Convidecia Explained

Drug Name:AD5-nCOV
Type:vaccine
Target:SARS-CoV-2
Vaccine Type:viral
Tradename:Convidecia
Legal Status:Full list of Convidecia authorizations
Routes Of Administration:Intramuscular, Nebulizer
Atc Prefix:J07
Atc Suffix:BN02
Drugbank:DB15655
Synonyms:PakVac

AD5-nCOV, trade-named Convidecia, is a single-dose[1] viral vector vaccine for COVID-19 that is also used as an inhaled booster. It was developed by CanSino Biologics, with Phase III trials conducted in Argentina, Chile, Mexico, Pakistan, Russia, and Saudi Arabia with 40,000 participants.

In February 2021, global data from Phase III trials and 101 COVID cases showed that the intramuscular version of the vaccine had a 65.7% efficacy in preventing moderate symptoms of COVID-19, and 91% efficacy in preventing severe disease.[2] It has similar efficacy to the Janssen vaccine, another one-shot adenovirus vector vaccine with 66% efficacy in a global trial.[3] Convidecia is similar to other viral vector vaccines like AZD1222, Gam-COVID-Vac, and Ad26.COV2.S.[4] Its single-dose regimen and normal refrigerator storage requirement (2° to 8 °C) could make it a favorable vaccine option for many countries. It is currently under evaluation for emergency use listing by the WHO.[5] On May 19 2022, WHO issued EUL for the vaccine.[6]

A Phase I study published in The Lancet showed two doses of a nebulised version of Convidecia (inhaled through the mouth) resulted in neutralising antibody responses similar to the existing one-dose injection.[7] Convidecia and the Pakistani version called PakVac are approved for use by some countries in Asia, Europe,[8] and Latin America.[9] [10] Production capacity for Ad5-NCov should reach 500 million doses in 2021. Manufacturing will take place in China,[11] with filling and finishing of the vaccine additionally also taking place in Malaysia, Mexico, and Pakistan.[12]

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 administered as an intramuscular injection 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, and 100% for preventing severe disease.[2]

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 the Janssen vaccine, another one-shot adenovirus vaccine found to be 66% effective in a global trial.

Pharmacology

Convidecia is a viral vector vaccine similar to AstraZeneca's AZD1222 and Gamaleya's Gam-COVID-Vac.[4]

Manufacturing

Ad5-nCOV can be stored in less extreme cold conditions compared to mRNA vaccines.[13] [3]

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.

In February, Mexico received the first batch of active ingredients for Convidecia, which is being filled and finished in Querétaro by Drugmex.[14]

In Malaysia, filling and finishing of the vaccine for distribution would be completed by Solution Biologics.[15]

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.[16]

If the vaccine is approved in Russia, Petrovax said it has the ability to fill and finish 4 million doses per month to start with, eventually reaching a target of 10 million doses a month in 2021.[17] The company eventually hopes to build a plant within 3 years to manufacture Convidecia in Russia.[18]

History

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 Wuhan, Hubei province.[19]

In April, Ad5-nCoV became the first COVID-19 vaccine candidate in the world to begin Phase II trials.[20] 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.[21] 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.[22] 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.

In August, China's National Intellectual Property Administration issued the country's first COVID-19 vaccine patent to CanSino.[23]

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.[24] [25] If the vaccine trials were successful, then the National Research Council would work with CanSino to produce and distribute the vaccine in Canada.[25] 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.[26]

Trials of inhaled version (Convidecia Air)

In September 2020, CanSino began a Phase I trial in China with 144 adults to determine safety and immunogenicity when inhaled through the mouth with nebulizer rather than intramuscular injection, with results published in 2021.[27] On June 3, 2021, expansion of clinical trials was approved by the NMPA and the nasal spray applied for Emergency Use Listing.[28]

In July 2021, results published in The Lancet showed two doses of the inhaled version resulted in neutralising antibody responses similar to the existing one-dose injection and recommended the efficacy and cost-effectiveness of the nasal vaccine to be evaluated in Phase II/III studies.

