FDA fast-tracks two experimental Pfizer, BioNTech vaccine candidates for COVID-19

Pfizer and partner BioNTech announced Monday that BNT162b1 and BNT162b2, two of the four investigational vaccine candidates in their BNT162 mRNA-based vaccine programme against SARS-CoV-2, have received fast-track designations from the FDA. Last week, BioNTech CEO Ugur Sahin suggested that his company would be ready to seek regulatory approval of a coronavirus vaccine by December.

The fast-track designation "signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2," remarked Peter Honig, senior vice president for global regulatory affairs at Pfizer. He added "we look forward to continue working closely with the FDA throughout the clinical development of this programme, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates."

BNT162b1 and BNT162b2, both nucleoside-modified RNAs, are the two most advanced vaccine candidates in the BNT162 programme currently being evaluated in ongoing Phase I/II clinical studies in the US and Germany. BNT162b1 encodes an optimised SARS-CoV-2 receptor-binding domain antigen, while BNT162b2 encodes an optimised SARS-CoV-2 full-length spike protein antigen.

The companies recently reported positive early Phase I/II results showing that BNT162b1 led to higher levels of antibodies than convalescing COVID-19 patients at day 28, which was seven days after study participants had received a second dose (for related analysis, see ViewPoints: BioNTech and Pfizer boost COVID-19 vaccine hopes).

They also reiterated that, subject to regulatory approval, they expect to start a Phase IIb/III trial as soon as later this month and are anticipating enrolling up to 30,000 subjects. Further, if the ongoing studies are successful, and the vaccine candidate receives regulatory approval, the companies said they expect to make up to 100 million doses by the end of this year and potentially more than 1.2 billion doses by the end of 2021.

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