Pfizer’s Covid Vaccine Reportedly Set For Full FDA Approval Next Week

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Pfizer’s Covid Vaccine Reportedly Set For Full FDA Approval Next Week

Topline

The Food and Drug Administration hopes to grant full approval to Pfizer and BioNTech’s coronavirus vaccine next week, the New York Times and Politico reported, an earlier-than-expected step some health experts think would boost vaccination rates as Covid-19 cases climb nationwide.

Key Facts

The FDA is aiming to approve the vaccine — which currently has an emergency use authorization — by Monday, though that timeline could be delayed as staffers sift through paperwork, the Times reported, citing unnamed sources.

Politico reported that regulators are set to finish their approval process next week.

The FDA has publicly promised to move quickly on vetting the vaccine but hasn’t committed to a hard timeline, though the Times reported earlier this month the agency gave itself a Labor Day deadline.

Pfizer referred Forbes to the FDA for all approval-related questions, and the FDA did not immediately respond to a request for comment.

Key Background

The FDA granted emergency use authorization to Pfizer and Moderna’s Covid-19 vaccines late last year, and Johnson & Johnson’s single-shot vaccine joined the roster earlier this year. Drugmakers need to submit extensive safety data to earn an emergency use authorization, which indicates that a drug’s benefits outweigh its risks, but full approval is a more time-consuming process that requires more data and vetting. Some public health experts want the FDA to grant full approval as quickly as possible, arguing the designation could boost Americans’ confidence in the vaccines and encourage some hesitant people to get immunized. Plus, the step could lead to more vaccine mandates: The Pentagon says it will require the U.S. military’s roughly 1.4 million personnel to be vaccinated as soon as a vaccine is fully approved; some colleges are waiting for full approval before rolling out mandates for students; and some hospitals will require their staff to get vaccinated following FDA approval.

Big Number

60.4%. That’s the share of Americans who are at least partially vaccinated against Covid-19, according to data from the Centers for Disease Control and Prevention. An average of 438,270 people lined up for their first vaccine shot every day last week, nearly double the average in early July, though vaccinations are still well below their April peak, when the CDC reported 2 million new first doses every day.

Further Reading

The F.D.A. is aiming to give full approval to Pfizer’s Covid vaccine on Monday (New York Times)

FDA approval of Pfizer Covid shot could come next week (Politico)

Why Hasn’t The FDA Fully Approved Any Covid-19 Vaccines Yet? (Forbes)

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