufacturing to produce 100 million doses of its COVID-19 vaccine by year’s end. Novavax said the funding will enable it to complete late-stage clinical studies aimed at evaluating the safety and efficacy of NVX-CoV2373.

In June, Novavax said biotech investor and executive David Mott was joining its board as an independent director, after recently acquiring nearly 65,000 shares of the company’s common stock. Also, Novavax was awarded a $60 million contract by the U.S. Department of Defense (DoD) for the manufacturing of NVX‑CoV2373. Through the Defense Health Program, the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense Enabling Biotechnologies (JPEO-CBRND-EB) agreed to support production of several vaccine components to be manufactured in the U.S.  Novavax plans to deliver this year for DoD 10 million doses of NVX‑CoV2373 that could be used in Phase II/III trials, or under an Emergency Use Authorization (EUA) if approved by the FDA.

Also in June, AGC Biologics said it will partner with Novavax on large-scale GMP production of Matrix-M– significantly increasing Novavax’ capacity to deliver doses in 2020 and 2021—through an agreement whose value was not disclosed. And Novavax joined The PolyPeptide Group to announce large-scale GMP production by the global CDMO of two unspecified key intermediate components used in the production of Matrix-M.

In May, Novavax acquired Praha Vaccines from the India-based Cyrus Poonawalla Group for $167 million cash, in a deal designed to ramp up Novavax’s manufacturing capacity for NVX-CoV2373. Praha Vaccines’ assets include a 150,000-square foot vaccine and biologics manufacturing facility and other support buildings in Bohumil, Czech Republic. Novavax said the Bohumil facility is expected to deliver an annual capacity of over 1 billion doses of antigen starting in 2021 for the COVID-19 vaccine.

The Bohumil facility is completing renovations that include the addition of Biosafety Level-3 (BSL-3) capabilities. The site’s approximately 150 employees with “significant experience” in vaccine manufacturing and support have joined Novavax, the company said.

On May 11, Novavax joined CEPI in announcing up to $384 million in additional funding for the company toward clinical development and large-scale manufacturing of NVX-CoV2373. CEPI agreed to fund preclinical as well as Phase I and Phase II studies of NVX-CoV2373. The funding multiplied CEPI’s initial $4 million investment in the vaccine candidate, made two months earlier. Novavax’s total $388 million in CEPI funding accounted for 87% of the total $446 million awarded by the Coalition toward COVID-19 vaccine R&D as of that date.

Novavax identified its COVID-19 vaccine candidate in April. The company said NVX-CoV2373 was shown to be highly immunogenic in animal models measuring spike protein-specific antibodies, antibodies that block the binding of the spike protein to the receptor, and wild-type virus neutralizing antibodies. High levels of spike protein-specific antibodies with ACE-2 human receptor binding domain blocking activity and SARS-CoV-2 wild-type virus neutralizing antibodies were also seen after a single immunization.

In March, Emergent Biosolutions disclosed it retained an option to allocate manufacturing capacity for an expanded COVID-19 program under an agreement with Novavax to provide “molecule-to-market” contract development and manufacturing (CDMO) services to produce Novavax’s NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate.

Earlier in March, Emergent announced similar services to support clinical development of Novavax’s COVID-19 vaccine candidate, saying March 10 it agreed to produce the vaccine candidate and had initiated work, anticipating the vaccine candidate will be used in a Phase I study within the next four months. In February, Novavax said it had produced and was assessing multiple nanoparticle vaccine candidates in animal models prior to identifying an optimal candidate for human testing.

References

  1. ^ “Company Overview of Novavax, Inc”Bloomberg.comArchived from the original on 24 February 2017. Retrieved 2 June2019.
  2. ^ https://www.globenewswire.com/news-release/2021/03/01/2184674/0/en/Novavax-Reports-Fourth-Quarter-and-Full-Year-2020-Financial-Results-and-Operational-Highlights.html
  3. Jump up to:a b c d e Bell, Jacob (November 14, 2016). “Novavax aims to rebound with restructuring, more trials”BioPharma Dive. Washington, D.C.: Industry Dive. Archived from the original on 2017-03-29. Retrieved 2017-03-28.
  4. ^ Thomas, Katie; Twohey, Megan (2020-07-16). “How a Struggling Company Won $1.6 Billion to Make a Coronavirus Vaccine”The New York TimesISSN 0362-4331. Retrieved 2021-01-29.
  5. ^ Taylor, Nick Paul (3 June 2013). “Novavax makes $30M bid for adjuvant business”FiercePharmaArchived from the original on 14 September 2016. Retrieved 9 September 2016.
  6. ^ “Gaithersburg Biotech Receives Grant Worth up to $89 million”Bizjournals.comArchived from the original on 2017-04-01. Retrieved 2017-03-28.
  7. ^ “With promising RSV data in hand, Novavax wins $89M Gates grant for PhIII | FierceBiotech”Fiercebiotech.comArchivedfrom the original on 2017-04-14. Retrieved 2017-03-28.
  8. ^ “Novavax RSV vaccine found safe for pregnant women, fetus”Reuters. 2016-09-29. Archived from the original on 2016-10-07. Retrieved 2017-03-28.
  9. ^ Herper, Matthew. “Gates Foundation Backs New Shot To Prevent Babies From Dying Of Pneumonia”ForbesArchived from the original on 2016-09-21. Retrieved 2017-03-28.
  10. ^ “Novavax’s Ebola vaccine shows promise in early-stage trial”Reuters. 2017-07-21. Archived from the original on 2016-10-02. Retrieved 2017-03-28.
  11. Jump up to:a b c d e f Adams, Ben (September 16, 2016). “Novavax craters after Phase III RSV F vaccine failure; seeks path forward”FierceBiotech. Questex. Archived from the original on 18 August 2020. Retrieved 25 Jan 2020.
  12. ^ Shtrubel, Marty (December 12, 2019). “3 Biotech Stocks That Offer the Highest Upside on Wall Street”Biotech. Nasdaq. Archived from the original on 2020-01-26. Retrieved 25 Jan 2020.
  13. Jump up to:a b Budwell, George (January 20, 2020). “3 Top Biotech Picks for 2020”Markets. Nasdaq. Novavax: A catalyst awaits. Archivedfrom the original on 2020-01-25. Retrieved 25 Jan 2020.
  14. ^ Mark Terry (February 16, 2018). “Why Novavax Could be a Millionaire-Maker Stock”. BioSpace. Archived from the original on 22 November 2020. Retrieved 6 March 2020.
  15. Jump up to:a b Eric Sagonowsky (2020-05-11). “Novavax scores $384M deal, CEPI’s largest ever, to fund coronavirus vaccine work”FiercePharmaArchived from the original on 2020-05-16. Retrieved 2020-05-12.
  16. ^ “Novavax addresses urgent global public health needs with innovative technology”novavax.comArchived from the original on 10 September 2020. Retrieved 30 August 2020.
  17. ^ Sara Gilgore (January 15, 2020). “Novavax earns key FDA status for its flu vaccine. Wall Street took it well”. Washington Business Journal. Archived from the original on 10 November 2020. Retrieved 6 March 2020.
  18. ^ Sara Gilgore (February 26, 2020). “Novavax is working to advance a potential coronavirus vaccine. So are competitors”Washington Business JournalArchived from the original on March 16, 2020. Retrieved March 6, 2020.
  19. ^ Nidhi Parekh (July 24, 2020). “Novavax: A SARS-CoV-2 Protein Factory to Beat COVID-19”Archived from the original on November 22, 2020. Retrieved July 24, 2020.
  20. ^ “Covid-19: Novavax vaccine shows 89% efficacy in UK trials”BBC news. Retrieved 1 February 2021.

Further reading

External links

General References

  1. Novavax Pipeline Page [Link]
  2. Novavex News Release [Link]
TypePublic
Traded asNasdaqNVAX
Russell 2000 Component
IndustryBiotechnology
Founded1987; 34 years ago [1]
HeadquartersGaithersburg, Maryland,United States
Area servedWorldwide
Key peopleStanley Erck (CEO)
ProductsVaccines
RevenueIncrease $475.2 Million (2020)[2]
Number of employees500+[3]
Websitewww.novavax.com 

The Novavax COVID-19 vaccine, codenamed NVX-CoV2373, and also called SARS-CoV-2 rS (recombinant spike) protein nanoparticle with Matrix-M1 adjuvant, is a COVID-19 vaccine candidate developed by Novavax and Coalition for Epidemic Preparedness Innovations (CEPI). It requires two doses[1] and is stable at 2 to 8 °C (36 to 46 °F) (refrigerated).[2]

Description

NVX-CoV2373 has been described as both a protein subunit vaccine[3][4][5] and a virus-like particle vaccine,[6][7] though the producers call it a “recombinant nanoparticle vaccine”.[8]

The vaccine is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein. The baculovirus then infects a culture of Sf9 moth cells, which create the spike protein and display it on their cell membranes. The spike proteins are then harvested and assembled onto a synthetic lipid nanoparticle about 50 nanometers across, each displaying up to 14 spike proteins.[3][4][8]

The formulation includes a saponin-based adjuvant.[3][4][8]

Development

In January 2020, Novavax announced development of a vaccine candidate, codenamed NVX-CoV2373, to establish immunity to SARS-CoV-2.[9] Novavax’s work is in competition for vaccine development among dozens of other companies.[10]

In March 2020, Novavax announced a collaboration with Emergent BioSolutions for preclinical and early-stage human research on the vaccine candidate.[11] Under the partnership, Emergent BioSolutions will manufacture the vaccine at large scale at their Baltimore facility.[12] Trials have also taken place in the United Kingdom, and subject to regulatory approval, at least 60 million doses will be manufactured by Fujifilm Diosynth Biotechnologies in Billingham for purchase by the UK government.[13][14] They also signed an agreement with Serum Institute of India for mass scale production for developing and low-income countries.[15] It has also been reported, that the vaccine will be manufactured in Spain.[16] The first human safety studies of the candidate, codenamed NVX-CoV2373, started in May 2020 in Australia.[17][18]

In July, the company announced it might receive $1.6 billion from Operation Warp Speed to expedite development of its coronavirus vaccine candidate by 2021—if clinical trials show the vaccine to be effective.[19][20] A spokesperson for Novavax stated that the $1.6 billion was coming from a “collaboration” between the Department of Health and Human Services and Department of Defense,[19][20] where Gen. Gustave F. Perna has been selected as COO for Warp Speed. In late September, Novavax entered the final stages of testing its coronavirus vaccine in the UK. Another large trial was announced to start by October in the US.[21]

In December 2020, Novavax started the PREVENT-19 (NCT04611802) Phase III trial in the US and Mexico.[22][full citation needed][23]

On 28 January 2021, Novavax reported that preliminary results from the United Kingdom trial showed that its vaccine candidate was more than 89% effective.[24][2] However, interim results from a trial in South Africa showed a lower effectiveness rate against the 501.V2 variant of the virus, at around 50-60%.[1][25]

On 12 March 2021, they announced their vaccine candidate was 96.4% effective in preventing the original strain of COVID-19 and 86% effective against the U.K variant. It proved 55% effective against the South African variant in people without HIV/AIDS. It was also 100% effective at preventing severe illness.[citation needed]

Deployment

On 2 February 2021, the Canadian Prime Minister Justin Trudeau announced that Canada has signed a tentative agreement for Novavax to produce millions of doses of its COVID-19 vaccine in Montreal, Canada, once it’s approved for use by Health Canada, making it the first COVID-19 vaccine to be produced domestically.[26]

