A research institute run by China’s military received approval to conduct human clinical trials of a new Covid-19 vaccine developed using advanced genetics technology, in a notable breakthrough for China’s quickly developing pharmaceutical industry.
The approval comes as other Chinese drugmakers move to expand testing of more traditional coronavirus vaccines outside China.
The Academy of Military Medical Sciences, run by the People’s Liberation Army, said this week that regulators had granted it permission to test a Covid-19 vaccine built using so-called messenger RNA on human subjects, making it the first such vaccine ever to reach the clinical-trial stage in China.
The experimental technology, referred to as mRNA for short, uses genetic material that tricks the body’s cells into producing proteins resembling those on the surface of the coronavirus. That in turn triggers an immune response that is supposed to protect a person against exposure to the actual virus.
in the U.S. and Germany’s BioNTech started testing their mRNA-based vaccine candidates on volunteers in their respective countries in the spring. Moderna is expected to begin a phase-three trial next month and has already said its vaccine showed early positive results in human tests.
Chinese researchers have less experience in more sophisticated vaccine technologies compared to some of their Western peers, although no mRNA-based vaccines have ever been approved for public use by any country.
Progress in developing a vaccine would help China deflect criticism of the Communist Party’s suppression of news of the virus after it first emerged in the central Chinese city of Wuhan late last year.
By greenlighting the PLA to pursue a new technology in humans first, Beijing is also indicating the mRNA candidate in China that it sees as most promising and that it is choosing to fast-track. Germany’s BioNTech wants to test its mRNA-based vaccine in China, but has yet to get approval.
The new PLA vaccine was approved for testing on people on June 19, according to state media. It brings the number of China-developed vaccines given the go-ahead for clinical trials to eight.
The first two phases of clinical trials are mostly to test safety and can be done anywhere. The third stage is aimed at determining how effective a vaccine is—something that can only be done in areas where the virus is still spreading.
Two other Chinese drugmakers are pushing Covid-19 vaccine candidates that have already undergone initial human trials in China into phase-three tests in Brazil and the United Arab Emirates. Both state-owned China National Biotec Group Co., or CNBG, and the private Chinese firm Sinovac Biotech Ltd., which is collaborating with government medical institutions, are venturing abroad because of the current low spread of coronavirus inside China.
Not counting the PLA’s new vaccine, a total of 16 Covid-19 vaccine candidates were undergoing human clinical trials around the world as of Wednesday, according to World Health Organization data. Scientists expect multiple vaccines to be on the market, though it is still too early to tell which vaccine in the global pipeline will be most effective.
The Chinese military, in collaboration with
CanSino Biologics Inc.,
has been seeking approval from Canada to test one of its earlier vaccine candidates there. Its mRNA-based candidate shows how Beijing wants to catch up in the cutting-edge methods.
Four of China’s vaccine candidates being tested in humans are based on an older technique that attempts to trigger an immune response by exposing a person to a weakened version of the virus cultivated in a petri dish.
The PLA said its mRNA vaccine candidate triggered an immune response and antibodies in mice and monkeys. For this project, it is working with private companies Suzhou Abogen Biosciences Co. and Shenzhen-listed Yunnan Walvax Biotechnology Co., according to the Chinese Clinical Trial Registry.
The phase-one trials will run in the eastern city of Hangzhou and in a town in the southwestern region of Guangxi. A hospital in Hangzhou started recruiting participants on Tuesday.
Sinovac’s trial in Brazil aims to recruit 9,000 volunteers with the help of government-backed Instituto Butantan. CNBG’s vaccine candidate was endorsed by health authorities in the U.A.E. earlier this week. Neither firm has said when those tests will begin.
The initial rollout of viable vaccines is expected to differ by country, although governments are expected to give priority to health-care workers. China has also shown interest in giving its vaccines to state-owned employees working abroad.
—Raffaele Huang contributed to this article.
Write to Chao Deng at Chao.Deng@wsj.com
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