Today, August 23, the U.S. Food and Drug Administration approved the first COVID-19 vaccine.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. 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 Acting FDA Commissioner Janet Woodcock, M.D. “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.”
The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.
You can read the full press release from the FDA here.
The vaccine also continues to be available under emergency use authorization (EUA) for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
“What great news to hear today that the COVID-19 vaccine produced by Pfizer received official approval for use in patients 16 and older,” said Dr. Jayanthi Ravisankar, pediatrician with White House Clinics.
Dr. Ravi is encouraging everyone 12 and older to be vaccinated.
“Knowing how strenuous the safety standards are for official FDA approval, this recognition demonstrates how safe and effective the immunization is and will hopefully encourage those not yet vaccinated to act now and get the shot,” she said. “With school back in session across the state, we are fortunate to be able to offer children ages 12-15 those same safe and effective protections under the FDA’s emergency use authorization for the Pfizer vaccine.”
If you’ve still not received the safe, effective and now fully FDA-approved Comirnaty vaccine (formerly known as Pfizer), visit White House Clinics today.