FDA Fully Approves Pfizer's COVID-19 Vaccine

August 23, 2021

The U.S. Food and Drug Administration today fully approved use of Pfizer-BioNTech’s COVID-19 vaccine—with no reservations.

If you’ve resisted getting immunized due to the qualifying term “emergency use authorization,” rest assured: The FDA and U.S. Centers for Disease Control and Prevention have complete confidence in the vaccine—and so can you.

That news couldn’t come at a better time. Getting vaccinated is even more vital now that the Delta variant of COVID-19 is swiftly smiting the United States. More than 90% of those who’ve died or are fighting for their lives in ICUs due to Delta have been unvaccinated.

While eagerly anticipated, this full blessing was not rushed. The FDA reviewed hundreds of thousands of pages of documents after Pfizer applied for complete validation on May 7. That was 10 times the amount of research it reviewed last December for Pfizer’s emergency-use authorization.

Today’s ruling also had the advantage of real-world data: 52% of Americans are fully vaccinated. Adding to that were results from large and long-term clinical trials and studies.

Moderna requested final approval June 1, though the vaccine maker has not yet given the FDA complete data. Johnson & Johnson has not applied for its vaccine’s approval.

Three of 10 unvaccinated people said they’d be more likely to be inoculated once a vaccine was fully approved, say recent polls by the Kaiser Family Foundation.

The information in this article is accurate as of August 23, 2021. It was clinically reviewed by Dr. Binita Patel.

In Dec. 2021, the CDC issued a preferential recommendation for the use of the mRNA COVID-19 vaccines currently available in the U.S. (Pfizer and Moderna) over the Johnson & Johnson vaccine, citing rare but serious side effects. Throughout the pandemic, Memorial Hermann has closely followed guidance from the CDC as well as the U.S. Food & Drug Administration (FDA) and the State. As such, Memorial Hermann now recommends the Pfizer and Moderna COVID-19 vaccines over the Johnson & Johnson vaccine for those who meet vaccine eligibility.