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ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

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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 LIFE SCIENCES 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 PLUS year tenure till date June 2021, 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, 90 Lakh plus views on dozen plus blogs, 233 countries, 7 continents, 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 33 lakh plus views on New Drug Approvals Blog in 233 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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MVC COVID-19 vaccine, Taiwan’s covid vaccine


Taiwan's president gets jabbed with first domestic COVID-19 vaccine to stamp personal approval

Medigen vaccine

MVC COVID-19 vaccine

  • MVC-COV1901

track it https://covid19.trackvaccines.org/vaccines/24/

MVC-COV1901 is a vaccine candidate developed and commercialized by Medigen Vaccine Biologics Corporation. The vaccine candidate contains a perfusion form of the SARS-Cov2 recombinant spike protein. Medigen has combined forces with Dynavax, which offers an advanced adjuvant, CpG 1018 (also known as ISS-1018), for use with its vaccine. As of September 2020, the vaccine candidate is in Phase 1 clinical trials to assess its safety and immunogenicity (NCT04487210).

The MVC COVID-19 vaccine, designated MVC-COV1901 and also known as the Medigen COVID-19 vaccine, is a protein subunit COVID-19 vaccine developed by Medigen Vaccine Biologics Corporation [zh] in Taiwan, American company Dynavax Technologies and the U.S. National Institute of Health.[1][2]

This vaccine is made by the recombinant S-2P spike protein adjuvanted with CpG 1018 supplied by Dynavax.[3] Preliminary results from Phase I trials on 77 participants were published in June 2021, indicating what the authors described as “robust” immune system response elicited by the vaccine.[4]

The study authors have assessed the humoral immune response by measuring quantities of binding IgG to S protein, and also the cellular immune response by measuring the quantities of IFN-γ and IL-4 secreting T cells.[4]

Taiwan-based Medigen Vaccine Biologics Corporation (MVC) and Dynavax Technologies Corporation, in the US, have announced the rollout of its COVID-19 vaccine, MVC-COV1901. Approximately 600,000 people are anticipated to receive the Medigen vaccine this week.

Ryan Spencer, Chief Executive Officer of Dynavax commented, “We are pleased that Medigen’s vaccine is now available for the people of Taiwan. We are very excited for this first, of hopefully multiple, EUAs and approvals for COVID-19 vaccines that include CpG 1018 adjuvant. Considering the limitations of current vaccines and the global vaccine shortage, we believe adjuvanted vaccines can contribute significantly to current vaccination efforts.”

In July, MVC received Taiwan Emergency Use Authorization and approval for inclusion in Taiwan’s COVID-19 vaccine immunization program, MVC-COV1901.

MVC COVID-19 vaccine is indicated for adults over 20 years old and is administered in two doses 28 days apart for prevention of COVID-19.

The Advisory Committee recommended that MVC should submit safety monitoring report monthly during the declared EUA period and should submit a vaccine effectiveness report within one year after obtaining EUA approval.

(CNN)Taiwan’s President Tsai Ing-wen received her first shot of the island’s homegrown Covid-19 vaccine on Monday, a public show of support for the new drug which is central to plans for inoculation self sufficiency amid low immunization rates and struggles to obtain vaccines from overseas.Monday’s island-wide rollout of the Medigen Covid-19 vaccine, developed by Taipei-based Medigen Vaccine Biologics Corporation, comes after the drug was approved for emergency use last month by Taiwanese authorities for anyone above 20 years old, with at least 28 days between the two doses.The vaccine has yet to complete phase 3 clinical trials and no efficacy data is available.  Paul Torkehagen, Medigen’s director of overseas business development, told CNN in May that the company designed a “very large” phase 2 clinical trial to ensure the vaccine’s safety and effectiveness, with 3,800 participants. Normally, a stage 2 clinical trial only involves several hundred people. Data from the trials showed that 99.8% of participants were able to form antibodies against Covid-19 after taking two doses of the vaccine, Medigen’s CEO Charles Chen said.   Taiwanese President Tsai Ing-wen, center, receives her first shot of the island's first domestically developed coronavirus vaccine at the Taiwan University Hospital in Taipei, Taiwan on Monday, August 23.
Taiwanese President Tsai Ing-wen, center, receives her first shot of the island’s first domestically developed coronavirus vaccine at the Taiwan University Hospital in Taipei, Taiwan on Monday, August 23.   
Taiwan’s Centers for Disease Control said in a July 19 statement that the vaccine posed no serious health effects. Taiwan has ordered 5 million doses of the vaccine from Medigen and more than 700,000 people have already signed up to receive it, according to Reuters.In a Facebook post after receiving the vaccine at a hospital in Taipei, Tsai said she hadn’t suffered from any post-vaccination pain and thanked the health care workers who had administered the shot.”Taking the vaccine can protect yourself, your family, as well as medical staff,” Tsai wrote. “Let’s do our part in boosting Taiwan’s collective defense against the virus!”With its borders sealed to most travelers and strict measures enacted to contain local outbreaks, Taiwan has so far been largely successful in containing Covid-19, reporting fewer than 16,000 total confirmed infections and 828 deaths. But the island has struggled to vaccinate its more than 23 million population, partly due to difficulties obtaining doses from international suppliers.Taiwan’s government has only managed to import around 10 million Covid-19 vaccines, according to Reuters. In July it ordered another 36 million doses of the Moderna shot.Fewer than 5% of Taiwan’s population has received both doses of their Covid-19 vaccine, according to Reuters, as the island delays second dose vaccinations so more people can receive a first shot.On Monday, Taiwan reported four new Covid-19 cases, according to the Central Epidemic Command Center (CECC). Authorities announced on the weekend they would ease virus prevention measures to allow for larger gatherings and the opening of study centers and indoor amusement parks.But Health and Welfare Minister Chen Shih-chung said current Covid-19 restrictions — which include the closure of bars and nightclubs — would remain in place until at least September 6, with the possibility of an extension if the global outbreak continued to grow.Taiwan could become increasingly isolated if it keeps pursuing its “Covid zero” strategy, with both Australia and New Zealand hinting they might abandon the approach once vaccinations reach a certain level.In an opinion piece published on Sunday, Australian Prime Minister Scott Morrison said that while lockdowns to prevent Covid-19 transmission were “sadly necessary for now,” they may not be once vaccination rates increased to the targets of 70% and 80%.”This is what living with Covid is all about. The case numbers will likely rise when we soon begin to open up. That is inevitable,” he said.In neighboring New Zealand, which has also attempted to eliminate the virus within its borders, Covid-19 response minister Chris Hipkins told local media the highly-contagious Delta variant raised “some pretty big questions about what the long-term future of our plans are.”“At some point we will have to start to be more open in the future,” he said.

History

On 16 February 2020, Medigen Vaccine Biologics Corp. (MVC) signed a collaboration agreement with National Institutes of Health (NIH) for COVID-19 vaccine development. The partnership will allow MVC to obtain NIH’s COVID-19 vaccine and related biological materials to conduct animal studies in Taiwan.[5]

On 23 July 2020, Medigen Vaccine Biologics (MVC) announced collaboration with Dynavax Technologies to develop COVID-19 vaccine. The COVID-19 candidate vaccine will have the combination of SARS-CoV2 spike protein created by MVC and Dynavax’s vaccine adjuvant CpG 1018, which was used in a previously FDA-approved adult hepatitis B vaccine.[6][7]

Clinical trials

On 13 October 2020, Medigen Vaccine Biologics received Taiwan’s government subsidies for the initiation of Phase 1 Clinical Trial in Taiwan starting early October. The Phase 1 Clinical Trial was held at National Taiwan University Hospital with 45 participants ranging the age of 20-50.[8][9]

On 25 January 2021, Medigen Vaccine Biologics initiated Phase 2 Clinical Trial for its COVID-19 vaccine candidate MVC-COV1901 with the first participant being dosed. The Phase 2 Clinical Trial for the MVC COVID-19 vaccine was a randomized, double-blinded, and multi-center clinical trial, planned to enroll 3,700 participants of any age 20 above.[3][10][11]

On 10 June 2021, Medigen Vaccine Biologics released its COVID-19 vaccine Phase 2 interim analysis results, which demonstrates good safety profile in participants. The Phase 2 Clinical Trial in the end included 3,800 participants with all participants receiving second dose by 28 April 2021. Medigen Vaccine Biologics announced that it will request Emergency Use Authorization (EUA) with the concluding of the Phase 2 Clinical Trial.[12]

On 20 July 2021, Medigen Vaccine Biologics filed a Phase 3 Clinical Trial IND application with Paraguay’s regulatory authority, which was later approved. The Phase 3 Clinical Trial, however, was different from regular Phase 3 Clinical Trial, which uses immune-bridging trial to compare the performance of MVC COVID-19 vaccine with the Oxford-AstraZeneca COVID-19 vaccine.[13] The decision was a controversial announcement as immune-bridging trials were not fully approved or widely accepted by health authorities. In addition, the accuracy of immune-bridging trials were also been questioned for years.[citation needed]

Adolescents trial

In July 2021, Medigen commenced phase II trials for adolescents aged 12-18.[14]

Authorization

   Full authorization  Emergency authorization

See also: List of COVID-19 vaccine authorizations § Medigen

On July 19, 2021, MVC COVID-19 vaccine obtained Emergency Use Authorization (EUA) approval from the Taiwanese government after fulfilling EUA requirements set by Taiwanese authority.[15] The EUA, however, was met with controversy due to the lack of efficacy data and Phase 3 Clinical Trial. On August 23, 2021, President Tsai Ing-Wen was among the first Taiwanese to receive a dose of the vaccine. [16]

References

  1. ^ “Dynavax and Medigen Announce Collaboration to Develop a Novel Adjuvanted COVID-19 Vaccine Candidate”. GlobeNewswire. 23 July 2020. Retrieved 7 June 2021.
  2. ^ 黃驛淵 (10 June 2021). “【獨家】【國產疫苗解盲1】高端實體疫苗針劑首曝光 「每天9萬劑」生產基地直擊” (in Chinese). Mirror Media.
  3. Jump up to:a b “Medigen Vaccine Biologics COVID-19 Vaccine Adjuvanted with Dynavax’s CpG 1018 Announces First Participant Dosed in Phase 2 Clinical Trial in Taiwan”http://www.medigenvac.com. Retrieved 7 August 2021.
  4. Jump up to:a b Hsieh SM, Liu WD, Huang YS, Lin YJ, Hsieh EF, Lian WC, Chen C, Janssen R, Shih SR, Huang CG, Tai IC, Chang SC (25 June 2021). “Safety and immunogenicity of a Recombinant Stabilized Prefusion SARS-CoV-2 Spike Protein Vaccine (MVCCOV1901) Adjuvanted with CpG 1018 and Aluminum Hydroxide in healthy adults: A Phase 1, dose-escalation study”EClinicalMedicine: 100989. doi:10.1016/j.eclinm.2021.100989ISSN 2589-5370PMC 8233066PMID 34222848.
  5. ^ “MVC and NIH Collaborate to Develop COVID-19 Vaccine”http://www.medigenvac.com. Retrieved 7 August 2021.
  6. ^ “Medigen Collaborates with Dynavax to Develop Novel Adjuvanted COVID-19 Vaccine Candidate”http://www.medigenvac.com. Retrieved 7 August 2021.
  7. ^ “MVC Signed an License Agreement with NIH on COVID-19 Vaccine”. Medigen. 5 May 2020. Retrieved 27 July 2021.
  8. ^ “Medigen’s COVID-19 Vaccine Combined with Dynavax’s CpG 1018 Adjuvant Receives Taiwan Government Subsidy with First Participant Dosed in Early October”http://www.medigenvac.com. Retrieved 7 August 2021.
  9. ^ “A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adult (COVID-19)”clinicaltrials.gov. United States National Library of Medicine. Retrieved 11 March 2021.
  10. ^ “A Study to Evaluate the Safety and Immunogenicity of MVC-COV1901 Against COVID-19”clinicaltrials.gov. United States National Library of Medicine. Retrieved 11 March 2021.
  11. ^ “A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Elderly Adults”clinicaltrials.gov. United States National Library of Medicine. 28 March 2021. Retrieved 3 April 2021.
  12. ^ “MVC Released COVID-19 Vaccine Phase 2 Interim Analysis Result”http://www.medigenvac.com. Retrieved 7 August 2021.
  13. ^ “MVC Announces Paraguay Approval of IND Application for Phase 3 Clinical Trial”http://www.medigenvac.com. Retrieved 7 August 2021.
  14. ^ “A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adolescents”clinicaltrials.gov. United States National Library of Medicine. 6 July 2021. Retrieved 6 July 2021.
  15. ^ “MVC COVID-19 Vaccine Obtains Taiwan EUA Approval”http://www.medigenvac.com. Retrieved 7 August 2021.
  16. ^ Taiwan begins contested rollout of new Medigen domestic vaccineNikkei Asia, Erin Hale, August 23, 2021
Vaccine description
TargetSARS-CoV-2
Vaccine typeProtein subunit
Clinical data
Other namesMVC-COV1901
Routes of
administration
Intramuscular
Legal status
Legal statusFull and Emergency Authorizations: List of MVC COVID-19 vaccine authorizations
Identifiers
DrugBankDB15854
Part of a series on the
COVID-19 pandemic
COVID-19 (disease)SARS-CoV-2 (virus)CasesDeaths
showTimeline
showLocations
showInternational response
showMedical response
showEconomic impact and recession
showImpacts
 COVID-19 portal

////////Medigen vaccine, MVC COVID-19 vaccine, SARS-CoV-2, covid 19, corona virus, taiwan, approvals 2021, iss 1018, CpG 1018, MVC-COV1901

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CVnCoV, zorecimeran, CureVac COVID-19 vaccine



CVnCoV

cas 2541470-90-8 

An optimized, non-chemical modified mRNA encoding the prefusion-stabilized full-length spike protein of SARS-CoV-2 virus (Curevac)

zorecimeranCureVac COVID-19 vaccine

CureVac/Bayer

GSK

NCT04674189 NCT04449276 NCT04515147 NCT04652102
EudraCT-2020-004066-19

mRNA-based vaccine

PHASE 3

CVnCoVHumoral and cellular responsesCD4+ T-cells, CD8+ T-cellsN/AN/ARhesus macaque[124]

124. Rauch S, Gooch K, Hall Y, Salguero FJ, Dennis MJ, Gleeson FV. et almRNA vaccine CVnCoV protects non-human primates from SARS-CoV-2 challenge infectionbioRxiv. 2020. 2020 12.23.424138

The CureVac COVID-19 vaccine is a COVID-19 vaccine candidate developed by CureVac N.V. and the Coalition for Epidemic Preparedness Innovations (CEPI).[1] The vaccine showed inadequate results in its Phase III trials with only 47% efficacy.[2] The European Medicines Agency stated that: “(…) medicine developers should design studies to demonstrate a rate of efficacy of at least 50%.”[3].

The CVnCov Vaccine (or CV07050101) is in development by CureVac AG. The vaccine uses mRNA technology to create a protein associated with SARS-CoV2, and upon administration and replication, to initiate subsequent immune responses in the body. As of June 2020, the company received regulatory approval from German and Belgian Authorities to commence Phase 1 clinical trials of this vaccine (NCT04449276).

Efficacy

On 16 June 2021,[4] CureVac said its vaccine showed 47% efficacy from its Phase III trial. This was based on interim analysis of 134 COVID cases in its Phase III study conducted in Europe and Latin America. The final analysis for the trials requires a minimum of 80 additional cases.[2]

Pharmacology

CVnCoV is an mRNA vaccine that encodes the full-length, pre-fusion stabilized coronavirus spike protein, and activates the immune system against it.[5][6][7] CVnCoV technology does not interact with the human genome.[6] CVnCoV uses unmodified RNA,[8] unlike the Pfizer–BioNTech COVID-19 vaccine and Moderna COVID-19 vaccine, which both use nucleoside-modified RNA.[9]

Manufacturing

Manufacturing of mRNA vaccines can be performed rapidly in high volume,[10] including use of portable, automated printers (“RNA microfactories”) for which CureVac has a joint development partnership with Tesla.[11]

mRNA vaccines require stringent cold chain refrigeration throughout manufacturing, distribution and storage.[12][13] The CureVac technology for CVnCoV uses a non-modified, more natural mRNA less affected by hydrolysis, enabling storage at 5 °C (41 °F) and relatively simplified cold chain requirements that facilitate up to three months of storage and distribution to world regions that do not have specialized ultracold equipment.[6][10]

CureVac has a European-based network to accelerate manufacturing of CVnCoV, if proven safe and effective, for production of up to 300 million doses in 2021 and 600 million doses in 2022.[10][14] An estimated 405 million doses will be provided to EU states.[14]

Clinical trials

In November 2020, CureVac reported results of a Phase I-II clinical trial that CVnCoV (active ingredient zorecimeran) was well-tolerated, safe, and produced a robust immune response.[15][16]

In December 2020, CureVac began a Phase III clinical trial of CVnCoV with 36,500 participants.[17][18] Bayer will provide clinical trial support and international logistics for the Phase III trial, and may be involved in eventual manufacturing should the vaccine prove to be safe and effective.[19][20] In February 2021, the EU’s CHMP started a rolling review of CVnCoV.[21][22] In April 2021, the same procedure began in Switzerland.[23]

Brand names

The manufacturer currently markets the vaccine under the name CVnCoV.[24] Zorecimeran is the proposed international nonproprietary name (pINN).[25]

References

  1. ^ “CureVac focuses on the development of mRNA-based coronavirus vaccine to protect people worldwide”CureVac(Press release). 15 March 2020. Retrieved 17 February 2021.
  2. Jump up to:a b Burger, Ludwig (16 June 2021). “CureVac fails in pivotal COVID-19 vaccine trial with 47% efficacy”Reuters. Retrieved 17 June 2021.
  3. ^ https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-studies-approval#what-is-the-level-of-efficacy-that-can-be-accepted-for-approval?-section
  4. ^ “CureVac Provides Update on Phase 2b/3 Trial of First-Generation COVID-19 Vaccine Candidate, CVnCoV”. 16 June 2021.
  5. ^ https://www.curevac.com/wp-content/uploads/2020/10/20201023-CureVac-Manuscript-draft-preclinical-data.pdf
  6. Jump up to:a b c Schlake T, Thess A, Fotin-Mleczek M, Kallen KJ (November 2012). “Developing mRNA-vaccine technologies”RNA Biology9(11): 1319–30. doi:10.4161/rna.22269PMC 3597572PMID 23064118.
  7. ^ “Understanding mRNA COVID-19 vaccines”. US Centers for Disease Control and Prevention. 18 December 2020. Retrieved 5 January 2021.
  8. ^ “COVID-19”. CureVac. Retrieved 21 December 2020.
  9. ^ Dolgin, Elie (25 November 2020). “COVID-19 vaccines poised for launch, but impact on pandemic unclear”. Nature Biotechnology: d41587–020–00022-y. doi:10.1038/d41587-020-00022-yPMID 33239758S2CID 227176634.
  10. Jump up to:a b c Nawrat A (3 December 2020). “Q&A with CureVac: resolving the ultra-cold chain logistics of Covid-19 mRNA vaccines”. Pharmaceutical Technology. Retrieved 5 January 2021.
  11. ^ “Tesla to make molecule printers for German COVID-19 vaccine developer CureVac”Reuters. 2 July 2020. Retrieved 19 December 2020.
  12. ^ Kartoglu U, Milstien J (July 2014). “Tools and approaches to ensure quality of vaccines throughout the cold chain”Expert Review of Vaccines13 (7): 843–54. doi:10.1586/14760584.2014.923761PMC 4743593PMID 24865112.
  13. ^ Hanson CM, George AM, Sawadogo A, Schreiber B (April 2017). “Is freezing in the vaccine cold chain an ongoing issue? A literature review”Vaccine35 (17): 2127–2133. doi:10.1016/j.vaccine.2016.09.070PMID 28364920.
  14. Jump up to:a b Kansteiner F (17 November 2020). “CureVac, armed with COVID-19 vaccine deal, plots ‘pandemic-scale’ Euro manufacturing expansion”. FiercePharma, Questex LLC. Retrieved 5 January2021.
  15. ^ “CureVac’s Covid-19 vaccine induces immune response in study”. Clinical Trials Arena. 3 November 2020. Retrieved 5 January 2021.
  16. ^ “CureVac’s COVID-19 vaccine triggers immune response in Phase I trial”Reuters. 2 November 2020. Retrieved 5 January2021.
  17. ^ “Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older”. EU Clinical Trials Register. 19 November 2020. Retrieved 5 January 2021. Proposed INN: zorecimeran
  18. ^ “A Study to Determine the Safety and Efficacy of SARS-CoV-2 mRNA Vaccine CVnCoV in Adults”ClinicalTrials.gov. 8 December 2020. NCT04652102. Retrieved 19 December 2020.
  19. ^ Burger L (7 January 2021). “CureVac strikes COVID-19 vaccine alliance with Bayer”Reuters. Retrieved 17 February 2021.
  20. ^ “CureVac and Bayer join forces on COVID-19 vaccine candidate CVnCoV”CureVac (Press release). 7 January 2021. Retrieved 17 February 2021.
  21. ^ “EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)”European Medicines Agency (EMA) (Press release). 11 February 2021. Retrieved 12 February 2021.
  22. ^ “CureVac Initiates Rolling Submission With European Medicines Agency for COVID-19 Vaccine Candidate, CVnCoV”CureVac(Press release).
  23. ^ “CureVac starts review process in Switzerland for COVID-19 vaccine hopeful”Reuters. 19 April 2021. Retrieved 19 April 2021.
  24. ^ “Celonic and CureVac Announce Agreement to Manufacture over 100 Million Doses of CureVac’s COVID-19 Vaccine Candidate, CVnCoV”CureVac (Press release). 30 March 2021. Retrieved 14 April 2021.
  25. ^ World Health Organization (October 2020). “International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 124 – COVID-19 (special edition)” (PDF). WHO Drug Information34 (3): 668–69. Archived (PDF) from the original on 27 November 2020.

External links

Scholia has a profile for zorecimeran (Q97154239).
Vaccine description
TargetSARS-CoV-2
Vaccine typemRNA
Clinical data
Other namesCVnCoV, CV07050101
Routes of
administration
Intramuscular
ATC codeNone
Identifiers
DrugBankDB15844
UNII5TP24STD1S
Part of a series on the
COVID-19 pandemic
COVID-19 (disease)SARS-CoV-2 (virus)
showTimeline
showLocations
showInternational response
showMedical response
showImpact
 COVID-19 portal
  1. Rego GNA, Nucci MP, Alves AH, Oliveira FA, Marti LC, Nucci LP, Mamani JB, Gamarra LF: Current Clinical Trials Protocols and the Global Effort for Immunization against SARS-CoV-2. Vaccines (Basel). 2020 Aug 25;8(3). pii: vaccines8030474. doi: 10.3390/vaccines8030474. [Article]
  2. Speiser DE, Bachmann MF: COVID-19: Mechanisms of Vaccination and Immunity. Vaccines (Basel). 2020 Jul 22;8(3). pii: vaccines8030404. doi: 10.3390/vaccines8030404. [Article]
  3. CureVac & Covid-19 [Link]
  4. Smart Patients [Link]
  5. Regulatory News [Link]

////////////zorecimeran, CVnCoV, CV07050101, CORONA VACCINE, COVID 19, VACCINE, CUREVAC, SARS-CoV-2, CV07050101, SARS-CoV-2 mRNA vaccine

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ARCT-021 (LUNAR-COV19)


ARCT-021 (LUNAR-COV19)

cas 2541451-24-3

A lipid-enabled and UnlockedNucleomonomer Agent modified RNA (LUNAR) of self-replicating RNA for vaccination against spike protein of SARS-CoV-2 (Arcturus)

Self-replicating RNA vaccine

Arcturus Therapeutics and Duke-NUS Medical School, Singapore
  • OriginatorArcturus Therapeutics
  • ClassCOVID-19 vaccines; RNA vaccines; Viral vaccines
  • Mechanism of ActionImmunostimulants
  • Orphan Drug StatusNo
  • New Molecular EntityNo
  • Available For LicensingYes – COVID 2019 infections
  • Phase IICOVID 2019 infections
  • 01 Mar 2021Arcturus Therapeutics has patent pending for STARR platform in USA
  • 01 Mar 2021Immunogenicity data from a preclinical studies in COVID-2019 infections released by Arcturus Therapeutics
  • 01 Mar 2021Arcturus Therapeutics completes a phase I/II trial in COVID-2019 infection in the Singapore

ref International Journal of Biological Sciences (2021), 17(6), 1446-1460. https://www.ijbs.com/v17p1446.htm

LUNAR-COV19T7m7GpppNmNYesVEEV-FL-SN1-methyl pseudouridineSilicon column 
protein[54]

ARCT-021: Currently undergoing phase 1/2 clinical trials, it combines two technologies, i.e., saRNA STARR™ and LUNAR® lipid-mediated delivery method. It was designed to enhance and extend antigen expression, enabling vaccination at lower doses [87]. In addition, LUNAR® lipids are pH-sensitive and biodegradable, causing minimal lipid accumulation in cells after multiple dosing [87]The Arcturus COVID-19 vaccine, commonly known as ARCT-021 and LUNAR-COV19, is a COVID-19 vaccine candidate developed by Arcturus Therapeutics.

LUNAR-
COV19
1Day 00.2 μg and 10 μg (Preclinical)IMArcturus TherapeuticsN/APhase 2NCT04668339 NCT04480957[54]

54. de Alwis R, Gan ES, Chen S, Leong YS, Tan HC, Zhang SL. et alA Single Dose of Self-Transcribing and Replicating RNA Based SARS-CoV-2 Vaccine Produces Protective Adaptive Immunity In MicebioRxiv. 2020. 2020 09.03.280446
Development

Arcturus Therapeutics partnered with Singapore’s Duke–NUS Medical School to develop a COVID-19 vaccine.[1] The company also partnered with Catalent, a contract development and manufacturing organization, to manufacture multiple batches of Arcturus’ COVID-19 mRNA vaccine candidate.[2]

Clinical research

Phase I-II

LUNAR-COV19 clinical trials in humans began in July 2020.[3] On 4 January 2021, Arcturus Therapeutics started phase-2 clinical trials.[4]

Deployment

Arcturus has entered into development and supply agreements with the Economic Development Board of Singapore and supply agreements with the Israel Ministry of Health for LUNAR-COV19.[5][6]

Arcturus Therapeutics Receives FDA Allowance to Proceed with Phase 2 Study of ARCT-021 (LUNAR-COV19) Vaccine Candidate in the United States

https://www.businesswire.com/news/home/20210104005377/en/Arcturus-Therapeutics-Receives-FDA-Allowance-to-Proceed-with-Phase-2-Study-of-ARCT-021-LUNAR-COV19-Vaccine-Candidate-in-the-United-States

Phase 2 study to be conducted in the U.S. and Singapore, and will evaluate both single dose and two dose priming regimens of ARCT-021 in up to 600 participants

Anticipate interim Phase 2 data in early 2021; targeting global Phase 3 study start in Q2 2021 which could allow application for emergency use authorization/conditional approval in H2 2021January 04, 2021 07:01 AM Eastern Standard Time

SAN DIEGO–(BUSINESS WIRE)–Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a leading clinical-stage messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, today announced that the Company has received allowance of the Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for the Phase 2 clinical study of its vaccine candidate ARCT-021 following review of data from the Phase 1/2 study.

Arcturus Therapeutics Receives FDA Allowance to Proceed with Phase 2 Study of ARCT-021 (LUNAR-COV19) Vaccine Candidate in the United States

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Arcturus previously announced that the ARCT-021 Phase 2 study had been approved to proceed by the Singapore Health Sciences Authority (HSA), who reviewed the same data as reviewed by the FDA. These Phase 1/2 study results demonstrated favorable tolerability and both humoral and cellular immunogenicity following administration of ARCT-021.

The Phase 2 study will enroll 600 participants, with 450 receiving ARCT-021 and 150 receiving placebo. Both older and younger adult participants will be included. Early interim analyses of safety and immunogenicity will be performed to inform dose selection for a Phase 3 study, which is targeted to start in Q2 2021, if the Phase 2 study is successful.

“Allowance of the IND for our ARCT-021 Phase 2 clinical study represents an important milestone for the program and we look forward to starting to screen study participants at U.S. and Singapore clinical sites very soon,” said Steve Hughes, M.D., Chief Medical Officer of Arcturus. “We have advanced ARCT-021 to Phase 2 based on promising interim results from our Phase 1/2 study and extensive preclinical data. Our prior clinical results show that ARCT-021 administration results in humoral and cellular immunogenicity, and we are encouraged by an increasing body of evidence highlighting the potential importance of T cells in providing protection against SARS-CoV-2 infection and COVID-19. We believe that ARCT-021 holds promise to be a highly effective vaccine with a differentiated clinical profile, including the potential to only require a single dose for protection.”

About Arcturus Therapeutics

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a clinical-stage mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR™ mRNA Technology and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus’ diverse pipeline of RNA therapeutic and vaccine candidates includes self-replicating mRNA vaccine programs for SARS-CoV-2 (COVID-19) and Influenza, and other programs to potentially treat Ornithine Transcarbamylase (OTC) Deficiency, Cystic Fibrosis, and Cardiovascular Disease along with partnered programs including Glycogen Storage Disease Type 3, Hepatitis B Virus, and non-alcoholic steatohepatitis (NASH). Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense RNA, microRNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (205 patents and patent applications, issued in the U.S., Europe, Japan, China and other countries). Arcturus’ commitment to the development of novel RNA therapeutics has led to collaborations with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., Takeda Pharmaceutical Company Limited, CureVac AG, Synthetic Genomics Inc., Duke-NUS Medical School, and the Cystic Fibrosis Foundation. For more information visit www.ArcturusRx.com. In addition, please connect with us on Twitter and LinkedIn.

References

  1. ^ Teo J (15 April 2020). “Coronavirus: Clinical trials for Singapore’s vaccine project could start in August”The Straits Times. Retrieved 27 April 2020.
  2. ^ Stanton D (6 May 2020). “With Arcturus, Catalent bags another COVID project”Bioprocess Insider. Retrieved 8 May 2020.
  3. ^ Clinical trial number NCT04480957 for “Phase 1/2 Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects” at ClinicalTrials.gov
  4. ^ “Arcturus Therapeutics Receives FDA Allowance to Proceed with Phase 2 Study of ARCT-021 (LUNAR-COV19) Vaccine Candidate in the”. Bloomberg. 4 January 2021. Retrieved 17 January 2021.
  5. ^ Anwar N (26 November 2020). “Singapore’s co-developed vaccine candidate is in ‘good shape’ for delivery in 2021”. CNBC. Retrieved 18 March 2021.
  6. ^ Cheok M, Mookerjee I (5 August 2020). “Singapore Will Get First Claim to Any Successful Arcturus Vaccine”. Bloomberg. Retrieved 18 March 2021.

External links

Scholia has a profile for Lunar-COV19 (Q98713328).
Vaccine description
TargetSARS-CoV-2
Vaccine typemRNA
Clinical data
Other namesARCT-021, LUNAR-COV19
Routes of
administration
Intramuscular
Part of a series on the
COVID-19 pandemic
COVID-19 (disease)SARS-CoV-2 (virus)
showTimeline
showLocations
showInternational response
showMedical response
showImpact
 COVID-19 portal

/////////COVID-19, SARS-CoV-2, corona virus, singapore, ARCT 021, LUNAR-COV19

wdt-23

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ABDALA, CIGB-66


Cuban president praises progress of Abdala vaccine against Covid-19

ABDALA

CIGB-66, is a COVID-19 vaccine

Cuba says Abdala vaccine 92.28% effective against coronavirus

The announcement came just days after the government said another homegrown vaccine, Soberana 2, has proved to be 62% effective with just two of its three doses.

https://health.economictimes.indiatimes.com/news/industry/cuba-says-abdala-vaccine-92-28-effective-against-coronavirus/83735386

  • June 22, 2021, 10:03 IST

HavanaCuba said on Monday that its three-shot Abdala vaccine against the coronavirus has been proved 92.28% effective in last-stage clinical trials.

The announcement came just days after the government said another homegrown vaccine, Soberana 2, has proved to be 62% effective with just two of its three doses.

“Hit by the pandemic, our scientists at the Finlay Institute and Center for Genetic Engineering and Biotechnology have risen above all the obstacles and given us two very effective vaccines,” President Miguel Diaz-Canel tweeted.

The announcement came from state-run biopharmaceutical corporation BioCubaFarma, which oversees Finlay, the maker of Soberana 2, and the Center for Genetic Engineering and Biotechnology, the producer of Abdala.

Both vaccines are expected to be granted emergency authority by local regulators shortly.

Cuba, whose biotech sector has exported vaccines for decades, has five coronavirus vaccine candidates.

The Caribbean’s largest island is facing its worst Covid-19 outbreak since the start of the pandemic following the arrival of more contagious variants, setting new records for daily coronavirus cases.

The Communist-run country has opted not to import foreign vaccines but to rely on its own. Some experts said it was a risky bet but it appears to have paid off, putting Cuba in position to burnish its scientific reputation, generate much-needed hard currency through exports and strengthen the vaccination drive worldwide.

Several countries from Argentina and Jamaica to Mexico, Vietnam and Venezuela have expressed an interest in buying Cuba’s vaccines. Iran started producing Soberana 2 earlier this year as part of late-phase clinical trials.

