Vaccine developer BioNTech completed a Phase II clinical trial of its COVID-19 vaccine in China in January but has yet to release its results, a registry of such trials showed on Tuesday (May 10).
The vaccine, based on messenger mRNA technology, is one of the most widely used worldwide against COVID, but has yet to receive approval in China, which has vaccinated 89% of its 1.4 billion population with several domestically developed non-mRNA shots.
“With the application for authorization of our mRNA COVID-19 vaccine BNT162b2 on the Chinese Mainland, we have submitted a comprehensive data package to the respective authorities,” a BioNTech spokesperson said.
The company did not specify when a regulatory decision from mainland China is expected. Additionally, Shanghai Fosun Pharmaceutical Group Co, BioNTech’s Chinese partner for the vaccine, did not respond to a request for comment.
The Phase II trial on the vaccine’s safety and immunogenicity began in late 2020.