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. 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
The Lancet in August 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. In August, China's
National Intellectual Property Administration issued the country's first COVID-19 vaccine
patent to CanSino. 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.
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. On June 3, 2021, expansion of clinical trials was approved by the NMPA and the nasal spray applied for Emergency Use Listing. 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. Rollout of inhaled boosters was underway in October.
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. In October 2020,
Mexico began Phase III trials on 15,000 volunteers. 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. 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 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.
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. 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.
Authorizations On 25 June 2020, China approved the vaccine for limited use by the military. In February 2021, China approved the vaccine for general use. In February 2021, Mexico approved the vaccine for emergency use. In February 2021,
Pakistan approved the vaccine for emergency use. In March,
Hungary approved the vaccine for emergency use. In March,
Moldova authorized use of the vaccine. On 7 September 2021,
National Agency of Drug and Food Control (BPOM) has issued emergency use authorization in Indonesia. 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. ==Economics==