The Food and Drug Administration made a major pharmaceutical move on Monday, announcing the agency fully approved one of the three available COVID-19 vaccines for use. While folks around the globe have been getting vaccinated for the last eight months, the shots have only been approved under emergency use authorization and it looks like that no longer applies to Pfizer-BioNTech.
The FDA announced the Pfizer vaccine has met the administrations very “rigorous” standards for emergency use as well as overall safety and effectiveness.
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“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 products,” said acting FDA Commissioner Janet Woodcock, M.D.
The Pfizer vaccine has been available since Dec. 11, 2020 for individuals 16 years of age and older, Commissioner Woodcock hopes the new approval will encourage more people to get vaccinated.
“While millions of people have already safely 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 U.S.”
Pfizer’s vaccine uses mRNA–a genetic material used in the body. The mRNA is used in the vaccination to make a “mimic” of one of the proteins in the virus that causes COVID-19. The FDA notes that the messenger RNA is only in the body for a short period of time and “does not alter an individual’s genetic material.”
The Moderna and Johnson&Johnson vaccines are still available for individuals but have not yet received the FDA’s full approval.
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