BackGermany's BioNTech, Fosun launch covid vaccine trial in China
The trial is part of BioNTech’s global development program aimed at supporting a global supply upon regulatory approval.
PremiumGermany's BioNTech and China's Shanghai Fosun Pharmaceutical have announced the start of another COVID-19 vaccine trial in China. BioNTech and Fosun Pharma are jointly developing the COVID-19 vaccine candidate in China.
The randomized, placebo-controlled, observer-blinded Phase 1 clinical trial in China will enroll 144 healthy subjects to evaluate the safety and immunogenicity of the vaccine as well as to confirm dose selection, BioNTech said in a statement.
"The study is designed to support the regulatory approval process for the Chinese market and intends to confirm that the safety and immunogenicity profile observed in participants from the German and U.S. trials is comparable to that of Chinese participants," BioNTech said in a statement.
The trial is part of BioNTech’s global development program aimed at supporting a global supply upon regulatory approval.
BioNTech said the dose range selection was determined based on early data from clinical trials conducted in Germany and the United States. The participants will be dosed in Taizhou Clinical Phase1 Center, Jiangsu province.
The study is designed to support the regulatory approval process for the Chinese market and intends to confirm that the safety and immunogenicity profile observed in participants from the German and US trials is comparable to that of Chinese participants. The ongoing clinical studies conducted in Germany and the United States will continue to support studies in China.
“We are proud to be among the first international biopharmaceutical companies to initiate a clinical trial of a COVID-19 vaccine candidate in China as part of our effort to make our vaccine available globally, if approved. This is an important step toward our goal to reach marketing authorization and ensure vaccine supply in China to help prevent new COVID-19 outbreaks in the most populous country in the world," said CEO and Co-founder of BioNTech, Ugur Sahin.
Unlock a world of Benefits! From insightful newsletters to real-time stock tracking, breaking news and a personalized newsfeed – it's all here, just a click away! Login Now!
