FDA Grants Full Approval to Pfizer-BioNTech COVID-19 Vaccine

This makes it the first COVID-19 vaccine to move past the emergency approval status in the US.

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Pfizer-BioNtech Vaccine

The United States Food and Drug Administration (FDA) on Monday, 23 August, granted full approval to Pfizer-BioNTech COVID-19 vaccine, making it the first COVID-19 vaccine to move past the emergency approval status in the US.

The US Food and Drug Administration's acting commissioner Janet Woocock said, "the FDA's approval of this vaccine is a milestone as we continue to battle the Covid-19 pandemic," AFP reported.

The federal agency under the Department of Health and Human Service had granted emergency approval to the vaccine in December 2020, and later in May, authorised its use to all above 12 years of age.

As per a report by Reuters, the Centre for Disease Control and Prevention data shows that over 204 million Pfizer shots have been administered so far.

The full approval assumed significance as public health officials believe that it will convince several hesitant citizens of the vaccine's safety and efficacy.

The vaccination drive in the US has suffered a setback owing to vaccine hesitancy, Reuters reported.


Woocock says, "While millions of people have already safely received COVID-19 vaccines, we recognise that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated."

The decision came on the back of the vaccine's clinical trials, which included a longer duration of follow-up and a safety and efficacy evaluation among over 40,000 people, AFP reported.

(with inputs from AFP and Reuters)

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