Progress on BioNTech and Pfizer's COVID-19 vaccine candidate BNT162b2

The German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase II/III clinical trial in Germany of BNT162b2, the vaccine candidate under development by domestic biotech BioNTech (Nasdaq: BNTX) and US pharma giant Pfizer (NYSE: PFE).

The study in Germany is part of the global pivotal Phase II/III program BioNTech and Pfizer initiated in July this year. The placebo-controlled trial evaluates the safety and efficacy of BNT162b2 in up to 30,000 participants between 18 and 85 years of age. The participants receive either BNT162b2 or placebo. The study will be conducted in about 120 sites globally, including regions with significant expected SARS-CoV-2 transmission. As of today, the trial enrollment has exceeded 25,000 participants.

“A large, controlled Phase III study is a crucial prerequisite to prove the safety and efficacy of a vaccine,” stressed Ugur Sahin, chief executive and co-founder of BioNTech, adding: “The integration of sites in Europe, and now especially in Germany, is aimed at supporting an approval in Europe.”