On Sept. 7, 2020, Pfizer and BioNTech announced that the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 2/3 clinical trial in Germany for their BNT162b2 vaccine candidate.

The study in Germany is part of the global pivotal Phase 2/3 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 received either BNT162b2 or placebo. The study was to be conducted in approximately 120 sites globally, including regions with significant expected SARS-CoV-2 transmission. To date, the trial enrollment had exceeded 25,000 participants.

BNT162b2 remains under clinical study and is currently not approved for distribution anywhere in the world. Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020 and, 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.