PHILADELPHIA (KYW Newsradio) — The Food and Drug Administration’s vaccine advisory committee has endorsed kid-size doses of Pfizer's shots for 5- to 11-year-olds.
The 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 despite their use of a much higher shot dose.
The panel met Tuesday to discuss whether or not to recommend it for approval. A Children's Hospital of Philadelphia doctor on the panel says, from what he has witnessed, avoiding coronavirus in kids is a priority.
These discussions about vaccinating younger children are taking place deep into the school year, with COVID-19 cases trending downward after the most recent surge in new cases caused by the delta variant. However, with winter and the holidays approaching, health experts are emphasizing the need to get vaccinated to get the best protection against becoming seriously sick.
Dr. Paul Offit, a member of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), and director of the Vaccine Education Center at CHOP, says even though kids aren’t as likely as adults to get seriously sick from COVID-19, that doesn’t mean they don’t need the vaccine’s protection.
"We certainly see a number of children with this disease — some of whom are in the intensive care unit, some of whom are very sick," Offit said. "And if you can avoid it, and avoid it safely — which, for all appearances, now that’s the case — then do that."
The VRBPAC is tasked with determining, based on the available scientific data, if the benefits of the Pfizer vaccine for children outweigh the risks.
In his opening remarks, top FDA official Dr. Peter Marks said that should be the focus, and not the arguments taking place around the country about whether or not such a vaccine should be required.
"To be clear, today’s discussion is going to be about the scientific data that are presented and it’s not about vaccine mandates which are left to other entities outside of FDA," Marks said.
CDC data presented on Tuesday shows how critical it is that kids get protection. Officials believe close to 2 million COVID-19 cases among kids 5-11 is likely an undercount. Even though, researchers say, kids are just as likely to get COVID-19 as adults, they’re less likely to be reported as cases.
There have been 8,300 hospitalizations in that age group, with higher rates for Black, Native American and Hispanic children. And, one-third of that total have had to go to the intensive care unit.
The FDA, in its analysis, said Pfizer’s trials show the vaccine to be safe and effective, with typical side effects like soreness at the injection site, headache and fatigue.
"There were no reports of myocarditis/pericarditis or anaphylaxis, and no participant deaths," the agency wrote. Myocarditis and pericarditis are conditions where the body's immune system causes inflammation of heart muscle tissue, or the outer lining of the heart, respectively. Anaphylaxis is a severe, potentially life-threatening allergic reaction.
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Younger children, just like those 12 and above, would get two shots, three weeks apart. The difference is the dosage. Kids 5-11 would get 10 micrograms of the vaccine, which is one-third of the amount given to older children and adults.
The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision within days. Next, the CDC’s own independent panel of experts will discuss the vaccine proposal on Nov. 2 and 3, before going to the CDC for a final decision.
In anticipation of full approval, the administration of President Joe Biden says there are enough doses for the 28 million children in the U.S. who are between the ages of 5 and 11. The vaccines would be packaged in a way to make them easier to store and distribute. The White House said 25,000 pediatricians’ offices and primary care sites would have access to the vaccine, along with pharmacies, children’s hospitals and health systems across the country.
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