References

  1. Jump up to:a b Wadman M, Jon C (28 January 2021). “Novavax vaccine delivers 89% efficacy against COVID-19 in UK—but is less potent in South Africa”Sciencedoi:10.1126/science.abg8101.
  2. Jump up to:a b “New Covid vaccine shows 89% efficacy in UK trials”BBC News. 28 January 2021. Retrieved 28 January 2021.
  3. Jump up to:a b c Wadman M (November 2020). “The long shot”Science370 (6517): 649–653. Bibcode:2020Sci…370..649Wdoi:10.1126/science.370.6517.649PMID 33154120.
  4. Jump up to:a b c Wadman M (28 December 2020). “Novavax launches pivotal U.S. trial of dark horse COVID-19 vaccine after manufacturing delays”Sciencedoi:10.1126/science.abg3441.
  5. ^ Parekh N (24 July 2020). “Novavax: A SARS-CoV-2 Protein Factory to Beat COVID-19”Archived from the original on 22 November 2020. Retrieved 24 July 2020.
  6. ^ Chung YH, Beiss V, Fiering SN, Steinmetz NF (October 2020). “COVID-19 Vaccine Frontrunners and Their Nanotechnology Design”ACS Nano14 (10): 12522–12537. doi:10.1021/acsnano.0c07197PMC 7553041PMID 33034449.
  7. ^ Medhi R, Srinoi P, Ngo N, Tran HV, Lee TR (25 September 2020). “Nanoparticle-Based Strategies to Combat COVID-19”ACS Applied Nano Materials3 (9): 8557–8580. doi:10.1021/acsanm.0c01978PMC 7482545.
  8. Jump up to:a b c “Urgent global health needs addressed by Novavax”Novavax. Retrieved 30 January 2021.
  9. ^ Gilgore S (26 February 2020). “Novavax is working to advance a potential coronavirus vaccine. So are competitors”Washington Business JournalArchived from the original on 16 March 2020. Retrieved 6 March 2020.
  10. ^ “COVID-19 vaccine tracker (click on ‘Vaccines’ tab)”. Milken Institute. 11 May 2020. Archived from the original on 6 June 2020. Retrieved 12 May 2020. Lay summary.
  11. ^ Gilgore S (10 March 2020). “Novavax’s coronavirus vaccine program is getting some help from Emergent BioSolutions”Washington Business JournalArchived from the original on 9 April 2020. Retrieved 10 March 2020.
  12. ^ McCartney R. “Maryland plays an outsized role in worldwide hunt for a coronavirus vaccine”Washington PostArchived from the original on 7 May 2020. Retrieved 8 May 2020.
  13. ^ Boseley S, Davis N (28 January 2021). “Novavax Covid vaccine shown to be nearly 90% effective in UK trial”The Guardian. Retrieved 29 January 2021.
  14. ^ Brown M (14 August 2020). “60m doses of new covid-19 vaccine could be made in Billingham – and be ready for mid-2021”TeesideLive. Reach. Retrieved 29 January 2021.
  15. ^ “Novavax signs COVID-19 vaccine supply deal with India’s Serum Institute”Reuters. 5 August 2020.
  16. ^ “Spain, again chosen to produce the vaccine to combat COVID-19”This is the Real Spain. 18 September 2020.
  17. ^ Sagonowsky E (11 May 2020). “Novavax scores $384M deal, CEPI’s largest ever, to fund coronavirus vaccine work”FiercePharmaArchived from the original on 16 May 2020. Retrieved 12 May 2020.
  18. ^ “Novavax starts clinical trial of its coronavirus vaccine candidate”. CNBC. 25 May 2020. Archived from the original on 26 May 2020. Retrieved 26 May 2020.
  19. Jump up to:a b Thomas K (7 July 2020). “U.S. Will Pay $1.6 Billion to Novavax for Coronavirus Vaccine”The New York TimesArchived from the original on 7 July 2020. Retrieved 7 July 2020.
  20. Jump up to:a b Steenhuysen J (7 July 2020). “U.S. government awards Novavax $1.6 billion for coronavirus vaccine”ReutersArchived from the original on 14 September 2020. Retrieved 15 September 2020.
  21. ^ Thomas K, Zimmer C (24 September 2020). “Novavax Enters Final Stage of Coronavirus Vaccine Trials”The New York TimesISSN 0362-4331Archived from the original on 28 September 2020. Retrieved 28 September 2020.
  22. ^ Clinical trial number NCT04611802 for “A Study Looking at the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults at Risk for SARS-CoV-2” at ClinicalTrials.gov
  23. ^ “Phase 3 trial of Novavax investigational COVID-19 vaccine opens”National Institutes of Health (NIH). 28 December 2020. Retrieved 28 December 2020.
  24. ^ Lovelace B (28 January 2020). “Novavax says Covid vaccine is more than 89% effective”CNBC.
  25. ^ Facher L, Joseph A (28 January 2021). “Novavax says its Covid-19 vaccine is 90% effective in late-stage trial”Stat. Retrieved 29 January 2021.
  26. ^ “Canada signs deal to produce Novavax COVID-19 vaccine at Montreal plant”CP24. 2 February 2021. Retrieved 2 February2021.
Vaccine description
TargetSARS-CoV-2
Vaccine typeSubunit
Clinical data
Other namesNVX-CoV2373
Routes of
administration
Intramuscular
ATC codeNone
Identifiers
DrugBankDB15810
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////////////// Novavax,  COVID-19,  vaccine, CORONA VIRUS, NVX-CoV2373, SARS-CoV-2 rS,  TAK 019

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BBIBP-CorV, Sinopharm COVID-19 vaccine


Sinopharm COVID-19 vaccine (2021) K (cropped).jpeg

BBIBP-CorV, Sinopharm COVID-19 vaccine

 
CAS Number2503126-65-4
  • Inactivated novel coronavirus (2019-CoV) vaccine (Vero cells)
  • Purified inactivated SARS-CoV-2 Vaccine

ref Lancet Infectious Diseases (2021), 21(1), 39-51.

BBIBP-CorV, also known as the Sinopharm COVID-19 vaccine,[1] is one of two inactivated virus COVID-19 vaccines developed by Sinopharm. In late December 2020, it was in Phase III trials in ArgentinaBahrainEgyptMoroccoPakistanPeru, and the United Arab Emirates (UAE) with over 60,000 participants.[2]

On December 9, the UAE announced interim results from Phase III trials showing BBIBP-CorV had a 86% efficacy against COVID-19 infection.[3] In late December, Sinopharm announced that its internal analysis indicated a 79% efficacy.[4] While mRNA vaccines like the Pfizer–BioNTech COVID-19 vaccine and mRNA-1273 showed higher efficacy of +90%, those present distribution challenges for some nations as they require deep-freeze facilities and trucks. BIBP-CorV could be transported and stored at normal refrigerated temperatures.[5]

BBIBP-CorV shares similar technology with CoronaVac and BBV152, other inactivated virus vaccines for COVID-19 being developed in Phase III trials.[6][7]

BBIBP-CorV is being used in vaccination campaigns by certain countries in Asia,[8][9][10] Africa,[11][12][13] South America,[14][15] and Europe.[16][17][18] Sinopharm expects to produce one billion doses of BBIBP-CorV in 2021.[19] By February 21, Sinopharm said more than 43 million doses of the vaccine had been administered in total.[20]

BBIBP-CorV vaccine contains a SARS-CoV-2 strain inactivated inside Vero Cells. Investigation shows this vaccine induces neutralizing antibodies in several mammalian species while also showing protective efficacy with SARS-CoV-2 challenge in rhesus macaques2. As of August 2020, this vaccine is being tested for prophylaxis against COVID-19 in human clinical trials.

A vaccination certificate of BBIBP-CorV (Beijing Institute of Biological Products, Sinopharm).

Clinical research

Main article: COVID-19 vaccine

Phases I and II

In April 2020, China approved clinical trials for a candidate COVID-19 vaccine developed by Sinopharm‘s Beijing Institute of Biological Products[21] and the Wuhan Institute of Biological Products.[22] Both vaccines are chemically-inactivated whole virus vaccines for COVID-19.

On October 15, the Beijing Institute of Biological Products published results of its Phase I (192 adults) and Phase II (448 adults) clinical studies for the BBIBP-CorV vaccine, showing BBIBP-CorV to be safe and well-tolerated at all tested doses in two age groups. Antibodies were elicited against SARS-CoV-2 in all vaccine recipients on day 42. These trials included individuals older than 60.[21]

On August 13, the Wuhan Institute of Biological Products published interim results of its Phase I (96 adults) and Phase II (224 adults) clinical studies. The report noted the inactivated COVID-19 vaccine had a low rate of adverse reactions and demonstrated immunogenicity, but longer-term assessment of safety and efficacy would require Phase III trials.[22]

BIBP-CorV may have characteristics favorable for vaccinating people in the developing world. While mRNA vaccines, such as the Pfizer–BioNTech COVID-19 vaccine and Moderna COVID-19 vaccine showed higher efficacy of +90%, mRNA vaccines present distribution challenges for some nations, as some may require deep-freeze facilities and trucks. By contrast, BIBP-CorV can be transported and stored at normal refrigeration temperatures.[23] While Pfizer and Moderna are among developers relying on novel mRNA technology, manufacturers have decades of experience with the inactivated virus technology Sinopharm is using.[23]

Phase III

Africa and Asia

On July 16, Sinopharm began conducting a Phase III vaccine trial of 31,000 volunteers in the UAE in collaboration with G42 Healthcare, an Abu Dhabi-based company.[24] By August, all volunteers had received their first dose and were to receive the second dose within the next few weeks.[25] On December 9, UAE’s Ministry of Health and Prevention announced the official registration of BBICP-CorV, after an interim analysis of the Phase III trial showed BBIBP-CorV to have a 86% efficacy against COVID-19 infection.[26] The vaccine had a 99% sero-conversion rate of neutralizing antibodies and 100% effectiveness in preventing moderate and severe cases of the disease.[27]

On September 2, Sinopharm began a Phase III trial in Casablanca and Rabat on 600 people.[28][29] In September, Egypt opened registration for a Phase III trial to last one year and enroll 6,000 people.[30]

In August 2020, Sinopharm began a Phase III clinical trial in Bahrain on 6,000 citizens and resident volunteers.[31][32] In a November update, 7,700 people had volunteered in the trials.[33] Also in late August, Sinopharm began a Phase III clinical trial in Jordan on 500 volunteers at Prince Hamzah Hospital.[34][35]

In Pakistan, Sinopharm began working with the University of Karachi on a trial with 3,000 volunteers.[36]

South America

On September 10, Sinopharm began a Phase III trial in Peru with the long-term goal of vaccinating a total of 6,000 people between the ages of 18 and 75.[37] In October, the trials were expanded to include an additional 6,000 volunteers.[38] On January 26, a volunteer in the placebo group of the vaccine trials had died.[39]

On September 16, Argentina began a Phase III trial with 3,000 volunteers.[40]

Manufacturing

Sinopharm’s Chariman Yang Xioyun has said the company could produce one billion doses in 2021.[19]

In October, Dubai’s G42 Healthcare reached manufacturing agreements to provide UAE and other regional states with BBIBP-CorV, with the UAE producing 75 to 100 million doses in 2021.[41]

In December, Egypt announced an agreement between Sinopharm and Egyptian Holding Company for Biological Products & Vaccines (VACSERA) for the vaccine to be manufactured locally,[42] which would also be exported to other African countries.[43]

In December, AP reported Morocco plans to produce BBIBP-CorV locally.[44]

In March, Serbia announced plans to produce 24 million doses of BBIBP-CorV annually starting in October. The production volume would be sufficient to meet the needs of Serbia and all of its neighbors, deputy prime minister Branislav Nedimović noted.[45]

In March, Belarus was looking to produce BBIBP-CorV locally.[18]

Marketing and Distribution

 
show  Full authorizationshow  Emergency authorizationshow  Received donated doses  Eligible COVAX recipient (assessment in progress)[86]

On February 21, 2021 Sinopharm said more than 43 million doses of BBIBP-CorV had been administered so far, including more than 34 million administered in China and the rest internationally.[20]

Asia

In February, Afghanistan was pledged 400,000 doses of BBIBP-CorV by China.[82]

In November 3, 2020 Bahrain granted emergency use authorization of BBIBP-CorV for frontline workers.[33] In December, Bahrain approved Sinopharm’s vaccine, citing data from Phase III clinical trials that showed an 86% efficacy rate.[87]

In February, Brunei received the first batch of Sinopharm vaccines donated by China.[84]

In January, Cambodia said China would provide a million doses.[88] Cambodia granted emergency use authorization on February 4[89] and started the vaccination campaign on February 10 with the first 600,000 doses.[90]

