Ad5-nCoV

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AD5-nCOV
Vaccine description
Target diseaseCOVID-19
Clinical data
Trade namesConvidicea
Routes of
administration		Intramuscular injection, Nasal spray
Legal status
Legal status
Identifiers
DrugBank
Part of a series on the
COVID-19 pandemic
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SARS-CoV-2 (Wikimedia colors).svg COVID-19 Portal

AD5-nCOV, trade-named Convidicea, is a COVID-19 vaccine candidate being developed by Chinese biopharmaceutical company CanSino Biologics.[1] Development of AD5-nCOV began in early 2020 and it entered Phase I testing in March and Phase II testing in April. Beginning in August 2020, it is currently in Phase III trials in Argentina, Chile, Mexico, Pakistan, Russia, and Saudi Arabia with over 40,000 people[2] as both a double-dose[2] and single dose administration.[3]

Convidicea is a viral vector vaccine similar to AstraZeneca's AZD1222 and Gamaleya's Gam-COVID-Vac.[4] In November, CanSino said it would begin interim analysis of Phase III results when 50 infection cases were found.[1]

Clinical research[edit]

Technology and background[edit]

Convidicea is a viral vector vaccine similar to AstraZeneca's AZD1222 and Gamaleya's Gam-COVID-Vac which are also in Phase III clinical trials for COVID-19.[4] Ad5- nCOV can be stored in less extreme cold conditions compared to mRNA vaccines.[5] Cansino's trials in Chile,[3] Mexico,[6] and Pakistan[5] requires one dose compared to other vaccines which require 2 doses.

Phase I-II[edit]

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. The team registered an experimental COVID-19 vaccine for Phase I trial on 17 March 2020 to test its safety.[7] The vaccine was tried on 108 healthy volunteers in Wuhan.[7]

In April, Ad5-nCoV became the first COVID-19 vaccine candidate in the world to begin Phase II trials.[8] The Phase II trial results were published in the peer-reviewed journal Lancet on 20 July 2020 and noted neutralizing antibody and T cell responses in the 508 eligible participants.[9] In September, the amount of COVID-19 antibodies in subjects from the Phase I trials remained high six months after the first shot. The high levels of antibodies suggested the shots may provide immunity for an extended period of time, although Phase III results were still required.[10] 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.[11]

In August, China's National Intellectual Property Administration issued the country's first COVID-19 vaccine patent to the company.[12]

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 on the COVID-19 vaccine produced by CanSino.[13] If the vaccine trials were successful, then the National Research Council would work with CanSino to produce and distribute the vaccine in Canada. Scott Halperin, director of the Canadian Center for Vaccinology, had hoped the clinical trials would begin as early as within two weeks.[14] 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.[15]

Phase III[edit]

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.[16]

In October, Mexico received the first batch of the vaccine for Phase III trials on 10,000 to 15,000 volunteers. Phase III trails were to be performed in Chihuahua, Durango, Nuevo León, Jalisco, Aguascalientes, Michoacán, Guerrero, Oaxaca, Morelos, Quintana Roo, Veracruz, Puebla, Hidalgo and Mexico City and began during the first week of November.[17][18]

In September, Russia's NPO Petrovax began Phase III trials on 500 volunteers,[19] which Petrovax later received approval from the government to expand to 8,000 more volunteers.[20][21]

In September, Pakistan began Phase III trials on 40,000 volunteers as part of a global multi-center study.[2] As of December, about 13,000 volunteers have participated in trials of Ad5-nCoV, with each volunteer receiving a payment of $50. The Washington Post reported that volunteers who were recently interviewed all spoke on the condition of anonymity, citing hospital officials' instructions that their identities be kept confidential. Javed Akram, vice chancellor of University of Health Sciences, Lahore and a member of Pakistan's national science task force on the coronavirus said there has been no adverse events with respect to the trials so far.[5]

In November, Chile approved Phase III trials on 5,200 volunteers to be managed by University of La Frontera and including centers from Araucanía, Los Ríos, Los Lagos and Metropolitan regions. The Chile trials require only one dose of the vaccine.[3][22]

In December, Argentina's Fundación Hupedes began Phase III trials in 11 health centers in the metropolitan area of Buenos Aires and Mar del Plata.[23]

In November, CanSino said it would begin interim analysis of Phase III results when 50 infection cases are found.[1]

Nasal spray trials[edit]

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.[24]

Manufacturing[edit]

Cansino is planning to produce 100 to 200 million doses per year at facilities to be completed by 2021, according to CEO Yu Xuefeng.[25]

Once Russia has approved the vaccine, Petrovax said it would produce more than 4 million doses a month in 2020 and 10 million doses per month in 2021.[26]

Emergency use authorization[edit]

China[edit]

On June 25, China approved Ad5-nCoV for limited use by the military for a period of one year. In a statement by Cansino, “Ad5-nCoV is currently limited to military use only and its use cannot be expanded to a broader vaccination range without the approval of the Logistics Support Department.”[27]

Mexico[edit]

In late December, it was reported Convidicea would be submitted for review by Mexican health regulator Cofepris. Convidicea would be administered in a single dose, compared to Tozinameran, which is delivered in two doses several weeks apart. President Andres Manuel Lopez Obrador said he expected the vaccine to begin arriving in January 2020.[28]