Cuba’s authorities have already started administering the experimental vaccines en masse as part of “intervention studies” they hope will slow the spread of the virus.

About a million of the country’s 11.2 million residents have been fully vaccinated to date.

Daily cases have halved in the capital, Havana, since the start of the vaccination campaign a month ago, using Abdala, according to official data.

Cuba has reported a total of 169,365 Covid-19 cases and 1,170 deaths.

ABDALA, technical name CIGB-66, is a COVID-19 vaccine candidate developed by the Center for Genetic Engineering and Biotechnology in Cuba.[1][2] This vaccine candidate, named after a patriotic drama by Cuban independence hero José Martí, is a protein subunit vaccine containing COVID-derived proteins that trigger an immune response.[3] However, none of the clinical trial full results have been published. This candidate followed a previous one called CIGB-669 (MAMBISA).[4]

The vaccine is one of two Cuba-developed COVID-19 vaccines in Phase III trials.[5][6][7]

Clinical research

Phase I/II

In July 2020, CIGB-66 commenced phase I/II clinical trials.[8]

Phase III

The Phase III trial compares 3 doses of the vaccine administered at 0, 14 and 28 days against a placebo, with the primary outcome measuring the proportion of cases reported for each group 14 days after the third dose.

The trial was registered on 18 March 2021. The first dose was administered on 22 March and by April 4, the 48,000 participants had received their first dose,[9][10] and second doses started being administered from April 5.[11][12] Third doses have started being administered on 19 April[13][14][15] and on May 1, 97% of the original participants had received their 3 doses, the others 3% were lost in the process.

Intervention study

124,000 people aged 19 to 80 received 3 doses of the vaccine as part of an intervention study, with the primary outcome measuring the proportion of cases and deaths for the vaccinated compared to the unvaccinated population.[16]

A wider intervention study with the 1.7 million inhabitants of Havana is expected to start in May with the ABDALA and Soberana 2 vaccine.[17]

Efficacy

From May 3, the efficacy of the vaccine will start being evaluated.[18][19][20]

The “first evaluation of efficacy” can begin when there is 50 cases, then there is a second evaluation at 100 cases and a definitive efficacy can “finally be demonstrated” at 150 cases, Cuban Center for Genetic Engineering and Biotechnology director said.[21]

Production outside Cuba

Venezuela has claimed that it will manufacture the vaccine[22] but this claim has not yet materialised.[23] State-owned EspromedBIO will manufacture the vaccine but some “arrangements” are needed to start production.[24] In April, Nicolás Maduro said that a capacity of 2 Million doses per month is hoped to be reach by “August, September approximately”.[25

In June 2021, Vietnam’s Ministry of Health announced that negotiations were ongoing between Cuba and Vietnam for Abdala vaccine production. The Institute of Vaccines and Medical Biologicals (IVAC) was named as the focal point for receiving technology transfer.[26]

References

  1. ^ “ABDALA Clinical Study – Phase III”rpcec.sld.cu. Registro Público Cubano de Ensayos Clínicos. Retrieved 22 March 2021.
  2. ^ “ABDALA Clinical Study”rpcec.sld.cu. Registro Público Cubano de Ensayos Clínicos. Retrieved 22 March 2021.
  3. ^ Yaffe H (31 March 2021). “Cuba’s five COVID-19 vaccines: the full story on Soberana 01/02/Plus, Abdala, and Mambisa”LSE Latin America and Caribbean blog. Retrieved 31 March 2021.
  4. ^ “MAMBISA Study”rpcec.sld.cu. Registro Público Cubano de Ensayos Clínicos. Retrieved 22 March 2021.
  5. ^ “Three-shot Cuban COVID-19 vaccine candidate moves forward in phase III”http://www.bioworld.com. Retrieved 10 April 2021.
  6. ^ “Cuba’s Abdala COVID-19 vaccine enters phase 3 clinical trial – Xinhua | English.news.cn”http://www.xinhuanet.com. Retrieved 10 April 2021.
  7. ^ Zimmer C, Corum J, Wee SL. “Coronavirus Vaccine Tracker”The New York TimesISSN 0362-4331. Retrieved 10 April 2021.
  8. ^ “ABDALA Clinical Study”rpcec.sld.cu. Registro Público Cubano de Ensayos Clínicos. Retrieved 21 March 2021.
  9. ^ BioCubaFarma (4 April 2021). “[Translated] “The application of the 1st dose of #Abdala, in volunteer 48 thousand, of the Phase III Clinical Trial. Next Monday, April 5, the application of the 2nd dose of this vaccine candidate begins. #VcaunasCubanasCovid19 .””Twitter. Retrieved 10 April 2021.
  10. ^ “Covid Check-in: Cuba’s Homegrown Vaccines”AS/COA. Retrieved 10 April 2021.
  11. ^ BioCubaFarma (5 April 2021). “[Translated] “The application of the 2nd dose of the vaccine candidates begins today #Abdala and #Soberana02 , as part of the 3rd phase of the clinical trial. Workers of @Emcomed1 in Havana and eastern provinces, from very early hours they carry out their distribution until the vaccination centers””Twitter (in Spanish). Retrieved 10 April 2021.
  12. ^ “Two Cuban Vaccines Start Second Dose Phase III Trials”Kawsachun News. 5 April 2021. Retrieved 10 April 2021.
  13. ^ “Abdala: Comienza tercera dosis en el Oriente cubano”http://www.cuba.cu (in Spanish). Retrieved 21 April 2021.
  14. ^ BioCubaFarma. “[Translated] “Application of the 3rd dose of the vaccine candidate begins #Abdala in the provinces of Granma, Santiago de Cuba and Guantánamo. The application of the 2nd dose of #Soberana02 within the framework of the EC Phase III.#VacunasCubanasCovid19”Twitter. Retrieved 21 April 2021.
  15. ^ Noticias, Agencia Cubana de. “Convergen múltiples voluntades para éxito de estudio Abdala en Bayamo”ACN (in Spanish). Retrieved 21 April 2021.
  16. ^ “ABDALA-Intervention | Registro Público Cubano de Ensayos Clínicos”rpcec.sld.cu. Retrieved 10 April 2021.
  17. ^ Ministerio de Salud Pública en Cuba. “Sitio oficial de gobierno del Ministerio de Salud Pública en Cuba”Sitio oficial de gobierno del Ministerio de Salud Pública en Cuba (in Spanish). Retrieved 23 April 2021.
  18. ^ “Scientists announce Abdala’s administration of 3rd dose will finish”http://www.plenglish.com/index.php?o=rn&id=66941&SEO=scientists-announce-abdalas-administration-of-3rd-dose-will-finish (in Spanish). Retrieved 2 May 2021.
  19. ^ Noticias, Agencia Cubana de. “Concluye aplicación de vacuna Abdala en Oriente de Cuba”ACN (in Spanish). Retrieved 2 May2021.
  20. ^ “Cuba conclui ensaios clínicos de candidata a vacina contra covid-19”R7.com (in Portuguese). 2 May 2021. Retrieved 2 May2021.
  21. ^ “Abdala cerca de concluir la fase III de ensayos clínicos; Mambisa se alista para avanzar a nueva fase (+Video)”Granma.cu (in Spanish). Retrieved 3 May 2021.
  22. ^ “Cuba says it’s ‘betting it safe’ with its own Covid vaccine”NBC News. Retrieved 10 April 2021.
  23. ^ “Maduro struggles to make his grand vaccine promise”Eminetra.co.uk. 2 May 2021. Retrieved 3 May 2021.
  24. ^ “Venezuela producirá la vacuna cubana anticovid Abdala”http://www.efe.com (in Spanish). Retrieved 3 May 2021.
  25. ^ Apr 11, Reuters /; 2021; Ist, 16:27. “Indonesian President orders Java rescue efforts after quake kills 8 – Times of India”The Times of India. Retrieved 3 May 2021.
  26. ^ Ministry of Health Vietnam (16 June 2021). “Bộ trưởng Bộ Y tế đàm phán với Cuba về hợp tác sản xuất vaccine”giadinh.net.vn(in Vietnamese). Retrieved 17 June 2021.

External links

Scholia has a profile for Abdala (Q106390652).
Vaccine description
TargetSARS-CoV-2
Vaccine typeProtein subunit
Clinical data
Other namesABDALA
Routes of
administration
Intramuscular
Part of a series on the
COVID-19 pandemic
COVID-19 (disease)SARS-CoV-2 virus (variants)
showTimeline
showLocations
showInternational response
showMedical response
showImpact
 COVID-19 portal

//ABDALA, CUBA, CIGB-66,  COVID-19,  vaccine, CORONA VIRUS, SARS-CoV-2

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QazCovid-in


Kazakhstan joins list of countries with homegrown COVID-19 vaccines
Kazakhstan starts vaccination of volunteers with domestic QazCovid-in  vaccine

QazCovid-in

QazCovid-inVaccinePhase I/II/IIIThe QazCovid-in vaccine is an inactivated vaccine. Inactive viral vaccines are created by propagating viruses in cell culture (such as in Vero cells) and/or by inactivation using a chemical reagent (such as beta-propiolactone or formaldehyde). Upon vaccination, this allows the body to generate a diverse immune response against numerous viral antigens while having no threat of actually being infected because the virus is inactive.NEWS FEED December 31, 2020The Republic of Khazakstan’s QazCovid-in COVID19 vaccine enters phase 3 with an expected 3000 participants. August 28, 2020QazCovid-in, an inactive viral vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan enters Phase 1/2 clinical trials.ORGANIZATIONSResearch Institute for Biological Safety Problems, National Scientific Center for Phthisiopulmonology of the Republic of Kazakhstan, City polyclinic No. 4 of the UZO of Almaty, Clinic of the International Institute of Postgraduate Education, City Multidisciplinary Hospital of the Health Department of the Akimat of Zhambyl RegionCOUNTRIES INVOLVED TRIAL PARTICIPANTS

Phase 1: 44

Phase 2: 200

Phase 3: 3000CLINICAL TRIAL NUMBERNCT04530357NCT04691908

QazCovid-in, also known as QazVac, is an inactivated virus vaccine developed by the Research Institute for Biological Safety Problems in Kazakhstan.[499]

Kazakhstan[499]

https://fortune.com/2021/04/26/new-covid-19-vaccine-kazakhstan-qazvac/

A new vaccine on the scene: Kazakhstan begins rollout of homegrown QazVac

The world’s approved COVID-19 vaccines have all come from large economies such as the U.S., China, the U.K., Russia, and India. Until today.

On Monday, Kazakhstan started rolling out its homegrown vaccine, now known as QazVac. Before a rebranding at the end of last month, it was called QazCovid-in, but the central Asian country’s government decided that name might be a turnoff for the public.

The vaccine was developed by Kazakhstan’s Research Institute for Biological Safety Problems, which claimed 96% efficacy in the second stage of clinical trials. The final phase is still ongoing, with a conclusion expected in July, but Kazakh health authorities decided it was fine to begin the rollout as long as the 3,000-participant Phase III trial was at least halfway finished.

This isn’t an adenovirus vector vaccine like those from Johnson & Johnson and AstraZeneca—though it does share their relatively mild refrigeration requirements—nor is it an mRNA-based jab like the BioNTech/Pfizer and Moderna vaccines. Instead, it uses an inactivated form of the SARS-CoV-2 virus itself, much like China’s CoronaVac and India’s Covaxin, which are both in use, and Valneva’s vaccine, which isn’t there yet. The QazVac regimen comprises two doses, to be administered three weeks apart.

‘Turn the tide’

Health Minister Alexei Tsoi was one of the first QazVac recipients on Monday morning. Tsoi was at the start of this month on the receiving end of a public dressing-down by President Kassym-Jomart Tokayev, who was furious about the sluggish start to the country’s inoculation campaign amid rising case numbers.

“You must turn the tide, otherwise a personnel decision that is going to be very disappointing for you will follow,” Tokayev told Tsoi. The vaccination campaign, which had previously focused on frontline workers, then reportedly sprang to life for others too in the oil-rich country.

Thus far, Kazakhstan’s vaccination drive has been powered by Russia’s Sputnik V, which has been produced locally for the past couple of months (Tokayev opted for the Russian shot, rather than waiting for QazVac). By late last week, just over 800,000 people had received their first dose. Kazakhstan has a population of 18.8 million people; the government plans to inoculate 2 million each month.

Tokayev tweeted Friday that domestic production would provide vaccine availability to all citizens. If so, that would be a remarkable turnaround—Almaty health officials said five weeks ago that the largest Kazakh city had run out of vaccines, and mass vaccination would not be realistic in the near future.

QazVac may have given Tokayev the opportunity to praise Kazakhstan’s scientific prowess, but production remains a bottleneck. The first batch to be distributed runs to only 50,000 doses, and the next tranche, to be produced in May, will be of the same volume.

Tsoi said Monday that the Kazakh government was talking to Turkish manufacturers about increasing production capacity.

QazCovid-in, commercially known as QazVac,[1][2] is a COVID-19 vaccine developed by the Research Institute for Biological Safety Problems in Kazakhstan.[3][4][5] QazCoVac-P is a second COVID-19 vaccine developed by the Kazakh Biosafety Research Institute and in clinical trials.[6]

Clinical research

QazVac is currently in Phase 3 (III) of the Clinical Trial, which is expected to be fully completed by 9 July 2021.[7][8] It is unclear when the first preliminary results will be published.[9][10]

The administration of the vaccine for the general population began at the end of April 2021.[11] The Research Institute Kunsulu Zakarya’s Director General’s justification is that the trial is almost 50% completed and “people who have received [the] vaccine feel well; there have been no side-effects and the effectiveness of the vaccine is high”.[12]

Production

The vaccine was first manufactured by Kazakhstan’s Research Institute of Biological Safety Problems. Production capacity has been capped at 50,000 doses per month.

Beginning in June 2021, the vaccine is slated[13] to be packaged in large bulk to be bottled in Turkey by a major Turkish company.[14][15] This will allow for a production capacity of 500,000-600,000 doses per month.[16] The contract is still being negotiated,[17] despite earlier claims that suggesting the deal had already been finalized.[18][19]

Vaccine innoculation

The first batch of 50,000 doses was delivered on 26 April 2021, and vaccination began shortly after.[20] In June 2021, the capacity will increase to 100,000 doses per month, regardless of the contract for bottling in Turkey.[21]

Authorization

   Full authorization  Emergency authorization

See also: List of COVID-19 vaccine authorizations § QazCovid-in

Characteristics

The vaccine can be stored at standard refrigeration temperatures (2°C-8°C) and is a two-dose régime with the doses administered twenty-one days apart.[22]

References

  1. ^ “Kazakhstan: Officials under fire over vaccination failures | Eurasianet”eurasianet.org. Retrieved 11 April 2021.
  2. ^ INFORM.KZ (31 March 2021). “Vaccination with homegrown QazVac vaccine likely to start in late April”http://www.inform.kz. Retrieved 11 April 2021.
  3. ^ Yergaliyeva A (20 December 2020). “Kazakhstan Begins Vaccinating 3,000 Volunteers With Self-Made QazCovid-in”The Astana Times. Retrieved 2 March2021.
  4. ^ Clinical trial number NCT04691908 for “Immunogenicity, Efficacy and Safety of QazCovid-in® COVID-19 Vaccine” at ClinicalTrials.gov
  5. ^ “Reactogenicity, Safety and Immunogenicity of QazCovid-in® COVID-19 Vaccine – Full Text View – ClinicalTrials.gov”clinicaltrials.gov.
  6. ^ “Kazakh Biosafety Research Institute Begins Clinical Trials of Another Vaccine Against COVID-19”. The Astana Times.
  7. ^ INFORM.KZ (31 March 2021). “Vaccination with homegrown QazVac vaccine likely to start in late April”http://www.inform.kz. Retrieved 11 April 2021.
  8. ^ “QazVac готова и уже на подходе”Время (in Russian). Retrieved 11 April2021.
  9. ^ INFORM.KZ (9 April 2021). “3rd stage of clinical trials of QazCovid-in vaccine to be 50% complete by Apr 15”http://www.inform.kz. Retrieved 11 April 2021.
  10. ^ “Kazakhstan’s COVID-19 vaccine to be bottled in Turkey”http://www.aa.com.tr. Retrieved 11 April 2021.
  11. ^ tengrinews.kz (9 April 2021). “Как правильно применять казахстанскую вакцину QazVac, рассказал ученый”Главные новости Казахстана – Tengrinews.kz (in Russian). Retrieved 11 April 2021.
  12. ^ “QazVac готова и уже на подходе”Время (in Russian). Retrieved 11 April2021.
  13. ^ It’s unclear at which level of preparation the vaccine will be send to Turkey.
  14. ^ MENAFN. “Kazakh COVID-19 vaccine to be bottled in Turkey”menafn.com. Retrieved 11 April 2021.
  15. ^ “QazVac готова и уже на подходе”Время (in Russian). Retrieved 11 April2021.
  16. ^ “Kazakhstan Launches Production of First Homegrown Vaccine, ‘QazVac'”caspiannews.com. Retrieved 26 April 2021.
  17. ^ INFORM.KZ (21 April 2021). “Healthcare Ministry comments on production of QazVac vaccine”http://www.inform.kz. Retrieved 22 April 2021.
  18. ^ “К концу апреля в Казахстане будет выпущено 50000 доз собственной вакцины”“СНГ СЕГОДНЯ” – последние новости стран СНГ читайте на SNG.TODAY. Retrieved 12 April 2021.
  19. ^ “Kazakhstan’s COVID-19 vaccine to be bottled in Turkey”http://www.aa.com.tr. Retrieved 12 April 2021.
  20. ^ contributor, Guest (26 April 2021). “Kazakhstan launches QazVac, its own COVID-19 vaccine”EU Reporter. Retrieved 26 April 2021.
  21. ^ “Казахстанскую вакцину QazVac будут разливать в Турции”informburo.kz(in Russian). 9 April 2021. Retrieved 12 April 2021.
  22. ^ INFORM.KZ (26 April 2021). “Health Minister Alexei Tsoi to be one of the first to get homegrown QazCovid-in vaccine”http://www.inform.kz. Retrieved 26 April 2021.

