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Days after the Food and Drug Administration (FDA) approved a booster dose of the Pfizer-BioNTech COVID vaccine for children ages 12 to 15, a Centers for Disease Control and Prevention (CDC) panel voted to recommend expansion of the boosters, potentially opening eligibility to 5 million kids.
The panel made the decision Wednesday on whether the booster was safe for younger teens, and if they should get a booster as soon as possible or if it should simply be an option for anyone who wants it.
Following the recommendation that the children should get the shots as soon as possible, about 5 million 12- to 15-year-olds would become eligible for the booster immediately if it is approved by CDC director Dr. Rochelle Walensky, because their last dose was at least five months ago.
Similar boosters were approved for 16- and 17-year-olds last month, and the CDC also recommended that approval should be upgraded to say the teenagers "should" get the booster.
In total, about 13.5 million children aged 12 to 15 have received two Pfizer does, according to the CDC.
A key piece of the advisers' data was U.S. evidence that COVID hospitalizations and symptomatic cases are about seven to 11 times more common among unvaccinated teens than those who are vaccinated.
All Americans 16 and older are encouraged to get a booster, which health authorities say offer the best chance at avoiding the highly contagious Omicron variant.
Vaccines still offer strong protection against serious illness from any type of COVID-19, including the highly contagious Omicron variant, especially after a booster. But Omicron can slip past a layer of the vaccines' protection to cause breakthrough infections.
Studies show a booster dose at least temporarily revs up virus-fighting antibodies to levels that offer the best chance at avoiding symptomatic infection, even from Omicron.
Fending off even a mild infection is harder for vaccines to do than protecting against serious illness, so giving teens a booster for that temporary jump in protection is like playing whack-a-mole, cautioned Dr. Sarah Long of Drexel University. But she said the extra shots were worth it given how highly contagious the Omicron variant is, and how many kids are catching it.
More importantly, if a child with a mild infection spreads it to a more vulnerable parent or grandparent who then dies, the impact "is absolutely crushing," said Dr. Camille Kotton of Massachusetts General Hospital.
"Let's whack this one down," agreed Dr. Jamie Loehr of Cayuga Family Medicine in Ithaca, New York.
The vaccine made by Pfizer and its partner BioNTech is the only option for American children of any age.
New U.S. guidelines say anyone who received two Pfizer vaccinations and is eligible for a booster can get it five months after their last shot, rather than the six months previously recommended.
Children tend to suffer less serious illness from COVID-19 than adults. But child hospitalizations are rising during the Omicron wave—the vast majority of them unvaccinated.
During the public comment part of Wednesday's meeting, Dr. Julie Boom of Texas Children's Hospital said a booster recommendation for younger teens "cannot come soon enough."
The chief safety question for adolescents is a rare side effect called myocarditis, a type of heart inflammation seen mostly in younger men and teen boys who get either the Pfizer or Moderna vaccines. The vast majority of cases are mild—far milder than the heart inflammation COVID-19 can cause—and they seem to peak in older teens, those 16 and 17.
The FDA decided a booster dose was as safe for the younger teens as the older ones based largely on data from 6,300 12- to 15-year-olds in Israel who got a Pfizer booster five months after their second dose. Israeli officials said Wednesday that they've seen two cases of mild myocarditis in this age group after giving more boosters, 40,000.
Earlier this week, FDA vaccine chief Dr. Peter Marks said the side effect occurs in about 1 in 10,000 men and boys ages 16 to 30 after their second shot. But he said a third dose appears less risky, by about a third, probably because more time has passed before the booster than between the first two shots.
The Associated Press contributed to this report.
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A 2020 graduate of Kent State University with a Bachelor's degree in Journalism, Aaron has worked as an assigning editor ... Read more