Jump to content

Convidecia

From Wikipedia, the free encyclopedia
AD5-nCOV
A multi-dose vial ofConvidecia(AD5-nCOV)filled and finishedin Mexico
Vaccine description
TargetSARS-CoV-2
Vaccine typeViral vector
Clinical data
Trade namesConvidecia
Other namesPakVac
Routes of
administration		Intramuscular,Nebulizer
ATC code
Legal status
Legal status
Identifiers
DrugBank
Part ofa serieson the
COVID-19 pandemic
Scientifically accurate atomic model of the external structure of SARS-CoV-2. Each "ball" is an atom.
Scientifically accurate atomic model of the external structure of SARS-CoV-2. Each "ball" is an atom.
Timeline
2019
2020
2021
2022
2023
Locations
By country and territory
By conveyance
International response
National responses
Medical response
Vaccines
Current vaccines
Variants
Variants of concern
Other variants
Economic impactandrecession
By country
By sport
Impacts
Long COVID
Society
Politics
virus iconCOVID-19 portal

AD5-nCOV,trade-namedConvidecia,is a single-dose[1]viral vector vaccinefor COVID-19that is also used as an inhaled booster. It was developed byCanSino Biologics,withPhase III trialsconducted inArgentina,[2]Chile,[3]Mexico,[4]Pakistan,[5]Russia,[6]andSaudi Arabia[7]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 ofCOVID-19,and 91% efficacy in preventing severe disease.[8]It has similar efficacy to theJanssen vaccine,another one-shot adenovirus vector vaccine with 66% efficacy in a global trial.[9][1]Convidecia is similar to other viral vector vaccines likeAZD1222,Gam-COVID-Vac,andAd26.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]It is currently under evaluation for emergency use listing by theWHO.[11]On May 19 2022, WHO issued EUL for the vaccine.[12]

A Phase I study published inThe Lancetshowed two doses of a nebulised version of Convidecia (inhaled through the mouth) resulted in neutralising antibody responses similar to the existing one-dose injection.[13]

Convidecia and the Pakistani version calledPakVacare approved for use by some countries in Asia,[14][15][16]Europe,[17][18]and Latin America.[19][20][21]Production capacity for Ad5-NCov should reach 500 million doses in 2021. Manufacturing will take place in China,[22]withfilling and finishingof the vaccine additionally also taking place in Malaysia,[16]Mexico,[23]and Pakistan.[24]

Efficacy

[edit]

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 ofCOVID-19and 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.[8]

While the efficacy rates were lower than thePfizer–BioNTechandModernavaccines, 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 theJanssen vaccine,another one-shotadenovirus vaccinefound to be 66% effective in a global trial.[9][1]

Pharmacology

[edit]

Convidecia is aviral vector vaccinesimilar toAstraZeneca'sAZD1222andGamaleya'sGam-COVID-Vac.[10]

Manufacturing

[edit]

Ad5-nCOV can be stored in less extreme cold conditions compared tomRNA vaccines.[25][9]

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.[22]

In February, Mexico received the first batch of active ingredients for Convidecia, which is beingfilled and finishedinQuerétaroby Drugmex.[23]

In Malaysia, filling and finishing of the vaccine for distribution would be completed by Solution Biologics.[16]

In May, Pakistan began filling and finishing 3 million doses a month at the National Institute of Health, which would be branded asPakVacfor domestic distribution.[26]

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.[27]The company eventually hopes to build a plant within 3 years to manufacture Convidecia in Russia.[28]

History

[edit]

Clinical trials

[edit]

Phase I-II

[edit]

In early 2020,Chen Weiled a joint team of the Institute of Biotechnology, theAcademy 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 forPhase Itrialin 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 inWuhan,Hubeiprovince.[29]

In April, Ad5-nCoV became the first COVID-19 vaccine candidate in the world to beginPhase IItrials.[30]The Phase II trial results were published in the peer-reviewed journalThe Lancetin August 2020, and noted neutralizing antibody and T cell responses based on statistical analyses of data involving 508 eligible participants.[31]In September, Zeng Guang, chief scientist of theChinese 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.[32]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.[33]