External links

Scholia has a profile for QazCovid-in (Q99518269).

The QazCovid-in vaccine, an inactivated vaccine, was developed and tested in the Kazakh Research Institute for Biological Safety Problems1. It demonstrated high efficacy, safety, and immunogenicity at 96% in initial Phase I and II trials (NCT04530357), and will now be undergoing upcoming Phase III trials2,3.

  1. The Astana Times: Kazakhstan Begins Vaccinating 3,000 Volunteers With Self-Made QazCovid-in [Link]
  2. The Lancet: COVID-19 response in central Asia [Link]
  3. Economic Research Institute: QazCovid-in [Link]
Vaccine description
TargetSARS-CoV-2
Vaccine typeInactivated
Clinical data
Routes of
administration
Intramuscular
Identifiers
DrugBankDB16441
Part of a series on the
COVID-19 pandemic
COVID-19 (disease)SARS-CoV-2 virus (variants)
showTimeline
showLocations
showInternational response
showMedical response
showImpact
 COVID-19 portal

///////////QazVac, COVID 19, vaccine, QazCovid-in, kazakhastan, SARS-CoV-2, corona virus

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Convidicea (Ad5-nCoV)


A vial of Convidecia vaccine
Vaccine description
TargetSARS-CoV-2
Vaccine typeViral vector
Clinical data
Trade namesConvidecia
Routes of
administration
IntramuscularIntranasal
ATC codeNone
Legal status
Legal statusFull and Emergency authorizations
Identifiers
DrugBankDB15655

Convidicea (Ad5-nCoV)

Recombinant vaccine (adenovirus type 5 vector)

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

CanSino Biologics, china

see https://covid19.trackvaccines.org/vaccines/2/

AD5-nCOV, trade-named Convidecia, is a single-dose[1] viral vector vaccine for COVID-19 developed by CanSino Biologics. It conducted its Phase III trials in Argentina,[2] Chile,[3] Mexico,[4] Pakistan,[5] Russia,[6] and Saudi Arabia[7] with 40,000 participants.

In February 2021, global data from Phase III trials and 101 COVID cases showed that the vaccine had a 65.7% efficacy in preventing moderate symptoms of COVID-19, and 91% efficacy in preventing severe disease.[8] It has similar efficacy to Johnson & Johnson’s Ad26.COV2.S, another one-shot adenovirus vector vaccine with 66% efficacy in a global trial.[9][1] Convidecia is similar to other viral vector vaccines like AZD1222Gam-COVID-Vac, and Ad26.COV2.S.[10] Its single-dose regimen and normal refrigerator storage requirement (2°to 8 °C) could make it a favorable vaccine option for many countries.[9]

Convidecia is approved for use by some countries in Asia,[11][12][13] Europe,[14][15] and Latin America.[16][17][18] Production capacity for Ad5-NCov should reach 500 million doses in 2021. Manufacturing will take place in China,[19] Malaysia,[13] Mexico,[20] and Pakistan.[21]

Ad5-nCoV is a recombinant adenovirus type-5 vector (Ad5) vaccine currently being investigated for prophylaxis against SARS-CoV-2.1,2 It is being developed by CanSino Biologics Inc., in partnership with the Beijing Institute of Biotechnology, who in March 2020 announced the approval of a phase I clinical trial (ChiCTR2000030906)1 with an expected completion in December 2020. The study will evaluate antibody response in healthy patients between the ages of 18 and 60 who will receive one of three study doses, with follow-up taking place at weeks 2 and 4 and months 3 and 6 post-vaccination.2

  1. Chinese Clinical Trial Register: A phase I clinical trial for recombinant novel coronavirus (2019-COV) vaccine (adenoviral vector) [Link]
  2. Antibody Society: COVID-19 Archives [Link]

Technology

Convidecia is a viral vector vaccine similar to AstraZeneca‘s AZD1222 and Gamaleya‘s Gam-COVID-Vac.[10] Ad5-nCOV can be stored in less extreme cold conditions compared to mRNA vaccines.[22][9]

Efficacy

In February 2021, data released from an interim analysis of Phase III trials with 30,000 participants and 101 COVID cases showed that globally, the vaccine had an efficacy of 65.7% at preventing moderate cases of COVID-19 and 90.98% efficacy at preventing severe cases. In the Pakistan trial subset, the vaccine had an efficacy of 74.8% at preventing symptomatic cases 100% for preventing severe disease.[8]

While the efficacy rates were lower than the Pfizer–BioNTech and Moderna vaccines, its single-dose regimen and normal refrigerator storage requirement (2 to 8 °C) could make it a favorable option for many countries. It has similar efficacy to Johnson & Johnson’s Ad26.COV2.S, another one-shot adenovirus vaccine found to be 66% effective in a global trial.[9][1]

Clinical trials

Phase I-II

In early 2020, Chen Wei led a joint team of the Institute of Biotechnology, the Academy of Military Medical Sciences and CanSino Biologics to develop AD5-nCOV. According to the Chinese state media, the team registered an experimental COVID-19 vaccine for Phase I trial in China on 17 March 2020 to test its safety. The trial was conducted on 108 healthy adults aged 18 to 60 in two medical facilities in WuhanHubei province.[23]

In April, Ad5-nCoV became the first COVID-19 vaccine candidate in the world to begin Phase II trials.[24] The Phase II trial results were published in the peer-reviewed journal The Lancet in August 2020, and noted neutralizing antibody and T cell responses based on statistical analyses of data involving 508 eligible participants.[25] In September, Zeng Guang, chief scientist of the Chinese Center for Disease Control and Prevention said the amount of COVID-19 antibodies in subjects from the Phase I trials remained high six months after the first shot. Zeng said the high levels of antibodies suggested the shots may provide immunity for an extended period of time, although Phase III results were still required.[26] On September 24, CanSino began Phase IIb trials on 481 participants to evaluate the safety and immunogenicity of Ad5-nCoV for children ages 6–17 and elderly individuals ages 56 and above.[27]

In August, China’s National Intellectual Property Administration issued the country’s first COVID-19 vaccine patent to CanSino.[28]

On 16 May 2020, Canadian Prime Minister Justin Trudeau announced Health Canada had approved Phase II trials to be conducted by the Canadian Center for Vaccinology (CCfV) on the COVID-19 vaccine produced by CanSino. Scott Halperin, director of the CCfV said the vaccine would not be the only one going into clinical trials in Canada, and any potential vaccine would not be publicly available until after Phase 3 is complete.[29][30] If the vaccine trials were successful, then the National Research Council would work with CanSino to produce and distribute the vaccine in Canada.[30] In August 2020, the National Research Council disclosed the vaccine had not been approved by Chinese customs to ship to Canada, after which the collaboration between CanSino and the Canadian Center for Vaccinology was abandoned.[31]

Nasal spray trials

In September, CanSino began a Phase I trial in China with 144 adults to determine the safety and immunogenicity of the vaccine to be administered as a nasal spray, in contrast with most COVID-19 vaccine candidates which require intramuscular injection.[32] On June 3, 2021, Chen Wei announced the expansion of clinical trials was approved by the NMPA, in the meantime, they are applying for Emergency Use Listing for the nasal spray.[33]

Phase III

In August, Saudi Arabia confirmed it would begin Phase III trials on 5,000 people for Ad5-nCoV in the cities of Riyadh, Dammam, and Mecca.[7]

In October, Mexico began Phase III trials on 15,000 volunteers.[34][4]

In September, Russia began Phase III trials on 500 volunteers,[35] which Petrovax later received approval from the government to expand to 8,000 more volunteers.[36][6]

In September, Pakistan began Phase III trials on 40,000 volunteers as part of a global multi-center study.[5] As of December, about 13,000 volunteers have participated in trials of Ad5-nCoV.[22]

In November, Chile began Phase III trials on 5,200 volunteers to be managed by University of La Frontera.[37][3]

In December, Argentina’s Fundación Huésped began Phase III trials in 11 health centers in the metropolitan area of Buenos Aires and Mar del Plata.[2]

Combination trials

In April 2021, a new trial was registered in Jiangsu involving one dose of Convidecia followed by a dose of ZF2001 28 or 56 days later using different technologies as a way to further boost efficacy.[38]

Manufacturing

In February, Chen Wei who lead the development of the vaccine, said annual production capacity for Ad5-NCov could reach 500 million doses in 2021.[19]

In February, Mexico received the first batch of active ingredients for Convidecia, which is being packaged in Querétaro by Drugmex.[20]

In Malaysia, final filling and packaging of the vaccine for distribution would be completed by Solution Biologics.[13]

In May, Pakistan began filling and finishing 3 million doses a month at the National Institute of Health, which would be branded as PakVac for domestic distribution.[39]

If the vaccine is approved in Russia, Petrovax said it would produce 10 million doses per month in 2021.[40]

Marketing and deployment

 
  Full authorization  Emergency authorization  Eligible COVAX recipient (ongoing assessment)[41]

See also: List of COVID-19 vaccine authorizations § Convidecia

Asia

On 25 June 2020, China approved the vaccine for limited use by the military.[42] In February 2021, China approved the vaccine for general use.[11]

In February, Malaysia‘s Solution Biologics agreed to supply 3.5 million doses to the government.[43] The doses would be delivered starting in April with 500,000 complete doses, with the rest in bulk to be finished by Solution Biologics.[13]

In October, Indonesia reached an agreement with CanSino to deliver 100,000 doses in November 2020, with the expectation that an additional 15 to 20 million doses would be delivered in 2021.[44]

In February, Pakistan approved the vaccine for emergency use.[45] The country purchased 20 million doses of the vaccine[12] of which the first 3 million doses are to arrive in May.[12]

Europe

In March, Hungary granted emergency use approval for the vaccine.[14]

In March, Moldova authorized use of the vaccine.[46]

North America

In December 2020, Mexico‘s Foreign Minister Marcelo Ebrard signed an agreement for 35 million doses.[47] In February, Mexico approved the vaccine for emergency use.[48] Mexico received active ingredients for 2 million doses with a total of 6 million doses expected to arrive in February.[16]

South America

In June, Argentina approved emergency use of the vaccine and ordered 5.4 million doses.[17]

In June, Brazil announced plans to purchase 60 million doses.[49] In May, Brazil began reviewing the vaccine for emergency use.[50]

In March, Chile signed a deal for 1.8 million doses for delivery between May and June,[51] for which emergency use approval was granted in April.[18]

In June, Ecuador approved emergency use and ordered 6 million doses for delivery between June and August 2021.[52]

References

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  2. Jump up to:a b “Comenzará en la Argentina un nuevo estudio de vacuna recombinante contra el SARS-CoV-2”infobae (in Spanish). 14 December 2020. Retrieved 2020-12-15.
  3. Jump up to:a b “Gob.cl – Article: Science Minister: “We Work With Maximum Rigor So That Science And Technology Benefit People’S Health””Government of Chile. Retrieved 2020-11-21.
  4. Jump up to:a b “Chinese Covid vaccine trials to be expanded to five more states”Mexico News Daily. 2020-11-10. Retrieved 2020-11-11.
  5. Jump up to:a b “Phase III Trial of A COVID-19 Vaccine of Adenovirus Vector in Adults 18 Years Old and Above – Full Text View – ClinicalTrials.gov”clinicaltrials.gov. Retrieved 2020-10-21.
  6. Jump up to:a b Reuters Staff (2020-12-07). “Russia approves clinical trials for Chinese COVID-19 vaccine Ad5-Ncov: Ifax”Reuters. Retrieved 2020-12-07.
  7. Jump up to:a b Eltahir N (9 August 2020). “CanSino to start Phase III trial of COVID-19 vaccine in Saudi”Reuters. Retrieved 9 August 2020.
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  10. Jump up to:a b Zimmer C, Corum J, Wee SL (2020-06-10). “Coronavirus Vaccine Tracker”The New York TimesISSN 0362-4331. Retrieved 2020-12-12.
  11. Jump up to:a b Liu R (2021-02-25). “China approves two more domestic COVID-19 vaccines for public use”Reuters. Retrieved 2021-02-26.
  12. Jump up to:a b c “Pakistan purchases over 30 million COVID doses from China: sources”ARY NEWS. 2021-04-25. Retrieved 2021-04-26.
  13. Jump up to:a b c d “Malaysia to receive CanSino vaccine this month | The Malaysian Insight”http://www.themalaysianinsight.com. Retrieved 2021-04-03.
  14. Jump up to:a b Ashok R (2021-03-22). “UPDATE 2-China’s CanSino Biologics COVID-19 vaccine receives emergency use approval in Hungary”Reuters. Retrieved 2021-03-22.
  15. ^ “Membrii NITAG au venit cu recomandări privind utilizarea vaccinurilor împotriva COVID-19 în Republica Moldova”Ministerul Sănătății, Muncii și Protecţiei Sociale. 2021-03-03. Retrieved 2021-05-21.
  16. Jump up to:a b “‘Our gratitude always’: From China’s CanSino, Mexico welcomes biggest vaccine shipment yet”Reuters. 2021-02-11. Retrieved 2021-02-11.
  17. Jump up to:a b “Argentina issues emergency approval to China’s single-dose Cansino COVID-19 vaccine”Reuters. 2021-06-11. Retrieved 2021-06-11.
  18. Jump up to:a b “ISP Approves Emergency Use And Importation Of Cansino Vaccine To Fight COVID-19”Institute of Public Health of Chile. Retrieved 2021-04-08.
  19. Jump up to:a b “China can hit 500-mln-dose annual capacity of CanSinoBIO COVID-19 vaccine this year”finance.yahoo.com. Retrieved 2021-02-28.
  20. Jump up to:a b Solomon DB (2021-02-28). “China’s CanSino says first vaccines packaged in Mexico will be ready in March”Reuters. Retrieved 2021-03-12.
  21. ^ “Pakistan develops homemade anti-Covid vaccine ‘PakVac'”The Express Tribune. 2021-05-24. Retrieved 2021-05-25.
  22. Jump up to:a b Constable P, Hussain S. “Defying fears and skepticism, thousands in Pakistan volunteer for Chinese vaccine trials”The Washington PostISSN 0190-8286. Retrieved 2021-01-01.
  23. ^ Cui J (23 March 2020). “Human vaccine trial gets underway”China Daily. Retrieved 18 April 2020.
  24. ^ Xie J (15 April 2020). “China Announces Phase 2 of Clinical Trials of COVID-19 Vaccine”Voice of America. Retrieved 18 April2020.
  25. ^ Zhu FC, Guan XH, Li YH, Huang JY, Jiang T, Hou LH, et al. (August 2020). “Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial”Lancet396 (10249): 479–488. doi:10.1016/S0140-6736(20)31605-6PMC 7836858PMID 32702299.
  26. ^ O’Brien E (2020-09-25). “Covid Antibodies Endure Over Six Months in China Trial Subjects”http://www.bloomberg.com. Retrieved 2020-09-29.
  27. ^ “Phase IIb Clinical Trial of A COVID-19 Vaccine Named Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) – Full Text View – ClinicalTrials.gov”clinicaltrials.gov. Retrieved 2020-10-21.
  28. ^ Yu S (17 August 2020). “China grants country’s first COVID-19 vaccine patent to CanSino: state media”Reuters. Retrieved 17 August 2020.
  29. ^ Bogart N (16 May 2020). “Health Canada approves first clinical trial for potential COVID-19 vaccine”CTV News. Retrieved 7 September 2020.
  30. Jump up to:a b Ryan H (May 16, 2020). “Canada’s first COVID-19 vaccine trials approved for Halifax university”CBC News. Retrieved January 4, 2021.
  31. ^ Cooke A (26 August 2020). “Canadian COVID-19 clinical trial scrapped after China wouldn’t ship potential vaccine”CBC News. Retrieved 7 September 2020.
  32. ^ “A Clinical Trial of a Recombinant Adenovirus 5 Vectored COVID-19 Vaccine (Ad5-nCoV) With Two Doses in Healthy Adults – Full Text View – ClinicalTrials.gov”clinicaltrials.gov. Retrieved 25 September 2020.
  33. ^ Cao X, Liu Y (2021-06-04). “陈薇院士:雾化吸入式新冠疫苗正在申请紧急使用”Sci Tech Daily. Chinanews.com. Retrieved 2021-06-04.
  34. ^ “México recibe el primer lote de la vacuna candidata de CanSino Biologics; alistan pruebas”EL CEO (in Spanish). 2020-11-03. Retrieved 2020-11-03.
  35. ^ “Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Against COVID-19 – Full Text View – ClinicalTrials.gov”clinicaltrials.gov. Retrieved 2020-10-21.
  36. ^ Bloomberg News (2020-11-25). “Russia’s Richest Man Seeks Global Market for Local Covid-19 Drug – BNN Bloomberg”BNN. Retrieved 2020-11-28.
  37. ^ Yáñez PL (2020-11-15). “Así funcionan las cuatro vacunas que se probarán en Chile”La Tercera. Retrieved 2020-11-17.
  38. ^ “China trials mixing of CanSinoBIO’s and Zhifei Longcom’s COVID-19 vaccines -data”Reuters. 2021-04-19. Retrieved 2021-06-16.
  39. ^ “Covid vaccine: Pakistan starts production of CanSino, China’s single-dose jab”Khaleej Times. Retrieved 2021-05-28.
  40. ^ “Russian Recruits Show ‘No Side Effects’ in Chinese Coronavirus Vaccine Trials”The Moscow Times. 2020-09-21. Retrieved 2020-09-22.
  41. ^ “Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process”World Health Organization (WHO).
  42. ^ Reuters Staff (2020-06-29). “CanSino’s COVID-19 vaccine candidate approved for military use in China”Reuters. Retrieved 2020-12-13.
  43. ^ Reuters Staff (2021-02-04). “Malaysia’s Solution Group to supply 3.5 million doses of CanSino vaccine to government”Reuters. Retrieved 2021-02-04.
  44. ^ Taufiqurrahman M. “Indonesia can be manufacutring hub for COVID-19 vaccine, says Chinese foreign minister”. Jakarta Post. Retrieved 13 October 2020.
  45. ^ Shahzad A (2021-02-12). “Pakistan approves Chinese CanSinoBIO COVID vaccine for emergency use”Reuters. Retrieved 2021-02-12.
  46. ^ “Membrii NITAG au venit cu recomandări privind utilizarea vaccinurilor împotriva COVID-19 în Republica Moldova”Ministerul Sănătății, Muncii și Protecţiei Sociale. 2021-03-03. Retrieved 2021-05-21.
  47. ^ Reuters Staff (2020-12-10). “Mexico agrees to buy 35 million doses of CanSino COVID vaccine”Reuters. Retrieved 2020-12-10.
  48. ^ “Mexico approves China’s CanSino and Sinovac COVID-19 vaccines”Reuters. 10 February 2021.
  49. ^ “Brazil to buy single-shot Chinese COVID-19 vaccine”Reuters. 2021-06-15. Retrieved 2021-06-16.
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Further reading

