Pfizer-two-dose BioNTech’s vaccine for persons aged 16 and older received full FDA approval on Monday. The Covid vaccine, which may now be marketed under its brand name Comirnaty, is the first to receive full approval.
“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, M.D.
“While millions of people have already 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 US.”
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Tens of millions of shots have already been administered under an emergency use authorization (EUA) that was granted on December 11, 2020.
The decision to award it approval was based on updated data from the drug’s clinical trial, including a longer duration of follow-up, with safety and effectiveness evaluated among more than 40,000 people.
The US military has previously announced it will mandate the vaccine as soon as it receives full approval, and a slew of private businesses and universities are expected to follow.
Meanwhile, Zydus Cadila, whose Covid vaccine ZyCoV-D for adults and children aged 12 years and above got approval yesterday, said it hopes to produce one crore doses per month by October.
However, Covid-19 is continuing to spread around the world, with 212,554,454 confirmed cases and 4,443,898 deaths across nearly 200 countries recorded since China reported its first cases in December 2019. The US remains the worst-hit country with 38,231,787 cases, followed by India, Brazil, Russia and France.
