Chinese drug regulators completed an expert panel review of a COVID-19 mRNA vaccine co-developed by Fosun Pharma and Germany's BioNTech, and now the shot is in the administrative review stage, according to Fosun.
The Shanghai-based pharmaceutical company is sticking with its previously announced plan to start domestic trial production by the end of August, Fosun Chairman Wu Yifang said Wednesday at a shareholders meeting.
Chinese authorities plan to use the vaccine, which goes by the brand name Comirnaty, as a booster shot for people who have received inactivated-virus vaccines, people close to regulators told Caixin. The booster shot is likely to be offered free of charge.
China has administered more than 1.2 billion vaccine doses, as of July 1, according to the National Health Commission. Most people have received inactivated-virus vaccines made by Sinovac and state-owned Sinopharm Group that have demonstrated lower efficacy than mRNA vaccines.
While awaiting regulatory clearance, Fosun Pharma and BioNTech started preparations and bought equipment for their Shanghai-based joint venture. Installation of production lines in the Shanghai plant is set to be completed in August, Fosun said in June.
Fosun and BioNTech in May announced plans to set up the Shanghai facility to produce BioNTech's mRNA vaccine Comirnaty, also known as BNT162b2. The venture is part of a broader partnership formed in early 2020 to bring the vaccine to China.
Wu said the Shanghai factory will hit its annual production capacity of 1 billion doses of COVID-19 vaccine by the end of this year. With the assistance of Fosun's other facilities, monthly output can expand to 100 million to 200 million doses, Wu said.
Fosun sealed a deal to sell 10 million vaccine doses to Taiwan following months of on-again, off-again talks that finally reached a breakthrough after the island experienced a recent COVID-19 outbreak.
The University of Hong Kong is studying the effect of mixing shots of BioNTech's Comirnaty and one made by Sinovac Life Sciences. Fosun and the Chinese government are also conducting vaccine-mixing research. The currently available data suggest favorable results, Wu said.
The efficacy of the Chinese shots ranges from 50% to almost 80% in trials and real-world studies, significantly lower than the mRNA vaccines developed by Moderna and Pfizer-BioNTech. That has raised concerns they may not be effective in taming the virus's more infectious variants.
The Pfizer-BioNTech and Moderna vaccines cover all existing variants and can provide a high degree of protection, although with reduced effectiveness, said Jin Dongyan, a molecular virologist at the University of Hong Kong.
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Caixinglobal.com is the English-language online news portal of Chinese financial and business news media group Caixin. Nikkei recently agreed with the company to exchange articles in English.