External links

Scholia has a profile for Ad5-nCoV (Q96695265).

/////////Convidicea, Ad5-nCoV, Recombinant vaccine, adenovirus type 5 vector, CanSino Biologics, china, SARS-CoV-2, corona virus, vaccine, covid 19

Convidecia

 
  Full authorization  Emergency authorization  Eligible COVAX recipient (ongoing assessment)[2]

Convidecia is a viral vector vaccine[478] produced by the Chinese company CanSino Biologics and the Beijing Institute of Biotechnology of the Academy of Military Medical Sciences.Full (1)

  1. China[479]

Emergency (8)

  1. Argentina[480]
  2. Chile[481]
  3. Ecuador[482]
  4. Hungary[483][272]
  5. Malaysia[484]
  6. Mexico[436]
  7. Moldova[229]
  8. Pakistan[485]

wdt-17

NEW DRUG APPROVALS

one time

$10.00

EpiVacCorona


Russia approves 2nd coronavirus vaccine "EpiVacCorona"

Origin of EpiVacCorona antigenes

  1. MKIEEGKLVIWINGDKGYNGLAEVGKKFEKDTGIKVTVEHPDKLEEKFPQVAATGDGPDIIFWAHDRFGGYAQSGLLAEITPDKAFQDKLYPFTWDAVRYNGKLIAYPIAVEALSLIYNKDLLPNPPKTWEEIPALDKELKAKGKSALMFNLQEPYFTWPLIAADGGYAFKYENGKYDIKDVGVDNAGAKAGLTFLVDLIKNKHMNADTDYSIAEAAFNKGETAMTINGPWAWSNIDTSKVNYGVTVLPTFKGQPSKPFVGVLSAGINAASPNKELAKEFLENYLLTDEGLEAVNKDKPLGAVALKSYEEELAKDPRIAATMENAQKGEIMPNIPQMSAFWYAVRTAVINAASGRQTVDEALKDAQTNSSSNNNNNNNNNNLGDNGPQNQRNAPRITFGGPSDSTGSNQNGERSGARSKQRRPQGLPNNTASWFTALTQHGKEDLKFPRGQGVPINTNSSPDDQIGYYRRATRRIRGGDGKMKDLSPRWYFYYLGTGPEAGLPYGANKDGIIWVATEGALNTPKDHIGTRNPANNAAIVLQLPQGTTLPKGFYAEGSRGGSQASSRSSSRSRNSSRNSTPGSSRGTSPARMAGNGGDAALALLLLDRLNQLESKMSGKGQQQQGQTVTKKSAAEASKKPRQKRTATKAYNVTQAFGRRGPEQTQGNFGDQELIRQGTDYKHWPQIAQFAPSASAFFGMSRIGMEVTPSGTWLTYTGAIKLDDKDPNFKDQVILLNKHIDAYKTFPPTEPKKDKKKKADETQALPQRQKKQQTVTLLPAADLDDLSKQLQQSMSSADSTQA. “Carrier protein sequence”.

EpiVacCorona

Federal Budgetary Research Institution State Research Center of Virology and Biotechnology

peptide, russia

PATENT https://www.fips.ru/registers-doc-view/fips_servlet?DB=RUPAT&DocNumber=2743594&TypeFile=htmlRU 2 743 594 RU 2 743 593RU 2 743 595 RU 2 738 081 Science (Washington, DC, United States) (2021), 372(6538), 116-117. 

EpiVacCorona (Russian: ЭпиВакКорона, tr. EpiVakKorona) is a peptide-based vaccine against COVID-19 developed by the VECTOR center of Virology.[1][2][3] It consists of three chemically synthesized peptides (short fragments of a viral spike protein) that are conjugated to a large carrier protein. This protein is a fusion product of a viral nucleocapsid protein and a bacterial MBP protein.The third phase of a clinical trial, which should show whether the vaccine is able to protect people from COVID-19 or not, was launched in November 2020 with more than three thousand participants.[2] It is assumed it will be completed in August 2021.[2] According to the vaccine developers, the peptides and the viral part of the chimeric protein should immunize people who received this vaccine against SARS-CoV-2 and trigger the production of protective antibodies. However, some experts in the field have expressed concerns about the selection of peptides for use as vaccine antigens.[3][4] In addition, there are also serious concerns about the vaccine immunogenicity data, which have fueled independent civic research efforts[5][6][7] and criticism by some experts.[3][8][4][9][10] Meanwhile, the EpiVacCorona has received vaccine emergency authorization in a form of government registration and is available for vaccination outside the clinical trials.[11] The vaccine delivered via intramuscular route and aluminum hydroxide serves as an immunological adjuvant.

Description[edit]

Origin of EpiVacCorona antigenes

Composition

The vaccine includes three chemically synthesized short fragments of the viral spike protein – peptides, which, according to the developers of EpiVacCorona represent the protein regions containing B-cell epitopes that should be recognized by the human immune system.

These peptides are represented by following amino acid sequences:

1) CRLFRKSNLKPFERDISTEIYQAGS, 2) CKEIDRLNEVAKNLNESLIDLQE, 3) CKNLNESLIDLQELGKYEQYIK.[1][12][13]

In the vaccine all peptides are conjugated to a carrier protein, which is an expression product of the chimeric gene. This chimeric gene was created by fusion of two genes originating from different organisms, namely a gene encoding a viral nucleocapsid protein and a gene encoding a bacterial maltose-binding protein (MBP). The fusion chimeric gene expressed in Escherichia coli. The sequence of the chimeric protein is available from the patent.[4] The genetic construct of the chimeric gene also includes a short genetic fragment encoding a polyhistidine-tag, which is used to purify the chimeric protein from E. coli lysate. After the purification, the protein is conjugated with three peptides in a way that only one variant of the peptide molecule is attached to each protein molecule. As a result, three types of conjugated molecules are created: chimeric protein with attached peptide number 1, the same protein with peptide number 2, and finally the same protein with peptide number 3. All three types of conjugated molecules are included in the vaccine.[citation needed]

EpiVacCorona: antigens origin and composition

Vaccine antigens and antibodies

According to the developers’ publications,[14][5][6] vaccine antigens are three peptides of the spike protein and a chimeric protein consisting of two parts (viral nucleocapsid protein and bacterial maltose-binding protein). In addition, the polyhistidine-tag – a short peptide that is introduced into a vaccine composition to purify a chimeric protein from a bacterial lysate – is also a vaccine antigen against which antibodies can form in those who have received the vaccine. A person vaccinated with EpiVacCorona can develop antibodies not only to the peptides of the spike protein, but also to other antigens present in the vaccine. According to Anna Popova who is a head of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare, it takes 42 days for those vaccinated with EpiVacCorona to develop immunity.[15]

figure2

Development

Immunogenic peptide screening in rabbits for EpiVacCorona design

Preclinical studies

The primary screening of peptides for the search for the most immunogenic ones was carried out in animals. The level of antibodies that was triggered by each tested peptide after administration to rabbits was measured. In the test, hemocyanin protein was used as a carrier protein for the studied peptides. Further, on six species of animals (mice, rats, rabbits, African green monkeys, rhesus monkeys, guinea pigs), the vaccine was shown to be harmless in terms of such parameters as general toxicity, allergic properties, and mutagenic activity. In four species of animals (hamsters, ferrets, African green monkeys, rhesus monkeys), specific activity was shown: immunogenicity and protective properties against SARS-CoV-2. The main results of preclinical studies are published in the “Bulletin of the Russian Academy of Medical Sciences”.[12][13]

Clinical studies

The studies development timeline was reported in Russian media in January 2021.[16] There are currently two clinical trials of EpiVacCorona registered in the ClinicalTrials.gov database.[17][18][2]

Phase I-II

The trial “Study of the Safety, Reactogenicity and Immunogenicity of “EpiVacCorona” Vaccine for the Prevention of COVID-19 (EpiVacCorona)”[18] was registered in clinical trial database with ClinicalTrials.gov identifier: NCT04780035. Another trial with the same title was registered with ClinicalTrials.gov Identifier: NCT04527575. Results of the trial that included data on 86 participants were published in Russian Journal of Infection and Immunity, indicating preliminary evidence of safety and an immune response.[1] The publication reports preliminary results of the first two phases of clinical trials of the vaccine in volunteers, of which 14 people aged 18-30 years participated in the first phase, and 86 volunteers aged 18-60 years in the second phase. It is claimed that antibodies were formed in 100% of the volunteers, and the vaccine is also claimed to be safe.[1]

EpiVacCorona Vaccine Development Timeline

Phase III

The third phase of a clinical trial, which should show whether the vaccine is able to protect people from COVID-19 or not, was launched in November 2020 with more than three thousand participants planned. It is expected to be completed in September 2021.[2] In the clinical trials database the phase III trial etitled “Study of the Tolerability, Safety, Immunogenicity and Preventive Efficacy of the EpiVacCorona Vaccine for the Prevention of COVID-19[2]” was registered only in March 2021 with ClinicalTrials.gov Identifier: NCT04780035. Phase 3-4 trial was registered in Russia at 18.11.2020 with 4991 participants planned.[19]

Intellectual property

The following patents of the Russian Federation for invention have been published, which protect the EpiVacCorona vaccine:

Peptide immunogens and vaccine composition against coronavirus infection COVID-19 using peptide immunogens” (No. 2738081). There are 7 peptides in patented vaccine compositions.

Peptide immunogens and vaccine composition against coronavirus infection COVID-19 using peptide immunogens” (No. 2743593). The patented vaccine composition contains 2 peptides.

Peptide immunogens used as a component of a vaccine composition against coronavirus infection COVID-19″ (No. 2743594). The patented vaccine composition contains 3 peptides.

Vaccine composition against coronavirus infection COVID-19″ (No. 2743595). The patented vaccine composition contains 3 peptides.

In all of these patents, the carrier protein is referred to as a chimeric fusion protein with an amino acid sequence derived from two parts, a bacterial maltose binding protein and a viral nucleocapsid protein.[20]

EpiVacCorona vaccine registration certificate

Authorization

 
  Full authorization  Emergency authorization

See also: List of COVID-19 vaccine authorizations § EpiVacCorona

The VECTOR has received vaccine emergency authorization in a form of government registration in October 2020.[21]

In Russia phase III clinical study is called post-registration study. Therefore, government registration of the vaccine means permission to perform phase III clinical research and public vaccination outside of clinical trials as well.[21] Since December 2020, the vaccine has been released for public vaccination in Russia.[22]

As of March 2021, Turkmenistan is the only foreign state to register EpiVacCorona with full authorization.[23][24]

Russia’s Chief Health Officer Anna Popova said: “In December 2020 the EpiVacCorona documents were presented to the World Health Organization, and we are expecting a decision from WHO.”[25] However, Deutsche Welle reports “As of March 1, the WHO had yet to receive an Expression of Interest (EOI) from EpiVacCorona’s developers, “VECTOR,” to enable WHO experts to evaluate their vaccine.”[26]

Export

The Deputy Director-General of the World Health Organization (WHO) Dr. Soumya Swaminathan during news conference in Geneva that took place in October 2020, told: “We will only be able to have a position on a vaccine when we see results of the phase III clinical trials.”[27] According to the center’s director Rinat Maksyutov, many government and non-government organizations want to test or be involved in the production of the vaccine.[28] As of March 30, Venezuela obtained 1000 doses of the Russian EpiVacCorona vaccine for a trial.[29] Venezuela also has reached a deal to purchase doses of the vaccine, as well as manufacture it locally, Vice President Delcy Rodriguez provided this information on June 4, 2021.[30] Turkmenistan expects to receive EpiVacCorona, as the vaccine has already been approved for use in that country.[31]

Controversy

Independent study of clinical trial participants

Ministry of Health’s response to a request from trial participants to perform independent antibody screening tests

English translation of Ministry of Health’s response to a request from trial participants to perform independent antibody screening tests.

At the start of the Phase III, trial participants and those vaccinated outside the trial began to form a community through the Telegram messenger network. On January 18, 2021, the members of the community turned to the Ministry of Health of the Russian Federation with an open letter, in which they stated that the production of antibodies after vaccination among them is much lower than declared by vaccine developers. Study participants claimed that antibodies were not found in more than 50% of those who documented their participation in the study, although only 25% of the participants should have had a placebo according to the study design. The trial participants also claimed that negative results were obtained using the a special ELISA test developed and recommended by VECTOR for EpiVacCorona detection.[5][6][4] More questions about the quality and protectiveness of antibodies induced by EpiVacCorona appeared along with the first results of a special antibody VECTOR’s test, when, with a positive special test, negative results of all other commercially available tests were otained: LIAISON SARS-CoV-2 S1 / S2 IgG – DiaSorin, IgM / IgG – Mindray, SARS-CoV-2 IgG – Abbott Architect, Anti-SARS-CoV-2 ELISA (IgG) – Euroimmun, Access SARS-CoV-2 IgG (RBD) – Beckman Coulter, “SARS-CoV-2-IgG-ELISA -BEST “-” Vector-Best “,” Anti-RBD IgG “- Gamaleya Research Center.[5][6][4][8] Clinical trial participants conducted their own antibody mini-study that was performed in independent Russian laboratory. The study participants asked Dr. Alexander Chepurnov, the former head of the infectious diseases department at VECTOR, who now works at another medical institute, to check neutralizing antibodies presence in their serum samples.[3] They also sent to Dr. Chepurnov control serum samples from former COVID-19 patients or people vaccinated with another Russian vaccine, Sputnik V, which is known to trigger the production of neutralizing antibodies.[32] All serum samples were blinded before antibody tests. On 23 March 2021, the participants reported the results of their mini-study in an open letter to the Ministry of Health of the Russian Federation.[6][7] According to the letter, even with the help of the VECTOR antibody detection system, antibodies were detected only in 70-75% of those vaccinated with EpiVacCorona. However, the level of antibodies was very low. Moreover, according to the letter, virus-neutralizing antibodies were not detected in the independent research Dr. Alexander Chepurnov laboratory at all.[3][6][7] The trial participants asked Ministry of Health in their open letter to perform independent study for the verification of their findings.[3][6][7] In addition, the letter reports 18 cases of COVID-19 cases as of March 22, 2021 among those who received the vaccine and became ill (sometimes severe) three weeks or later after the second dose of EpiVacCorona.[33][6][7] April 20, 2021 the study participants got a reply, with refusal of performing any additional verification antibody tests or investigation of sever COVID-19 cases among vaccinated individuals. The reply include the following text: “Considering that the listed immunobiological preparations (vaccines) for the prevention of COVID-19 are registered in the prescribed manner, their effectiveness and safety have been confirmed.”

