Pfizer-BioNTech Covid Vaccine Gains FDA Approval

It was a big day on Monday for Pfizer and BioNTech, as the Food and Drug Administration (FDA) gave their Covid vaccine approval.

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

The company said the data showed the vaccine was 91 percent effective in preventing infection.

The FDA has approved the coronavirus vaccine for people 16 and older. It is the first vaccine to move beyond emergency use status in the United States.

U.S. Defense Secretary Lloyd J. Austin III will be sending guidelines to the country’s 1.4 million active duty service members mandating that they be vaccinated, the Pentagon announced on Monday.

“If you’re not vaccinated yet, now is the time,” President Biden said on Twitter.

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

A recent poll by the Kaiser Family Foundation 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.

“I think that is a vanishingly small number of people in real life, ” said Alison Buttenheim, an associate professor of nursing at the University of Pennsylvania.
Buttenheim said, “Mandates simplify things for people.”

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

Dr. Peter Marks, the F.D.A.’s top vaccine regulator, said, “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.”

Regulators are still reviewing Moderna’s application for full approval of its vaccine and a decision could take several weeks. Johnson & Johnson is expected to apply soon for full approval.

Disclaimer: We have no position in any of the companies mentioned and have not been compensated for this article.