The Food and Drug Administration has given full approval of the Pfizer-BioNTech COVID-19 vaccine.

  • The FDA said the Pfizer-BioNTech COVID-19 vaccine is the first vaccine to get full approval.

The vaccine will now be marketed as Comirnaty (pronounced “koe-mir’-na-tee”), which will be used to prevent COVID-19 in those 16 years and older.

  • The vaccine still has emergency approval for those 12 to 15 years old, according to the FDA. But it does not have full approval for those age groups.
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Is the COVID-19 vaccine already approved?

The Pfizer-BioNTech COVID-19 vaccine received emergency use authorization back in December 2020. This allowed the U.S. to distribute the vaccine en masse to health care workers, vulnerable people and, eventually, the entire American population.

What does COVID-19 vaccine full approval mean?

Full approval would be a significant step forward in the vaccine’s reach, as several Americans are holding out for full approval before they get the shot, according to experts.

  • “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,” said acting FDA Commissioner Janet Woodcock in a statement. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
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There’s also an expectation that this step will lead businesses to require vaccines now that it has the FDA’s full approval. Of course, the FDA’s approval only applies to Pfizer-BioNTech’s coronavirus vaccine, so it’s unclear what this would mean for those who received the Moderna COVID-19 vaccine or the Johnson & Johnson COVID-19 vaccine.