The Food and Drug Administration issued full approval to the Pfizer COVID vaccine on Monday morning. The vaccine, which was granted FDA emergency use authorization in December, will now be marketed under the name Comirnaty for Americans 16-years-old or older.
“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 in a 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.,” she said.
Surgeon General expects more Vaccine mandates now that FDA approval has been granted.
The Food and Drug Administration is pushing to approve Pfizer two-dose COVID vaccine Monday, further expediting an earlier timeline for licensing the shot, according to people familiar with the agency’s planning.
Regulators were working to finish the process by Friday but were still working through a substantial amount of paperwork and negotiation with the company.
The approval is expected to pave the way for a series of vaccination requirements by public and private organizations who were awaiting final regulatory action before implementing mandates. Federal and state health officials are also hoping that an approved vaccine will draw interest from some Americans who have been hesitant.
Some universities and hospitals are expected to mandate inoculation once a vaccine is fully approved. The Pentagon earlier this month said it plans to make COVID vaccinations mandatory for the country’s 1.3 million active-duty troops “no later” than the middle of next month, or sooner if the FDA acts earlier.