Pfizer will seek emergency approval for Covid vaccine in November

PFIZER will apply to the US Food and Drug Administration to seek emergency approval of its Covid-19 vaccine in November.

CEO Albert Bourla said on Friday that Pfizer would seek emergency approval for the new Covid vaccine as soon as safety data is available, assuming it receives positive results from the ongoing trials. Bourla said that a target date of the third week of November was based on Pfizer’s “best estimates”

In order to grant emergency approvals for vaccines, the FDA requires two months of safety data for half of the trial participants.

Bourla said that Pfizer should have enough data to establish that the vaccine is effective by the end of October.All trial participants will continued to be monitored by the company for two years after the trials have been completed.

Given the current timelines it is unlikely that the vaccine will be approved prior to the elections.

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