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FDA preparing to authorize Pfizer Covid vaccine for 12- to 15-year-olds as early as next week

Biden said his administration has been making plans so that this age group can begin to be vaccinated quickly.
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WASHINGTON — President Joe Biden on Tuesday announced a new phase in his push to vaccinate Americans against Covid-19 that includes a focus on children as young as 12.

Although no vaccine is currently authorized in the United States for people under 16, the Food and Drug Administration is expected to approve Pfizer's request to amend its emergency use authorization to include adolescents ages 12 to 15 as early as next week, according to a senior administration official with knowledge of the situation.

"Today I want American parents to know that if that announcement comes, we are ready to move immediately to make about 20,000 pharmacy sites across the country ready to vaccinate those adolescents as soon as the FDA grants its OK," Biden said during remarks at the White House Tuesday.

Biden said that vaccines would be given directly to pediatricians so parents could discuss any questions with their family doctors and that kids could get shots from people they are comfortable and familiar with. Vaccinations would also still be available to kids 12 and older at pharmacies and other community centers.

For children who might spend their summer vacations in different parts of the country — raising concerns about their ability to get second shots at the same locations as the first — Biden said they would have the option to get the two doses at different vaccination sites.

In early April, Pfizer asked the FDA to expand its emergency use authorization to include adolescents ages 12 to 15 after it said its clinical trials showed that the vaccine was safe and 100 percent effective for that age range. The FDA granted emergency use authorization to people ages 16 and older late last year.

Asked Tuesday about the prospect of a decision from the FDA, White House press secretary Jen Psaki said, "I can't get ahead of the FDA process." Biden stressed in his speech Tuesday that "the FDA, and the FDA alone, will make that decision."

Biden encouraged parents to take their kids to get vaccinated once shots do become available.

"We know that adolescents are at risk from Covid-19. Although serious illness at the age range is rare, they can still get sick and spread the virus to others. So my hope is that if the vaccine is authorized, parents will take advantage of it and get their kids vaccinated," he said.