Pfizer and BioNTech Get Fast Track Status for Two COVID-19 Vaccines

Two COVID-19 vaccine candidates being developed by Pfizer and BioNTech have received fast-track status from the FDA.

The vaccines, BNT162b1 and BNT162b2, are the most advanced of four messenger RNA vaccines the companies are evaluating in phase 1/2 clinical trials in the U.S and Germany. The FDA granted the designations based on promising early data from those trials, as well as animal immunogenicity studies.

Pfizer and BioNTech have already released preliminary data from the U.S. trial of BNT162b1, and they plan to release data from the German trial of the vaccine this month (DID, July 2). The companies also plan to begin late-stage trials of the vaccine candidates in 30,000 participants later this month.

If a vaccine is approved, the drugmakers expect to manufacture up to 100 million doses by the end of the year and over 1.2 billion doses by the end of 2021.

The FDA also granted fast track designation in May to Moderna’s COVID-19 vaccine candidate mRNA-1273. The company is expected to begin phase 3 testing of the vaccine this month (DID, May 13).

Vaccine candidates from Pfizer/BioNTech and Moderna are among those selected for accelerated development under the Trump Administration’s Operation Warp Speed. Also in the running are AstraZeneca, Johnson & Johnson, Merck, Sanofi, Novavax and Innovia (DID, June 4). — Jordan Williams