Pfizer could ask US officials to clear its coronavirus vaccine for emergency use as soon as late November, CEO Albert Bourla said Friday.
The Manhattan-based drugmaker expects to know whether or not the vaccine works by the end of this month, but the company still has to prove the shot is safe and can be manufactured properly to seek a so-called emergency use authorization, Bourla said.
“A key point that I’d like to make clear is that effectiveness would satisfy only one of the three requirements and, alone, would not be enough for us to apply for approval for public use,” he wrote in an open letter posted to Pfizer’s website.
Assuming clinical research shows the vaccine is effective, “Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November,” Bourla said, noting that the Food and Drug Administration wants two months of safety data for vaccines seeking emergency use approvals.
The comments indicate that a crucial vaccine for the deadly coronavirus won’t be ready by the Nov. 3 presidential election despite President Trump’s desire for drugmakers to produce one faster.
Pfizer’s vaccine is one of four candidates going through late-stage clinical trials in the US. Massachusetts-based biotech firm Moderna has said it may know in November whether its shot is effective, but both Johnson & Johnson and AstraZeneca have had to pause their studies after participants got sick.
Bourla — who pledged earlier this month that politics would not play a role in Pfizer’s vaccine push — said the company’s application for emergency approval would be reviewed by US Food and Drug Administration scientists along with a panel of independent experts at a public meeting.
Pfizer, which is developing its vaccine with German biotech firm BioNTech, has been working for months to build manufacturing capacity for the shot and plans to share results from its clinical trial as quickly as possible, according to Bourla.
“In the spirit of candor, we will share any conclusive readout (positive or negative) with the public as soon as practical, usually a few days after the independent scientists notify us” whether the vaccine is effective, he said.
Pfizer shares climbed 1.2 percent in premarket trading Friday to $37.00 as of 6:55 a.m.
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