FDA advisers back Pfizer’s COVID-19 vaccine for kids
The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision within days
FDA advisory committee reviewing Pfizer vaccine data for ages 5-11 'extremely important': Dr. Siegel
Pfizer asked for FDA approval of its COVID vaccine for children ages 5 to 11. The advisory committee is expected to look over critical data before consenting to the jab, according to Fox News medical contributor Dr. Marc Siegel.
A panel of U.S. health advisers on Tuesday endorsed kid-size doses of Pfizer’s COVID-19 vaccine, moving the U.S. closer to beginning vaccinations in children ages 5 to 11.
A Food and Drug Administration advisory panel voted unanimously with one abstention that the vaccine’s benefits in preventing COVID-19 in that age group outweigh any potential risks — including a heart-related side effect that’s been very rare in teens and young adults who get a much higher dose.
FILE - In this Sept. 21, 2021, file photo, Jackson State University student Kendra Daye, right, reacts as Tameiki Lee, a nurse with the Jackson-Hinds Comprehensive Health Center, injects her with the Pfizer COVID-19 vaccine, in Jackson, Miss. The num (AP Photo/Rogelio V. Solis / AP Newsroom)
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The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision within days.
If the FDA authorizes the kid-size doses, there’s still another step: Next week, the Centers for Disease Control and Prevention will have to decide whether to recommend the shots and which youngsters should get them.
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The Pfizer Inc. logo is seen on the lab coat of an employee at the company's research and development facility in Cambridge, Massachusetts, U.S., on Monday, Oct. 26, 2015. Pfizer is expected to report quarterly earnings on October 27. Photographer: S ( Scott Eisen/Bloomberg via Getty Images / Getty Images)
While children are at lower risk of severe COVID-19 than older people, 5- to 11-year-olds still have faced substantial illness -- including over 8,300 hospitalizations reported, about a third requiring intensive care, and nearly 100 deaths.
The dose for young children is just one-third of the Pfizer shot already recommended for everyone 12 and older. Moderna also is studying its vaccine for young children.
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A study of elementary schoolchildren found the Pfizer shots are nearly 91% effective at preventing symptomatic infection -- even though the youngsters received just a third of the dose given to teens and adults.
Los Angeles, CA - April 15: Liesl Eibschutz, a medical student from Dartmouth University, loads a syringe with Pfizer COVID-19 vaccine before giving it to people on the first day that people ages 16 and up can receive the vaccine at Kedren Health on (Getty Images)
In a preliminary analysis last week, Food and Drug Administration reviewers said that protection would "clearly outweigh" the risk of a very rare side effect in almost all scenarios of the pandemic. Now FDA’s advisers are combing through that data to see if they agree.