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China Consortium Starts Phase I Trial of mRNA Vaccine for COVID-19
A consortium of three China entities has begun Phase I tests of ARCoV, a messenger RNA vaccine for COVID-19. The three partners are the People's Liberation Army (PLA) Academy of Military Sciences, Suzhou Abogen Biosciences and Walvax Biotech. The candidate is the first mRNA vaccine for COVID-19 approved for China trials. In animal tests, ARCoV induced high levels of neutralizing antibodies and also induced protective T cell immune responses.
According to Chengfeng Qin, the project leader and a researcher at PLA Academy of Military Sciences, the domestically developed mRNA vaccine has three advantages:
• The selection of vaccine antigen target is more precise, improving safety;
• Core raw materials and equipment have been locally sourced, facilitating rapid expansion of production capacity;
• ARCoV can be stored at room temperature for a week, reducing the costs of cold chain distribution.
The Phase I trial, which will be conducted in Hangzhou's Shulan Hospital, plans to recruit 168 healthy individuals, half of them aged 18 to 59 years old and the other half aged at least 60 years, to evaluate the safety and tolerance of the mRNA vaccine.
The volunteers will receive two doses of the vaccine, and will be able to leave the research center after confirming the absence of any abnormality.
There is at least two other mRNA vaccines waiting for China approval to begin clinical trials. In March, Shanghai Fosun Pharma (SHA: 600196; HK: 02196) and BioNTech SE (NSDQ: BNTX) of Germany agreed to a $135 million deal to develop BioNTech's mRNA vaccine candidate for COVID-19 in China. Fosun made a $50 million investment in BioNTech and will pay up to $85 million in milestones. The two companies will share gross profits from China sales while Fosun will be in charge of China commercialization.
For the rest of the world, BioNTech partnered the vaccine with Pfizer. The two companies reported preliminary results from a US Phase I test of the vaccine, BNT162b1, today. Even at low dosing levels, the BioNTech-Pfizer-Fosun mRNA vaccine candidate showed higher antibody levels than post-disease patients. The two companies will discontinue testing high doses of the mRNA vaccine because many patients in the cohort developed fevers. The responses of the trial subjects were compared with antibody levels individuals who had recovered from the virus.
Tianjin CanSino is waiting for China approval to begin testing its mRNA vaccine for COVID-19. The company's other vaccine for COVID-19, which is delivered by a genetically engineered adenovirus, has already started Phase II trials in China.