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FDA to approve Pfizer Covid vaccine for 12 to 15 year olds as early as next week

WASHINGTON – President Joe Biden on Tuesday announced a new phase in his efforts to vaccinate Americans against Covid-19, which focuses on children as young as 12.

Although no vaccines are currently authorized in the United States for people under the age of 16, the Food and Drug Administration is expected to approve Pfizer’s request to change its emergency use authorization to include adolescents aged 12. at 15 from next week, according to a high-level administration. official knowing the situation.

“Today, I want American parents to know that if this announcement arrives, we are ready to act immediately to make approximately 20,000 drugstore sites across the country ready to vaccinate these teens as soon as the FDA grants approval,” Biden said during his remarks at the White House Tuesday.

Biden said vaccines will be given directly to pediatricians so parents can discuss any issues with their family doctor and children can get vaccinated by people they are comfortable and familiar with. Vaccines would also be available for children 12 and older at pharmacies and other community centers.

For children who might be spending their summer vacation in different parts of the country – raising concerns about their ability to get a second vaccine in the same places as the first – Biden said they would have the option of getting both doses at different vaccination sites.

In early April, Pfizer asked the FDA to extend its emergency use authorization to include adolescents ages 12 to 15 after it said its clinical trials showed the vaccine to be 100% safe and effective for this age group. The FDA granted emergency use authorization to people aged 16 and over late last year.

Asked Tuesday about the prospect of an FDA decision, White House press secretary Jen Psaki said, “I can’t get ahead of the FDA process.” Biden stressed in his speech on Tuesday that “the FDA, and the FDA alone, will make this decision.”

Biden encouraged parents to take their children to get vaccinated once the vaccines are available.

“We know that adolescents are at risk of Covid-19. Although serious illnesses at this age are rare, they can still get sick and pass the virus on to others. So, I hope that if the vaccine is allowed, the parents will benefit from it. and get their children vaccinated, ”he said.

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