Pfizer, BioNTech start late-stage study of their lead COVID vaccine candidate

Riley Griffin, Bloomberg News

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Pfizer Inc. and BioNTech SE said they would begin a later-stage trial for their top coronavirus vaccine candidate, with a goal of submitting it for regulatory review as soon as October.

The drugmakers said Monday that they had selected a lead vaccine candidate from within a broader development program and will proceed with a late-stage safety and efficacy trial of the experimental shot in a two-dose regimen.

The move pushes the New York-based pharmaceutical giant and its German partner closer to the finish line, placing them alongside companies like Moderna Inc. and AstraZeneca Plc in the race to bring a shot to market to curb the pandemic.

Pfizer shares gained as much as three per cent in after-hours trading in New York on Monday, while U.S.-traded shares of BioNTech rose 5.2 per cent.

Pfizer and BioNTech said they have moved their BNT162b2 vaccine candidate, one of four shots they had been developing, into a late-stage trial of up to 30,000 patients age 18 to 85. The companies expect to assess the shot in the U.S. and more than 120 sites globally, particularly in regions where outbreaks are expected to occur.

Assuming success in the clinic, Pfizer and BioNTech will seek to submit the shot to regulators for review in October, according to a statement. If they receive an authorization or approval, the companies plan to supply 100 million doses before the end of the year.