FDA Authorizes Pfizer COVID Vaccine for Teens 12-15

Ralph Ellis
May 10, 2021

The US Food and Drug Administration (FDA) on Monday granted emergency use authorization (EUA) for the Pfizer coronavirus vaccine to be given to children 12-15 years old.

The much-expected decision increases the likelihood that schools in the United States will fully reopen in the fall — a goal of both the Biden and Trump administrations.

Acting FDA Commissioner Janet Woodcock, MD, called the decision "a significant step" in "returning to a sense of normalcy."

"Today's action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic," she said in a statement. "Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations."

The Pfizer adolescent vaccine is not yet a done deal, though.

Next, the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices will decide on Wednesday whether to recommend use of the vaccine in this age group. After that, CDC Director Rochelle Walensky, MD, will decide whether to give the green light for the vaccine to be administered to that age group.

The FDA action on Monday amends the December 11 emergency use authorization that allowed the Pfizer vaccine to be given to people 16 and older. Pfizer was the first company to receive an EUA for its adult vaccine and is the first to receive authorization for its adolescent vaccine. Pfizer is conducting clinical trials on much younger children, too.

The Moderna and Johnson & Johnson vaccines are authorized for people 18 and up. Moderna has also launched clinical trials in children.

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Reviewed on 5/11/2021
SOURCE: Medscape, May 10, 2021.

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