In September 2022, CanSino announced that Convidecia Air had been approved as a booster Covid-19 vaccine in China.[29] Rollout of inhaled boosters was underway in October.[30]

Phase III

In August 2020, Saudi Arabia confirmed it would begin Phase III trials on 5,000 people for Ad5-nCoV in the cities of Riyadh, Dammam, and Mecca.[31]

In October 2020, Mexico began Phase III trials on 15,000 volunteers.[32] [33]

In September 2020, Russia began Phase III trials on 500 volunteers, which Petrovax later received approval from the government to expand to 8,000 more volunteers.[34] [35]

In September 2020, Pakistan began Phase III trials on 40,000 volunteers as part of a global multi-center study. As of December, about 13,000 volunteers have participated in trials of Ad5-nCoV.

In November 2020, Chile began Phase III trials on 5,200 volunteers to be managed by the University of La Frontera.[36] [37]

In December 2020, Argentina's Fundación Huésped began Phase III trials in 11 health centers in the metropolitan area of Buenos Aires and Mar del Plata.[38]

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.[39]

In July, 2021, Cansino said it would begin combination trials with a dose of Sputnik V followed by a dose of Convidecia. This would address a supply shortage of Sputnik V, which has had difficulties in supplying the second dose in sufficient quantities compared to the first dose.[40]

Authorizations

On 25 June 2020, China approved the vaccine for limited use by the military.[41] In February 2021, China approved the vaccine for general use.[42]

In February 2021, Mexico approved the vaccine for emergency use.[43]

In February 2021, Pakistan approved the vaccine for emergency use.[44]

In March, Hungary approved the vaccine for emergency use.[45]

In March, Moldova authorized use of the vaccine.[8]

On 15 June 2021, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has issued conditional registration for emergency use of the vaccine.[46]

On 7 September 2021, National Agency of Drug and Food Control (BPOM) has issued emergency use authorization in Indonesia.[47]

On 4 September 2022, China's National Medical Products Administration granted approval for the Convidecia Air, an inhaled version of the Convidecia vaccine, to be used as a booster dose.[48] [49]

Economics

Americas

In December 2020, Mexico's Foreign Minister Marcelo Ebrard signed an agreement for 35 million doses.[50] Mexico received active ingredients for 2 million doses with a total of 6 million doses expected to arrive in February.[51]

In June 2021, Argentina approved emergency use of the vaccine and ordered 5.4 million doses.

In October 2021, Brazil's Bionn SA signed a deal to distribute the vaccine in Brazil, which included producing the vaccine domestically.[52]

In March, Chile signed a deal for 1.8 million doses for delivery between May and June,[53] for which emergency use approval was granted in April.

In June, Ecuador approved emergency use and ordered 6 million doses for delivery between June and August 2021.[54]

Asia

In October 2020, 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.[55]

In February 2021, Malaysia's Solution Biologics agreed to supply 3.5 million Convidecia doses to the government.[56] The doses would be delivered starting in April with 500,000 complete doses, with the rest in bulk to be finished by Solution Biologics.

In February 2021, Pakistan purchased 20 million doses of the vaccine[57] of which the first 3 million doses were to arrive in May.[57]

In June 2021, Malaysia's coordinating minister for COVID-19 Immunisation, Khairy Jamaluddin, confirmed refugee communities in Malaysia would receive the vaccine; with the first shipment due to arrive in late July.[58] By 19 September 2021, more than 70,000 people in Malaysia had received the Convidecia vaccine. The COVID-19 Immunisation Task Force has prioritised the single-dose vaccine for communities living in remote areas including the Orang Asli as well as the homeless and undocumented individuals. Priority states for the CanSino vaccine included Sabah, Johor, Kedah, Kelantan, Perak, Sabah, and Terengganu.[59]

