Wednesday, Sep 23

Germany's coronavirus vaccine on track to seek regulatory review

BioNTech and US drug giant Pfizer released data from phase 2/3 trial of the BNT162b2 mRNA-based vaccine in the US and Germany.
21.08.2020 - 15:15

German-based biotech firm BioNTech announced late Thursday that vaccine candidate for coronavirus with US drug giant Pfizer was on track for regulatory review as early as October.

“Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review of BNT162b2 as early as October 2020,” said the company statement.

"THE PLAN IS TO SUPPLY UP TO 100 MILLION DOSES WORLDWIDE BY THE END OF 2020"

“If regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021,” it added.

The companies also released additional data from phase 2/3 trial of the BNT162b2 mRNA-based vaccine in the US and Germany.

“We are especially pleased to offer these early data showing our vaccine candidate’s promising safety and immunogenicity profile from the US trial and we look forward to sharing T cell immune response data from the German trial in the near future,” said Kathrin Jansen, head of vaccine research and development at Pfizer.

The companies said “across all populations, BNT162b2 administration was well tolerated with mild to moderate fever in fewer than 20 percent of the participants.”