Pfizer's Vaccine May Get Full FDA Approval By Early Next Month

by Christina Marfice
Daniel Pockett/Getty

People familiar with FDA plans say the organization has set an “unofficial” deadline to fully approve a vaccine by Labor Day

The delta variant of COVID-19 is tearing through much of the United States, driving increases in cases and hospitalizations nearly everywhere. At the same time, while vaccination rates have picked up a bit, they’re far lower than the April peak, with 3.5 million shots were being administered each day. But now, the FDA is set to give full approval to a COVID-19 vaccine, perhaps as early as the beginning of next month — a move that could help increase vaccination rates again.

Sources inside the FDA told the New York Times that the agency has accelerated its timetable to give full approval to Pfizer-BioNTech’s coronavirus vaccine, aiming for an unofficial deadline of Labor Day. President Biden said last week that he expects a vaccine to receive full FDA approval sometime in the fall, and in response to his comments, the agency said in a statement that it’s “taken an all-hands-on-deck approach” to fully approving the vaccine. Full FDA approval is expected to inspire more confidence in the safety and efficacy of the shots, as well as spark a wave of new vaccine mandates for hospital workers, college students and federal troops.

Some universities and hospitals, the Defense Department and at least one major city, San Francisco, have announced plans to make vaccines mandatory, but only once they receive full FDA approval. The vaccines that have been administered in the U.S. up until this point, made by Pfizer, Moderna, and Johnson & Johnson, received emergency use authorization from the FDA before any shots were given.

As the delta variant has fueled surges in cases, the FDA has been under more public pressure to give full approval to a vaccine.

“I just have not sensed a sense of urgency from the F.D.A. on full approval,” Dr. Ashish K. Jha, the dean of the Brown University School of Public Health, told the New York Times. “And I find it baffling, given where we are as a country in terms of infections, hospitalizations and deaths.”

So far, around 192 million Americans have received at least one COVID-19 shot, which amounts to around 58 percent of the nation’s total population, and 70 percent of adults. Still, the country is recording an average of 86,000 new COVID infections each day, a 142 percent increase from just two weeks ago.

In a recent poll, the Kaiser Family Foundation found that three out of every 10 unvaccinated people said they’d be more willing to get a shot if it had full FDA approval. However, the agency warned that many of those people may have been using FDA approval as a “proxy” excuse for remaining unvaccinated amid pressure from family and friends.