Academician Wang Junzhi Hails BNT162b2 mRNA COVID-19 Vaccine as a Model of Global R&D Collaboration

On December 4, Wang Junzhi, Academician of the Chinese Academy of Engineering and Deputy Head of the Expert Group under the Vaccine Research and Development Task Force of the Scientific Research Assault Team, delivered a speech on “Progress in the R&D of Vaccines and Drugs for COVID-19” at the 8th World Congress of Integrative Medicine. When introducing COVID-19 vaccines with publicly disclosed Phase III clinical trial results worldwide, he specifically highlighted BNT162b2, the mRNA COVID-19 vaccine developed through the collaboration between Fosun Pharmaceutical, Pfizer, and BioNTech, stating that “BNT162b2 is a successful example of international cooperation in vaccine development.”

According to reports, this vaccine received emergency use authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) on December 2, 2020, becoming the first COVID-19 vaccine globally to be approved for emergency use based on Phase III clinical trial results. As early as March, when the global pandemic situation was still uncertain, Fosun Pharmaceutical entered into a cooperation agreement with Germany’s BioNTech. A few days later, Pfizer also signed a collaboration deal with BioNTech. “Now that the Phase III clinical results have been released abroad, data can be shared, including with China, allowing us to directly apply for import registration of the mRNA vaccine in our country. This is highly advantageous for us,” introduced Wang Junzhi.

According to public data, as of December 2, there were a total of 214 vaccines under development worldwide. Among them, 51 had entered clinical trials (14 in China), and 14 had entered Phase III clinical trials (6 in China). Nucleic acid vaccines have made rapid progress globally. The BNT162b2 vaccine, jointly developed by Fosun Pharmaceutical and its global partners BioNTech and Pfizer, has met all primary efficacy endpoints in its overseas Phase III clinical trials, demonstrating a 95% efficacy in preventing COVID-19.

The BNT162b2 vaccine has previously submitted applications for Emergency Use Authorization (EUA) or conditional marketing authorization to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), with rolling submissions underway globally, including in Australia, Canada, and Japan. The FDA and EMA are expected to announce their decisions on the authorization applications in December.

It is reported that on March 13, 2020, Fosun Pharmaceutical and BioNTech entered into a strategic cooperation agreement to jointly develop and commercialize COVID-19 vaccine products based on BioNTech’s proprietary mRNA technology platform in mainland China and the Hong Kong, Macao, and Taiwan regions. Since the establishment of this partnership, Fosun Pharmaceutical has been deeply involved in the research and development of mRNA vaccines. In addition to engaging in comprehensive and in-depth discussions with its partner on R&D plans and advancing clinical trials within China, Fosun Pharmaceutical designed and completed animal challenge studies for multiple mRNA vaccine candidates, including BNT162b2, in collaboration with Chinese research institutions, and promptly shared the results with its partner.

Currently, the BNT162b2 vaccine has initiated Phase II clinical trials in China, with a planned enrollment of 960 healthy subjects aged 18 to 85 years, to evaluate the safety and immunogenicity of this candidate vaccine in support of its domestic marketing authorization application. Fosun Pharmaceutical will strive to expedite the market launch of the vaccine in China, premised on ensuring its clinical safety and efficacy.