The US Food and Drug Administration (FDA) has granted full approval to the Pfizer-BioNTech COVID-19 vaccine.
“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,” said Acting FDA Commissioner Janet Woodcock, M.D.
The FDA added that the vaccine will now be marketed commercially as Comirnaty.
FDA’s approval came after Pfizer-BioNTech filed for licensing on May 7, the fastest approval in history.
The Pfizer vaccine has been available for Emergency Use Authorization (EUA) since Dec. 11, 2020, and has been approved for use on subjects aged 12-15 since May 10, 2021.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” reassured the FDA.
The FDA added that they analyzed effectiveness data from 40,000 subjects and found that it was 91% effective in preventing COVID-19.
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