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.”
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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