(RTTNews) - Immunotherapy company BioNTech SE (BNTX) and pharma major Pfizer Inc. (PFE) said Wednesday that the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 1/2 clinical trial for BioNTech's BNT162 vaccine program to prevent COVID-19 infection.
The trial for BNT162 is the first clinical trial of a COVID-19 vaccine candidate to start in Germany, and will also be conducted in the United States, upon regulatory approval, which is expected shortly. The two companies are jointly developing BNT162.
BioNTech will provide its partners clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe.
In addition, BioNTech will be collaborating with Fosun Pharma to develop BNT162 in China, where the companies expect to conduct trials.
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