Market and deployment[edit]

In September, Malaysia's Solution Biologics signed a manufacturing and commercialization agreement for the marketing and distribution of the vaccine in the country.[29]

In October, Indonesia reached an agreement with Cansino to deliver 100,000 doses in 2020, with an additional 15 to 20 million doses in 2021.[30]

In December, Mexico's Foreign Minister Marcelo Ebrard signed an agreement with Cansino for 35 million doses of the vaccine.[31]

See also[edit]

References[edit]

  1. ^ a b c Reuters Staff (2020-11-21). "CanSino to test coronavirus vaccine candidate in Argentina and Chile". Reuters. Retrieved 2020-11-21.CS1 maint: uses authors parameter (link)
  2. ^ a b c "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.
  3. ^ a b c Yáñez PL (2020-11-15). "Así funcionan las cuatro vacunas que se probarán en Chile". La Tercera. Retrieved 2020-11-17.
  4. ^ a b Zimmer C, Corum J, Wee SL (2020-06-10). "Coronavirus Vaccine Tracker". The New York Times. ISSN 0362-4331. Retrieved 2020-12-12.
  5. ^ a b c Constable, Pamela; Hussain, Shaiq. "Defying fears and skepticism, thousands in Pakistan volunteer for Chinese vaccine trials". Washington Post. ISSN 0190-8286. Retrieved 2021-01-01.
  6. ^ Comunicación, Estudio Alterna (2020-12-03). "The Chinese Coronavirus Vaccine Started Phase 3 Trials in Mexico". Hospital CMQ. Retrieved 2021-01-01.
  7. ^ a b Cui J (23 March 2020). "Human vaccine trial gets underway". China Daily. Retrieved 18 April 2020.
  8. ^ Xie J (15 April 2020). "China Announces Phase 2 of Clinical Trials of COVID-19 Vaccine". Voice of America. Retrieved 18 April 2020.
  9. ^ 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". Lancet. 396 (10249): 479–488. doi:10.1016/S0140-6736(20)31605-6. PMID 32702299.
  10. ^ O'Brien E (2020-09-25). "Covid Antibodies Endure Over Six Months in China Trial Subjects". www.bloomberg.com. Retrieved 2020-09-29.
  11. ^ "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.
  12. ^ Yu S (17 August 2020). "China grants country's first COVID-19 vaccine patent to CanSino: state media". Reuters. Retrieved 17 August 2020.
  13. ^ Bogart N (16 May 2020). "Health Canada approves first clinical trial for potential COVID-19 vaccine". CTV News. Retrieved 7 September 2020.
  14. ^ Ryan H (16 May 2020). "Canada's first COVID-19 vaccine trials approved for Halifax university". CBC News. Retrieved 7 September 2020.
  15. ^ Cooke A (26 August 2020). "Canadian COVID-19 clinical trial scrapped after China wouldn't ship potential vaccine". CBC News. Retrieved 7 September 2020.
  16. ^ Eltahir N (9 August 2020). "CanSino to start Phase III trial of COVID-19 vaccine in Saudi". Reuters. Retrieved 9 August 2020.
  17. ^ "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.
  18. ^ "Chinese Covid vaccine trials to be expanded to five more states". Mexico News Daily. 2020-11-10. Retrieved 2020-11-11.
  19. ^ "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.
  20. ^ Bloomberg News (2020-11-25). "Russia's Richest Man Seeks Global Market for Local Covid-19 Drug - BNN Bloomberg". BNN. Retrieved 2020-11-28.
  21. ^ Reuters Staff (2020-12-07). "Russia approves clinical trials for Chinese COVID-19 vaccine Ad5-Ncov: Ifax". Reuters. Retrieved 2020-12-07.
  22. ^ "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.
  23. ^ "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.
  24. ^ "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.
  25. ^ Mak E. "Cansino's shares up 86% on STAR debut, plans annual production of 200 million". www.bioworld.com (13 August 2020). Retrieved 31 August 2020.
  26. ^ "Russian Recruits Show 'No Side Effects' in Chinese Coronavirus Vaccine Trials". The Moscow Times. 2020-09-21. Retrieved 2020-09-22.
  27. ^ Reuters Staff (2020-06-29). "CanSino's COVID-19 vaccine candidate approved for military use in China". Reuters. Retrieved 2020-12-13.
  28. ^ Beth Solomon, Diana (28 December 2020). "Mexico elderly could get coronavirus vaccines in January". Reuters. Retrieved 28 December 2020.
  29. ^ "Solution Group unit inks deal with CanSino for vaccine distribution". The Malaysian Reserve. 2020-09-24. Retrieved 2020-09-28.
  30. ^ Taufiqurrahman M. "Indonesia can be manufacutring hub for COVID-19 vaccine, says Chinese foreign minister". Jakarta Post. Retrieved 13 October 2020.
  31. ^ Reuters Staff (2020-12-10). "Mexico agrees to buy 35 million doses of Cansino COVID vaccine". Reuters. Retrieved 2020-12-10.
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