BioNTech, Fosun Pharma Start Early Stage COVID-19 Vaccine Study in China

Germany-based BioNTech and Fosun Pharma have begun a phase 1 trial of their COVID-19 vaccine candidate BNT162b1 in China.

The trial will enroll 144 healthy participants, who will either receive two 10-microgram or 30-microgram doses of the vaccine 21 days apart, or a placebo. The first 72 participants have already been dosed, the companies said.

The trial is designed to support regulatory approval in China, and to confirm previous safety and immunogenicity findings from German and U.S. trials.

The German drugmaker is developing COVID-19 vaccine candidates in collaboration with Pfizer, and Pfizer will commercialize an approved vaccine globally except in China, where Fosun will have exclusive rights.

BNT162b1 is one of two mRNA-based vaccine candidates developed by Pfizer and BioNTech to receive Fast-Track designations by the FDA (DID, July 14). The other candidate, BNT162b2, advanced to an international global phase 2/3 trial last week. That study will involve up to 30,000 participants at approximately 120 sites globally (DID, July 28).

Pfizer and BioNTech signed an agreement with Japan’s Ministry of Health late last month to supply 120 million doses of BNT162b2. They have also secured a contract from the Canadian government for delivery of an undisclosed number of doses of a working vaccine next year. — Jordan Williams