Further reading

Notes and References

  1. Web site: It's not just Johnson & Johnson: China has a single-dose COVID-19 vaccine that has 65% efficacy. 2021-02-11. Fortune.
  2. Web site: 8 February 2021. CanSinoBIO's COVID-19 vaccine 65.7% effective in global trials, Pakistan official says. 2021-02-08. Reuters.
  3. News: 2021-02-08. China's CanSino Covid Vaccine Shows 65.7% Efficacy. Bloomberg.com. 2021-02-10.
  4. News: 2020-06-10. Coronavirus Vaccine Tracker. The New York Times. 2020-12-12. 0362-4331. Zimmer C, Corum J, Wee SL.
  5. Web site: 15 July 2021. Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process. live. World Health Organization. https://web.archive.org/web/20210716114105/https://extranet.who.int/pqweb/sites/default/files/documents/Status_COVID_VAX_15July2021.pdf . 2021-07-16 .
  6. Web site: 19 May 2022. WHO Validates 11th Vaccine for COVID-19. World Health Organization.
  7. Wu S, Huang J, Zhang Z, Wu J, Zhang J, Hu H, Zhu T, Zhang J, Luo L, Fan P, Wang B, Chen C, Chen Y, Song X, Wang Y, Si W, Sun T, Wang X, Hou L, Chen W . 6 . Safety, tolerability, and immunogenicity of an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in adults: preliminary report of an open-label and randomised phase 1 clinical trial . English . The Lancet. Infectious Diseases . July 2021 . 21 . 12 . 1654–1664 . 34324836 . 8313090 . 10.1016/S1473-3099(21)00396-0 .
  8. Web site: 2021-03-03. Membrii NITAG au venit cu recomandări privind utilizarea vaccinurilor împotriva COVID-19 în Republica Moldova. 2021-05-21. Ministerul Sănătății, Muncii și Protecţiei Sociale. en.
  9. Web site: 2021-06-11. Argentina issues emergency approval to China's single-dose Cansino COVID-19 vaccine. 2021-06-11. Reuters.
  10. Web site: ISP Approves Emergency Use And Importation Of Cansino Vaccine To Fight COVID-19. 2021-04-08. Institute of Public Health of Chile. https://web.archive.org/web/20210407194622/https://www.ispch.cl/noticia/isp-aprueba-uso-de-emergencia-e-importacion-de-la-vacuna-covid-19-de-laboratorio-cansino/ . 2021-04-07 .
  11. Web site: China can hit 500-mln-dose annual capacity of CanSinoBIO COVID-19 vaccine this year. 2021-02-28. finance.yahoo.com. 27 February 2021 . https://web.archive.org/web/20210227110726/https://finance.yahoo.com/news/china-hit-500-mln-dose-103509138.html . 2021-02-27 .
  12. Web site: 2021-05-24. Pakistan develops homemade anti-Covid vaccine 'PakVac'. 2021-05-25. The Express Tribune. en.
  13. News: Constable P, Hussain S . Defying fears and skepticism, thousands in Pakistan volunteer for Chinese vaccine trials. The Washington Post. 2021-01-01. 0190-8286.
  14. News: Solomon DB . 2021-02-28. China's CanSino says first vaccines packaged in Mexico will be ready in March. Reuters. 2021-03-12.
  15. Web site: Malaysia to receive CanSino vaccine this month The Malaysian Insight. 2021-04-03. www.themalaysianinsight.com. en.
  16. Web site: Covid vaccine: Pakistan starts production of CanSino, China's single-dose jab. live. 2021-05-28. Khaleej Times. en. https://web.archive.org/web/20210525055112/https://www.khaleejtimes.com/coronavirus-pandemic/covid-vaccine-pakistan-starts-production-of-cansino-chinas-single-dose-jab . 2021-05-25 .
  17. Web site: 2020-09-21. Russian Recruits Show 'No Side Effects' in Chinese Coronavirus Vaccine Trials. 2020-09-22. The Moscow Times.
  18. Web site: Petrovax wins in two categories of Russian Pharma Inspiration Awards competition. live. 2021-07-09. petrovax.com. en. https://web.archive.org/web/20210709191432/https://petrovax.com/press_centre/news/2021/1883/ . 2021-07-09 .
  19. News: Cui J . Human vaccine trial gets underway. China Daily. 23 March 2020. 18 April 2020.
