Chinese Coronavirus Vaccine Candidate Approved For Human Trials In UAE
Health authorities from the United Arab Emirates (UAE) announced the commencement of the world’s first phase III clinical trial of a COVID-19 inactivated vaccine, the UAE Embassy in China said in a tweet.
The human trial will be conducted in the UAE through a partnership between Chinese pharma company Sinopharm China National Biotec Group (CNBG) and UAE’s Group 42 (G42), an Abu Dhabi-based artificial intelligence and cloud computing company.
The trial will be led by G42 in the UAE under the supervision of the Department of Health of Abu Dhabi.
The clinical trial process is usually divided into three phases. Phase I mainly looks into the safety of the vaccine and the Phase II evaluates immunogenicity and explores the immunization process in a limited number of individuals.
The Phase III considers the safety and effectiveness of the vaccine in a larger population sample. This late-stage trial is shifted to the UAE as China has few confirmed COVID-19 cases and hence it does not meet the conditions for phase III trial of the vaccine’s safety and efficacy on a large scale, reports said.
The COVID-19 inactivated vaccine, developed by the Wuhan Institute of Biological Products under Sinopharm CNBG, has passed phases I and II clinical trials without showing any serious adverse reactions, with 100 percent of the volunteers generating antibodies after two doses in 28 days.
The human trials for the vaccine began on April 12 in Wuzhi County in central China’s Henan Province. CNBG said a total of 1,120 volunteers aged 18-59 were inoculated with two doses in 28 days. All volunteers generated high levels of neutralizing antibodies during the randomized, double-blind and placebo-controlled trial. The antibodies block pathogens from infecting human cells.
The partnership between Group 42 and Sinopharm CNBG plans to accelerate the development of a safe and effective vaccine that can be marketed by the end of 2020 or early 2021, Group 42 said in a statement.
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