Pfizer, First COVID-19 Vaccine To Receive Full FDA Approval

The FDA approval of the Pfizer vaccine marks a major milestone in the fight against COVID-19.

At the start of COVID-19, no one thought it would turn out to be the worst global pandemic of the century. Many in the early days dismissed the deadly virus as the flu that will go away within days. Fast forward almost two years later, COVID-19 has infected close to a quarter of a billion people worldwide and killed just under 4.5 million.

With the staggering death toll and seeing the virus and its variants rapidly spreading, the global economy was grounded to a standstill. World leaders for the first time had a common enemy and that was COVID-19. The top scientists and infectious disease researchers from around the world had unlimited funds to come up with a vaccine to fight COVID-19. And with that type of resource at their disposal, multiple vaccines were developed and given emergency authorization of use within record time.

Today, the U.S. Food and Drug Administration (FDA) 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 (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“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 safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instil additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” 

The approval of the Pfizer-BioNTech COVID-19 Vaccine is a significant win for the war against vaccines. There still remains many that are hesitant to be inoculated for fear the vaccine was not safe. Today’s announcement should put that argument to rest.

The FDA hopes to have other vaccines approved within the months to follow.

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