publication date: Jul. 17, 2020

Drugs & Targets

Pfizer and BioNTech receive FDA Fast Track designation for investigational COVID-19 vaccine candidates 

Two out of four investigational vaccine candidates by Pfizer Inc. and BioNTech SE received Fast Track designation from FDA.

The candidates are from the companies’ BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2), which are being developed to help protect against SARS-CoV-2. BNT162b1 and BNT162b2 are the two most advanced vaccine candidates in the BNT162 program currently being evaluated in ongoing Phase I/II clinical studies in the United States and Germany, the sponsors said.

This designation was granted based on preliminary data from phase I/II studies in the United States and Germany as well as animal immunogenicity studies. The companies released early data from the ongoing U.S. phase I/II study for the product candidate BNT162b1 on July 1. The manuscript is available on the online preprint server medRxiv and is concurrently undergoing scientific peer-review for potential publication. Early data from the German trial of BNT162b1 are expected to be released in July.

The BNT162 program is evaluating at least four experimental vaccines, each of which represent a unique combination of messenger RNA 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 antigen, while BNT162b2 encodes an optimized SARS-CoV-2 full-length spike protein antigen.

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. The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world.

Subject to regulatory approval, Pfizer and BioNTech are expecting to start a phase IIb/III trial later this month … Continue reading Pfizer and BioNTech receive FDA Fast Track designation for investigational COVID-19 vaccine candidates

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