The US Food and Drug Administration (FDA) on Monday gave full approval to the Pfizer-BioNTech Covid-19 vaccine.
It is the first Covid-19 vaccine to receive full approval, and will now be marketed as Comirnaty, the regulator said in a statement. It will be used for the prevention of Covid-19 disease in individuals 16 years of age and older. At the same time, the two-shot mRNA- based vaccine will continue to be available under emergency use authorisation (EUA), including for individuals 12 through 15 years of age.
President Joe Biden shared the news on Twitter and encouraged Americans to keep rolling up their sleeves. “The FDA has officially approved the Pfizer COVID-19 vaccine. While all three COVID vaccines have met FDA’s strict standards for emergency use, this FDA approval should give added confidence that this vaccine is safe and effective,” he wrote. “If you’re not vaccinated yet, now is the time.”
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” acting FDA commissioner Dr Janet Woodcock said in a statement. “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. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Prior to Monday, Pfizer’s vaccine was only approved for use on an emergency basis, meaning it was considered somewhat experimental despite data showing it is safe and effective. Emergency use authorization requires less clinical trial data, with the FDA only requiring two months of follow-up before approving the shot for those 16 and older last year compared to six months for full approval.
ARTICLE: PAUL MURDOCH
MANAGING EDITOR: CARSON CHOATE
PHOTO CREDITS: NY DAILY NEWS
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