FDA Reportedly Hopes To Fully Approve Pfizer’s Covid Vaccine By Labor Day

FDA Reportedly Hopes To Fully Approve Pfizer’s Covid Vaccine By Labor Day


Federal regulators are aiming to grant full approval to Pfizer’s coronavirus vaccine by early September, the New York Times reported Tuesday, a step some experts believe will boost vaccinations as coronavirus cases surge nationwide.

Key Facts

The Food and Drug Administration internally hopes to finish the full approval process for Pfizer’s vaccine — which currently has an emergency use authorization — by Labor Day, the Times reported, citing unnamed sources.

An anonymous official told health news site Stat last week the FDA is in a “sprint” to grant full approval, and an FDA spokesperson described its efforts as an “all-hands-on-deck approach” in a statement to Stat and the Times.

President Joe Biden suggested last month that full approval could arrive as soon as August or as late as October.

Pfizer referred a request for comment to the FDA, and the FDA did not immediately respond to questions from Forbes.

Key Background

The FDA allowed vaccines by Pfizer, Moderna and Johnson & Johnson to reach American patients more quickly than usual because it granted emergency use authorization, which requires the vaccines’ benefits to outweigh their “known and potential risks.” In contrast, full FDA approval requires more safety data, involves a more time-intensive vetting process and is more permanent than emergency use authorization. It’s common for the approval process to take months, but some health experts have pressed the FDA to move rapidly, arguing full approval could boost public confidence in the vaccines at a time when millions of Americans remain skeptical of them. Plus, the imprimatur of official FDA approval could push more schools and workplaces to mandate vaccines, former Surgeon General Jerome Adams argued last month.

Chief Critic

“Quickest path to 70% [vaccination rate] in many communities is via organizational vaccine mandates, but lack of FDA licensure leave schools, colleges, businesses in a legal quandary,” Adams tweeted in July.

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