COVID-19: BioNTech Commences Phase 2 Vaccine Trials in China with Fosun

BioNTech, once a frontrunner in the global vaccine race, gained emergency approval in the UK recently. As the mRNA vaccine (BNT162b2), co-developed with Pfizer, is found more than 95% effective in preventing COVID-19, BioNTech has turned to the Chinese market to collect clinical data of the vaccine for regulatory approval in China.

BNT162b2 Enters Phase 2 Trials in China

On November 25, BioNTech and Fosun Pharmaceutical (Fosun) announced the start of Phase 2 clinical trial in China to evaluate the safety and immunogenicity of BNT162b2. The trial will be conducted by Jiangsu Provincial Center for Disease Control and Prevention in Taizhou and Lianshui, Jiangsu Province, for biologics license application in China.

“As an important part of global research and development, the Phase 2 clinical study with BNT162b2 in China will not only provide key data for the launch of the vaccine in China but also may play a positive role in the widespread promotion and use of the vaccine throughout Asia and around the world.” President of Global Research and Development and Chief Medical Officer of Fosun Pharma Dr. Aimin Hui said.

Primary Endpoints

The trial involves 960 healthy adults (18 to 85 years old) who will be separated into 2 groups. While 720 subjects are intravenously injected with BNT162b2, the remaining 240 subjects will be given a placebo. The humoral immune responses of the participants will be examined 1 month after the second shots of vaccines. Besides, the safety and tolerability of BNT162b2 will be observed on the 7th and 14th day after every shot. The primary endpoint is to look at patients’ seroconversion rates (SCR) and geometric mean titer (GMT) of SARS-CoV-2 serum neutralizing titers.

Vaccine Strategies in China

Fosun is a healthcare company in China that strives to develop and manufacture innovative small molecule drugs, high-value generic drugs, biologics, and cell therapy.

Fosun became BioNTech’s strategic partner in China in March; the goal is to further develop and commercialize the COVID-19 vaccine. The two have commenced the phase 1 clinical trial of BNT162b1 in August, while on November 13, BNT162b2 received the green light from China regulatory authorities for clinical trials. Fosun announced in August that once BNT162 vaccines are approved, it will supply 10 million doses to Hong Kong and Macao.

By Tyler Chen

Related Article：Final Analysis Suggests Pfizer, BioNTech’s COVID-19 Vaccine is Safe with 95% Efficacy

References

1. https://investors.biontech.de/news-releases/news-release-details/biontech-and-fosun-pharma-announce-start-phase-2-clinical-trial
2. http://www.chictr.org.cn/showproj.aspx?proj=64544
3. https://www.fosun.com/language/hk/p/51290.html

Author

Tyler Chen

"Never go to a doctor whose office plants have died."- Erma Bombeck