Aug. 5, 2021 -- The FDA is accelerating its timeline to fully approve Pfizer’s COVID-19 vaccine, with the aim of completing the process by Labor Day, according to The New York Times.

With a surge in coronavirus cases due to the contagious Delta variant, President Joe Biden has urged Americans to get vaccinated and said last week that he expected full approval by the early fall. This week, officials familiar with the FDA’s plans said the agency’s unofficial deadline is early September or sooner.

Full approval could boost vaccination rates among those who are hesitant to get a shot. About 3 in 10 unvaccinated people have said they would be more likely to get a shot if the vaccine were fully approved, according to a recent poll by the Kaiser Family Foundation.

In a statement to The New York Times, the FDA said that full approval could increase public confidence in the vaccine, which has prompted the agency to take an “all-hands-on-deck approach” to complete the process.

Some universities, hospitals and cities — including San Francisco — are expected to mandate vaccination once a shot is fully approved, the newspaper reported. The Defense Department, for instance, will require service members to get a shot or undergo regular testing once the FDA makes the announcement.

The Pfizer vaccine has been used under an FDA emergency use authorization since December. Pfizer filed an application for full approval on May 7.

Moderna, which also makes a two-dose COVID-19 vaccine, filed for full approval on June 1 but is still submitting data to the FDA, the newspaper reported. Johnson & Johnson has not filed for full approval but has plans to do so later this year.

During the approval process, the FDA reviews hundreds of thousands of documents and real-world data to see how the vaccine has worked since emergency use authorization, according to STAT News. That includes verifying data about vaccine efficacy, immune responses and adverse reactions. The FDA can typically complete a priority review in 6 to 8 months, and the agency has already been working on an expedited timeline for the Pfizer vaccine.

WebMD Health News Brief

Sources

The New York Times: “F.D.A. Aims to Give Final Approval to Pfizer Vaccine by Early Next Month.”

Kaiser Family Foundation: “KFF COVID-19 Vaccine Monitor: June 2021.”

STAT News: “FDA, under pressure, plans ‘spring’ to accelerate review of Pfizer’s Covid-19 vaccine for full approval.”

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