Vaccine criticism by independent experts

Some independent experts criticized the vaccine design[3][4] and clinical data presentation in the publication.[8][9][10] The experts are saying that peptide selection is “crucial” for the innovative peptide approach, which VECTOR uses for EpiVacCorona design. However, some researchers are not convinced that the viral spike protein peptides selected for the vaccine are actually “visible” by human immune system.[3][4][34] They stated that these peptides do not overlap[35] with peptides that have been shown in several publications to contain human linear B cell epitopes in spike protein of SARS-CoV-2.[36][37][38][39][40] Moreover, the study was criticized for the lack of positive control of convalescent plasma samples in reports related to neutralizing antibody titers in vaccinated individuals.[1][10] The same study was also criticized for presence of detectable antibodies in negative controls samples that were not discussed by authors.[1][10] In addition, vaccine developers have been criticized for aggressively advertising their vaccine efficacy prior to the completion of phase III clinical trial. The most substantial criticism came from Dr. Konstantin Chumakov, who currently serves as the Associate Director for Research at the FDA Office of Vaccines Research and Review. Dr. Chumakov said: “I would not be in a hurry to call this peptide formulation a vaccine yet, because its effectiveness has not yet been proven…For the introduction of such a vaccine, the level of evidence must be much higher, and therefore the developers of EpiVacCorona, before launching their vaccine on the market, had to conduct clinical trials and prove that their vaccine actually protects against the disease. However, such tests were not carried out, which is absolutely unacceptable.”[41]

The title page of the “EpiVacCorona” patent with Anna’s Popova name among inventors

Conflict of interest

The vaccine design was protected by several already issued patents (see section above). In each patent one of its co-authors is a namesake of Anna Popova who is a head of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare. This patent authorship represents an issue as far as Anna Popova is a head of the Russian agency that is charged with overseeing vaccine safety and efficacy. As a co-author of these patents, she might have an interest in promoting the vaccine despite its shortcomings.

References

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  20. ^MKIEEGKLVIWINGDKGYNGLAEVGKKFEKDTGIKVTVEHPDKLEEKFPQVAATGDGPDIIFWAHDRFGGYAQSGLLAEITPDKAFQDKLYPFTWDAVRYNGKLIAYPIAVEALSLIYNKDLLPNPPKTWEEIPALDKELKAKGKSALMFNLQEPYFTWPLIAADGGYAFKYENGKYDIKDVGVDNAGAKAGLTFLVDLIKNKHMNADTDYSIAEAAFNKGETAMTINGPWAWSNIDTSKVNYGVTVLPTFKGQPSKPFVGVLSAGINAASPNKELAKEFLENYLLTDEGLEAVNKDKPLGAVALKSYEEELAKDPRIAATMENAQKGEIMPNIPQMSAFWYAVRTAVINAASGRQTVDEALKDAQTNSSSNNNNNNNNNNLGDNGPQNQRNAPRITFGGPSDSTGSNQNGERSGARSKQRRPQGLPNNTASWFTALTQHGKEDLKFPRGQGVPINTNSSPDDQIGYYRRATRRIRGGDGKMKDLSPRWYFYYLGTGPEAGLPYGANKDGIIWVATEGALNTPKDHIGTRNPANNAAIVLQLPQGTTLPKGFYAEGSRGGSQASSRSSSRSRNSSRNSTPGSSRGTSPARMAGNGGDAALALLLLDRLNQLESKMSGKGQQQQGQTVTKKSAAEASKKPRQKRTATKAYNVTQAFGRRGPEQTQGNFGDQELIRQGTDYKHWPQIAQFAPSASAFFGMSRIGMEVTPSGTWLTYTGAIKLDDKDPNFKDQVILLNKHIDAYKTFPPTEPKKDKKKKADETQALPQRQKKQQTVTLLPAADLDDLSKQLQQSMSSADSTQA. “Carrier protein sequence”.
  21. Jump up to:a b “Russia begins post-registration trials of EpiVacCorona Covid-19 vaccine”http://www.clinicaltrialsarena.com. Retrieved 25 April 2021.
  22. ^ “Вакцина “ЭпиВакКорона” поступила в гражданский оборот”РИА Новости (in Russian). 11 December 2020. Retrieved 23 April 2021.
  23. ^ “Turkmenistan registers vaccines for the prevention of infectious diseases”Turkmenistan Today. 29 January 2021.
  24. ^ “Turkmenistan: Master Berdymukhamedov goes to Moscow | Eurasianet”eurasianet.org. Retrieved 25 April 2021.
  25. ^ “Russia submits EpiVacCorona vaccine documents to WHO – Rospotrebnadzor head Popova”interfax.com. Retrieved 23 April 2021.
  26. ^ Welle (www.dw.com), Deutsche. “Two more Russian vaccines: What we do and don’t know | DW | 09.03.2021”DW.COM. Retrieved 23 April 2021.
  27. ^ “COVID-19 vaccine: WHO in talks with Russia on its second vaccine EpiVacCorona”mint. 16 October 2020. Retrieved 9 June 2021.
  28. ^ “Vector Center says has over 45 inquiries from abroad about its EpiVacCorona vaccine”TASS. Retrieved 25 April 2021.
  29. ^ Foundation, Thomson Reuters. “Venezuela receives doses of Russian EpiVacCorona vaccine for trials”news.trust.org. Retrieved 25 April 2021.
  30. ^ “Venezuela to purchase and manufacture Russia’s EpiVacCorona vaccine”Reuters. 5 June 2021. Retrieved 13 June 2021.
  31. ^ turkmenportal. “Turkmenistan Approves Use of Russia’s EpiVacCorona Vaccine | Society”Business Turkmenistan Information Center. Retrieved 25 April 2021.
  32. ^ Jones, Ian; Roy, Polly (20 February 2021). “Sputnik V COVID-19 vaccine candidate appears safe and effective”The Lancet397 (10275): 642–643. doi:10.1016/S0140-6736(21)00191-4ISSN 0140-6736PMC 7906719PMID 33545098.
  33. ^ “Участники КИ “ЭпиВакКороны” продолжают исследовать эффективность вакцины”pcr.news. Retrieved 24 April 2021.
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  36. ^ Yi, Zhigang; Ling, Yun; Zhang, Xiaonan; Chen, Jieliang; Hu, Kongying; Wang, Yuyan; Song, Wuhui; Ying, Tianlei; Zhang, Rong; Lu, HongZhou; Yuan, Zhenghong (December 2020). “Functional mapping of B-cell linear epitopes of SARS-CoV-2 in COVID-19 convalescent population”Emerging Microbes & Infections9 (1): 1988–1996. doi:10.1080/22221751.2020.1815591ISSN 2222-1751PMC 7534331PMID 32844713.
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External links

EpiVacCorona vaccine
Vaccine description
TargetSARS-CoV-2
Vaccine typePeptide subunit
Clinical data
Trade namesEpiVacCorona
Routes of
administration
Intramuscular
ATC codeNone
Legal status
Legal statusRegistered in Russia on 14 October 2020 RU Registered.TU approved.Full list : List of EpiVacCorona COVID-19 vaccine authorizations
Identifiers
DrugBankDB16439
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COVID-19 pandemic
COVID-19 (disease)SARS-CoV-2 (virus)
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 COVID-19 portal

EpiVacCorona Vaccine, developed by the Vektor State Research Center of Virology and Biotechnology in Russia, is based on peptide-antigens that facilitate immunity to the SARS-CoV-2 virus1. It is currently being tested in Phase I/II clinical trials for safety and immunogenicity (NCT04527575)1,2.

  1. Precision Vaccinations: VACCINE INFO EpiVacCorona Vaccine [Link]
  2. The Pharma Letter: Russia’s EpiVacCorona vaccine post-registration trials started [Link]

//////EpiVacCorona, SARS-CoV-2, RUSSIA, CORONA VIRUS, COVID 19, VACCINE, PEPTIDE

wdt-16

NEW DRUG APPROVALS

ONE TIME

$10.00

ZF2001, ZIFIVAX


Republic of Uzbekistan
Oʻzbekiston Respublikasi  (Uzbek)
FlagState emblem

ZF2001

ZIFIVAX

CAS 2609662-31-7 

A COVID-19 vaccine comprising a dimeric form of SARS-CoV-2 receptor-binding domain (RBD) produced in China hamster ovary (CHO) cells and adjuvanted with aluminum hydroxide (Anhui Zhifei Longcom/Institute of Microbiol. China Academy of Sciences)

Recombinant vaccine

Anhui Zhifei Longcom Biopharmaceutical, Institute of Microbiology of the Chinese Academy of Sciences

China, Uzbekistan

CHO Cells Recombinant Vaccine

  • ZF-2001
  • ZF-UZ-VAC2001
  • Chinese Academy of Sciences (Originator)
  • Zhifei Longcom (Originator)

Human SARS-CoV-2 (Covid-19 coronavirus) vaccine consisting of recombinant dimer comprising two RBD domains (R319-K527) of the spike glycoprotein of SARS-CoV-2 fused via a disulfide link; expressed in CHO cells

ZF-2001 is a recombinant coronavirus vaccine jointly developed by the Institute of Microbiology of the Chinese Academy of Sciences and Zhifei Longcom. The vaccine became available in 2021 in Uzbekistan under an emergency use authorization for the prevention of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (COVID-19). The vaccine is currently evaluated in phase III clinical trials.

This vaccine candidate, developed in China, uses SARS-CoV-2 protein subunits that are entirely engineered, created, and secreted by Chinese Hamster Ovary (CHO) cells1. The vaccine candidate is sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. and is undergoing phase I clinical trials to evaluate safety and tolerability.

ZF2001, trade-named ZIFIVAX, is an adjuvanted protein subunit COVID-19 vaccine developed by Anhui Zhifei Longcom in collaboration with the Institute of Microbiology at the Chinese Academy of Sciences.[1][2] As of December 2020, the vaccine candidate was in Phase III trials with 29,000 participants in ChinaEcuadorMalaysiaPakistan, and Uzbekistan.[3][4]

ZF2001 employs technology similar to other protein-based vaccines in Phase III trials from NovavaxVector Institute, and Medicago.[5] It is administered in 3 doses over a period of 2 months.[6]

ZF2001 was first approved for use in Uzbekistan and later China.[7][8] Production capacity is expected to be one billion doses a year.[6] Phase II results published in The Lancet on the three dose administration showed seroconversion rates of neutralizing antibodies of between 92% to 97%.[9]

Anhui Zhifei Longcom Biopharmaceuticals began a phase 3 clinical trial for its recombinant protein vaccine candidate in December, according to the WHO. State-run China Global Television Network in November reported that a one-year trial would take place in Uzbekistan and aim to recruit 5,000 volunteers. Anhui Zhifei is a unit of private firm Chongqing Zhifei Biological Products. It is co-developing the vaccine with the Chinese Academy of Sciences, a government institution.

Emergency Use Authorization received in UZ by Zhifei Longcom for the prevention of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (COVID-19)

Description

As described in Cell, the CoV spike receptor-binding domain (RBD) is an attractive vaccine target for coronaviruses but is constrained by limited immunogenicity, however a dimeric form of MERS-CoV RBD offers greater protection. The RBD-dimer significantly increases neutralizing antibodies compared to a conventional monomeric form and protected mice against MERS-CoV infection. CoV RBD-dimer have been produced at high yields in pilot scale production.[10]

Rather than injecting a whole virus, subunit vaccines contains virus particles specially selected to stimulate an immune response. Because the fragments are incapable of causing disease, subunit vaccines are considered very safe.[11] Subunit vaccines in widespread use include the Hepatitis B vaccine and Pertussis vaccine. However, as only a few viral components are included in the vaccine which does not display the full complexity of the virus, their efficacy may be limited.[12] Subunit vaccines are delivered alongside adjuvants and booster doses may be required.[11]

According to industry experts, production for this kind of vaccine is stable and reliable, and easier to achieve large-scale industrial production at home and overseas. However it was noted it can be very inconvenient for people to come back for a second and third dose.[6]

figure2

ZF2001 (Anhui Zhifei Longcom Biopharmaceutical/Chinese Academy of Medical Sciences)

The latest subunit vaccine candidate to enter Phase 3 clinical studies is the adjuvanted RBD-dimeric antigen designed by Anhui Zhifei Longcom Biopharmaceutical and the Institute of Microbiology of the Chinese Academy of Medical Sciences. Phase 3 clinical study was launched on December104 and will be initially carried out in China and Uzbekistan while Indonesia, Pakistan and Ecuador will follow as study sites (Clinical Trial Identifier: NCT04646590 and Registration Number: ChiCTR2000040153). The design of the study involves recruitment of 22,000 volunteers from China and 7000 subjects outside China for a total of 29,000 volunteers. There are still no published results on this candidate, however data from its Phase 2 placebo-controlled clinical trial (Clinical Trial Identifier: NCT04466085) conducted on a total of 900 participants ranging from 18 to 59 years old suggest that a 2 or 3 dose regimen is evaluated. Each immunization will be separated by the next by 4 weeks.

Development

Phase I and II trials and results

In June, Longcom began a double-blind, randomized, placebo parallel controlled Phase I trial with 50 participants aged 18–59 in Chongqing divided into low-dose, high-dose, and placebo groups.[13]

In July, Longcom began a randomized, double-blind, placebo-controlled Phase II trial with 900 participants aged 18–59 in ChangshaHunan divided into low-dose, high-dose, and placebo groups.[14] In August, an additional Phase II trial was launched with 50 participants aged 60 and above.[15][1]

In Phase II results published in The Lancet, on the two-dose schedule, seroconversion rates of neutralizing antibodies after the second dose were 76% (114 of 150 participants) in a 25 μg group and 72% (108 of 150) in a 50 μg group. On the three-dose schedule, seroconversion rate of neutralizing antibodies after the third dose were 97% (143 of 148 participants) in the 25 μg group and 93% (138 of 148) in the 50 μg group. 7 to 14 days after the administration of the third dose, the GMTs of neutralizing antibodies reached levels that were significantly higher than observed in human convalescent serum of recovering COVID-19 patients, especially in the 25 μg group.[9]

Phase III trials

In December, Longcom began enrollment of a Phase III randomized, double-blind, placebo-controlled clinical trial for 29,000 participants, including 750 participants between 18-59 and 250 participants 60 and older in China and 21,000 participants between 18-59 and 7,000 participants 60 and older outside China.[16][17]

In December, Malaysia‘s MyEG announced it would conduct Phase III trials. If the trials were successful, MyEG would be the sole distributor of ZF2001 in Malaysia for 3 years.[4]

In December, Uzbekistan began a year-long Phase III trial of ZF2001 with 5,000 volunteers between 18 and 59.[18][19]

In December, Ecuador‘s Minister of Health, Juan Carlos Zevallos announced Phase III trials would involve between 5,000 and 8,000 volunteers.[20]

In February, Pakistan‘s Drug Regulatory Authority (DRAP) approved Phase III trials with approximately 10,000 participants to be conducted at UHS Lahore, National Defense Hospital, and Agha Khan Hospital.[21]

Discussions to begin Phase III trials are also underway in Indonesia.[17][22]

COVID-19 Variants

In February, lab studies of twelve serum samples taken from recipients of BBIBP-CorV and ZF2001 retained neutralizing activity against the Beta variant although with weaker activity than against the original virus.[23] For ZF-2001, geometric mean titers declined by 1.6-fold, from 106.1 to 66.6, which was less than antisera from mRNA vaccine recipients with a 6-folds decrease.[24] Preliminary clinical data from Novavax and Johnson & Johnson also showed they were less effective in preventing COVID-19 in South Africa, where the new variant is widespread.[23]