In August, China'sNational Intellectual Property Administrationissued the country's first COVID-19 vaccinepatentto CanSino.[34]

On 16 May 2020, Canadian Prime MinisterJustin TrudeauannouncedHealth Canadahad 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.[35][36]If the vaccine trials were successful, then theNational Research Councilwould work with CanSino to produce and distribute the vaccine in Canada.[36]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.[37]

Trials of inhaled version (Convidecia Air)

[edit]

In September 2020, CanSino began a Phase I trial in China with 144 adults to determine safety and immunogenicity when inhaled through the mouth withnebulizerrather than intramuscular injection,[38]with results published in 2021.[39]On June 3, 2021, expansion of clinical trials was approved by the NMPA and the nasal spray applied for Emergency Use Listing.[40]

In July 2021, results published inThe Lancetshowed 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.[13]

In September 2022, CanSino announced that Convidecia Air had been approved as a booster Covid-19 vaccine in China.[41]Rollout of inhaled boosters was underway in October.[42]

Phase III

[edit]

In August 2020,Saudi Arabiaconfirmed it would beginPhase IIItrials on 5,000 people for Ad5-nCoV in the cities of Riyadh, Dammam, and Mecca.[7]

In October 2020,Mexicobegan Phase III trials on 15,000 volunteers.[43][4]

In September 2020,Russiabegan Phase III trials on 500 volunteers,[44]which Petrovax later received approval from the government to expand to 8,000 more volunteers.[45][6]

In September 2020,Pakistanbegan 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.[25]

In November 2020,Chilebegan Phase III trials on 5,200 volunteers to be managed by theUniversity of La Frontera.[46][3]

In December 2020,Argentina'sFundación Huésped began Phase III trials in 11 health centers in the metropolitan area ofBuenos AiresandMar del Plata.[2]

Combination trials

[edit]

In April 2021, a new trial was registered inJiangsuinvolving one dose of Convidecia followed by a dose ofZF200128 or 56 days later using different technologies as a way to further boost efficacy.[47]

In July, 2021, Cansino said it would begin combination trials with a dose ofSputnik Vfollowed 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.[48]

Authorizations

[edit]
See also:List of COVID-19 vaccine authorizations § Convidecia
Full authorization
Emergency authorization
Allowed for travel


On 25 June 2020, China approved the vaccine for limited use by the military.[49]In February 2021, China approved the vaccine for general use.[14]

In February 2021, Mexico approved the vaccine for emergency use.[50]

In February 2021,Pakistanapproved the vaccine for emergency use.[51]

In March,Hungaryapproved the vaccine for emergency use.[17]

In March,Moldovaauthorized use of the vaccine.[18]

On 15 June 2021, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has issued conditional registration for emergency use of the vaccine.[52]

On 7 September 2021,National Agency of Drug and Food Control(BPOM) has issued emergency use authorization in Indonesia.[53]

On 4 September 2022, China'sNational Medical Products Administrationgranted approval for theConvidecia Air,an inhaled version of the Convidecia vaccine, to be used as a booster dose.[54][55]

Economics

[edit]

Americas

[edit]

In December 2020,Mexico's Foreign MinisterMarcelo Ebrardsigned an agreement for 35 million doses.[56]Mexico received active ingredients for 2 million doses with a total of 6 million doses expected to arrive in February.[19]

In June 2021,Argentinaapproved emergency use of the vaccine and ordered 5.4 million doses.[20]

In October 2021,Brazil's Bionn SA signed a deal to distribute the vaccine in Brazil, which included producing the vaccine domestically.[57]

In March,Chilesigned a deal for 1.8 million doses for delivery between May and June,[58]for which emergency use approval was granted in April.[21]

In June,Ecuadorapproved emergency use and ordered 6 million doses for delivery between June and August 2021.[59]

Asia

[edit]

In October 2020,Indonesiareached 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.[60]

In February 2021,Malaysia's Solution Biologics agreed to supply 3.5 million Convidecia doses to the government.[61]The doses would be delivered starting in April with 500,000 complete doses, with the rest in bulk to be finished by Solution Biologics.[16]

