FDA gives full approval to Pfizer COVID-19 vaccine
Thomas McDonald
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The U.S. Food and Drug Administration has granted full approval to the Pfizer vaccine for COVID-19, which has been in use under emergency use authorization.
“Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older,” the FDA said in a statement.
Acting FDA Commissioner Janet Woodcock, M.D., said that the approval was a milestone in the battle against the virus.
“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,” Woodcock said in a statement following the approval.
“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,” Woodcock added.
In May, Pfizer completed its submission of a “biologics license application” for the vaccine, providing all the documentation required for full approval. The company tells its investors that it plans to get FDA approval for younger children and booster shots.
Moderna plans to finish its application for approval later this month, while Johnson & Johnson is currently gathering data from its two-dose regimens trials and plans to file for full approval later this year.
Officials hope that with FDA approval comes an increase in confidence in the vaccine among those hesitant to receive it. Vaccination mandates are also expected to become more widespread following the approval. FDA approval will also speed up the military’s vaccination requirements which the Pentagon announced will begin this fall.
Earlier this month, Defense Secretary Lloyd Austin announced that he would be asking President Biden to approve making the COVID-19 vaccine a requirement for all military personnel by mid-September or when the FDA approves, whichever comes first.
“I have every confidence that Service leadership and your commanders will implement this new vaccination program with professionalism, skill, and compassion,” Austin said at the time.
Up until now, vaccines in the military were voluntary because they were under emergency use authorization by the FDA. President Biden said he “strongly” agreed with Austin’s request to make the vaccines mandatory.
Nearly 630,000 Americans have died from COVID-19, according to John Hopkins University. At least 200,421,787 Americans, or 61% of the population, have received at least one dose. Overall, 169,998,983 Americans, or 52% of the population have been fully vaccinated.