|Vaccine type||Viral vector|
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AD5-nCOV, trade-named Convidecia, is a single-dose viral vector vaccine for COVID-19 developed by CanSino Biologics. Since late 2020, it has been in Phase III trials 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 vaccine had a 65.7% efficacy in preventing moderate symptoms of COVID-19, and 91% efficacy in preventing severe disease. It has similar efficacy to Johnson & Johnson's Ad26.COV2.S, another one-shot adenovirus vector vaccine with 66% efficacy in a global trial. Convidecia is similar to other viral vector vaccines like AZD1222, Gam-COVID-Vac, and Ad26.COV2.S. Its single-dose regimen and normal refrigerator storage requirement (2°to 8 °C) could make it a favorable vaccine option for many countries.
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.
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.
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.
In April, Ad5-nCoV became the first COVID-19 vaccine candidate in the world to begin Phase II trials. 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. 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. 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.
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. If the vaccine trials were successful, then the National Research Council would work with CanSino to produce and distribute the vaccine in Canada. 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.
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.
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.
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.
In Malaysia, final filling and packaging of the vaccine for distribution would be completed by Solution Biologics.
Marketing and deployment
In February, Malaysia's Solution Biologics agreed to supply 3.5 million doses to the government. 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 December, Mexico's Foreign Minister Marcelo Ebrard signed an agreement with CanSino for 35 million doses of the vaccine. On February 10, the Mexican health regulator Cofepris approved the vaccine for emergency use. Mexico received active ingredients for 2 million doses with a total of 6 million doses expected to arrive in February.
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|Scholia has a profile for Ad5-nCoV (Q96695265).|