In China, Sinopharm obtained an EUA in July.[91] In October, it began offering the vaccine for free to students going abroad for higher studies.[92] On December 30, China‘s National Medical Products Administration approved BBIBP-CorV for general use.[93][8] In February, Macau received the first 100,000 doses of 400,000 doses.[94]

In October, Indonesia reached an agreement with Sinopharm to deliver 15 million dual-dose vaccines in 2020.[95]

In February, Iran approved emergency use of BBIBP-CorV,[96] and received the first batch of 250,000 doses on February 28.[97]

In January, Iraq approved BBIBP-CorV for emergency use[98] and has signed agreements for 2 million doses. The first doses arrived on March 2.[99]

In January, Jordan approved BBIBP-CorV for emergency use[100] and started its vaccination campaign on January 13.[101]

In March, Kyrgyzstan received a donation of 150,000 doses of the vaccine.[102]

In January, Laos began vaccinating medical workers at hospitals in Vientiane [103] and received another 300,000 doses in early February.[104]

In March, Lebanon received a donation of 50,000 doses at its request,[105] for which it granted emergency use authorization on March 2.[106]

In March, Maldives granted emergency approval for use. At the time of approval, the country had received 18,000 doses and was awaiting 200,000 additional doses.[107]

In February, Mongolia received a donation of 300,000 doses.[108] On March 10, Governor of Ulaanbaatar D. Sumiyabazar and Deputy Prime Minister S. Amarsaikhan received the first doses of BBIBP-CorV.[109]

In February, Nepal approved the vaccine for emergency use, allowing a donation of 500,000 doses to enter the country.[110]

In December, Pakistan‘s purchased 1.2 million doses,[111] which was approved for emergency use on January 18,[112] and began a vaccination campaign on February 2.[10]

In March, Palestine said it would receive 100,000 doses donated by China.[113]

In March 19, Sri Lanka approved the vaccine for emergency use, allowing a donation of 600,000 doses by China to enter the country.[114]

On 14 September 2020, the United Arab Emirates approved the vaccine for front-line workers following successful interim Phase III trials.[24] In December, the country registered BBIBP-CorV after it reviewed the results of the interim analysis.[26] In March, a small number of people who have reduced immunity against diseases, have chronic illnesses, or belong to high-risk groups have been given a 3rd booster shot.[115]

Africa

In February, Algeria received a donation of 200,000 doses.[83]

Egypt plans to buy 40 million doses of Sinpharm’s vaccine[116] which was approved for regulatory use on January 3.[116] President Abdel Fattah el-Sisi announced a vaccination campaign starting 24 January.[11]

In February, Equatorial Guinea received a donation of 100,000 doses which arrived on February 10. The country began vaccinations on February 15.[56]

In March, Gabon received a donation of 100,000 doses which was the second vaccine approved for use in the country.[117]

Morocco placed orders for 41 million vaccine doses from Sinopharm and 25 million from AstraZeneca, for a total of 66 million doses.[118] Morocco granted emergency use approval on January 23,[119] and the first 500,000 doses arrived on January 27.[12]

In February, Mozambique received a donation of 200,000 doses[120] and planned to start vaccinations on March 8.[121]

In March, Namibia received a donation of 100,000 doses and announced the start of vaccinations in the Khomas and Erongo regions.[122]

In March, Niger received a donation of 400,000 doses with vaccinations to begin on March 27.[123]

In February, Senegal received 200,000 doses in Dakar[124] and began vaccinating health workers on February 22.[125]

In February, Sierra Leone received a donation of 200,000 doses.[126] It was approved for emergency use and vaccinations began on March 15.[127]

In January, Seychelles said it would begin administering vaccinations on January 10 with 50,000 doses it had received as a gift from the UAE.[128]

In March, Republic of the Congo received 100,000 doses with vaccinations prioritizing the medically vulnerable and those over 50.[129]

In February, Zimbabwe purchased 600,000 doses on top of 200,000 doses donated by China,[130] and started vaccinations on February 18.[13] Zimbabwe later purchased an additional 1.2 million doses.[131]

North America

In February, the Dominican Republic ordered 768,000 doses of BBIBP-CorV.[132]

In March, Dominica received 20,000 doses of BBIBP-CorV which it began using in its vaccination campaign on March 4.[133]

In March, Mexico announced it would order 12 million doses of BBIBP-CorV pending approval by its health regulator.[134]

South America

In February, Argentina authorized emergency use of BBIBP-CorV[135] ahead of the arrival of 904,000 doses on February 26.[136]

In February, Bolivia purchased 400,000 doses on top of 100,000 doses donated by China,[137] and started its vaccination campaign on February 26.[15]

In March, Guyana received a donation of 20,000 doses of BBIBP-CorV.[138] Vaccinations were to start on March 7.[139]

In January, Peru purchased 38 million doses of BBIBP-CorV.[140] Peru granted emergency approval for BBIBP-CorV on January 27[141] and started vaccinations on February 9 with the first 300,000 doses.[14]

In March, Venezuela granted approval for BBIBP-CorV to be used in the country.[142] The first 500,000 doses arrived on March 2.[143]

Europe

In February, Belarus received a donation of 100,000 doses[144] and began using the vaccine on March 15.[18]

In January, Hungary became first EU member to approve BBIBP-CorV, signing a deal for 5 million doses.[145] The first 550,000 doses arrived in Budapest on February 16[146] and vaccinations started on February 24.[17] Prime Minister Viktor Orbán was vaccinated with BBIBP-CorV on February 28.[147]

In March, Moldova received 2,000 doses donated by the UAE[148] which will be used to vaccinate doctors at the State University of Mediecne and Pharmacy starting on March 22.[149]

In March 3, Montenegro received a donation of 30,000 doses of BBIBP-CorV.[85]

In February, North Macedonia signed an agreement for 200,000 doses of BBIBP-CorV, with which they hoped to launch their vaccination program later that month.[150]

In January, Serbia received one million doses, making it the first country in Europe to receive BBIBP-CorV.[151] On January 19, Serbia approved the vaccine and Health Minister Zlatibor Lončar became the first person to receive a shot.[16]

Controversies

Lack of public data

Unlike Moderna‘s MRNA-1273OxfordAstraZeneca‘s AZD1222, and Johnson & Johnson‘s Ad26.COV2.S, there is little public information about the Chinese vaccine’s safety or efficacy.[152] The UAE said it had reviewed Sinopharm’s interim data analysis which showed the vaccine was 100% effective to prevent moderate and severe instances of COVID-19, but did not say whether it had independently analyzed the case data in its review. It was unclear how Sinopharm drew conclusions, since the UAE announcement of the approval for BBIBP-CorV noticeably lacked details such as the number of COVID-19 cases in the placebo or active group or the volunteers ages.[153]

As of December 30, 2020, no detailed efficacy data of the vaccine has been released to the public. A Sinopharm executive said detailed data would be released later and published in scientific journals in China and internationally.[8]

Sinopharm president Wu Yonglin said the trial results exceeded the WHO’s requirements, but a director at a large pharmaceutical company in Shanghai expressed skepticism over the trials and the expectation that drug regulators in Bahrain and the UAE would not hold the same standard as the U.S. Food and Drug Administration.[154]

Unauthorized use in Asia

On December 30, Philippine Defense Secretary Delfin Lorenzana said in an interview that at least one minister and president Rodrigo Duterte‘s bodyguards were provided BBIBP-CorV which were “smuggled” but that he felt what happened was “justified”. Brigadier General Jesus Durante, head of the Presidential Security Guard (PSG), said he felt compelled and “took the risk” to have some of his men vaccinated because they provide close-in security to Duterte, who at 75 is highly vulnerable to COVID-19.[155] Ingming Aberia, an author at The Manila Times commented that FDA director-general Enrique Domingo had reason to believe Sinopharm may cause harm to the consuming public given that no COVID-19 vaccine license was issued, but out of “self-preservation”, he would not initiate charges against PSG.[156]

On January 1, Mainichi Shimbun reported that 18 wealthy people, including several owners of leading Japanese companies, have been vaccinated with Sinopharm vaccines since November 2020. The vaccines were brought in by a Chinese consultant close to a senior member of the Chinese Communist Party.[157] The Chinese embassy in Japan later expressed its dissatisfaction at the unverified claims by Japanese news media.[158]

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External links

A vial of the BBIBP-CorV COVID‑19 vaccine
Vaccine description
TargetSARS-CoV-2
Vaccine typeInactivated
Clinical data
Routes of
administration
Intramuscular
ATC codeNone
Legal status
Legal statusAuthorization for use in BahrainChinaEgyptIraqPakistanSerbiaUnited Arab EmiratesIran (emergency use)
Identifiers
CAS Number2503126-65-4
DrugBankDB15807
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 COVID-19 Portal
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How the Sinopharm Vaccine Works

By Jonathan Corum and Carl ZimmerUpdated March 22, 2021Leer en español

In early 2020, the Beijing Institute of Biological Products created an inactivated coronavirus vaccine called BBIBP-CorV. Clinical trials run by the state-owned company Sinopharm showed that it had an efficacy rate of 79 percent. China approved the vaccine and soon began exporting it to other countries.

A Vaccine Made From Coronaviruses

BBIBP-CorV works by teaching the immune system to make antibodies against the SARS-CoV-2 coronavirus. The antibodies attach to viral proteins, such as the so-called spike proteins that stud its surface.

Spikes

Spike

protein

gene

CORONAVIRUS

To create BBIBP-CorV, the Beijing Institute researchers obtained three variants of the coronavirus from patients in Chinese hospitals. They picked one of the variants because it was able to multiply quickly in monkey kidney cells grown in bioreactor tanks.

Killing the Virus

Once the researchers produced large stocks of the coronaviruses, they doused them with a chemical called beta-propiolactone. The compound disabled the coronaviruses by bonding to their genes. The inactivated coronaviruses could no longer replicate. But their proteins, including spike, remained intact.

Beta-

propiolactone

INACTIVATED

CORONAVIRUS

Inactivated

genes

The researchers then drew off the inactivated viruses and mixed them with a tiny amount of an aluminum-based compound called an adjuvant. Adjuvants stimulate the immune system to boost its response to a vaccine.

Inactivated viruses have been used for over a century. Jonas Salk used them to create his polio vaccine in the 1950s, and they’re the bases for vaccines against other diseases including rabies and hepatitis A.

Prompting an Immune Response

Because the coronaviruses in BBIBP-CorV are dead, they can be injected into the arm without causing Covid-19. Once inside the body, some of the inactivated viruses are swallowed up by a type of immune cell called an antigen-presenting cell.

INACTIVATED

CORONAVIRUS

Engulfing

the virus

ANTIGEN-

PRESENTING

CELL

Digesting

virus proteins

Presenting

virus protein

fragments

HELPER

T CELL

The antigen-presenting cell tears the coronavirus apart and displays some of its fragments on its surface. A so-called helper T cell may detect the fragment. If the fragment fits into one of its surface proteins, the T cell becomes activated and can help recruit other immune cells to respond to the vaccine.

Making Antibodies

Another type of immune cell, called a B cell, may also encounter the inactivated coronavirus. B cells have surface proteins in a huge variety of shapes, and a few might have the right shape to latch onto the coronavirus. When a B cell locks on, it can pull part or all of the virus inside and present coronavirus fragments on its surface.

A helper T cell activated against the coronavirus can latch onto the same fragment. When that happens, the B cell gets activated, too. It proliferates and pours out antibodies that have the same shape as their surface proteins.

ACTIVATED

HELPER

T CELL

INACTIVATED

CORONAVIRUS

Activating

the B cell

Matching

surface proteins

B CELL

SECRETED

ANTIBODIES

Stopping the Virus

Once vaccinated with BBIBP-CorV, the immune system can respond to an infection of live coronaviruses. B cells produce antibodies that stick to the invaders. Antibodies that target the spike protein can prevent the virus from entering cells. Other kinds of antibodies may block the virus by other means.