In February 2021,Pakistanpurchased 20 million doses of the vaccine[15]of which the first 3 million doses were to arrive in May.[15]

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.[62]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 theOrang Aslias well as the homeless and undocumented individuals. Priority states for the CanSino vaccine includedSabah,Johor,Kedah,Kelantan,Perak,Sabah,andTerengganu.[63]

References

[edit]
  1. ^abc"It's not just Johnson & Johnson: China has a single-dose COVID-19 vaccine that has 65% efficacy".Fortune.Retrieved2021-02-11.
  2. ^ab"Comenzará en la Argentina un nuevo estudio de vacuna recombinante contra el SARS-CoV-2".infobae(in European Spanish). 14 December 2020.Retrieved2020-12-15.
  3. ^ab"Gob.cl - Article: Science Minister:" We Work With Maximum Rigor So That Science And Technology Benefit People'S Health "".Government of Chile.Retrieved2020-11-21.
  4. ^ab"Chinese Covid vaccine trials to be expanded to five more states".Mexico News Daily.2020-11-10.Retrieved2020-11-11.
  5. ^abClinical trial numberNCT04526990for "Phase III Trial of A COVID-19 Vaccine of Adenovirus Vector in Adults 18 Years Old and Above" atClinicalTrials.gov
  6. ^ab"Russia approves clinical trials for Chinese COVID-19 vaccine Ad5-Ncov: Ifax".Reuters.2020-12-07.Retrieved2020-12-07.
  7. ^abEltahir N (9 August 2020)."CanSino to start Phase III trial of COVID-19 vaccine in Saudi".Reuters.Retrieved9 August2020.
  8. ^ab"CanSinoBIO's COVID-19 vaccine 65.7% effective in global trials, Pakistan official says".Reuters.8 February 2021.Retrieved2021-02-08.
  9. ^abcd"China's CanSino Covid Vaccine Shows 65.7% Efficacy".Bloomberg.2021-02-08.Retrieved2021-02-10.
  10. ^abZimmer C, Corum J, Wee SL (2020-06-10)."Coronavirus Vaccine Tracker".The New York Times.ISSN0362-4331.Retrieved2020-12-12.
  11. ^"Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process"(PDF).World Health Organization.15 July 2021.Archived(PDF)from the original on 2021-07-16.
  12. ^"WHO Validates 11th Vaccine for COVID-19".World Health Organization.19 May 2022.
  13. ^abWu S, Huang J, Zhang Z, Wu J, Zhang J, Hu H, et al. (July 2021)."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.doi:10.1016/S1473-3099(21)00396-0.PMC8313090.PMID34324836.
  14. ^abLiu R (2021-02-25)."China approves two more domestic COVID-19 vaccines for public use".Reuters.Retrieved2021-02-26.
  15. ^abc"Pakistan purchases over 30 million COVID doses from China: sources".ARY NEWS.2021-04-25.Retrieved2021-04-26.
  16. ^abcd"Malaysia to receive CanSino vaccine this month | The Malaysian Insight".themalaysianinsight.Retrieved2021-04-03.
  17. ^abAshok R (2021-03-22)."UPDATE 2-China's CanSino Biologics COVID-19 vaccine receives emergency use approval in Hungary".Reuters.Retrieved2021-03-22.
  18. ^ab"Membrii NITAG au venit cu recomandări privind utilizarea vaccinurilor împotriva COVID-19 în Republica Moldova".Ministerul Sănătății, Muncii și Protecţiei Sociale.2021-03-03.Retrieved2021-05-21.
  19. ^ab"'Our gratitude always': From China's CanSino, Mexico welcomes biggest vaccine shipment yet ".Reuters.2021-02-11.Retrieved2021-02-11.
  20. ^ab"Argentina issues emergency approval to China's single-dose Cansino COVID-19 vaccine".Reuters.2021-06-11.Retrieved2021-06-11.
