Please ensure Javascript is enabled for purposes of website accessibility
FDA Expected to OK Pfizer Vaccine for Teens Within Week
gvw_ap_news
By Associated Press
Published 4 years ago on
May 4, 2021

Share

WASHINGTON โ€” The U.S. Food and Drug Administration is expected to authorize Pfizerโ€™s COVID-19 vaccine for youngsters ages 12 to 15 by next week, according to a federal official and a person familiar with the process, setting up shots for many before the beginning of the next school year.

The announcement is set to come a month after the company found that its shot, which is already authorized for those age 16 and older, also provided protection for the younger group.

Approval for Teens to Come Within Week, Even Younger by Fall

The federal official, speaking on the condition of anonymity to preview the FDAโ€™s action, said the agency was expected to expand its emergency use authorization for Pfizerโ€™s two-dose vaccine by 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 and added that it is expected that the FDA will approve Pfizerโ€™s use by even younger children sometime this fall.

The FDA action will be followed by a meeting of a federal vaccine advisory committee to discuss whether to recommend the shot for 12- to 15-year-olds. Shots could begin after the Centers for Disease Control and Prevention adopts the committeeโ€™s recommendation. Those steps could be completed in a matter of days.

The New York Times first reported on the expected timing for the authorization.

Pfizer in late March released preliminary results from a vaccine study of 2,260 U.S. volunteers ages 12 to 15, showing there were no cases of COVID-19 among fully vaccinated adolescents compared with 18 among those given dummy shots.

Similar Side Effects as Young Adults

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

Pfizer isnโ€™t the only company seeking to lower the age limit for its vaccine. Results also are expected by the middle of this year from a U.S. study of Modernaโ€™s vaccine in 12- to 17-year-olds.

But in a sign that the findings were promising, the FDA already allowed both companies to begin U.S. studies in children 11 and younger, working their way to as young as 6 months old.

More than 131 million doses of Pfizerโ€™s vaccine have already been administered in the U.S., where demand for vaccines among adults has dramatically slowed in recent weeks.

While younger people are at dramatically lower risk of serious side effects from COVID-19, they have made up a larger share of new virus cases as a majority of U.S. adults have been at least partially vaccinated and as higher-risk activities like indoor dining and contact sports have resumed in most of the country. Officials hope that extending vaccinations to teens will further accelerate the nationโ€™s reduced virus caseload and allow schools to reopen with minimal disruptions this fall.

The U.S. has ordered at least 300 million doses of the Pfizer shot by the end of July, enough to protect 150 million people.

RELATED TOPICS:

DON'T MISS

Senate Rebukes Trumpโ€™s Tariffs as Some Republicans Vote to Halt Taxes on Canadian Imports

UP NEXT

Western US Sees Sharp Increase in Extreme Weather Impact

Fresno Firefighters Save Dog From Canal and Now Sheโ€™s Ready for Adoption

7 hours ago

Big Brands Spend Just Enough on X to Avoid Muskโ€™s โ€˜Naughty Listโ€™

7 hours ago

Senate Rebukes Trumpโ€™s Tariffs as Some Republicans Vote to Halt Taxes on Canadian Imports

WASHINGTON โ€” The Senate passed a resolution Wednesday night that would thwart President Donald Trumpโ€™s ability to impose tariffs on Canada, ...

2 hours ago

Senate Minority Leader Chuck Schumer, D-N.Y., center, is joined from left by Sen. Tim Kaine, D-Va., Sen. Peter Welch, D-Vt., and Sen. Angela Alsobrooks, D-Md., as they speak to reporters about President Donald Trump's tariffs on foreign countries, at the Capitol, in Washington, Wednesday, April 2, 2025. (AP Photo/J. Scott Applewhite)
2 hours ago

Senate Rebukes Trumpโ€™s Tariffs as Some Republicans Vote to Halt Taxes on Canadian Imports

6 hours ago

Supreme Court Sides With the FDA in Its Dispute Over Sweet-Flavored Vaping Products

6 hours ago

Trump Announces Sweeping New Tariffs to Promote US Manufacturing, Risking Inflation and Trade Wars

A young Labrador mix rescued from a Fresno canal on Sunday, March 2, 2025, is thriving in a foster home after overcoming fear and trauma. (Instagram/Fresno Animal Center)
7 hours ago

Fresno Firefighters Save Dog From Canal and Now Sheโ€™s Ready for Adoption

7 hours ago

Big Brands Spend Just Enough on X to Avoid Muskโ€™s โ€˜Naughty Listโ€™

7 hours ago

Judge Dismisses Corruption Case Against New York City Mayor Eric Adams

7 hours ago

State Center Trustees Render Split Decision on Future of PLAs

8 hours ago

Californiaโ€™s Schools Chief Has a $200,000 Salary and a Side Gig

Help continue the work that gets you the news that matters most.

Search

Send this to a friend