ANTIBODIES

LIVE

VIRUS

Remembering the Virus

Sinopharm’s clinical trials have demonstrated that BBIBP-CorV can protect people against Covid-19. But no one can yet say how long that protection lasts. It’s possible that the level of antibodies drops over the course of months. But the immune system also contains special cells called memory B cells that might retain information about the coronavirus for years or even decades.

Vaccine Timeline

January, 2020 Sinopharm begins developing an inactivated vaccine against the coronavirus.

June Researchers report the vaccine produces promising results in monkeys. A Phase 1/2 trial shows that the vaccine doesn’t cause any serious side effects and enables people to make antibodies against the coronavirus.

A Sinopharm production plant in Beijing.Zhang Yuwei/Xinhua, via Associated Press

July A Phase 3 trial begins in the United Arab Emirates.

August Phase 3 trials begin in Morocco and Peru.

Preparing a Sinopharm dose in Lima, Peru.Ernesto Benavides/Agence France-Presse

Sept. 14 The U.A.E. gives emergency approval for Sinopharm’s vaccine to use on health care workers. Government officials and others begin to receive it.

November The chairman of Sinopharm says almost a million people in China have received Sinopharm vaccines.

Nov. 3 The ruler of Dubai, Sheikh Mohammed bin Rashid al-Maktoum, announces he received the vaccine.

Sheikh Mohammed before receiving the vaccine.Agence France-Presse

Dec. 9 The U.A.E. gives full approval to BBIBP-CorV, announcing it has an efficacy rate of 86 percent. But the government did not release any details with their announcement, leaving it unclear how they had come to their conclusions.

Dec. 13 Bahrain also approves the vaccine.

Vials of the Sinopharm vaccine at a packaging plant.Zhang Yuwei/Xinhua, via Associated Press

Dec. 30 Sinopharm announces that the vaccine has an efficacy of 79.34 percent, leading the Chinese government to approve it. The company has yet to publish detailed results of their Phase 3 trial.

Jan. 3, 2021 Egypt authorizes the vaccine for emergency use.

Sources: National Center for Biotechnology Information; Science; The Lancet; Lynda Coughlan, University of Maryland School of Medicine; Jenna Guthmiller, University of Chicago.

Data

/////////////BBIBP-CorV, Sinopharm,  COVID-19 vaccine, china, covid 19, corona virus, vaccine

#BBIBP-CorV, #Sinopharm,  #COVID-19 vaccine, #china, #covid 19, #corona virus, #vaccine

Moderna COVID-19 vaccine, mRNA 1273


moderna
Moderna COVID-19 vaccine.jpg

Moderna COVID-19 vaccine, mRNA 1273

CAS 2457298-05-2

An mRNA vaccine against SARS-CoV-2 expressing the prefusion-stabilized SARS-CoV-2 spike trimer

  • MRNA-1273 SARS-COV-2
  • CX 024414
  • CX-024414
  • CX024414
  • mRNA-1273
NAMEDOSAGESTRENGTHROUTELABELLERMARKETING STARTMARKETING END  
Covid-19 Vaccine ModernaInjection IntramuscularModerna Therapeutics Inc2020-12-23Not applicableCanada flag 
Moderna COVID-19 VaccineInjection, suspension0.2 mg/1mLIntramuscularModerna US, Inc.2020-12-18Not applicableUS flag 
FORMROUTESTRENGTH
InjectionIntramuscular 
Injection, suspensionIntramuscular0.2 mg/1mL

REFNature (London, United Kingdom) (2020), 586(7830), 516-527.bioRxiv (2020), 1-39Nature (London, United Kingdom) (2020), 586(7830), 567-571.  Nature Biotechnology (2020), Ahead of PrintJournal of Pure and Applied Microbiology (2020), 14(Suppl.1), 831-840.Chemical & Engineering News (2020), 98(46), 12.New England Journal of Medicine (2020), 383(16), 1544-1555.  Science of the Total Environment (2020), 725, 138277.JAMA, the Journal of the American Medical Association (2020), 324(12), 1125-1127.Advanced Drug Delivery Reviews (2021), 169, 137-151. bioRxiv (2021), 1-62.  bioRxiv (2021), 1-51.

The Moderna COVID-19 Vaccine (mRNA-1273) is a novel mRNA-based vaccine encapsulated in a lipid nanoparticle that encodes for a full-length pre-fusion stabilized spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Coronavirus disease 2019 (COVID-19) is a highly contagious infectious disease caused by the novel coronavirus, SARS-CoV-2, leading to a respiratory illness alongside other complications. COVID-19 has high interpatient variability in symptoms, ranging from mild symptoms to severe illness.5 A phase I, open-label, dose-ranging clinical trial (NCT04283461) was initiated in March 2020 in which 45 subjects received two intramuscular doses (on days 1 and 29).4 This trial was later followed by phase II and III trials, where the Moderna COVID-19 Vaccine demonstrated vaccine efficacy of 94.1%.5

On December 18, 2020, the FDA issued an emergency use authorization (EUA) for the Moderna COVID-19 Vaccine as the second vaccine for the prevention of COVID-19 caused by SARS-CoV-2 in patients aged 18 years and older, after the EUA issued for the Pfizer-BioNTech Covid-19 Vaccine on December 11, 2020. The Moderna COVID-19 Vaccine is administered as a series of two intramuscular injections, one month (28 days) apart. In clinical trials, there were no differences in the safety profiles between younger and older (65 years of age and older) study participants; however, the safety and effectiveness of the Moderna COVID-19 Vaccine have not been assessed in persons less than 18 years of age.5 On December 23, 2020, Health Canada issued an expedited authorization for the Moderna COVID-19 Vaccine.7

It is an RNA vaccine composed of nucleoside-modified mRNA (modRNA) encoding a spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles. It is one of the two RNA vaccines developed and deployed in 2020 against COVID‑19, the other being the Pfizer–BioNTech vaccine.The Moderna COVID‑19 vaccine, codenamed mRNA-1273, is a COVID‑19 vaccine developed by the United States National Institute of Allergy and Infectious Diseases (NIAID), the Biomedical Advanced Research and Development Authority (BARDA), and Moderna. It is administered by two 0.5 mL doses given by intramuscular injection given four weeks apart.[12]

On 18 December 2020, mRNA-1273 was issued an Emergency Use Authorization by the United States Food and Drug Administration (FDA).[6][13][14][15] It was authorized for use in Canada on 23 December 2020,[2][3] in the European Union on 6 January 2021,[10][16][11] and in the United Kingdom on 8 January 2021.[17]

Vaccine comparison

Design


Upon the announcement Moderna’s shares rose dramatically, and the chief executive officer (CEO) and other corporate executives began large program sales of their shareholdings.[26]In January 2020, Moderna announced development of an RNA vaccine, named mRNA-1273, to induce immunity to SARS-CoV-2.[18][19][20] Moderna’s technology uses a nucleoside-modified messenger RNA (modRNA) compound named mRNA-1273. Once the compound is inside a human cell, the mRNA links up with the cell’s endoplasmic reticulum. The mRNA-1273 is encoded to trigger the cell into making a specific protein using the cell’s normal manufacturing process. The vaccine encodes a version of the spike protein called 2P, which includes two stabilizing mutations in which the regular amino acids are replaced with prolines, developed by researchers at the University of Texas at Austin and the National Institute of Allergy and Infectious Diseases‘ Vaccine Research Center.[21][22][23][24] Once the protein is expelled from the cell, it is eventually detected by the immune system, which begins generating efficacious antibodies. The mRNA-1273 drug delivery system uses a PEGylated lipid nanoparticle drug delivery (LNP) system.[25]

Composition

The vaccine contains the following ingredients:[7][27]

Clinical trials

Phase I / II

In March 2020, the Phase I human trial of mRNA-1273 began in partnership with the U.S. National Institute of Allergy and Infectious Diseases.[29] In April, the U.S. Biomedical Advanced Research and Development Authority (BARDA) allocated up to $483 million for Moderna’s vaccine development.[30] Plans for a Phase II dosing and efficacy trial to begin in May were approved by the U.S. Food and Drug Administration (FDA).[31] Moderna signed a partnership with Swiss vaccine manufacturer Lonza Group,[32] to supply 300 million doses per annum.[33]

On 25 May 2020, Moderna began a Phase IIa clinical trial recruiting six hundred adult participants to assess safety and differences in antibody response to two doses of its candidate vaccine, mRNA-1273, a study expected to complete in 2021.[34] In June 2020, Moderna entered a partnership with Catalent in which Catalent will fill and package the vaccine candidate. Catalent will also provide storage and distribution.[35]

On 9 July, Moderna announced an in-fill manufacturing deal with Laboratorios Farmacéuticos Rovi, in the event that its vaccine is approved.[36]

On 14 July 2020, Moderna scientists published preliminary results of the Phase I dose escalation clinical trial of mRNA-1273, showing dose-dependent induction of neutralizing antibodies against S1/S2 as early as 15 days post-injection. Mild to moderate adverse reactions, such as fever, fatigue, headache, muscle ache, and pain at the injection site were observed in all dose groups, but were common with increased dosage.[37][38] The vaccine in low doses was deemed safe and effective in order to advance a Phase III clinical trial using two 100-μg doses administered 29 days apart.[37]

In July 2020, Moderna announced in a preliminary report that its Operation Warp Speed candidate had led to production of neutralizing antibodies in healthy adults in Phase I clinical testing.[37][39] “At the 100-microgram dose, the one Moderna is advancing into larger trials, all 15 patients experienced side effects, including fatigue, chills, headache, muscle pain, and pain at the site of injection.”[40] The troublesome higher doses were discarded in July from future studies.[40]

Phase III

Moderna and the National Institute of Allergy and Infectious Diseases began a Phase III trial in the United States on 27 July, with a plan to enroll and assign thirty thousand volunteers to two groups – one group receiving two 100-μg doses of mRNA-1273 vaccine and the other receiving a placebo of 0.9% sodium chloride.[41] As of 7 August, more than 4,500 volunteers had enrolled.

In September 2020, Moderna published the detailed study plan for the clinical trial.[42] On 30 September, CEO Stéphane Bancel said that, if the trial is successful, the vaccine might be available to the public as early as late March or early April 2021.[43] As of October 2020, Moderna had completed the enrollment of 30,000 participants needed for its Phase III trial.[44] The U.S. National Institutes of Health announced on 15 November 2020 that overall trial results were positive.[45]

On 30 December 2020, Moderna published results from the Phase III clinical trial, indicating 94% efficacy in preventing COVID‑19 infection.[46][47][48] Side effects included flu-like symptoms, such as pain at the injection site, fatigue, muscle pain, and headache.[47] The clinical trial is ongoing and is set to conclude in late-2022[49]

In November 2020, Nature reported that “While it’s possible that differences in LNP formulations or mRNA secondary structures could account for the thermostability differences [between Moderna and BioNtech], many experts suspect both vaccine products will ultimately prove to have similar storage requirements and shelf lives under various temperature conditions.”[50]

Since September 2020, Moderna has used Roche Diagnostics‘ Elecsys Anti-SARS-CoV-2 S test, authorized by the US Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) on 25 November 2020. According to an independent supplier of clinical assays in microbiology, “this will facilitate the quantitative measurement of SARS-CoV-2 antibodies and help to establish a correlation between vaccine-induced protection and levels of anti-receptor binding domain (RBD) antibodies.” The partnership was announced by Roche on 9 December 2020.[51]

A review by the FDA in December 2020, of interim results of the Phase III clinical trial on mRNA-1273 showed it to be safe and effective against COVID‑19 infection resulting in the issuance of an EUA by the FDA.[13]

It remains unknown whether the Moderna vaccine candidate is safe and effective in people under age 18 and how long it provides immunity.[47] Pregnant and breastfeeding women were also excluded from the initial trials used to obtain Emergency Use Authorization,[52] though trials in those populations are expected to be performed in 2021.[53]

In January 2021, Moderna announced that it would be offering a third dose of its vaccine to people who were vaccinated twice in its Phase I trial. The booster would be made available to participants six to twelve months after they got their second doses. The company said it may also study a third shot in participants from its Phase III trial, if antibody persistence data warranted it.[54][55][56]

