Pfizer Inc. and BioNTech SE have announced that two of the companies' four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against SARS-CoV-2 (the virus that causes COVID-19), received Fast Track designation from the U.S. Food and Drug Administration (FDA).
The two vaccine candidates were the "most advanced" out of four investigational vaccine candidates and were now tested in clinical studies in the USA and Germany, the companies announced in a joint statement. These preliminary data, together with additional preclinical and clinical data being generated, will be used by the two companies to determine a dose level and select among multiple vaccine candidates to seek to progress to a large, global Phase 2b/3 safety and efficacy trial.
The FDA grants fast track status to speed up the review of new drugs and vaccines that show the potential to address unmet medical needs. BNT162b1 and BNT162b2 are both nucleoside-modified RNAs formulated in lipid nanoparticles.
In early July the companies released early data from the ongoing Phase I/II trial of BNT162b1. 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.
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Peter Honig, Pfizer's senior vice president for global regulatory affairs, said it was an "important milestone". The BNT162 vaccine candidates are undergoing clinical studies and are not now approved for distribution anywhere in the world. That trial may involve up to 30,000 healthy participants and is anticipated to begin in late July 2020, if regulatory approval to proceed is received.
The companies said last month they're preparing to produce millions of vaccine doses this year and hundreds of millions in 2021. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. For more than 150 years, we have worked to make a difference for all who rely on us.