Pfizer Inc. said it could seek emergency-use authorization for its Covid-19 vaccine in the U.S. by late November if the shot is shown to be effective in a large late-stage trial.
Safety reviews will dictate the timeline, with the Food and Drug Administration requiring that at least half the people in the study be watched for side effects for two months. That milestone should be achieved in the third week of November, Pfizer Chief Executive Officer Albert Bourla said in an open letter published Friday on the company’s website.
“Let me be clear, assuming positive data, Pfizer will apply for emergency authorization use in the U.S. soon after the safety milestone is achieved,” Bourla wrote. An initial readout on whether the vaccine is effective could come later this month, depending on how quickly subjects in the trial — some of whom got a placebo shot — become infected with the virus.
Pfizer shares rose 2.5% in premarket U.S. trading.
Although Bourla’s letter puts to rest any notion that a vaccine could be cleared for emergency use in the U.S. before Election Day — a goal President Donald Trump had pushed for — the Pfizer CEO’s timetable could give the president a partial victory. If Pfizer is able to say in late October that the data show its inoculation protects people from the virus, that could let Trump claim his administration successfully pushed for a working vaccine before Nov. 3, regardless of whether the FDA has reviewed it.
The U.S. company and its German partnerBioNTech SE are on track to potentially be the first to show the efficacy of a Covid-19 vaccine. They and rival vaccine developers are working under a microscope, with almost unprecedented public interest in every detail of their clinical trials.Eli Lilly & Co., Johnson & Johnson andAstraZeneca Plc have had studies of possible vaccines or treatmentsdelayed because of safety concerns.
The letter confirmed a timeline laid out by BioNTech CEO Ugur Sahin this week. The partners haven’t had to stop their late-stage study over safety concerns, Sahin said.
A group of leading scientists previouslyurged Pfizer to wait until at least late November before seeking emergency authorization.
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