FDA grants Fast Track designation to two COVID-19 vaccines

The US Food and Drug Administration (FDA) has granted Fast Track designation to two of Pfizer Inc and BioNTech SE’s investigational SARS-CoV-2 vaccine candidates from their BNT162 mRNA-based vaccine program.

Fast Track is designed to facilitate the development and expedite the review of new drugs and vaccines that are intended to treat or prevent serious conditions that have the potential to address an unmet medical need.

BNT162b1 and BNT162b2 are the two most advanced vaccine candidates in the BNT162 program, the designation was based on preliminary data from ongoing Phase I/II clinical studies in the US and Germany, as well as animal immunogenicity studies.

In early July the companies released early data from the ongoing Phase I/II trial of BNT162b1. Early data from the German trial of BNT162b1 is 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 (mRNA) format and target antigen. BNT162b1 and BNT162b2 are both nucleoside-modified RNAs formulated in lipid nanoparticles. BNT162b1 encodes an optimised SARS-CoV-2 receptor-binding domain (RBD) antigen, while BNT162b2 encodes an optimised SARS-CoV-2 full-length spike protein antigen.

“The FDA’s decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2,” said Peter Honig, Senior Vice President, Global Regulatory Affairs, Pfizer. “We look forward to continue working closely with the FDA throughout the clinical development of this program, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates.”  

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. Subject to regulatory approval, the companies are expecting to start a Phase 2b/3 trial enrolling up to 30,000 subjects potentially as soon as the end of July. If the ongoing studies are successful, and the vaccine candidate receives regulatory approval, the companies currently expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.