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

WASHINGTON — President Joe Biden on Tuesday announced a brand new part in his push to vaccinate Americans towards Covid-19 that features a give attention to youngsters as younger as 12.

Although no vaccine is at present approved within the United States for folks below 16, the Food and Drug Administration is anticipated to approve Pfizer’s request to amend its emergency use authorization to include adolescents ages 12 to 15 as early as next week, in accordance to a senior administration official with information of the state of affairs.

“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 mentioned throughout remarks on the White House Tuesday.

Biden mentioned that vaccines could be given immediately to pediatricians so dad and mom might focus on any questions with their household docs and that children might get photographs from folks they’re snug and acquainted with. Vaccinations would additionally nonetheless be out there to youngsters 12 and older at pharmacies and different neighborhood facilities.

For youngsters who may spend their summer time holidays in several elements of the nation — elevating considerations about their skill to get second photographs on the identical places as the primary — Biden mentioned they’d have the choice to get the 2 doses at completely different vaccination websites.

In early April, Pfizer asked the FDA to develop its emergency use authorization to embrace adolescents ages 12 to 15 after it mentioned its scientific trials confirmed that the vaccine was safe and 100 percent effective for that age vary. The FDA granted emergency use authorization to folks ages 16 and older late final yr.

Asked Tuesday concerning the prospect of a call from the FDA, White House press secretary Jen Psaki mentioned, “I can’t get ahead of the FDA process.” Biden confused in his speech Tuesday that “the FDA, and the FDA alone, will make that decision.”

Biden inspired dad and mom to take their youngsters to get vaccinated as soon as photographs do turn out to be out there.

“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 mentioned.

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