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FDA expands Pfizer COVID vaccine authorization to ages 12-15

The Biden administration has said it was prepared to ship doses to 20,000 pharmacies around the country and directly to pediatricians.

The Food and Drug Administration announced Monday it is expanding emergency use authorization for Pfizer's COVID-19 vaccine to children ages 12-15.

The FDA action will be followed by the advisory committee's meeting, currently set for Wednesday. A draft agenda posted online says a vote would happen early Wednesday afternoon. If the committee gives the OK, the vaccines can then be distributed.

“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. 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," Acting FDA Commissioner Janet Woodcock said in a statement.

The agency said the two-dose vaccine has "met the statutory criteria" to allow the EUA to be amended, and says the "known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks."

Nearly 35% of the U.S. population and 44% of adults have been fully vaccinated as of Monday, according to the CDC. That means people who have received both doses of either the Pfizer or Moderna vaccines, or the single-dose Johnson & Johnson vaccine. Forty-six percent of the population and 58.2% have received at least one dose of one of those vaccines.

When could kids 12 to 15 get the COVID vaccine?

Shots could begin quickly after the Centers for Disease Control and Prevention adopts the advisory committee’s recommendation.

President Joe Biden said last week that the administration was prepared to ship doses to 20,000 pharmacies around the country and directly to pediatricians as soon as the authorization was made.

Pfizer in late March released preliminary results from a vaccine study of 2,260 U.S. volunteers ages 12 to 15, which showed its shot provided protection for the younger group. 

What are the COVID vaccine side effects for kids? 

The kids enrolled in the study had side effects similar to young adults, Pfizer said. The main side effects are pain, fever, chills and fatigue, particularly after the second dose. 

On Friday, Pfizer and BioNTech announced they had started the process to request full approval from the FDA for their mRNA coronavirus vaccine for adults 16 and older. 

The FDA has only given Emergency Use Authorization in December 2020 for the two-dose vaccine to be used on individuals 16 years of age and older. Since receiving the Emergency Use Authorization, more than 170 million doses of the vaccine have been delivered across the U.S.

Pfizer and BioNTech said data to support its vaccine will be submitted to the FDA on a "rolling basis" over the coming weeks. The companies requested a priority review, which asks the FDA to fast-track the application within six months instead of the usual 10 months.

For most people, the coronavirus causes mild or moderate symptoms. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia and death.

The United States has more than 32 million confirmed cases of COVID-19, according to data from Johns Hopkins University.

The Associated Press and Erin McHugh contributed to this report.