Manufacturing

The company’s vaccine manufacturing facility was put into use in September.[17] In February 2021, Pu Jiang, General Manager of Zhifei Longcom, said the company had an annual production capacity of 1 billion doses.[6]

Marketing and deployment

 
  Full authorization  Emergency authorization

See also: List of COVID-19 vaccine authorizations § RBD-Dimer

On March 1, Uzbekistan granted approval for ZF2001 (under tradename ZF-UZ-VAC 2001) after having taken part in the Phase III trials.[8] In March, Uzbekistan received 1 million doses and started vaccinations in April.[25] By May, a total of 3 million doses had been delivered.[26]

On March 15, China approve of ZF2001 for emergency use after being approved by Uzbekistan earlier in the month.[7]

References

  1. Jump up to:a b “Anhui Zhifei Longcom: RBD-Dimer – COVID19 Vaccine Tracker”covid19.trackvaccines.org. Retrieved 27 December2020.
  2. ^ “COVID-19 Vaccine: ZIFIVAX by Anhui Zhifei Longcom Biopharma, Institute of Microbiology Chinese Academy of Sciences”covidvax.org. Retrieved 27 December 2020.
  3. ^ “Fifth Chinese Covid-19 vaccine candidate ready to enter phase 3 trials”South China Morning Post. 20 November 2020. Retrieved 27 December 2020.
  4. Jump up to:a b Ying TP (7 December 2020). “MYEG to conduct phase 3 clinical trial for China’s Covid-19 vaccine in Msia | New Straits Times”NST Online. Retrieved 27 December 2020.
  5. ^ Zimmer C, Corum J, Wee SL (10 June 2020). “Coronavirus Vaccine Tracker”The New York TimesISSN 0362-4331. Retrieved 27 December 2020.
  6. Jump up to:a b c d “China’s production bottleneck ‘could be eased with latest Covid-19 vaccine'”South China Morning Post. 17 March 2021. Retrieved 18 March 2021.
  7. Jump up to:a b Liu, Roxanne (15 March 2021). “China IMCAS’s COVID-19 vaccine obtained emergency use approval in China”Reuters. Retrieved 15 March 2021.
  8. Jump up to:a b Mamatkulov, Mukhammadsharif (1 March 2021). “Uzbekistan approves Chinese-developed COVID-19 vaccine”Reuters. Retrieved 2 March 2021.
  9. Jump up to:a b Yang, Shilong; Li, Yan; Dai, Lianpan; Wang, Jianfeng; He, Peng; Li, Changgui; Fang, Xin; Wang, Chenfei; Zhao, Xiang; Huang, Enqi; Wu, Changwei (24 March 2021). “Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19 in adults: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials”The Lancet Infectious Diseases0doi:10.1016/S1473-3099(21)00127-4ISSN 1473-3099PMC 7990482PMID 33773111.
  10. ^ Dai L, Zheng T, Xu K, Han Y, Xu L, Huang E, et al. (August 2020). “A Universal Design of Betacoronavirus Vaccines against COVID-19, MERS, and SARS”Cell182 (3): 722–733.e11. doi:10.1016/j.cell.2020.06.035PMC 7321023PMID 32645327.
  11. Jump up to:a b “What are protein subunit vaccines and how could they be used against COVID-19?”http://www.gavi.org. Retrieved 27 December2020.
  12. ^ Dong Y, Dai T, Wei Y, Zhang L, Zheng M, Zhou F (October 2020). “A systematic review of SARS-CoV-2 vaccine candidates”Signal Transduction and Targeted Therapy5 (1): 237. doi:10.1038/s41392-020-00352-yPMC 7551521PMID 33051445.
  13. ^ Clinical trial number NCT04445194 for “Phase I Clinical Study of Recombinant Novel Coronavirus Vaccine” at ClinicalTrials.gov
  14. ^ Clinical trial number NCT04466085 for “A Randomized, Blinded, Placebo-controlled Trial to Evaluate the Immunogenicity and Safety of a Recombinant New Coronavirus Vaccine (CHO Cell) With Different Doses and Different Immunization Procedures in Healthy People Aged 18 to 59 Years” at ClinicalTrials.gov
  15. ^ Clinical trial number NCT04550351 for “A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Tolerability of Recombinant New Coronavirus Vaccines (CHO Cells) in Healthy People Aged 60 Years and Above” at ClinicalTrials.gov
  16. ^ Clinical trial number NCT04646590 for “A Phase III Randomized, Double-blind, Placebo-controlled Clinical Trial in 18 Years of Age and Above to Determine the Safety and Efficacy of ZF2001, a Recombinant Novel Coronavirus Vaccine (CHO Cell) for Prevention of COVID-19” at ClinicalTrials.gov
  17. Jump up to:a b c “Another Chinese Covid-19 vaccine enters late-stage human trials with a plan to produce 300 million doses annually”Business Insider. Retrieved 27 December 2020.
  18. ^ Reuters Staff (11 November 2020). “Uzbekistan to carry out late-stage trial of Chinese COVID-19 vaccine candidate”Reuters. Retrieved 27 December 2020.
  19. ^ “Uzbekistan poised to start trials on Chinese COVID-19 vaccine | Eurasianet”eurasianet.org. Retrieved 27 December 2020.
  20. ^ “Ecuador participará en ensayos de una vacuna china contra el covid-19”CNN (in Spanish). 29 December 2020. Retrieved 23 January 2021.
  21. ^ “China’s third vaccine enters Pakistan”The Nation. 15 February 2021. Retrieved 28 February 2021.
  22. ^ “Covid vaccine tracker: How do the leading jabs compare?”http://www.ft.com. 23 December 2020. Retrieved 27 December 2020.
  23. Jump up to:a b Liu, Roxanne (3 February 2021). “Sinopharm’s COVID-19 vaccine remained active against S.Africa variant, effect reduced – lab study”Reuters. Retrieved 29 March 2021.
  24. ^ Huang, Baoying; Dai, Lianpan; Wang, Hui; Hu, Zhongyu; Yang, Xiaoming; Tan, Wenjie; Gao, George F. (2 February 2021). “Neutralization of SARS-CoV-2 VOC 501Y.V2 by human antisera elicited by both inactivated BBIBP-CorV and recombinant dimeric RBD ZF2001 vaccines”bioRxiv: 2021.02.01.429069. doi:10.1101/2021.02.01.429069.
  25. ^ uz, Kun. “Uzbekistan receives 1 million doses of ZF-UZ-VAC 2001 vaccine”Kun.uz. Retrieved 28 March 2021.
  26. ^ Romakayeva, Klavdiya (18 May 2021). “Uzbekistan receives third batch of Chinese-Uzbek COVID-19 vaccine”Trend.Az. Retrieved 19 May 2021.

 

Vaccine description
TargetSARS-CoV-2
Vaccine typeProtein subunit
Clinical data
Trade namesZIFIVAX
Routes of
administration
Intramuscular
ATC codeNone
Identifiers
DrugBankDB15893
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Corbevax, BioE COVID-19, BECOV2D


Corbevax

BioE COVID-19, BECOV2D

the Baylor College of Medicine in Houston, United States,

Dynavax Technologies

Adjuvanted protein subunit vaccine

Corbevax is a “recombinant protein sub-unit” vaccine, which means it is made up of a specific part of SARS-CoV-2 — the spike protein on the virus’s surface.

The spike protein allows the virus to enter the cells in the body so that it can replicate and cause disease. However, when this protein alone is given to the body, it is not expected to be harmful as the rest of the virus is absent. The body is expected to develop an immune response against the injected spike protein. Therefore, when the real virus attempts to infect the body, it will already have an immune response ready that will make it unlikely for the person to fall severely ill.

Although this technology has been used for decades to make hepatitis B vaccines, Corbevax will be among the first Covid-19 vaccines to use this platform. Novavax has also developed a protein-based vaccine, which is still waiting for emergency use authorisation from various regulators.

How Corbevax was made

While it is indigenously produced, Corbevax’s beginnings can be traced to the Baylor College of Medicine’s National School of Tropical Medicine. The School had been working on recombinant protein vaccines for coronaviruses SARS and MERS for a decade.

“We knew all the techniques required to produce a recombinant protein (vaccine) for coronaviruses at high levels of efficiency and integrity,” said Dr Peter Hotez, Professor and Dean at the School.

When the genetic sequence for SARS-CoV-2 was made available in February 2020, researchers at the School pulled out the sequence for the gene for the spike protein, and worked on cloning and engineering it. The gene was then put into yeast, so that it could manufacture and release copies of the protein. “It’s actually similar to the production of beer. Instead of releasing alcohol, in this case, the yeast is releasing the recombinant protein,” Dr Hotez said.

After this, the protein was purified to remove any remnants of the yeast “to make it pristine”. Then, the vaccine was formulated using an adjuvant to better stimulate the immune response.

Most of these ingredients are cheap and easy to find.

In August, BCM transferred its production cell bank for this vaccine to Biological E, so that the Hyderabad-based company could take the candidate through trials. The vaccine has received approval for phase 3 trials, which the government expects will be over by July.

Biological E is also expected to scale up production for the world.

How Corbevax is different

Other Covid-19 vaccines approved so far are either mRNA vaccines (Pfizer and Moderna), viral vector vaccines (AstraZeneca-Oxford/Covishield, Johnson & Johnson and Sputnik V) or inactivated vaccines (Covaxin, Sinovac-CoronaVac and Sinopharm’s SARS-CoV-2 Vaccine–Vero Cell).

Inactivated vaccines, which include killed particles of the whole SARS-CoV-2 virus, attempt to target the entire structure of the virus. On the other hand, Corbevax, like the mRNA and viral vector Covid-19 vaccines, targets only the spike protein, but in a different way.

Viral vector and mRNA and vaccines use a code to induce our cells to make the spike proteins against which the body have to build immunity. “In this case (Corbevax), we’re actually giving the protein,” said Dr Hotez.

Like most other Covid-19 vaccines, Corbevax is administered in two doses. However, as it is made using a low-cost platform, it is also expected to be among the cheapest available in the country.

Why Corbevax matters

This is the first time the Indian government has placed an order for a vaccine that has not received emergency use authorisation, paying Rs 1,500 crore in advance to block an order that could vaccinate 15 crore Indian citizens. The Centre has provided major pre-clinical and clinical trial support towards the vaccine’s development, including a grant-in-aid of Rs 100 crore from the Department of Biotechnology.

A major reason for India placing such a big order is the difficulties it is facing in enhancing vaccine supplies. While the US, UK and the EU had made advance payments and at-risk investments into vaccines like Pfizer, AstraZeneca and Moderna, India waited until after its first two vaccines were approved before placing limited orders. Even after the government eased regulatory requirements for foreign vaccines, it did not receive a speedy response from companies like Pfizer and Moderna, their supplies already blocked through orders from other countries. India is currently in negotiations for a limited supply of Pfizer’s vaccine, and expecting to secure up to two billion doses of Covid vaccines by December this year. Given the ease with which it can be mass produced, Corbevax could make up a sizeable portion of this expected supply.

Biological E, the manufacturer of Corbevax

Biological E, headquartered in Hyderabad, was founded by Dr D V K Raju in 1953 as a biological products company that pioneered the production of heparin in India. By 1962, it forayed into the vaccines space, producing DPT vaccines on a large-scale. Today, it is among the major vaccine makers in India and, by its own claim, the “largest” tetanus vaccine producer in the world.

It has seven WHO-prequalified shots, including a five-in-one vaccine against diphtheria, tetanus, pertussis, hepatitis B and haemophilus influenza type-b infections. Its vaccines are supplied to over 100 countries and it has supplied more than two billion doses in the last 10 years alone.

Since 2013, the company has been under the management of Mahima Datla — the third generation of the founding family. During her time as managing director, the company has received WHO prequalification of its Japanese encephalitis, DTwP and Td as well as measles and rubella vaccines and also commenced commercial operations in the US.

REF

https://indianexpress.com/article/explained/corbevax-vaccine-biological-e-india-7344928/

Corbevax[1] or BioE COVID-19, is a COVID-19 vaccine candidate developed by Indian biopharmacutical firm Biological E. Limited (BioE), the Baylor College of Medicine in Houston, United States, and Dynavax Technologies. It is a protein subunit vaccine.[2][3][4][5]

Clinical research

Phase I and II trials

In phase I clinical trial was carried to evaluate the safety and immunogenicity of the vaccine candidate in about 360 participants.[5]The phase II concluded in April 2021.[6][7]

Phase III trials

In April 2021, the Drugs Controller General of India permitted the vaccine candidate to start phase III clinical trials. A total of 1,268 healthy participants between the age of 18 and 80 years to be selected from 15 sites across India for the trial and intended to be part of a larger global Phase III study.[8][7]

Manufacturing and Orders

In April 2021, the U.S. International Development Finance Corporation (DFC) announced that it would fund the expansion of BioE’s manufacturing capabilities, so that it could produce at least 1 billion doses by end of 2022.[9]

On 3 June, India’s Ministry of Health and Family Welfare pre-ordered 300 million doses of Corbevax.[10]

References

  1. ^ Bharadwaj, Swati (3 June 2021). “Telangana: Biological E starts at risk manufacturing of Corbevax”The Times of India. Retrieved 3 June 2021.
  2. ^ “A prospective open label randomised phase-I seamlessly followed by phase-II study to assess the safety, reactogenicity and immunogenicity of Biological E’s novel Covid-19 vaccine containing Receptor Binding Domain of SARS-CoV-2 for protection against Covid-19 disease when administered intramuscularly in a two dose schedule (0, 28D) to healthy volunteers”ctri.nic.inClinical Trials Registry India. 13 January 2021. CTRI/2020/11/029032. Archived from the original on 12 November 2020.
  3. ^ “CEPI partners with Biological E Limited to advance development and manufacture of COVID-19 vaccine candidate”cepi.netCEPI. Retrieved 5 March 2021.
  4. ^ Chui M (16 November 2020). “Biological E. Limited and Baylor COVID-19 vaccine begins clinical trial in India”Baylor College of Medicine.
  5. Jump up to:a b Leo L (16 November 2020). “Biological E initiates human trials of vaccine”Mint.
  6. ^ “Coronavirus | Biological E gets nod to start Phase III trials of COVID-19 vaccine”The Hindu. 24 April 2021.
  7. Jump up to:a b Leo, Leroy (24 April 2021). “Biological E completes phase-2 covid vaccine trial, gets SEC nod for phase-3”mint.
  8. ^ “A Prospective, multicentre, Phase II Seamlessly Followed by Phase III Clinical Study to Evaluate the Immunogenicity and Safety of Biological E’s CORBEVAX Vaccine for Protection Against COVID-19 Disease When Administered to COVID-19-Negative Adult Subjects”ctri.nic.inClinical Trials Registry India. 5 June 2021. CTRI/2021/06/034014.
  9. ^ Basu, Nayanima (25 April 2021). “US assures export of raw materials to India for Covid vaccines as Doval speaks to Sullivan”ThePrint.
  10. ^ “Health ministry buys 300 mn doses of Biological-E’s Covid vaccine in advance”Hindustan Times. 3 June 2021. Retrieved 4 June 2021.

External links

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///////////Biological E,  SARS-CoV-2, Baylor College, CORONA VIRUS, COVID 19, Corbevax, BioE COVID-19, BECOV2D, INDIA, Dynavax Technologies

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PTX-COVID19-B



PTX-COVID19-B

mRNA-based vaccine

Providence Therapeutics; Canadian government

bioRxiv (2021), 1-50.

https://www.biorxiv.org/content/10.1101/2021.05.11.443286v1

Safe and effective vaccines are needed to end the COVID-19 pandemic caused by SARS-CoV-2. Here we report the preclinical development of a lipid nanoparticle (LNP) formulated SARS-CoV-2 mRNA vaccine, PTX-COVID19-B. PTX-COVID19-B was chosen among three candidates after the initial mouse vaccination results showed that it elicited the strongest neutralizing antibody response against SARS-CoV-2. Further tests in mice and hamsters indicated that PTX-COVID19-B induced robust humoral and cellular immune responses and completely protected the vaccinated animals from SARS-CoV-2 infection in the lung. Studies in hamsters also showed that PTX-COVID19-B protected the upper respiratory tract from SARS-CoV-2 infection. Mouse immune sera elicited by PTX-COVID19-B vaccination were able to neutralize SARS-CoV-2 variants of concern (VOCs), including the B.1.1.7, B.1.351 and P.1 lineages. No adverse effects were induced by PTX-COVID19-B in both mice and hamsters. These preclinical results indicate that PTX-COVID19-B is safe and effective. Based on these results, PTX-COVID19-B was authorized by Health Canada to enter clinical trials in December 2020 with a phase 1 clinical trial ongoing (ClinicalTrials.gov number: NCT04765436).