  21. ^ab"ISP Approves Emergency Use And Importation Of Cansino Vaccine To Fight COVID-19".Institute of Public Health of Chile.Archived fromthe originalon 2021-04-07.Retrieved2021-04-08.
  22. ^ab"China can hit 500-mln-dose annual capacity of CanSinoBIO COVID-19 vaccine this year".finance.yahoo.27 February 2021. Archived fromthe originalon 2021-02-27.Retrieved2021-02-28.
  23. ^abSolomon DB (2021-02-28)."China's CanSino says first vaccines packaged in Mexico will be ready in March".Reuters.Retrieved2021-03-12.
  24. ^"Pakistan develops homemade anti-Covid vaccine 'PakVac'".The Express Tribune.2021-05-24.Retrieved2021-05-25.
  25. ^abConstable P, Hussain S."Defying fears and skepticism, thousands in Pakistan volunteer for Chinese vaccine trials".The Washington Post.ISSN0190-8286.Retrieved2021-01-01.
  26. ^"Covid vaccine: Pakistan starts production of CanSino, China's single-dose jab".Khaleej Times.Archivedfrom the original on 2021-05-25.Retrieved2021-05-28.
  27. ^"Russian Recruits Show 'No Side Effects' in Chinese Coronavirus Vaccine Trials".The Moscow Times.2020-09-21.Retrieved2020-09-22.
  28. ^"Petrovax wins in two categories of Russian Pharma Inspiration Awards competition".petrovax.Archivedfrom the original on 2021-07-09.Retrieved2021-07-09.
  29. ^Cui J (23 March 2020)."Human vaccine trial gets underway".China Daily.Retrieved18 April2020.
  30. ^Xie J (15 April 2020)."China Announces Phase 2 of Clinical Trials of COVID-19 Vaccine".Voice of America.Retrieved18 April2020.
  31. ^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.PMC7836858.PMID32702299.
  32. ^O'Brien E (2020-09-25)."Covid Antibodies Endure Over Six Months in China Trial Subjects".bloomberg.Archivedfrom the original on 2020-09-29.Retrieved2020-09-29.
  33. ^Clinical trial numberNCT04566770for "Phase IIb Clinical Trial of A COVID-19 Vaccine Named Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)" atClinicalTrials.gov
  34. ^Yu S (17 August 2020)."China grants country's first COVID-19 vaccine patent to CanSino: state media".Reuters.Retrieved17 August2020.
  35. ^Bogart N (16 May 2020)."Health Canada approves first clinical trial for potential COVID-19 vaccine".CTV News.Retrieved7 September2020.
  36. ^abRyan H (May 16, 2020)."Canada's first COVID-19 vaccine trials approved for Halifax university".CBC News.RetrievedJanuary 4,2021.
  37. ^Cooke A (26 August 2020)."Canadian COVID-19 clinical trial scrapped after China wouldn't ship potential vaccine".CBC News.Retrieved7 September2020.
  38. ^Clinical trial numberNCT04552366for "A Clinical Trial of a Recombinant Adenovirus 5 Vectored COVID-19 Vaccine (Ad5-nCoV) With Two Doses in Healthy Adults" atClinicalTrials.gov
  39. ^Wu S, Huang J, Zhang Z, Wu J, Zhang J, Hu H, et al. (December 2021)."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.doi:10.1016/S1473-3099(21)00396-0.PMC8313090.PMID34324836.
  40. ^Cao X, Liu Y (2021-06-04)."Trần vi viện sĩ: Sương mù hóa hút vào thức COVID-19 vắc-xin phòng bệnh đang ở xin khẩn cấp sử dụng".Sci Tech Daily.Chinanews.Retrieved2021-06-04.
  41. ^"CanSinoBIO's Convidecia Air™ Receives Approval in China".cansinotech.CanSino Bio.Retrieved29 October2022.
  42. ^Gao, Jiaxuan (December 2022)."Vaccination with CanSinoBIO's inhaled COVID-19 vaccine has begun in China".Journal of Biosafety and Biosecurity.4(2): 163.doi:10.1016/j.jobb.2022.12.002.PMC9791787.PMID36589793.
