CORONAVIRUS

FDA Expected To OK Pfizer Vaccine For Teens Within Week

May 3, 2021, 8:50 PM
FILE PHOTO (Photo by Scott Olson/Getty Images)...
FILE PHOTO (Photo by Scott Olson/Getty Images)
(Photo by Scott Olson/Getty Images)

WASHINGTON (AP) — The U.S. Food and Drug Administration is expected to authorize Pfizer’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.

The federal official, speaking on the condition of anonymity to preview the FDA’s action, said the agency was expected to expand its emergency use authorization for Pfizer’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 Pfizer’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 committee’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.

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 isn’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 Moderna’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 Pfizer’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 nation’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.

__

Lemire reported from New York.

KSL 5 TV Live

Top Stories

Coronavirus

Representative Tricia Derges (Credit: Missouri House of Representatives)...
Associated Press

Missouri lawmaker resigns from House after fraud conviction for selling Covid treatments

A Missouri GOP legislator has resigned after being convicted of falsely claiming she was giving patients stem cell treatments for COVID-19.
23 hours ago
FILE PHOTO (Photo by Jacob King - WPA Pool/Getty Images)...
MIKE STOBBE, AP Medical Writer

Moderna COVID-19 shots now an option for older kids in US

There is now a second COVID-19 option for kids ages 6 to 17 in the U.S.
10 days ago
Pfizer says it's COVID-19 vaccine is 100% effective in kids 12 to 15. (Justin Tallis-Pool/Getty Ima...
Jen Christensen, CNN

What are the COVID-19 vaccine side effects in young kids? Experts seek to ease parents’ concerns

Experts look at what side effects to expect from the COVID vaccine for children six months and older.
12 days ago
The Nurse Crisis and Patent Risk....
Debbie Worthen

Utah registered nurses are leaving the field, creating the ‘perfect storm’

"Without nurses, we can't have hospitals." Utah nurses are overworked and underpaid. Some say it's put people at risk.
13 days ago
Four-year-old Viola Fairfax-Panza Getting her COVID-19 vaccination, held by her mother Keke Fairfax...
Jed Boal

Salt Lake Co. distributes COVID vaccines for children 6-months and older

Salt Lake County begins COVID-19 vaccinations for children 6 months and older.
13 days ago
U.S. President Joe Biden speaks about Covid-19 vaccines for children, in the Roosevelt Room of the ...
ZEKE MILLER and JOSH BOAK, Associated Press

Biden visits clinic, celebrates COVID shots for kids under 5

President Joe Biden is celebrating that virtually all Americans can now get a COVID-19 shot after the authorization of vaccines for kids under 5 over the weekend.
13 days ago

Sponsored Articles

hand holding 3d rendering mobile connect with security camera for security solutions...
Les Olson

Wondering what security solutions are right for you? Find out more about how to protect your surroundings

Physical security helps everyone. Keep your employees, clients, and customers safe with security solutions that protect your workplace.
Many rattan pendant lights, hay hang from the ceiling.Traditional and simple lighting....
Lighting Design

The Best Ways to Style Rattan Pendant Lighting in Your Home

Rattan pendant lights create a rustic and breezy feel, and are an easy way to incorporate this hot trend into your home decor.
Earth day 2022...
1-800-GOT-JUNK?

How Are You Celebrating Earth Day 2022? | 4 Simple Ways to Celebrate Earth Day and Protect the Environment

Earth Day is a great time to reflect on how we can be more environmentally conscious. Here are some tips for celebrating Earth Day.
Get Money Online...

More Ways to Get Money Online Right Now in Your Spare Time

Here are 4 easy ways that you can get more money online if you have some free time and want to make a little extra on the side.
Lighting trends 2022...

Lighting Trends 2022 | 5 Beautiful Home Lighting Trends You Can Expect to See this Year and Beyond

This is where you can see the latest lighting trends for 2022 straight from the Lightovation Show at the Dallas World Trade Center.
What Can't You Throw Away in the Trash...

What Can’t You Throw Away in the Trash? | 5 Things You Shouldn’t Throw in to Your Trash Can

What can't you throw away in the trash? Believe it or not, there are actually many items that shouldn't be thrown straight into the trash.
FDA Expected To OK Pfizer Vaccine For Teens Within Week