Pfizer, BioNTech Coronavirus Vaccine Candidates Granted Fast Track Designation By FDA, Study On Track For July Start

Pfizer Inc. PFE and BioNTech SE – ADR BNTX announced an update on their coronavirus vaccine program Monday that sent both stocks sharply higher. 

Project Lightspeed Fast Tracked: Pfizer and its German partner BioNTech said two of the companies' four investigational vaccine candidates from their BNT162 RNA-based vaccine program — BNT162b1 and BNT162b2 — have been granted fast track designation from the FDA.

These two are the most advanced vaccine candidates in the BNT162 program, which is dubbed Project Lightspeed, and are being evaluated in Phase 1/2 clinical studies in the U.S. and Germany against SARS-CoV, the virus that causes COVID-19.

The fast track designation is accorded to new drugs and vaccines meant to treat or prevent serious conditions that address unmet needs. The designation helps expedite the development program.

With Monday's news, the combo's vaccine program appears to be ahead in the race for a successful coronavirus vaccine.

Pfizer and BioNTech said the FTD was granted based on positive preliminary U.S. Phase 1/2 data as well as animal immunogenicity studies for BNT162b1.

"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," Peter Honig, senior vice president of global regulatory affairs at Pfizer, said in a statement.  

What's Next For Pfizer/BioNTech:  Pfizer and BioNTech expect to release early data from the German trial of BNT162b1 in July.

The companies said they expect to start a Phase 2b/3 trial as soon as later this month, contingent upon regulatory approval, and are anticipating the enrollment of up to 30,000 subjects.

If the ongoing studies are successful and the vaccine candidate receives regulatory approval, the companies plan 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.

BNTX, PFE Price Action: In premarket trading Monday, Pfizer shares were rising 2.25% to $34.94 and BioNTech was rallying 9.51% to $77.05.

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