Pfizer Prepares To Apply For Emergency Use Authorization After Vaccine Reaches Safety Milestone, CEO Says


Pfizer CEO Albert Bourla attends the Forbes Healthcare 2019 Summit at Jazz at Lincoln Center on December 5, 2019 in New York City. Steven Ferdman / Getty Images

The Pfizer vaccine trial has reached its safety milestone and the company is preparing to file for an emergency use authorization, Pfizer CEO Albert Bourla said on Tuesday.

Pfizer announced on Nov. 9 that its coronavirus vaccine appears to be over 90% effective, according to initial data.

But the company did not yet have enough data to apply for emergency use authorization from the US Food and Drug Administration, which said it also wanted at least two months of safety data on at least half. vaccine trial volunteers from the time they get their second immunization.

“I think the questions about security as a whole have also been answered,” Bourla said in an interview with The New York Times. “Our security milestone has already been met and we are now preparing for submissions.”

Bourla said they were not yet sure how long-lasting protection against their vaccine would be. The Pfizer vaccine uses a messenger RNA, or mRNA, platform to produce an immune response.

“With mRNA technology, you can boost whenever you want,” Bourla said. People can be given an extra dose of a vaccine after immunity wears off, which is called a booster.

Bourla said that a boost, if needed, would likely only require a single dose.


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