In January 2021, Moderna started development of a new form of its vaccine, called mRNA-1273.351, that could be used as a booster shot against the 501.V2 variant of SARS-CoV-2 first detected in South Africa.[57][58] It also started testing to see if a third shot of the existing vaccine could be used to fend off the virus variants.[58] On 24 February, Moderna announced that it had manufactured and shipped sufficient amounts of mRNA-1273.351 to the National Institutes of Health to run Phase{ I clinical trials.[59] To increase the span of vaccination beyond adults, Moderna started the clinical trials of vaccines on childern age six to eleven in the U.S. and in Canada.[60]

Storage requirements

 Moderna vaccine being stored in a conventional medical freezer

The Moderna news followed preliminary results from the PfizerBioNTech vaccine candidate, BNT162b2, with Moderna demonstrating similar efficacy, but requiring storage at the temperature of a standard medical refrigerator of 2–8 °C (36–46 °F) for up to 30 days or −20 °C (−4 °F) for up to four months, whereas the Pfizer-BioNTech candidate requires ultracold freezer storage between −80 and −60 °C (−112 and −76 °F).[61][47] Low-income countries usually have cold chain capacity for refrigerator storage.[62][63] In February 2021, the restrictions on the Pfizer vaccine were relaxed when the U.S. Food and Drug Administration (FDA) updated the emergency use authorization (EUA) to permit undiluted frozen vials of the vaccine to be transported and stored at between −25 and −15 °C (−13 and 5 °F) for up to two weeks before use.[27][64][65]

Efficacy

The interim primary efficacy analysis was based on the per-protocol set, which consisted of all participants with negative baseline SARS-CoV-2 status and who received two doses of investigational product per schedule with no major protocol deviations. The primary efficacy endpoint was vaccine efficacy (VE) in preventing protocol defined COVID-19 occurring at least 14 days after dose 2. Cases were adjudicated by a blinded committee. The primary efficacy success criterion would be met if the null hypothesis of VE ≤30% was rejected at either the interim or primary analysis. The efficacy analysis presented is based on the data at the first pre-specified interim analysis timepoint consisting of 95 adjudicated cases.[66] The data are presented below.

Primary endpoint: COVID-19Cases n (%)
Incidence per 1000 person-years
Vaccine efficacy
(95% confidence interval)
Vaccine group (N = 13,934)Placebo group (N = 13,883)
All participants5 cases in 13,934 (<0.1%)1.84090 cases in 13,883 (0.6%)33.36594.5% (86.5-97.8%)
Participants 18–64 years of age5 cases in 10,407 (<0.1%)2.50475 cases in 10,384 (0.7%)37.78893.4% (83.7-97.3%)
65 and older0 cases in 3,52715 cases in 3,499 (0.4%)100%
Chronic lung disease0/6616/673100%
Significant cardiac disease0/6863/678100%
Severe obesity (BMI>40)1/90111/88491.2% (32-98.9%)
Diabetes0/13387/1309100%
Liver disease0/930/90 
Obesity (BMI>30)2/526946/520795.8% (82.6-99%)

Manufacturing

 An insulated shipping container with Moderna vaccine boxes ensconced by cold packs

Moderna is relying extensively on contract manufacturing organizations to scale up its vaccine manufacturing process. Moderna has contracted with Lonza Group to manufacture the vaccine at facilities in Portsmouth, New Hampshire in the United States, and in Visp in Switzerland, and is purchasing the necessary lipid excipients from CordenPharma.[67] For the tasks of filling and packaging vials, Moderna has entered into contracts with Catalent in the United States and Laboratorios Farmacéuticos Rovi in Spain.[67]

Purchase commitments

In June 2020, Singapore signed a pre-purchase agreement for Moderna, reportedly paying a price premium in order to secure early stock of vaccines, although the government declined to provide the actual price and quantity, citing commercial sensitivities and confidentiality clauses.[68][69]

On 11 August 2020, the U.S. government signed an agreement to buy one hundred million doses of Moderna’s anticipated vaccine,[70] which the Financial Times said Moderna planned to price at US$50–60 per course.[71] On November 2020, Moderna said it will charge governments who purchase its vaccine between US$25 and US$37 per dose while the E.U. is seeking a price of under US$25 per dose for the 160 million doses it plans to purchase from Moderna.[72][73]

In 2020, Moderna also obtained purchase agreements for mRNA-1273 with the European Union for 160 million doses and with Canada for up to 56 million doses.[74][75] On 17 December, a tweet by the Belgium Budget State Secretary revealed the E.U. would pay US$18 per dose, while The New York Times reported that the U.S. would pay US$15 per dose.[76]

In February 2021, Moderna said it was expecting US$18.4 billion in sales of its COVID-19 vaccine.[77]

Authorizations

 show  Full authorizationshow  Emergency authorization  Eligible COVAX recipient (assessment in progress)[96]

Expedited

 U.S. military personnel being administered the Moderna vaccineKamala Harris, Vice President of the United States, receiving her second dose of the Moderna vaccination in January 2021.

As of December 2020, mRNA-1273 was under evaluation for emergency use authorization (EUA) by multiple countries which would enable rapid rollout of the vaccine in the United Kingdom, the European Union, Canada, and the United States.[97][98][99][100]

On 18 December 2020, mRNA-1273 was authorized by the United States Food and Drug Administration (FDA) under an EUA.[6][8][13] This is the first product from Moderna that has been authorized by the FDA.[101][14]

On 23 December 2020, mRNA-1273 was authorized by Health Canada.[2][3] Prime Minister Justin Trudeau had previously said deliveries would begin within 48 hours of approval and that 168,000 doses would be delivered by the end of December.[102]

On 5 January 2021, mRNA-1273 was authorized for use in Israel by its Ministry of Health.[103]

On 3 February 2021, mRNA-1273 was authorized for use in Singapore by its Health Sciences Authority;[104] the first shipment arrived on 17 February.[105]

Standard

On 6 January 2021, the European Medicines Agency (EMA) recommended granting conditional marketing authorization[10][106] and the recommendation was accepted by the European Commission the same day.[11][16]

On 12 January 2021, Swissmedic granted temporary authorization for the Moderna COVID-19 mRNA Vaccine in Switzerland.[107][108]

Society and culture

Controversies

In May 2020, after releasing partial and non-peer reviewed results for only eight of 45 candidates in a preliminary pre-Phase I stage human trial directly to financial markets, the CEO announced on CNBC an immediate $1.25 billion rights issue to raise funds for the company, at a $30 billion valuation,[109] while Stat said, “Vaccine experts say Moderna didn’t produce data critical to assessing COVID-19 vaccine.”[110]

On 7 July, disputes between Moderna and government scientists over the company’s unwillingness to share data from the clinical trials were revealed.[111]

Moderna also faced criticism for failing to recruit people of color in clinical trials.[112]

Patent litigation

The PEGylated lipid nanoparticle (LNP) drug delivery system of mRNA-1273 has been the subject of ongoing patent litigation with Arbutus Biopharma, from whom Moderna had previously licensed LNP technology.[25][113] On 4 September 2020, Nature Biotechnology reported that Moderna had lost a key challenge in the ongoing case.[114]

Notes

  1. ^ US authorization also includes the three sovereign nations in the Compact of Free AssociationPalau, the Marshall Islands, and Micronesia.[93][94]

References

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Further reading

  • World Health Organization (2021). Background document on the mRNA-1273 vaccine (Moderna) against COVID-19: background document to the WHO Interim recommendations for use of the mRNA-1273 vaccine (Moderna), 3 February 2021 (Report). World Health Organization (WHO). hdl:10665/339218. WHO/2019-nCoV/vaccines/SAGE_recommendation/mRNA-1273/background/2021.1.

External links

Scholia has a profile for mRNA-1273 (Q87775025).
Wikimedia Commons has media related to Category:MRNA-1273.
Vials of Moderna COVID-19 vaccine
Vaccine description
TargetSARS-CoV-2
Vaccine typeRNA
Clinical data
Pronunciation/məˈdɜːrnə/ mə-DUR-nə[1]
Trade namesModerna COVID‑19 Vaccine, COVID‑19 Vaccine Moderna
Other namesmRNA-1273, CX-024414, COVID-19 mRNA Vaccine Moderna
AHFS/Drugs.comMultum Consumer Information
MedlinePlusa621002
License dataUS DailyMedModerna_COVID-19_Vaccine
Routes of
administration
Intramuscular
ATC codeNone
Legal status
Legal statusCA: Schedule D; Authorized by interim order [2][3]UK: Conditional and temporary authorization to supply [4][5]US: Standing Order; Unapproved (Emergency Use Authorization)[6][7][8][9]EU: Conditional marketing authorization granted [10][11]
Identifiers
DrugBankDB15654
UNIIEPK39PL4R4
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  1. Kaur SP, Gupta V: COVID-19 Vaccine: A comprehensive status report. Virus Res. 2020 Oct 15;288:198114. doi: 10.1016/j.virusres.2020.198114. Epub 2020 Aug 13. [PubMed:32800805]
  2. Jackson LA, Anderson EJ, Rouphael NG, Roberts PC, Makhene M, Coler RN, McCullough MP, Chappell JD, Denison MR, Stevens LJ, Pruijssers AJ, McDermott A, Flach B, Doria-Rose NA, Corbett KS, Morabito KM, O’Dell S, Schmidt SD, Swanson PA 2nd, Padilla M, Mascola JR, Neuzil KM, Bennett H, Sun W, Peters E, Makowski M, Albert J, Cross K, Buchanan W, Pikaart-Tautges R, Ledgerwood JE, Graham BS, Beigel JH: An mRNA Vaccine against SARS-CoV-2 – Preliminary Report. N Engl J Med. 2020 Jul 14. doi: 10.1056/NEJMoa2022483. [PubMed:32663912]
  3. Pharmaceutical Business Review: Moderna’s mRNA-1273 vaccine [Link]
  4. Clinical Trials: Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection [Link]
  5. FDA EUA Drug Products: Moderna COVID-19 Vaccine [Link]
  6. FDA Press Announcements: FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine [Link]
  7. Health Canada: Regulatory Decision Summary – Moderna COVID-19 Vaccine [Link]

////////CX 024414, CX-024414, CX024414, mRNA 1273, Moderna COVID-19 vaccine, COVID 19, CORONA VIRUS

CX 024414, CX-024414, CX024414, mRNA 1273, Moderna COVID-19 vaccine, COVID 19, CORONA VIRUS

#CX 024414,#CX-024414, #CX024414, #mRNA 1273, #Moderna COVID-19 vaccine, #COVID 19, #CORONA VIRUS

COVAXIN, BBV 152


covid vaccine india, corona vaccine, corona virus vaccine, first covid vaccine in inida

COVAXIN

CAS 2501889-19-4

  • Whole-Virion Inactivated SARS-CoV-2 Vaccine
  • UNII76JZE5DSN6
  • BBV 152
  • A whole virion inactivated COVID-19 vaccine candidate derived from SARS-CoV-2 strain NIV-2020-770

REF

medRxiv (2020), 1-21.

bioRxiv (2020), 1-32.

BBV152 (also known as Covaxin) is an inactivated virus-based COVID-19 vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research.

BBV152 is a vaccine candidate created by the Indian Council of Medical Research (ICMR). The candidate, a whole virion inactivated SARS-CoV-2 vaccine, was developed from a well-known SARS-CoV-2 strain and a vero cell platform (CCL-81) with adjuncts of either aluminum hydroxide gel (Algel) or a novel TLR7/8 agonist adsorbed gel. The components of the vaccine include BBV152A, BBV152B, and BBV152C. Animal studies in mice, rats, and rabbits reported BBV152 immunogenicity at two separate antigen concentrations with both types of adjuvants. The formulation with the TLR7/8 adjuvant specifically induced significant Th1 biased antibody responses and increased SARS-CoV-2 lymphocyte responses. Thus, as of July 2020, BBV152 is in Phase 1/2 clinical trials assessing safety and immunogenicity in humans (NCT04471519).