  20. News: Xie J . 15 April 2020. China Announces Phase 2 of Clinical Trials of COVID-19 Vaccine. Voice of America. 18 April 2020.
  21. Zhu FC, Guan XH, Li YH, Huang JY, Jiang T, Hou LH, Li JX, Yang BF, Wang L, Wang WJ, Wu SP, Wang Z, Wu XH, Xu JJ, Zhang Z, Jia SY, Wang BS, Hu Y, Liu JJ, Zhang J, Qian XA, Li Q, Pan HX, Jiang HD, Deng P, Gou JB, Wang XW, Wang XH, Chen W . 6 . 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 . August 2020 . 32702299 . 7836858 . 10.1016/S0140-6736(20)31605-6 . free .
  22. Web site: O'Brien E . 2020-09-25. Covid Antibodies Endure Over Six Months in China Trial Subjects. live. https://web.archive.org/web/20200929063235/https://www.bloomberg.com/news/articles/2020-09-25/covid-antibodies-endure-over-six-months-in-china-trial-subjects . 2020-09-29 . 2020-09-29. www.bloomberg.com.
  23. News: Yu S . 17 August 2020. China grants country's first COVID-19 vaccine patent to CanSino: state media. Reuters. 17 August 2020.
  24. News: Bogart N . Health Canada approves first clinical trial for potential COVID-19 vaccine . 7 September 2020 . CTV News . 16 May 2020.
  25. Web site: Canada's first COVID-19 vaccine trials approved for Halifax university . Ryan H . . May 16, 2020 . January 4, 2021 .
  26. News: Cooke A . 26 August 2020. Canadian COVID-19 clinical trial scrapped after China wouldn't ship potential vaccine . CBC News . 7 September 2020.
  27. Wu S, Huang J, Zhang Z, Wu J, Zhang J, Hu H, Zhu T, Zhang J, Luo L, Fan P, Wang B, Chen C, Chen Y, Song X, Wang Y, Si W, Sun T, Wang X, Hou L, Chen W . 6 . Safety, tolerability, and immunogenicity of an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in adults: preliminary report of an open-label and randomised phase 1 clinical trial . The Lancet. Infectious Diseases . 21 . 12 . 1654–1664 . December 2021 . 34324836 . 8313090 . 10.1016/S1473-3099(21)00396-0 .
  28. News: Cao X, Liu Y . 陈薇院士：雾化吸入式新冠疫苗正在申请紧急使用 . 2021-06-04 . Sci Tech Daily . Chinanews.com . 2021-06-04.
  29. Web site: CanSinoBIO's Convidecia Air™ Receives Approval in China . www.cansinotech.com . CanSino Bio . 29 October 2022.
  30. Gao . Jiaxuan . Vaccination with CanSinoBIO's inhaled COVID-19 vaccine has begun in China . Journal of Biosafety and Biosecurity . December 2022 . 4 . 2 . 163 . 10.1016/j.jobb.2022.12.002 . 36589793 . 9791787 .
  31. News: Eltahir N . CanSino to start Phase III trial of COVID-19 vaccine in Saudi. Reuters. 9 August 2020. 9 August 2020.
  32. Web site: 2020-11-03. México recibe el primer lote de la vacuna candidata de CanSino Biologics; alistan pruebas. 2020-11-03. EL CEO. es-MX.
  33. Web site: 2020-11-10. Chinese Covid vaccine trials to be expanded to five more states. 2020-11-11. Mexico News Daily.
  34. Web site: Bloomberg News . 2020-11-25. Russia's Richest Man Seeks Global Market for Local Covid-19 Drug - BNN Bloomberg. 2020-11-28. BNN.
  35. News: 2020-12-07. Russia approves clinical trials for Chinese COVID-19 vaccine Ad5-Ncov: Ifax. Reuters. 2020-12-07.
  36. Web site: Yáñez PL . 2020-11-15. Así funcionan las cuatro vacunas que se probarán en Chile. 2020-11-17. La Tercera.
  37. Web site: Gob.cl - Article: Science Minister: "We Work With Maximum Rigor So That Science And Technology Benefit People'S Health". 2020-11-21. Government of Chile.
  38. Web site: 14 December 2020 . Comenzará en la Argentina un nuevo estudio de vacuna recombinante contra el SARS-CoV-2. 2020-12-15. infobae. es-ES.
  39. Web site: 2021-04-19. China trials mixing of CanSinoBIO's and Zhifei Longcom's COVID-19 vaccines -data. 2021-06-16. Reuters.
  40. Web site: 2021-07-30. China's CanSino to pair its vaccine with Russia's Sputnik V in trial. 2021-07-30. South China Morning Post. en.
  41. News: 2020-06-29. CanSino's COVID-19 vaccine candidate approved for military use in China. Reuters. 2020-12-13.
