Two Pfizer, BioNTech vaccines win FDA Fast Track status

July 13, 2020

Two experimental SARS-CoV-2 vaccines developed jointly by Pfizer and BioNTech have received Fast Track status from the US FDA.

BNT162b1 and BNT162b2 are the most advanced of four potential vaccines from the partners' BNT162 mRNA-based vaccine program.

This designation — which will expedite review — was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the U.S. and Germany as well as animal immunogenicity studies. The companies released early data from the ongoing U.S. Phase 1/2 study for the product candidate BNT162b1 on July 1, 2020. Early data from the German trial of BNT162b1 are expected to be released later in July.

The Project Lightspeed vaccine development program is based on BioNTech’s proprietary mRNA-based technology platforms and supported by Pfizer’s global vaccine development capabilities. Each of the vaccines represent a unique combination of messenger RNA (mRNA) format and target antigen. BNT162b1 and BNT162b2 are both nucleoside-modified RNAs, formulated in lipid nanoparticles. BNT162b1 encodes an optimized SARS-CoV-2 receptor-binding domain (RBD) antigen, while BNT162b2 encodes an optimized SARS-CoV-2 full-length spike protein antigen.

Read the press release