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The FDA expected to OK the Pfizer vaccine for teens within a week



WASHINGTON (AP) – The U.S. Food and Drug Administration is expected to approve Pfizer’s COVID-19 vaccine for teens ages 12 to 15 next week, according to a federal official and a person familiar with the process, by setting fire to many before the start of the next school year.

The announcement is expected to come a month after the company found out that its shots, already approved for those aged 16 and over, also provided protection to the younger group.

The federal official, speaking on condition of anonymity to view the FDA̵

7;s action, said the agency was expected to expand its authorization application for Pfizer’s two-dose vaccine early next week and perhaps even sooner. The person familiar with the process, who spoke on condition of anonymity to discuss internal matters, confirmed the timeline, adding that it is expected that the FDA will approve Pfizer’s use of even younger children sometime this fall.

The FDA action will be followed by a meeting of a federal advisory committee on vaccines to discuss whether it should be recommended for 12- to 15-year-olds. Shots could begin after the Centers for Disease Control and Prevention adopted the committee’s recommendation. These steps could be completed in a matter of days.

The New York Times first reported on the expected timing of the approval.

At the end of March, Pfizer released preliminary results from a vaccine study of 2,260 U.S. volunteers ages 12 to 15 that showed no cases of COVID-19 among fully vaccinated adolescents compared with 18 among those who received narcotics.

Children had side effects similar to young adults, the company said. The main side effects are pain, fever, chills and fatigue, especially after the second dose. The study will continue to track participants for two years to obtain more information on long-term protection and safety.

Pfizer is not the only company seeking to lower the age limit for its vaccine. Results are also expected in the middle of this year from a US study of Moderna’s vaccine in 12- to 17-year-olds.

But in a sign that the results were promising, the FDA already allowed both companies to begin U.S. studies in children 11 and younger who worked their way all the way down to 6 months old.

More than 131 million doses of Pfizer’s vaccine have already been administered in the United States, where the demand for vaccines among adults has dropped dramatically in recent weeks.

While younger people have a dramatically lower risk of serious side effects from COVID-19, they have accounted for a greater proportion of new virus cases, as a majority of American adults are at least partially vaccinated and as higher-risk activities such as indoor dining and contact sports have resumed. in most of the country. Officials hope that expanding vaccinations to teens will further accelerate the country’s reduced virus caseload and allow schools to reopen with minimal disruption in the fall.

The United States has ordered at least 300 million doses of Pfizer shots by the end of July, enough to protect 150 million people.

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Lemire reported from New York.


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