  42. News: Liu R . 2021-02-25. China approves two more domestic COVID-19 vaccines for public use. Reuters. 2021-02-26.
  43. News: 10 February 2021. Mexico approves China's CanSino and Sinovac COVID-19 vaccines. Reuters.
  44. News: Shahzad A . 2021-02-12. Pakistan approves Chinese CanSinoBIO COVID vaccine for emergency use. Reuters. 2021-02-12.
  45. News: Ashok R . 2021-03-22. UPDATE 2-China's CanSino Biologics COVID-19 vaccine receives emergency use approval in Hungary. Reuters. 2021-03-22.
  46. Web site: Malaysia Approves Pfizer Jab For Teens, CanSino And J&J Covid-19 Vaccines. CodeBlue. 15 June 2021. 17 July 2021. https://web.archive.org/web/20210625173150/https://codeblue.galencentre.org/2021/06/15/malaysia-approves-pfizer-jab-for-teens-cansino-and-jj-covid-19-vaccines/. 25 June 2021. live.
  47. Web site: 2021-09-07. BPOM Terbitkan Izin Penggunaan Darurat Vaksin Covid-19 Produksi Johnson & Johnson dan Cansino. live. 2021-09-07. KOMPAS.com. id. https://web.archive.org/web/20210907113812/https://nasional.kompas.com/read/2021/09/07/18330171/bpom-terbitkan-izin-penggunaan-darurat-vaksin-covid-19-produksi-johnson . 2021-09-07 .
  48. News: China approves inhaled Covid vaccine . 6 September 2022 . . 5 September 2022 . https://web.archive.org/web/20220905154956/https://www.bbc.com/news/health-62793078 . 5 September 2022. live.
  49. News: CanSino's inhaled COVID vaccine gets emergency use approval in China . 6 September 2022 . . . 4 September 2022 . https://web.archive.org/web/20220905064435/https://asia.nikkei.com/Spotlight/Coronavirus/COVID-vaccines/CanSino-s-inhaled-COVID-vaccine-gets-emergency-use-approval-in-China . 5 September 2022.
  50. News: 2020-12-10. Mexico agrees to buy 35 million doses of CanSino COVID vaccine. Reuters. 2020-12-10.
  51. News: 2021-02-11. 'Our gratitude always': From China's CanSino, Mexico welcomes biggest vaccine shipment yet. Reuters. 2021-02-11.
  52. News: Mandl. Carolina. 2021-10-01. Brazil's Biomm signs deals to distribute Cansino COVID-19 vaccine. en. Reuters. 2021-10-02.
  53. News: Sherwood D . 2021-03-30. Chile inks deal for 1.8 million doses of CanSino COVID-19 vaccine as inoculation drive plows ahead. en. Reuters. 2021-03-30.
  54. Web site: Valencia A . Ecuador authorizes use of China's CanSino vaccine against COVID-19. live. 2021-06-16. Reuters. en. https://web.archive.org/web/20210823103842/https://www.saltwire.com/nova-scotia/news/ecuador-authorizes-use-of-chinas-cansino-vaccine-against-covid-19-100600368/ . 2021-08-23 .
  55. News: Taufiqurrahman M . Indonesia can be manufacturing hub for COVID-19 vaccine, says Chinese foreign minister . . 13 October 2020.
  56. News: 2021-02-04. Malaysia's Solution Group to supply 3.5 million doses of CanSino vaccine to government. Reuters. 2021-02-04.
  57. Web site: 2021-04-25. Pakistan purchases over 30 million COVID doses from China: sources. 2021-04-26. ARY NEWS. en-US.
  58. News: Timbuong J . 21 June 2021. Covid-19: Refugees in Malaysia to get CanSino vaccine, says Khairy. The Star. live. 22 June 2021. https://web.archive.org/web/20210622055729/https://www.thestar.com.my/news/nation/2021/06/21/covid-19-refugees-in-malaysia-to-get-cansino-vaccine-says-khairy. 22 June 2021.
  59. News: Ahmad R . INTERACTIVE: How single-dose Covid-19 vaccines help protect Malaysia's remote communities . 23 September 2021 . . 19 September 2021 . https://web.archive.org/web/20210923113832/https://www.thestar.com.my/news/nation/2021/09/19/interactive-how-single-dose-covid-19-vaccines-help-protect-malaysia039s-remote-communities?__sta=vhg.uosvpxalbzjswomsfs%7CQJFH&__stm_medium=bpn&__stm_source=smartech . 23 September 2021. live.

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