Clinical research

Phase I and II trials

In May 2020, Indian Council of Medical Research’s (ICMR‘s) National Institute of Virology approved and provided the virus strains for developing a fully indigenous COVID-19 vaccine.[1][2] In June 2020, the company got permission to conduct Phase I and Phase II human trials of a developmental COVID-19 vaccine named Covaxin, from the Drugs Controller General of India (DCGI), Government of India.[3] A total of 12 sites were selected by the Indian Council for Medical Research for Phase I and II randomised, double-blind and placebo-controlled clinical trials of vaccine candidate.[4][5][6]

In December 2020, the company announced the report for Phase I trials and presented the results through medRxiv preprint;[7][8] the report was later published in the The Lancet.[9]

On March 8, 2021, Phase II results were published in The Lancet. The study showed that Phase II trials had a higher immune response and induced T-cell response due to the difference in dosing regime from Phase I. The doses in Phase II were given at 4 weeks interval as opposed to 2 weeks in Phase I. Neutralization response of the vaccine were found significantly higher in Phase II.[10]

Phase III trials[edit]

In November 2020, Covaxin received the approval to conduct Phase III human trials[11] after completion of Phase I and II.[12] The trial involves a randomised, double-blinded, placebo-controlled study among volunteers of age group 18 and above and started on 25 November.[13] The Phase III trials involved around 26,000 volunteers from across India.[14] The phase III trials covered a total of 22 sites consisting several states in the country, including DelhiKarnataka and West Bengal.[15] Refusal rate for Phase III trials was much higher than that for Phase I and Phase II. As a result only 13,000 volunteers had been recruited by 22 December with the number increasing to 23,000 by 5 January. [16][17]

As on March 2021, the stated interim efficacy rate for phase III trial is 81%.[18][10]

B.1.1.7 (United Kingdom) variant

In December 2020, a new SARS‑CoV‑2 variantB.1.1.7, was identified in the UK.[19] A study on this variant was carried and preliminary results presented in biorxiv have shown Covaxin to be effective in neutralizing this strain.[20]

Manufacturing

The vaccine candidate is produced with Bharat Biotech’s in-house vero cell manufacturing platform[21] that has the capacity to deliver about 300 million doses.[22] The company is in the process of setting up a second plant at its Genome Valley facility in Hyderabad to make Covaxin. The firm is in talks with other state governments like Odisha[23] for another site in the country to make the vaccine. Beside this, they are also exploring global tie-ups for Covaxin manufacturing.[24]

In December 2020, Ocugen Inc entered a partnership with Bharat Biotech to co-develop Covaxin for the U.S. market.[25][26] In January 2021, Precisa Med entered an agreement with Bharat Biotech to supply Covaxin in Brazil[27]

Emergency use authorisation

 
show  Full authorizationshow  Emergency authorization

See also: COVID-19 vaccine § Trial and authorization status

Bharat Biotech has applied to the Drugs Controller General of India (DCGI), Government of India seeking an emergency use authorisation (EUA).[31] It was the third firm after Serum Institute of India and Pfizer to apply for emergency use approval.[32]

On 2 January 2021, the Central Drugs Standard Control Organisation (CDSCO) recommended permission for EUA,[33] which was granted on 3 January.[34] The emergency approval was given before Phase III trial data was published. This was criticized in some sections of the media.[35][36]

The vaccine was also approved for Emergency Use in Iran and Zimbabwe.[30][29]

References

  1. ^ “ICMR teams up with Bharat Biotech to develop Covid-19 vaccine”Livemint. 9 May 2020.
  2. ^ Chakrabarti A (10 May 2020). “India to develop ‘fully indigenous’ Covid vaccine as ICMR partners with Bharat Biotech”ThePrint.
  3. ^ “India’s First COVID-19 Vaccine Candidate Approved for Human Trials”The New York Times. 29 June 2020.
  4. ^ “Human clinical trials of potential Covid-19 vaccine ‘COVAXIN’ started at AIIMS”DD News. Prasar Bharati, Ministry of I & B, Government of India. 25 July 2020.
  5. ^ Press, Associated (25 July 2020). “Asia Today: Amid new surge, India tests potential vaccine”Washington Post. Retrieved 17 December 2020.
  6. ^ “Delhi: 30-year-old is first to get dose of trial drug Covaxin”The Indian Express. 25 July 2020.
  7. ^ Perappadan, Bindu Shajan (16 December 2020). “Coronavirus | Covaxin phase-1 trial results show promising results”The Hindu. Retrieved 17 December 2020.
  8. ^ Sabarwal, Harshit (16 December 2020). “Covaxin’s phase 1 trial result shows robust immune response, mild adverse events”Hindustan Times. Retrieved 17 December 2020.
  9. ^ Ella, Raches; Vadrevu, Krishna Mohan; Jogdand, Harsh; Prasad, Sai; Reddy, Siddharth; Sarangi, Vamshi; Ganneru, Brunda; Sapkal, Gajanan; Yadav, Pragya; Abraham, Priya; Panda, Samiran; Gupta, Nivedita; Reddy, Prabhakar; Verma, Savita; Rai, Sanjay Kumar; Singh, Chandramani; Redkar, Sagar Vivek; Gillurkar, Chandra Sekhar; Kushwaha, Jitendra Singh; Mohapatra, Satyajit; Rao, Venkat; Guleria, Randeep; Ella, Krishna; Bhargava, Balram (21 January 2021). “Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial”The Lancet Infectious Diseasesdoi:10.1016/S1473-3099(20)30942-7PMC 7825810PMID 33485468.
  10. Jump up to:a b Ella, Raches; Reddy, Siddhart; Jogdand, Harsh; Sarangi, Vamsi; Ganneru, Brunda; Prasad, Sai; Das, Dipankar; Dugyala, Raju; Praturi, Usha; Sakpal, Gajanan; Yadav, Pragya; Reddy, Prabhakar; Verma, Savita; Singh, Chandramani; Redkar, Sagar Vivek; Singh, Chandramani; Gillurkar, Chandra Sekhar; Kushwaha, Jitendra Singh; Mohapatra, Satyajit; Mohapatra, Satyajit; Bhate, Amit; Rai, Sanjay; Panda, Samiran; Abraham, Priya; Gupta, Nivedita; Ella, Krishna; Bhargav, Balram; Vadrevu, Krishna Mohan (8 March 2021). “Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomised, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomised phase 1 trial”The Lancet Infectious Diseasesdoi:10.1016/S1473-3099(21)00070-0.
  11. ^ “Coronavirus | Covaxin Phase III trial from November”The Hindu. 23 October 2020.
  12. ^ Ganneru B, Jogdand H, Daram VK, Molugu NR, Prasad SD, Kannappa SV, et al. (9 September 2020). “Evaluation of Safety and Immunogenicity of an Adjuvanted, TH-1 Skewed, Whole Virion InactivatedSARS-CoV-2 Vaccine – BBV152”. doi:10.1101/2020.09.09.285445S2CID 221635203.
  13. ^ “An Efficacy and Safety Clinical Trial of an Investigational COVID-19 Vaccine (BBV152) in Adult Volunteers”clinicaltrials.gov(Registry). United States National Library of Medicine. NCT04641481. Retrieved 26 November 2020.
  14. ^ “Bharat Biotech begins Covaxin Phase III trials”The Indian Express. 18 November 2020.
  15. ^ Sen M (2 December 2020). “List of states that have started phase 3 trials of India’s first Covid vaccine”mint.
  16. ^ “70%-80% Drop In Participation For Phase 3 Trials Of Covaxin: Official”NDTV. 17 December 2020.
  17. ^ “Bharat Biotech’s Covaxin given conditional nod based on incomplete Phase 3 trial results data”The Print. 3 January 2021.
  18. ^ Kumar, N. Ravi (3 March 2021). “Bharat Biotech says COVID-19 vaccine Covaxin shows 81% efficacy in Phase 3 clinical trials”The Hindu.
  19. ^ “Inside the B.1.1.7 Coronavirus Variant”The New York Times. 18 January 2021. Retrieved 29 January 2021.
  20. ^ Sapkal, Gajanan N.; Yadav, Pragya D.; Ella, Raches; Deshpande, Gururaj R.; Sahay, Rima R.; Gupta, Nivedita; Mohan, V. Krishna; Abraham, Priya; Panda, Samiran; Bhargava, Balram (27 January 2021). “Neutralization of UK-variant VUI-202012/01 with COVAXIN vaccinated human serum”bioRxiv: 2021.01.26.426986. doi:10.1101/2021.01.26.426986S2CID 231777157.
  21. ^ Hoeksema F, Karpilow J, Luitjens A, Lagerwerf F, Havenga M, Groothuizen M, et al. (April 2018). “Enhancing viral vaccine production using engineered knockout vero cell lines – A second look”Vaccine36 (16): 2093–2103. doi:10.1016/j.vaccine.2018.03.010PMC 5890396PMID 29555218.
  22. ^ “Coronavirus vaccine update: Bharat Biotech’s Covaxin launch likely in Q2 of 2021, no word on pricing yet”http://www.businesstoday.in. India Today Group. Retrieved 13 December2020.
  23. ^ “Odisha fast tracks coronavirus vaccine manufacturing unit”The New Indian Express. 7 November 2020.
  24. ^ Raghavan P (24 September 2020). “Bharat Biotech exploring global tie-ups for Covaxin manufacturing”The Indian Express.
  25. ^ Reuters Staff (22 December 2020). “Ocugen to co-develop Bharat Biotech’s COVID-19 vaccine candidate for U.S.” Reuters. Retrieved 5 January 2021.
  26. ^ “Bharat Biotech, Ocugen to co-develop Covaxin for US market”The Economic Times. Retrieved 5 January 2021.
  27. ^ “Bharat Biotech inks pact with Precisa Med to supply Covaxin to Brazil”mint. 12 January 2021.
  28. ^ Schmall E, Yasir S (3 January 2021). “India Approves Oxford-AstraZeneca Covid-19 Vaccine and 1 Other”The New York Times. Retrieved 3 January 2021.
  29. Jump up to:a b “Iran issues permit for emergency use for three other COVID-19 vaccines: Official”IRNA English. 17 February 2021.
  30. Jump up to:a b Manral, Karan (4 March 2021). “Zimbabwe approves Covaxin, first in Africa to okay India-made Covid-19 vaccine”Hindustan Times. Retrieved 6 March 2021.
  31. ^ Ghosh N (7 December 2020). “Bharat Biotech seeks emergency use authorization for Covid-19 vaccine”Hindustan Times.
  32. ^ “Coronavirus | After SII, Bharat Biotech seeks DCGI approval for Covaxin”The Hindu. 7 December 2020.
  33. ^ “Expert panel recommends granting approval for restricted emergency use of Bharat Biotech’s Covaxin”The Indian Express. 2 January 2021.
  34. ^ “Coronavirus: India approves vaccines from Bharat Biotech and Oxford/AstraZeneca”BBC News. 3 January 2021. Retrieved 3 January 2021.
  35. ^ “Disputes Mount, but Heedless Govt Intent on Rolling Vaccine Candidates Out”The Wire. 12 January 2021.
  36. ^ “AIPSN urges govt to reconsider emergency approval for Covaxin till Phase 3 data is published – Health News , Firstpost”Firstpost. 8 January 2021.

External links

Scholia has a profile for Covaxin / BBV152 (Q98703813).

COVAXIN®, Indias indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).

The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility.

The vaccine is developed using Whole-Virion Inactivated Vero Cell derived platform technology. Inactivated vaccines do not replicate and are therefore unlikely to revert and cause pathological effects. They contain dead virus, incapable of infecting people but still able to instruct the immune system to mount a defensive reaction against an infection.

Why develop Inactivated Vaccine? Conventionally, inactivated vaccines have been around for decades. Numerous vaccines for diseases such as Seasonal Influenza, Polio, Pertussis, Rabies, and Japanese Encephalitis use the same technology to develop inactivated vaccines with a safe track record of >300 million doses of supplies to date. It is the well-established, and time-tested platform in the world of vaccine technology.

