The U.S. Food and Drug Administration (FDA) on Monday granted full approval of Pfizer's
At conclusion of its review process of vaccine data from 40,000 trial participants, the FDA found the mRNA vaccine, which will be marketed as Comirnaty, to by 91% effective in preventing COVID, which was slightly lower than the 95% efficacy rating the shot received when it was authorized for emergency use by the FDA late last year.
Since then, more than 205 million Comirnaty doses have been administered in the United States, according to data compiled by the Centers for Disease Control and Prevention (CDC).
"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 Dr. Janet Woodcock in a press statement. "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 was fully approved for use in Americans aged 16 years or older. Comirnaty is still operating under an Emergency Use Authorization (EUA) for individuals between the ages of 12 to 15 years and for immunocompromised Americans receiving a third booster dose. Pfizer and BioNTech expect to receive full approval for those EUAs as the company continues to collect data.
While more than 60% of the total U.S. population has received at least one vaccine dose and over 50% are fully vaccinated, according to the CDC, there are still many Americans that are still hesitant to get vaccinated against COVID, even as vaccines have been proven to prevent severe disease. Public health officials hope that full approval of COVID vaccines may help more reluctant individuals to finally get vaccinated, which will help the nation curb rising hospitalization and death rates as the highly contagious Delta variant continues to rapidly spread.
"Those who have been waiting for full approval should go get your shot now," President Joe Biden said during a White House press briefing Monday afternoon, saying that the U.S. health regulator had evaluated "mountains" of clinical trial data and concluding that the COVID vaccine was both safe and effective.
"The overwhelming majority of people in the hospital with COVID-19 or almost all those dying from COVID-19 are not vaccinated," he told White House reporters. "If you're fully vaccinated--both shots, plus two weeks--your risk of severe illness with COVID-19 is very, very low."