PTX-COVID19-B is a messenger RNA (mRNA)-based COVID-19 vaccine, a vaccine for the prevention of the COVID-19 disease caused by an infection of the SARS-CoV-2 coronavirus, created by Providence Therapeutics—a private Canadian drug company co-founded by Calgary, Alberta-based businessman Brad T. Sorenson and San Francisco-based Eric Marcusson.[1] in 2013. A team of eighteen working out of Sunnybrook Research Institute in Toronto, Ontario developed PTX-COVID19-B[2] in less than four weeks, according to the Calgary Herald.[3] Human trials with sixty volunteers began on January 26, 2021 in Toronto.[4][5][6]

Providence, which has no manufacturing facilities, partnered with Calgary-based Northern mRNA—the “anchor tenant” in their future manufacturing facilities pending financing.[2]

On 30 April 2021, Sorenson announced that Providence Therapeutics would be leaving Canada and any vaccine that it developed would not be manufactured in Canada.[2]

Overview

Providence Therapeutics Holdings Inc. was co-founded in Toronto, Ontario[7][8] by Calgary, Alberta-based businessman Brad T. Sorenson and San Francisco-based Eric Marcusson Ph.D, who was also the Chief Scientific Officer.[9][3]

PTX-COVID19-B is a messenger RNA (mRNA)-based COVID-19 vaccine. In an interview with CTV news, Sorenson said they were “building some of the important building blocks for the messenger RNA … that provides instructions to cells … to build proteins that may treat or prevent disease”.

As of January 2021, Northern RNA’s Calgary lab was proposed as the site where manufacturing of PTX-COVID19-B would take place.[10] Providence Therapeutics’ partner, Northern RNA, which located at 421 7 Avenue SW in Calgary, has been described as Providence Therapeutics northern division.[7][8]

A February 2021 Manitoba government press release said that the Winnipeg-based Emergent BioSolutions would be manufacturing the vaccine.[11]

Human trials

Phase 1

Human trials began on January 26, 2021 with 60 volunteers between the ages of 18 to 65 in Toronto.[12][13][3] Of these, 15 would receive a placebo and 3 groups of 15 would receive different doses of the vaccine.[10] The volunteers will be monitored for 13 months. The company said that enough data would be available in May which could result in a Phase 2 clinical testing beginning soon after that, pending regulatory approval. If the results of a subsequent larger human trial are positive, the vaccine could enter a commercialization phase in 2022.[14] The Phase 1 clinical trial lead was Piyush Patel. At the 29 April meeting with the House of Commons, Sorenson estimated that PTX-COVID19-B could be approved by Health Canada by “January or February 2022”.[15]:8

Provincial funding

Shortly after the first human trials on PTX-COVID19-B began in late January, on 11 February 2021, Manitoba Premier Brian Pallister announced a “term sheet” between the province and Providence Therapeutics through which Manitoba would receive 2 million doses of PTX-COVID19-B pending its approval by Health Canada.[11] The term sheet includes “best-price guarantee” PTX-COVID19-B.[13] According to a provincial statement released by the Manitoba government, pending approval of the vaccine, the actual manufacturing would take place in Winnipeg by Emergent BioSolutions.[11] Pallister said that, “Building a secure, made-in-Canada vaccine supply will put Canadians at the head of the line to get a COVID vaccine, where we belong.”[11] The down payment would be 20% with a subsequent 40% to be paid when the vaccine was approved by Health Canada; the balance would be paid on delivery of the doses.[13] Specifics about the contract were released in April 2021: the total cost was estimated as CAD $36 million and the agreement included a clause for a non-refundable advance payment of CAD $7.2 million.[2] Sorenson made this comment to Global News: “Under no circumstances is Manitoba going to be on the hook for $7.2 million unless they get real value out of it”.

Federal funding

Canada’s National Research Council (NRC) provided Providence Therapeutics with CAD $5 million for the launch of January 2021 first phase of PTX-COVID19-B clinical trials.[2]

As part of the federal government’s “next generation manufacturing supercluster” program, Providence and Northern mRNA had also been “cleared to access up to $5 million” towards the manufacturing start up process, according to a federal government spokesperson.[2]

The CBC report in late April 2021 also stated that “it could be eligible for a slice of $113 million in additional funding from the National Research Council of Canada Industrial Research Assistance Program”. The federal government had provided funding to some other companies in Canada that were also working to develop a COVID-19 vaccine.[2]

Sorenson as Providence Therapeutics CEO posted an open letter to Prime Minister Justin Trudeau, in which he requested $CDN 150 million upfront to be used to pay for clinical trial and material costs.[16][9]

On 29 April 2021, Sorenson appeared before the House of Commons standing committee on international trade, to ask the Minister of ProcurementAnita Anand, to consider PTX-COVID19-B as an alternative to Moderna and Pfizer for the “2022 booster vaccines”.[15] Sorenson said that the NRC had approached Providence Therapeutics in 2020 after the company had announced their Phase I trial PTX-COVID19-B. Sorenson told the Standing Committee that, “We’ve had really good dialogue ever since phase I started. That process has gone on. That started probably [in February], as we geared up to conclude our phase I trial and release data. Although the NRC is capped at $10 million, which is certainly not sufficient to carry out phase II and phase III trials, the NRC has, through the bureaucracy, elevated us back up to the strategic innovation fund. That occurred about three weeks ago. We’re now working with the strategic innovation fund.”[15]:7

He later said that no reply had been received from the government.[17]

In a meeting with the federal COVID-19 vaccine task force and Sorenson, task force members expressed concerns that “Providence might not be able to scale up production fast enough”.[2]

Clinical trials

PTX-COVID19-B, an mRNA Humoral Vaccine, is Intended for Prevention of COVID-19 in a General Population. This Study is Designed to Evaluate Safety, Tolerability, and Immunogenicity of PTX-COVID19-B Vaccine in Healthy Seronegative Adults Aged 18-64… https://clinicaltrials.gov/ct2/show/NCT04765436

Hyderabad Drugmaker To Make Canada Firm’s mRNA Covid Vaccine In India.. https://www.ndtv.com/india-news/hyderabad-drugmaker-biological-e-to-make-canada-firms-mrna-covid-vaccine-in-india-2454000

Biological E., will run a clinical trial of Providence’s vaccine in India and seek emergency use approval for it, the company said in a statement

Hyderabad-based Biological E said on Tuesday it has entered into a licensing agreement with Providence Therapeutics Holdings to manufacture the Canadian company’s mRNA COVID-19 vaccine in India.

Biological E., which also has a separate deal to produce about 600 million doses of Johnson & Johnson’s COVID-19 shot annually, will run a clinical trial of Providence’s vaccine in India and seek emergency use approval for it, the company said in a statement.

Providence will sell up to 30 million doses of its mRNA vaccine, PTX-COVID19-B, to Biological E, and will also provide the necessary technology transfer of the shot, with a minimum production capacity of 600 million doses in 2022 and a target capacity of 1 billion doses.

Financial details of the transaction were not disclosed.

India has been struggling with a devastating second wave of the pandemic and has managed to fully vaccinate only about 3% of its population. On Monday, the Serum Institute of India said it will increase production of AstraZeneca’s shot by nearly 40% in June, a step towards bridging the shortfall in the country.

“The mRNA platform has emerged as the front runner in delivering the first vaccines for emergency use to combat the COVID-19 pandemic,” said Mahima Datla, Biological E.’s managing director.

Messenger ribonucleic acid (mRNA) vaccines prompt the body to make a protein that is part of the virus, triggering an immune response. US companies Pfizer and Moderna use mRNA technology in their COVID-19 shots.

The drug regulator has approved clinical trials of another mRNA vaccine developed by local firm Gennova Biopharmaceuticals, and the government has said it will fund the studies.

Providence Therapeutics Announces Very Favorable Interim Phase 1 Trial Data for PTX-COVID19-B, its mRNA Vaccine Against COVID-19

https://www.providencetherapeutics.com/providence-therapeutics-announces-very-favorable-interim-phase-1-trial-data-for-ptx-covid19-b-its-mrna-vaccine-against-covid-19May 12, 2021

CALGARY, AB, May 12, 2021 / – Providence Therapeutics Holdings Inc. (“Providence”) announced today very favorable interim clinical data of PTX-COVID19-B, its vaccine candidate against SARS-CoV-2 (“COVID-19”), from its Phase 1 study entitled “PRO-CL-001, A Phase 1, First-in-Human, Observer-Blinded, Randomized, Placebo Controlled, Ascending Dose Study to Evaluate the Safety, Tolerability, and Immunogenicity of PTX-COVID19-B Vaccine in Healthy Seronegative Adults Aged 18-64” (the “Phase 1 Study”), which found that PTX-COVID19-B met Providence’s target results for safety, tolerability, and immunogenicity in the participants of the Phase 1 Study.

Highlights from Providence Therapeutics’ “Phase 1 Study”:

  • PTX-COVID19-B was generally safe and well tolerated
  • PTX-COVID19-B exhibited strong virus neutralization capability across the 16µg, 40µg and 100µg dose cohorts
  • PTX-COVID19-B 40µg dose was selected for Phase 2 study
  • PTX-COVID19-B will be evaluated in additional Phase 1 population cohorts

The Phase 1 Study was designed with dose-escalations and was performed in seronegative adult subjects without evidence of recent exposure to COVID-19. The subjects were randomized to receive either the PTX-COVID19-B vaccine or a placebo in a 3:1 ratio. A total of 60 subjects participated in the Phase 1 Study.

The overall results of the Phase 1 Study are that PTX-COVID19-B was safe and well tolerated at the three dose levels of 16µg, 40µg and 100µg. Adverse events identified in the Phase 1 Study were generally mild to moderate in severity, self-resolving and transient. There were no serious adverse events reported in the Phase 1 Study. The most common adverse event reported in the Phase 1 Study was redness and pain at the injection site. Systemic reactions reported in the Phase 1 Study were generally mild to moderate and well tolerated with headache being the most common reaction reported. The reported adverse events of the Phase 1 Study were in line with the expectations of management of Providence as they compare very favorably to the adverse events data published on other mRNA vaccines for COVID-19 that have been approved for use by various health authorities around the world.

Based on the results of the Phase 1 Study, Providence intends to use a 40µg dose for the Phase 2 study of PTX-COVID19-B that is anticipated to be initiated in June 2021. Additional Phase 1 studies in adolescent and elderly populations are also planned to be undertaken by Providence.

PTX-COVID19-B vaccination induced high anti-S IgG antibodies:

Participants in the Phase 1 Study were vaccinated on day zero and day twenty-eight. Plasma samples were collected on day 1, day 8, day 28 (prior to the participant receiving the second dose), and day 42 to determine levels of IgG anti-S protein using electrochemiluminescence (“ECL”) assays from Meso Scale Discovery (“MSD”). Study participants in all three vaccine dose cohorts of the Phase 1 Study developed a strong IgG antibody response against Spike protein that was detected by day 28 and enhanced by day 42. No antibodies against S protein were detected in participants in the Phase 1 Study injected with placebo. The highest levels of antibodies were found in the 40 and 100 µg doses. By day 42, PTX-COVID19-B vaccinated participants had more than one log higher antibody levels than convalescent subjects-plasma (indicated in the dotted line) which was evaluated in the same assay.

Based on the interim data of the Phase 1 Study, the level of antibodies produced in participants by PTX-COVID19-B compare favorably to the levels of antibodies produced by other mRNA vaccines that have been approved for use against COVID-19 based on the recently published report from Stanford University, where IgG responses in individuals vaccinated with the COVID-19 mRNA vaccine compared to COVID-19 infected patients were evaluated[1].

PTX-COVID19-B vaccination induced high neutralizing antibody levels:

Neutralizing activity from the Phase 1 Study participants’ plasma was evaluated by S-ACE2 MSD assay. The results indicate that the antibodies block the interaction between S protein with the ACE2 receptor and the decrease in ECL signal is used to calculate percentage inhibition of the plasma at the same dilution. All participants in the Phase 1 Study from the 16, 40 and 100 µg dose levels showed blocking activity by day 28 and all of them reached 100% blocking activity by day 42 with samples diluted 1:100 or greater. Moreover, the quantification of the antibody levels in ng/mL with a reference standard showed that all participants in the Phase 1 Study produced neutralizing antibodies by day 28 with the first immunization and increase ten-fold by day 42, two weeks after the administration of the second dose. These results indicate that PTX-COVID19-B induced a strong neutralizing antibody response which compares very favorably to the published results of other mRNA vaccines. Further studies are being conducted by Providence to determine neutralization activity using a pseudo-virus assay.

Providence intends to advance a Phase 2 clinical trial in early June 2021, with multiple trial sites in Canada. The Phase 2 clinical trial is anticipated to be structured as a comparator trial using Pfizer/BioNTech vaccine as the positive control.

About Providence Therapeutics

Providence is a leading Canadian clinical stage biotechnology company pioneering mRNA therapeutics and vaccines with operations in Calgary, Alberta and Toronto, Ontario. In response to a worldwide need for a COVID-19 vaccine, Providence expanded its focus beyond oncology therapies and devoted its energy and resources to develop a world-class mRNA vaccine for COVID-19. Providence is focused on serving the needs of Canada, and other countries that may be underserved by large pharmaceutical programs. For more information, please visit providencetherapeutics.com.

References

  1. ^ “Canadian company urges human trials after COVID-19 vaccine results in mice”Lethbridge News Now. 5 August 2020. Retrieved 19 March 2021.
  2. Jump up to:a b c d e f g h Tasker, John Paul (30 April 2021). “COVID-19 vaccine maker Providence says it’s leaving Canada after calls for more federal support go unanswered”CBC News. Retrieved 1 May 2021.
  3. Jump up to:a b c Stephenson, Amanda (26 January 2021). “Made-in-Canada COVID vaccine to be manufactured in Calgary”Calgary Herald. Retrieved 22 March 2021.
  4. ^ Clinical trial number NCT04765436 for “PTX-COVID19-B, an mRNA Humoral Vaccine, is Intended for Prevention of COVID-19 in a General Population. This Study is Designed to Evaluate Safety, Tolerability, and Immunogenicity of PTX-COVID19-B Vaccine in Healthy Seronegative Adults Aged 18-64” at ClinicalTrials.gov
  5. ^ “Providence Therapeutics Holdings Inc: PTX-COVID19-B”. Montreal: McGill University. Retrieved 19 March 2021.
  6. ^ “Made-in-Canada coronavirus vaccine starts human clinical trials”. Canadian Broadcasting Corporation. 26 January 2021.
  7. Jump up to:a b “Company Profile”PitchBook.
  8. Jump up to:a b “Company Profile”DNB.
  9. Jump up to:a b Code, Jillian (5 February 2021). “‘Do something’ Made-In-Canada vaccine CEO pleads for federal government to respond”CTV News. Calgary, Alberta. Retrieved 22 March 2021.
  10. Jump up to:a b Fieldberg, Alesia (26 January 2021). “Providence Therapeutics begins first clinical trials of Canadian-made COVID-19 vaccine”CTV. Retrieved 2 May 2021.
  11. Jump up to:a b c d “Manitoba Supports Made-In-Canada COVID-19 Vaccine to Protect Manitobans” (Press release). 11 February 2021. Retrieved 3 May 2021.
  12. ^ Providence Therapeutics Holdings Inc.: a Phase I, First-in-Human, Observer-Blinded, Randomized, Placebo Controlled, Ascending Dose Study to Evaluate the Safety, Tolerability, and Immunogenicity of PTX-COVID19-B Vaccine in Healthy Seronegative Adults Aged 18-64 (Report). Clinical Trials via U.S. National Library of Medicine. 19 February 2021. Retrieved 1 May2021.
  13. Jump up to:a b c Gibson, Shane (11 February 2021). “Manitoba agrees to purchase 2M doses of Providence Therapeutics coronavirus vaccine”Global News. Retrieved 2 May 2021.
  14. ^ “Providence Therapeutics begins first clinical trials of Canadian-made COVID-19 vaccine”CTV. Retrieved 2 May 2021.
  15. Jump up to:a b c Evidence (PDF), 43rd Parliament, 2nd Session. Standing Committee on International Trade, 29 April 2021, retrieved 2 May2021
  16. ^ Sorenson, Brad (5 February 2021). “An Open Letter to the Government of Canada”. Retrieved 3 May 2021.
  17. ^ Dyer, Steven. “‘Canada had an opportunity’, Calgary company explores taking vaccine development out of Canada”CTV. Retrieved 2 May 2021.
Vaccine description
TargetSARS-CoV-2
Vaccine typemRNA
Clinical data
Routes of
administration
Intramuscular
Part of a series on the
COVID-19 pandemic
COVID-19 (disease)SARS-CoV-2 (virus)
showTimeline
showLocations
showInternational response
showMedical response
showImpact
 COVID-19 portal

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