Pfizer's COVID-19 Vaccine Is the First to Be Fully Approved by the FDA

The U.S. Food and Drug Administration had previously authorized the two-dose Pfizer-BioNTech vaccines for emergency use authorization in December.

COVID-Pfizer-Full-FDA-Approval-GettyImages-1265278862
Photo: Getty Images

The U.S. Food and Drug Administration marked a major milestone on Monday by granting approval of the Pfizer-BioNTech COVID-19 vaccine for individuals 16 years of age or older. The two-dose Pfizer-BioNTech vaccine, which received the green light for emergency use authorization by the FDA last December, is now the first coronavirus vaccine to receive full approval by the organization.

"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," said Janet Woodcock, M.D., acting FDA commissioner, in a statement on Monday. "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." (Related: How Effective Is the COVID-19 Vaccine)

Currently, more than 170 million Americans have been fully vaccinated against COVID-19, according to recent data from the Centers for Disease Control and Prevention, equating to 51.5 percent of the population. Of those 170 million people, more than 92 million have received the two-dose Pfizer-BioNTech vaccine, according to the CDC.

While more than 64 million people in the U.S. have been fully inoculated with the two-dose Moderna vaccine, according to recent CDC data, regulators are still in the process of reviewing the company's application for complete approval of its COVID-19 vaccine, The New York Times reported Monday. Under EUA — which also applies to the single-shot Johnson & Johnson vaccinethe FDA allows the usage of unapproved medical products during public health emergencies (such as the COVID-19 pandemic) to treat or prevent life-threatening illnesses.

With cases of COVID-19 continuing to rise nationwide due to the highly contagious Delta variant, the FDA's approval of the Pfizer-BioNTech vaccine could potentially lead to vaccination requirements among colleges, organizations, and hospitals, according to The New York Times. Certain cities, including New York, are already requiring workers and patrons to show proof of vaccination to participate in several indoor activities, including entertainment and dining.

Masking up and practicing social distancing are critical in the fight against COVID-19, but vaccines remain the best bet in protecting oneself and others. In the wake of Monday's groundbreaking news from the FDA, perhaps this will instill vaccine confidence in those potentially wary about receiving a dose.

The information in this story is accurate as of press time. As updates about coronavirus COVID-19 continue to evolve, it's possible that some information and recommendations in this story have changed since initial publication. We encourage you to check in regularly with resources such as the CDC, the WHO, and your local public health department for the most up-to-date data and recommendations.

Was this page helpful?
Related Articles