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BioNTech and Pfizer announce regulatory approval from German authority Paul-
Ehrlich-Institut to commence first clinical trial of COVID-19 vaccine
candidates
GlobeNewswire•April 22, 2020
- First COVID-19-related clinical trial to start in Germany
- Initial dose escalation phase to target dose range of 1μg to 100μg
- Clinical supply from BioNTech’s GMP-certified mRNA production facilities
in Europe
- Four vaccine candidates to enter clinical development
MAINZ, Germany and NEW YORK, April 22, 2020 (GLOBE NEWSWIRE) -- BioNTech SE
(Nasdaq: BNTX, “BioNTech” or “the Company”) and Pfizer Inc. (PFE), have
announced today 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. BioNTech and Pfizer are
jointly developing BNT162. The trial is the first clinical trial of a COVID-
19 vaccine candidate to start in Germany, and is part of a global
development program. Pfizer and BioNTech will also conduct trials for BNT162
in the United States upon regulatory approval, which is expected shortly.
Ehrlich-Institut to commence first clinical trial of COVID-19 vaccine
candidates
GlobeNewswire•April 22, 2020
- First COVID-19-related clinical trial to start in Germany
- Initial dose escalation phase to target dose range of 1μg to 100μg
- Clinical supply from BioNTech’s GMP-certified mRNA production facilities
in Europe
- Four vaccine candidates to enter clinical development
MAINZ, Germany and NEW YORK, April 22, 2020 (GLOBE NEWSWIRE) -- BioNTech SE
(Nasdaq: BNTX, “BioNTech” or “the Company”) and Pfizer Inc. (PFE), have
announced today 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. BioNTech and Pfizer are
jointly developing BNT162. The trial is the first clinical trial of a COVID-
19 vaccine candidate to start in Germany, and is part of a global
development program. Pfizer and BioNTech will also conduct trials for BNT162
in the United States upon regulatory approval, which is expected shortly.