Key Attributes:

  • COVAXIN® is included along with immune-potentiators, also known as vaccine adjuvants, which are added to the vaccine to increase and boost its immunogenicity.
  • It is a 2-dose vaccination regimen given 28 days apart.
  • It is a vaccine with no sub-zero storage, no reconstitution requirement, and ready to use liquid presentation in multi-dose vials, stable at 2-8oC.
  • Pre-clinical studies: Demonstrated strong immunogenicity and protective efficacy in animal challenge studies conducted in hamsters & non-human primates. For more information about our animal study, please visit our blog page on Non-Human Primates.
  • The vaccine received DCGI approval for Phase I & II Human Clinical Trials in July, 2020.
  • A total of 375 subjects have been enrolled in the Phase 1 study and generated excellent safety data without any reactogenicity. Vaccine-induced neutralizing antibody titers were observed with two divergent SARS-CoV-2 strains. Percentage of all the side-effects combined was only 15% in vaccine recipients. For further information, visit our blog page on phase 1 study.
  • In Phase 2 study, 380 participants of 12-65 years were enrolled. COVAXIN® led to tolerable safety outcomes and enhanced humoral and cell-mediated immune responses. Know more about our phase 2 study.
Covaxin phase 3 trials
  • A total of 25,800 subjects have been enrolled and randomized in a 1:1 ratio to receive the vaccine and control in a Event-Driven, randomized, double-blind, placebo-controlled, multicentre phase 3 study.

The purpose of this study is to evaluate the efficacy, safety, and immunogenicity of COVAXIN® in volunteers aged ≥18 years.

Of the 25,800 participants, >2400 volunteers were above 60 years of age and >4500 with comorbid conditions.

COVAXIN® demonstrated 81% interim efficacy in preventing COVID-19 in those without prior infection after the second dose.

COVAXIN® effective against UK variant strain:

Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralize the UK variant strains and other heterologous strains.

Global Acceptance of COVAXIN®:

Bharat biotech has been approached by several countries across the world for the procurement of COVAXIN®.

  • Clinical trials in other countries to commence soon.
  • Supplies from government to government in the following countries to take place: Mongolia, Myanmar, Sri Lanka, Philippines, Bahrain, Oman, Maldives and Mauritius.
Covaxin world map
A person holding a vial of the Covaxin vaccine
Vaccine description
TargetSARS-CoV-2
Vaccine typeInactivated
Clinical data
Trade namesCovaxin
Routes of
administration
Intramuscular
ATC codeNone
Legal status
Legal statusEUA : INDIRNZBW
Identifiers
DrugBankDB15847
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////////COVAXIN, BBV152, BBV 152, INDIA 2021, APPROVALS 2021, COVID 19, CORONA VIRUS, bharat biotech

#COVAXIN, #BBV152, #BBV 152, #INDIA 2021, #APPROVALS 2021, #COVID 19, #CORONA VIRUS, #bharat biotech

AZD1222 (ChAdOx1), Oxford–AstraZeneca COVID-19 vaccine, COVISHIELD


covishild

AZD1222 (ChAdOx1)

Identifiers
CAS Number2420395-83-9

ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) COVISHIELD™

  • DNA (recombinant simian adenovirus Ox1 ΔE1E3 vector human cytomegalovirus promoter plus human tissue plasminogen activator signal peptide fusion protein with severe acute respiratory syndrome coronavirus 2 isolate Wuhan-​Hu-​1 spike glycoprotein codon optimized-​specifying)

The University of Oxford, AstraZeneca vaccine is a vaccine that aims to protect against COVID-19.

serum institute

Manufacturer/developer: AstraZenecaUniversity of OxfordResearch name: AZD1222 (ChAdOx1)Vaccine type: Non-Replicating Viral VectorAdministration method: Intramuscular injection

Biological Components:

Covishield is a viral vector vaccine. It uses a weakened, non-replicating strain of Chimpanzee cold virus (adenovirus) to carry genetic material of the spike protein of SARS-CoV-2 into human cells

Vial of the Oxford–AstraZeneca vaccine manufactured by the Serum Institute of India (marketed as Covishield in India and in a few other countries).[5]

COVISHIELD INGREDIENTS

L-Histidine Ethanol

L-Histidine Hydrochloride Monohydrate,Magnesium Chloride

Hexahydrate Polysorbate 80*, Sucrose, Sodium Chloride

Disodium Edetate Dihydrate (EDTA) ,   Water for injection

Polysorbate 80 which is an ingredient of Covishield is known to cause anaphylactic reactions in patients as can be read here whereas Covaxin has no such component.

NAMEDOSAGESTRENGTHROUTELABELLERMARKETING STARTMARKETING END  
Astrazeneca Covid-19 VaccineInjection, suspension50000000000 {VP}/0.5mLIntramuscularAstraZeneca Pharmaceuticals LP2020-12-22Not applicableUS flag 
FORMROUTESTRENGTH
Injection, suspensionIntramuscular50000000000 {VP}/0.5mL

Storage Conditions:  can be stored at 2 to 8 degrees Celsius making them convenient to store and transport.

Mechanism of Immunization: Covishield – This vaccine produces antibodies against only a specific region of the virus. It contains a portion of the DNA that codes for the spike protein (S-protein). Once inside the cells, the DNA part first needs to enter the nucleus to create its mirror image (complementary RNA). Then this RNA comes out in the cytoplasm as a messenger and starts making S-protein through a machine available for this purpose called ribosome. Since it is S-protein that provokes immunity it may not be as close to natural immunity as created by Covaxin. If there are any long-term side effects of the DNA material remaining inside the nucleus (e.g. integration in human DNA) is not yet known. So far, DNA vaccines were only being tried out for treating cancer patients and never used for preventing infections in normal subjects.

Clinical Development: Covishield has been developed by AstraZeneca with Oxford university in the UK and is being manufactured by the Serum Institute India (SII) in Pune. Covishield has completed phase 3 trials in S. Africa, Brazil and UK. 90% of the subjects in these studies were under the age of 55 making the efficacy and safety data applicable to this age group. The company has presented bridging study results in Indian population to the regulatory authorities based on which the approval was granted by DCGI. This data is not yet available in the public domain

Dosage Regimen: Covishield has been recommended to be taken in 2 doses. Observation of data from the UK shows improved protection with a gap of 12 weeks between 2 doses; though currently the expert committee set up by the Drug Controller General of India (DCGI) has recommended a gap of 4 weeks. Covaxin has been recommended to be taken in 2 doses 4 weeks apart.

Efficacy: Covishield has an average efficacy of 70% when 2 doses are administered 4 weeks apart. This data is from a meta-analysis (pooled analysis of multiple studies) of 4 Covishield trials in 11,636 patients out of which 3 trials were single blind and one double blind in 3 different countries. The efficacy of Covishield was published in The Lancet (link to the article). Observation of data has shown that the efficacy improves as the gap between the 2 doses is increased reaching a reported efficacy of 82.4% with a 12-week gap. Since, the phase-3 trials were conducted with a 4-week interval, it has become the standard.

Protection against Mutations: Preliminary research shows both vaccines are effective against the variant of the novel coronavirus first detected in the UK but there is no data on their efficacy against the mutants found in South Africa and Brazil. Data against these 2 variants is yet to be generated for both these vaccines.

str1

. Consent: Covishield does not require any consent form as it has completed the phase-3 clinical trials

Who should not take Covishield?

Serum Institute of India’s factsheet said one should not get the Covishield vaccine if the person had a severe allergic reaction after a previous dose of this vaccine. Like Bharat Biotech, the SII factsheet also says that if a person is pregnant or plans to become pregnant or is breastfeeding she should tell the healthcare provider before taking the jab. People who have taken another anti-Covid vaccine should not take Covishield.

The ingredients of the Covishield vaccine are “L-Histidine, L-Histidine hydrochloride monohydrate, Magnesium chloride hexahydrate, Polysorbate 80, Ethanol, Sucrose, Sodium chloride, Disodium edetate dihydrate (EDTA), Water for injection,” it pointed out.

Side-effects of Covishield

Some of the very common side effects of the vaccines are tenderness, pain, warmth, redness, itching, swelling or bruising where the injection is given, generally feeling unwell, chills or feeling feverish, headache or joint aches.

Covishield is made by Serum Institute of India (SII) and Covaxin is manufactured by Bharat Biotech.

Over 50 lakh people have registered themselves on the Co-WIN portal since the window opened on Monday morning, the Centre said. Nearly 5 lakh beneficiaries above 60 or those aged 45-60 with comorbidities have received the first jab of Covid-19 vaccine till Tuesday evening.

Meanwhile, the govt has permitted all private hospitals to give Covid-19 vaccine if they adhere to the laid down norms and also asked the states and union territories to utilise the optimum capacity of private medical facilities empanelled under three categories. The states and Union Territories were also urged not to store, reserve, conserve or create a buffer stock of the COVID-19 vaccines, the Union Health Ministry said in a statement.

Sources:  https://www.bbc.com/news/world-asia-india-55748124

The Oxford–AstraZeneca COVID-19 vaccine, codenamed AZD1222,[7] is a COVID-19 vaccine developed by Oxford University and AstraZeneca given by intramuscular injection, using as a vector the modified chimpanzee adenovirus ChAdOx1.[18][19][20][21] One dosing regimen showed 90% efficacy when a half-dose was followed by a full-dose after at least one month, based on mixed trials with no participants over 55 years old.[6] Another dosing regimen showed 62% efficacy when given as two full doses separated by at least one month.[6]

The research is being done by the Oxford University’s Jenner Institute and Oxford Vaccine Group with the collaboration of the Italian manufacturer Advent Srl located in Pomezia, which produced the first batch of the COVID-19 vaccine for clinical testing.[22] The team is led by Sarah GilbertAdrian HillAndrew PollardTeresa Lambe, Sandy Douglas and Catherine Green.[23][22]

On 30 December 2020, the vaccine was first approved for use[11][24] in the UK’s vaccination programme,[25] and the first vaccination outside of a trial was administered on 4 January 2021.[26] The vaccine has since been approved by several medicine agencies worldwide, such as the European Medicines Agency,[12][14] and the Australian Therapeutic Goods Administration (TGA),[9] and has been approved for an Emergency Use Listing (EUL) by the World Health Organization.[27]

Vaccine platform

The AZD1222 vaccine is a replication-deficient simian adenovirus vector, containing the full‐length codon‐optimised coding sequence of SARS-CoV-2 spike protein along with a tissue plasminogen activator (tPA) leader sequence.[28][29].

The adenovirus is said replication-deficient because some of its essential genes were deleted and replaced by a gene coding for the spike. Following vaccination, the adenovirus vector enters the cells, releases its genes, those are transported to the cell nucleus, thereafter the cell’s machinery does the transcription in mRNA and the translation in proteins.

