In a move that’s been speculated about for months, the Food and Drug Administration (FDA) granted full approval to the Pfizer-BioNTech vaccine against COVID-19 for use in people aged 16 and older on Monday. “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.
Until now, all COVID-19 vaccines have fallen under the rubric of emergency use authorization according to FDA standards; now that the Pfizer vaccine has been approved, organizations including colleges, hospitals and corporations are expected to implement vaccine requirements. Recently, the state of Oregon and United Airlines became two of the first entities to announce that its employees would be required to show proof of vaccination within five to six weeks of regulatory approval from the FDA, and other states and organizations will likely follow their lead despite inevitable pushback from lawmakers like Texas Gov. Greg Abbott.
As of now, the Pfizer vaccine will still be available under emergency use authorization for people between the ages of 12 and 15, as well as for certain immunocompromised people receiving their third “booster” dose of the vaccine. Pfizer has the first COVID-19 vaccine approved by the FDA likely in part because it was the first company to apply; the application from the makers of the Moderna vaccine is still currently under review, and Johnson & Johnson is expected to apply for full approval soon.
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