FDA Grants Full Approval to Pfizer-BioNTech COVID-19 Vaccine

WASHINGTON — The Food and Drug Administration on Monday granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and over, making it the first to move beyond emergency use status in the United States.

The approval comes as parts of the nation are fighting a surge in cases due to a combination of resistance to vaccination and the spread of the highly infectious delta variant.

The Biden administration hopes Monday’s announcement will motivate at least some of the roughly 85 million unvaccinated Americans who are eligible for shots to get them.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,”  said Acting FDA Commissioner Janet Woodcock in a written statement.

“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” she continued.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.,” Woodcock added.

Pfizer said Monday that it presented the FDA with data from 44,000 clinical trial participants in the United States, as well as in the European Union, Turkey, South Africa and South America. 

The company said the data showed the vaccine was 91% effective in preventing infection — a slight drop from the 95% efficacy rate that the data showed when the agency decided to authorize the vaccine for emergency use in December. 

Pfizer said the decrease reflected the fact that researchers had more time to catch people who became infected.

The Pfizer-BioNTech vaccine will continue to only be authorized for emergency use for children ages 12 to 15 until Pfizer collects the necessary data required for full approval. 

A decision on whether to authorize the vaccine for children younger than 12 is likely to be at least several months away. 

So far, more than 92 million Americans — 54% of those fully inoculated — have gotten Pfizer shots. The majority of the rest received Moderna’s vaccine.

“We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, in a written statement.

A poll released in June by the Kaiser Family Foundation, which has been tracking public attitudes during the pandemic, found that three of every 10 unvaccinated people said that they would be more likely to get vaccinated with a shot that had been fully approved.