Convidecia

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AD5-nCOV
Vaccine description
TargetSARS-CoV-2
Vaccine typeViral vector
Clinical data
Trade namesConvidecia
Routes of
administration
Intramuscular, Intranasal
ATC code
  • None
Legal status
Legal status
Identifiers
DrugBank

AD5-nCOV, trade-named Convidecia, is a single-dose[1] viral vector vaccine for COVID-19 developed by CanSino Biologics. Since late 2020, it has been in 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 AZD1222, Gam-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 authorized for use in China,[11] Mexico,[12] Pakistan,[13], Hungary [14], and Chile.[15] Production capacity for Ad5-NCov should reach 500 million doses in 2021.[16]

Technology[edit]

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.[17][9]

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 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[edit]

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. 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.[18]

In April, Ad5-nCoV became the first COVID-19 vaccine candidate in the world to begin Phase II trials.[19] 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 based on statistical analyses of data involving 508 eligible participants.[20] 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.[21] 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.[22]

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]

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.[27]

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.[7]

In October, Mexico received the first batch of the vaccine for Phase III trials on 10,000 to 15,000 volunteers.[28][4]

In September, Russia's NPO Petrovax began Phase III trials on 500 volunteers,[29] which Petrovax later received approval from the government to expand to 8,000 more volunteers.[30][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.[17]

In November, Chile approved Phase III trials on 5,200 volunteers to be managed by University of La Frontera.[31][3]

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.[2]

Manufacturing[edit]

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.[16]

If the vaccine is approved in Russia, Petrovax said it would produce more than 4 million doses a month in 2020 and 10 million doses per month in 2021.[32]

In February, Mexico received the first batch of active ingredients for Convidecia, which is being packaged in Querétaro by Drugmex.[33]

In Malaysia, final filling and packaging of the vaccine for distribution would be completed by Solution Biologics.[34]

Marketing and deployment[edit]

Authorization and eligibility by country
  Full authorization
  Emergency authorization
  Eligible COVAX recipient (assessment in progress)[41]

Asia[edit]

On June 25, 2020, China approved Ad5-nCoV for limited use by the military for one year.[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.[34]

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 January, Pakistan was offered 20 million doses by CanSino[45] and approved the vaccine for emergency use on February 12.[13] The first 3 million doses are to arrive in April.[46]

Europe[edit]

In March, Hungary granted emergency use approval for the vaccine.[37]

North America[edit]

In December, Mexico's Foreign Minister Marcelo Ebrard signed an agreement with CanSino for 35 million doses of the vaccine.[47] On February 10, the Mexican health regulator Cofepris approved the vaccine for emergency use.[12] Mexico received active ingredients for 2 million doses with a total of 6 million doses expected to arrive in February.[48]

South America[edit]

In March, Chile signed a deal for 1.8 million doses of the vaccine to be delivered in May and June,[49] for which emergency approval was granted in April.[15]

References[edit]

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External links[edit]