  43. ^"México recibe el primer lote de la vacuna candidata de CanSino Biologics; alistan pruebas".EL CEO(in Mexican Spanish). 2020-11-03.Retrieved2020-11-03.
  44. ^Clinical trial numberNCT04540419for "Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Against COVID-19" atClinicalTrials.gov
  45. ^Bloomberg News (2020-11-25)."Russia's Richest Man Seeks Global Market for Local Covid-19 Drug - BNN Bloomberg".BNN.Retrieved2020-11-28.
  46. ^Yáñez PL (2020-11-15)."Así funcionan las cuatro vacunas que se probarán en Chile".La Tercera.Retrieved2020-11-17.
  47. ^"China trials mi xing of CanSinoBIO's and Zhifei Longcom's COVID-19 vaccines -data".Reuters.2021-04-19.Retrieved2021-06-16.
  48. ^"China's CanSino to pair its vaccine with Russia's Sputnik V in trial".South China Morning Post.2021-07-30.Retrieved2021-07-30.
  49. ^"CanSino's COVID-19 vaccine candidate approved for military use in China".Reuters.2020-06-29.Retrieved2020-12-13.
  50. ^"Mexico approves China's CanSino and Sinovac COVID-19 vaccines".Reuters.10 February 2021.
  51. ^Shahzad A (2021-02-12)."Pakistan approves Chinese CanSinoBIO COVID vaccine for emergency use".Reuters.Retrieved2021-02-12.
  52. ^"Malaysia Approves Pfizer Jab For Teens, CanSino And J&J Covid-19 Vaccines".CodeBlue. 15 June 2021.Archivedfrom the original on 25 June 2021.Retrieved17 July2021.
  53. ^"BPOM Terbitkan Izin Penggunaan Darurat Vaksin Covid-19 Produksi Johnson & Johnson dan Cansino".KOMPAS(in Indonesian). 2021-09-07.Archivedfrom the original on 2021-09-07.Retrieved2021-09-07.
  54. ^"China approves inhaled Covid vaccine".BBC News.5 September 2022.Archivedfrom the original on 5 September 2022.Retrieved6 September2022.
  55. ^"CanSino's inhaled COVID vaccine gets emergency use approval in China".Nikkei Asia.Reuters.4 September 2022. Archived fromthe originalon 5 September 2022.Retrieved6 September2022.
  56. ^"Mexico agrees to buy 35 million doses of CanSino COVID vaccine".Reuters.2020-12-10.Retrieved2020-12-10.
  57. ^Mandl, Carolina (2021-10-01)."Brazil's Biomm signs deals to distribute Cansino COVID-19 vaccine".Reuters.Retrieved2021-10-02.
  58. ^Sherwood D (2021-03-30)."Chile inks deal for 1.8 million doses of CanSino COVID-19 vaccine as inoculation drive plows ahead".Reuters.Retrieved2021-03-30.
  59. ^Valencia A."Ecuador authorizes use of China's CanSino vaccine against COVID-19".Reuters.Archivedfrom the original on 2021-08-23.Retrieved2021-06-16.
  60. ^Taufiqurrahman M."Indonesia can be manufacturing hub for COVID-19 vaccine, says Chinese foreign minister".The Jakarta Post.Retrieved13 October2020.
  61. ^"Malaysia's Solution Group to supply 3.5 million doses of CanSino vaccine to government".Reuters.2021-02-04.Retrieved2021-02-04.
  62. ^Timbuong J (21 June 2021)."Covid-19: Refugees in Malaysia to get CanSino vaccine, says Khairy".The Star.Archivedfrom the original on 22 June 2021.Retrieved22 June2021.
  63. ^Ahmad R (19 September 2021)."INTERACTIVE: How single-dose Covid-19 vaccines help protect Malaysia's remote communities".The Star.Archivedfrom the original on 23 September 2021.Retrieved23 September2021.

Further reading

[edit]
[edit]
Scholiahas a profile forAd5-nCoV(Q96695265).
Retrieved from "https://en.wikipedia.org/w/index.php?title=Convidecia&oldid=1237681013"