Pfizer may be within days of filing for an emergency use authorization for its Covid-19 vaccine, having collected the safety data necessary to submit an application to the Food and Drug Administration, CEO Albert Bourla said Tuesday.
“We are very close to submitting for an emergency use authorization,” Bourla said during the STAT Summit, which this year is a virtual event. Bourla sidestepped the question of whether Pfizer’s filing would be made this week.
“Let us not create expectations,” he said in conversation with STAT’s Matthew Herper. “We will announce it as soon as we are doing it.”
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The FDA required manufacturers to follow at least half of the people who received vaccine in their Phase 3 clinical trials for two months, to ensure there is at least that amount of safety data before a vaccine is considered for use.
Pfizer, which is producing a messenger RNA, or mRNA, vaccine, was the first to announce preliminary results from its Phase 3 trial. It is expected it will be the first Covid-19 vaccine cleared for use in the United States. If all goes according to plan, vaccinations could begin sometime in December.
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The Pfizer vaccine was shown to be strongly protective in a preliminary analysis of Phase 3 data, with efficacy of over 90%. The trial was designed to show if the vaccine protected against symptomatic Covid infection. Pfizer’s announcement was followed this week by word from Moderna that its vaccine — also an mRNA vaccine — had been shown to be highly protective.
Bourla said he was relieved to see that another vaccine was also successful and hoped there are many more, because the global need for Covid vaccines exceeds the capacity of any company to fill.
Asked how the company was able to move so swiftly — no vaccine has ever been produced this fast — Bourla said Pfizer had to make “zillions” of decisions in the process, and was blessed in making the right calls. “To get this done the stars needed to be aligned and stay aligned,” he said.
He denied allegations that the company played politics in the timing of the announcement that the vaccine worked. President Trump has alleged the news was held until after the Nov. 3 election to deny him a vaccine “win.”
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November 18, 2020 at 03:26AM
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Pfizer may file authorization request for Covid-19 vaccine within days - STAT
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