The one of interest is the spike protein, an external protein that enables the SARS-type coronavirus to enter cells through the enzymatic domain of ACE2.[30] Producing it following vaccination will prompt the immune system to attack the coronavirus through antibodies and T-cells if it later infects the body.[6]

History

2020 development

In February 2020, the Jenner Institute agreed a collaboration with the Italian company Advent Srl for the production of the first batch of a vaccine candidate for clinical trials.[31]

In March 2020,[32][33] after the Gates Foundation urged the University of Oxford to find a large company partner to get its COVID-19 vaccine to market, the university backed off from its earlier pledge to donate the rights to any drugmaker.[34] Also, the UK government encouraged the University of Oxford to work with AstraZeneca instead of Merck & Co., a US based company over fears of vaccine hoarding under the Trump administration.[35]

In June 2020, the US National Institute of Allergy and Infectious Diseases (NIAID) confirmed that the third phase of testing for potential vaccines developed by Oxford University and AstraZeneca would begin in July 2020.[36]

Clinical trials

In July 2020, AstraZeneca partnered with IQVIA to speed up US clinical trials.[37]

On 31 August 2020, AstraZeneca announced that it had begun enrolling adults for a US-funded, 30,000-subject late-stage study.[38]

On 8 September 2020, AstraZeneca announced a global halt to the vaccine trial while a possible adverse reaction in a participant in the United Kingdom was investigated.[39][40][41] On 13 September, AstraZeneca and the University of Oxford resumed clinical trials in the United Kingdom after regulators concluded it was safe to do so.[42] AstraZeneca was criticised for vaccine safety after concerns from experts noting the company’s refusal to provide details about serious neurological illnesses in two participants who received the experimental vaccine in Britain.[43] While the trial resumed in the UK, Brazil, South Africa, Japan[44] and India, it remained on pause in the US till 23 October 2020[45] while the Food and Drug Administration (FDA) investigated a patient illness that triggered the clinical hold, according to the United States Department of Health and Human Services (HHS) Secretary Alex Azar.[46]

On 15 October 2020, Dr João Pedro R. Feitosa, a 28-year-old doctor from Rio de Janeiro, Brazil, who received a placebo instead of the test vaccine in a clinical trial of AZD1222, died from COVID-19 complications.[47][48][49] The Brazilian health authority Anvisa announced that the trial would continue in Brazil.[50]

Results of Phase III trial

On 23 November 2020, Oxford University and AstraZeneca announced interim results from the vaccine’s ongoing Phase III trials.[6][51] There was some criticism of the methods used in the report, which combined results of 62% and 90% from different groups of test subjects given different dosages to arrive at a 70% figure.[52][53][54] AstraZeneca said it would carry out a further multi-country trial using the lower dose which had led to a 90% claim.[55]

The full publication of the interim results from four ongoing Phase III trials on 8 December 2020 clarified these reports.[56] In the group who received the first dose of active vaccine more than 21 days earlier, there were no hospitalisations or severe disease, unlike those receiving the placebo. Serious adverse events were balanced across the active and control arms in the studies, i.e. the active vaccine did not have safety concerns. A case of transverse myelitis was reported 14 days after booster vaccination as being possibly related to vaccination, with an independent neurological committee considering the most likely diagnosis to be of an idiopathic, short segment, spinal cord demyelination. The other two cases of transverse myelitis, one in the vaccine group and the other in the control group, were considered to be unrelated to vaccination.[56]

A subsequent analysis, published on 19 February, has shown an efficacy of 76% 22 days after the first dose and increase to 81.3% when the second dose is given 12 weeks or more after the first.[57]

2021 development

In February 2021, Oxford–AstraZeneca indicated developments to adapt the vaccine to target new variants of the coronavirus,[58] with expectation of a modified vaccine being available “in a few months” as a “booster jab”.[59] A key area of concern is whether the E484K mutation could impact the immune response and, possibly, current vaccine effectiveness.[60] The E484K mutation is present in the South African (B.1.351) and Brazilian (B.1.1.28) variants, with a small number of cases of the mutation also detected in infections by the original SARS-CoV-2 virus and the UK/Kent (B.1.1.7) variant.[60]

Scottish Study

A study was carried out by universities across Scotland of the effectiveness of first dose of Pfizer–BioNTech and Oxford–AstraZeneca COVID-19 vaccines against hospital admissions in Scotland, based on a national prospective cohort study of 5.4 million people. Between 8 December 2020 to 15 February 2021, 1,137,775 patients were vaccinated in the study, 490,000 of which were with the Oxford–AstraZeneca vaccine. The first dose of the Oxford–AstraZeneca vaccine was associated with a vaccine effect of 94% for COVID-19 related hospitalisation at 28–34 days post-vaccination. Results for both vaccines combined showed a vaccine effect for prevention of COVID-19 related hospitalisation which was comparable when restricting the analysis to those aged ≥80 years (81%). The majority of the patients over the age of 65 were given the Oxford–AstraZeneca vaccine. As of 22 February 2021, the study had not been peer-reviewed.[61][62]

Approvals

On 27 November 2020, the UK government asked the Medicines and Healthcare products Regulatory Agency to assess the AZD1222 vaccine for temporary supply,[63] and it was approved for use on 30 December 2020, as their second vaccine to enter the national rollout.[64]

On 4 January 2021, Brian Pinker, 82, became the first person to receive the Oxford–AstraZeneca COVID-19 vaccine outside of clinical trials.[26]

The European Medicines Agency (EMA) received an application for a conditional marketing authorisation (CMA) for the vaccine on 12 January 2021. A press release stated that a recommendation on this could be issued by the agency by 29 January, with the European Commission then making a decision on the CMA within days.[3] The Hungarian regulator unilaterally approved the vaccine instead of waiting for EMA approval.[65]

On 29 January 2021, the EMA recommended granting a conditional marketing authorisation for AZD1222 for people 18 years of age and older,[12][13] and the recommendation was accepted by the European Commission the same day.[14][66]

On 30 January 2021, the Vietnamese Ministry of Health approved the AstraZeneca vaccine for domestic inoculation, the first to be approved in Vietnam.[67]

The vaccine has also been approved by Argentina,[68] Bangladesh,[69] Brazil,[70] the Dominican Republic,[71] El Salvador,[72] India,[73][74] Malaysia,[75] Mexico,[76] Nepal,[77] Pakistan,[78] the Philippines,[79] Sri Lanka,[80] and Taiwan[81] regulatory authorities for emergency usage in their respective countries.

On 7 February 2021, the vaccine roll out in South Africa was suspended. Researchers from the University of the Witwatersrand said in a prior-to-peer analysis that the AstraZeneca vaccine provided minimal protection against mild or moderate disease infection among young people.[82][83] The BBC reported on 8 February 2021 that Katherine O’Brien, director of immunisation at the World Health Organization, indicated she felt it was “really plausible” the AstraZeneca vaccine could have a “meaningful impact” on the South African variant particularly in preventing serious illness and death.[84] The same report also indicated the Deputy Chief Medical Officer for England Jonathan Van-Tam said the (Witwatersrand) study did not change his opinion that the AstraZeneca vaccine was “rather likely” to have an effect on severe disease from the South African variant.[84]

On 10 February 2021, South Korea granted its first approval of a COVID-19 vaccine to AstraZeneca, allowing the two-shot regimen to be administered to all adults, including the elderly. The approval came with a warning, however, that consideration is needed when administering the vaccine to individuals over 65 years of age due to limited data from that demographic in clinical trials.[85][86]

On 10 February 2021, the World Health Organization (WHO) issued interim guidance and recommended the AstraZeneca vaccine for all adults, its Strategic Advisory Group of Experts also having considered use where variants were present and concluded there was no need not to recommend it.[87]

On 16 February 2021, the Australian Therapeutic Goods Administration (TGA) granted provisional approval for COVID-19 Vaccine AstraZeneca.[9][1]

On 26 February 2021, the vaccine was authorized with terms and conditions by Health Canada.[88]

Production and supply

The vaccine is stable at refrigerator temperatures and costs around US$3 to US$4 per dose.[89] On 17 December, a tweet by the Belgian Budget State Secretary revealed the European Union (EU) would pay €1.78 (US$2.16) per dose.[90]

According to AstraZeneca’s vice-president for operations and IT, Pam Cheng, the company would have around 200 million doses ready worldwide by the end of 2020, and capacity to produce 100 million to 200 million doses per month once production is ramped up.[52]

In June 2020, further to making 100 million doses available to the UK’s NHS for their vaccination programme,[91] AstraZeneca and Emergent BioSolutions signed a US$87 million deal to manufacture doses of the vaccine specifically for the US market. The deal was part of the Trump administration’s Operation Warp Speed initiative to develop and rapidly scale production of targeted vaccines before the end of 2020.[92] Catalent will be responsible for the finishing and packaging process.[93] The majority of manufacturing work will be done in the UK.[citation needed]

On 4 June 2020, the World Health Organization‘s (WHO) COVAX facility made initial purchases of 300 million doses from the company for low- to middle-income countries.[94] Also, AstraZeneca and Serum Institute of India reached a licensing agreement to supply 1 billion doses of the Oxford University vaccine to middle- and low-income countries, including India.[95][96]

On 29 September 2020, a grant from the Bill and Melinda Gates Foundation allowed COVAX to secure an additional 100 million COVID-19 vaccine doses either from AstraZeneca or from Novavax at US$3 per dose.[97]

On 13 June 2020, AstraZeneca signed a contract with the Inclusive Vaccines Alliance, a group formed by France, Germany, Italy, and the Netherlands, to supply up to 400 million doses to all European Union member states.[98][99][100] However, the European Commission intervened to stop the deal being formalised. It took over negotiations on behalf of the whole EU, signing a deal at the end of August.[101]

In August 2020, AstraZeneca agreed to provide 300 million doses to the USA for US$1.2 billion, implying a cost of US$4 per dose. An AstraZeneca spokesman said the funding also covers development and clinical testing.[102] It also reached technology transfer agreement with Mexican and Argentinean governments and agreed to produce at least 400 million doses to be distributed throughout Latin America. The active ingredients would be produced in Argentina and sent to Mexico to be completed for distribution.[103]

In September 2020, AstraZeneca agreed to provide 20 million doses to Canada.[104][105]

In October 2020, Switzerland signed an agreement with AstraZeneca to pre-order up to 5.3 million doses.[106][107]

On 5 November 2020, a tripartite agreement was signed between the government of Bangladesh, Serum Institute of India and Beximco Pharma of Bangladesh. Under the agreement Bangladesh ordered 30 million doses of Oxford–AstraZeneca vaccine from Serum through Beximco for $4 per shot.[108]

In November 2020, Thailand ordered 26 million doses of vaccine from AstraZeneca.[109] It would cover 13 million people,[110] approximately 20% of the population, with the first lot expected to be delivered at the end of May.[111][112][113] The public health minister indicated the price paid was $5 per dose;[114] AstraZeneca (Thailand) explained in January 2021 after a controversy that the price each country paid depended on production cost and differences in supply chain, including manufacturing capacity, labour and raw material costs.[115] In January 2021, the Thai cabinet approved further talks on ordering another 35 million doses[116] and the Thai FDA approved the vaccine for emergency use for 1 year.[117][118] Siam Bioscience, a company owned by Vajiralongkorn, will received technological transfer,[119] and has the capacity to manufacture up to 200 million doses a year for export to ASEAN.[120]

Also in November, the Philippines agreed to buy 2.6 million doses,[121] reportedly worth around ₱700 million (approximately $5.6/dose).[122]

In December 2020, South Korea signed a contract with AstraZeneca to secure 20 million doses of its vaccine, reportedly worth equivalently to those signed by Thailand and the Philippines,[123] with the first shipment expected as early as January 2021. As of January 2021, the vaccine remains under review by the South Korea Disease Control and Prevention Agency.[124][125] AstraZeneca signed a deal with South Korea’s SK Bioscience to manufacture its vaccine products. The collaboration calls for the SK affiliate to manufacture AZD1222 for local and global markets.[126]

On 7 January 2021, the South African government announced that they had secured an initial 1 million doses from the Serum Institute of India, to be followed by another 500,000 doses in February.[127]

Myanmar signed a contract with Serum Institute of India to secure 30 million doses of its vaccine in December 2020. Myanmar will get doses for 15 million people from February 2021.[128]

On 22 January 2021, AstraZeneca announced that in the event the European Union approved the COVID-19 Vaccine AstraZeneca, initial supplies would be lower than expected due to production issues at Novasep in Belgium. Only 31 million of the previously predicted 80 million doses would be delivered to the European Union by March 2021.[129] In an interview with Italian newspaper La Repubblica, AstraZeneca’s CEO Pascal Soriot said the delivery schedule for the doses in the European Union was two months behind schedule. He mentioned low yield from cell cultures in one large-scale European site.[130] Analysis published in The Guardian also identified an apparently low yield from bioreactors in the Belgium plant and noted the difficulties in setting up this form of process, with variable yields often occurring.[131] As a result, the European Union imposed export controls on vaccine doses; controversy erupted as to whether doses were being diverted to the UK, and whether or not deliveries to Northern Ireland would be disrupted.[132]

On 24 February 2021, Ghana became the first country in Africa to receive the Covid-19 vaccine through the COVAX initiative, where the facility sent six hundred thousand doses of AstraZeneca/Oxford jabs to Accra.[133]

Summary

Background

A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials.

Methods

This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.govNCT04324606NCT04400838, and NCT04444674.

Findings

Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation.

Interpretation

ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials.

Funding

UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D’Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland’s NIHR Clinical Research Network, and AstraZeneca.

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