Live Update
On Monday, the U.S. Food and Drug Administration issued the first full authorization for the COVID-19 vaccine, fully approving Pfizer’s two-dose injections.
The Pfizer-BioNTech vaccine will be sold as Comirnaty and is fully licensed for use by people 16 years and older, while people between 12 and 15 years old can still be vaccinated under the emergency use grant. Pifzer’s lens was authorized for emergency use in December 2020.
For individuals with suppressed immune systems or certain medical conditions, the third dose or booster injection is still under emergency use approval, although the booster injection will be available to all U.S. citizens in the coming weeks.
FDA Acting Commissioner Janet Woodcock, MD, said in a press release that the approval of Comirnaty is a “milestone” in the fight against the pandemic.
“Although this vaccine and other vaccines meet the FDA’s strict and scientific emergency use authorization standards, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets safety, effectiveness and manufacturing FDA’s requirements for approved products are of high standards,” Woodcock said.
“Although millions of people have been safely vaccinated against COVID-19, we recognize that for some people, the FDA-approved vaccine may now inject more confidence in vaccination.”
FDA members are scheduled to speak to the media at 11 am Eastern Time, and the briefing can be broadcast live here.
Check out Newsweek for more updates.
Patrick T. Fallon/AFP via Getty Images
