New Drug Approvals

Home » CORONAVIRUS » Convidicea (Ad5-nCoV)

Convidicea (Ad5-nCoV)

DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO .....FOR BLOG HOME CLICK HERE

ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

Categories

Recent Posts

Blog Stats

  • 3,546,681 hits

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 2,627 other followers

add to any

Share

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

  1. Jump up to:a b c “It’s not just Johnson & Johnson: China has a single-dose COVID-19 vaccine that has 65% efficacy”Fortune. Retrieved 2021-02-11.
  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.
  8. Jump up to:a b “CanSinoBIO’s COVID-19 vaccine 65.7% effective in global trials, Pakistan official says”Reuters. 8 February 2021. Retrieved 2021-02-08.
  9. Jump up to:a b c d “China’s CanSino Covid Vaccine Shows 65.7% Efficacy”Bloomberg.com. 2021-02-08. Retrieved 2021-02-10.
  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.
  50. ^ “Brazil in vaccine talks with Moderna, reviewing CanSino shot”Reuters. 2021-05-19. Retrieved 2021-05-21.
  51. ^ Sherwood D (2021-03-30). “Chile inks deal for 1.8 million doses of CanSino COVID-19 vaccine as inoculation drive plows ahead”Reuters. Retrieved 2021-03-30.
  52. ^ Valencia A. “Ecuador authorizes use of China’s CanSino vaccine against COVID-19”Reuters. Retrieved 2021-06-16.

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


Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.

DR ANTHONY CRASTO

Follow New Drug Approvals on WordPress.com

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 2,627 other followers

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

Personal Links

View Full Profile →

TWITTER

bloglovin

Follow my blog with Bloglovin The title of your home page You could put your verification ID in a comment Or, in its own meta tag Or, as one of your keywords Your content is here. The verification ID will NOT be detected if you put it here.
%d bloggers like this: