FDA panel recommends OK for Pfizer’s vaccine for kids 5 to 11

WASHINGTON — A federal vaccine advisory panel on Tuesday recommended authorizing Pfizer’s COVID-19 vaccine for children ages 5 to 11, a decision that means as soon as next week everyone in the United States over age 5 is expected to be eligible for a shot.

The vote by the Food and Drug Administration panel, with 17 yes votes and one abstention, followed a day-long hearing on whether the benefits of the vaccine outweigh any potential risks for children.

“To me, the question is pretty clear: We don’t want children to be dying of COVID, even if it is far fewer children than adults, and we don’t want them in the ICU,” said Amanda Cohn, chief medical officer at the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.

The next step lies with top FDA officials, who aren’t bound to follow the panel’s advice but typically do so. 

If they grant the emergency use authorization, then the CDC would weigh in early next week with additional guidelines before shots may be administered to the 28 million kids in the new age group.

That green light could help boost the number of people vaccinated as families plan for indoor holiday gatherings this winter, where the virus causing COVID-19 can spread more easily.

While kids have been at lower risk of infection and severe complications from the virus, CDC experts said Tuesday that the nearly 100 deaths among 5- to 11-year-olds mean it is one of the top 10 causes of death for that age group.

There have been more than 1.9 million infections in children ages 5 to 11, with the rate of those infections rising sharply over the summer. 

By mid-October, infections for the age group represented 10.6% of U.S. cases — a higher-than-expected rate, given the number of children in that age group. It’s also likely an under count based on antibody tests on children, with a study presented by the CDC projecting as many as 40% of kids in the age group may have already been infected.

More than 8,300 COVID-19 hospitalizations have occurred among children between 5 and 11, with one-third of those hospitalizations involving a stay in an intensive care unit, according to the FDA.

“Our hospital has been full for the last month or so with children who’ve been critically ill — not all of them have COVID, but many of them do,” said Jay Portnoy, an allergist at Children’s Mercy Hospital in Kansas City, Missouri, and a member of the panel. “I am looking forward to being able to actually do something to prevent that.”

Public health experts, as well as the Pfizer officials seeking FDA approval, also emphasized that COVID-19 infections can result in other consequences for children, such as school quarantines and closures that have caused chaos for school districts and working parents.

In addition to preventing infections and deaths in children who receive the shot, the vaccine “is also likely to confer additional benefits, including reduced transmission, improved herd immunity, and increased in-person learning, supporting child development,” said William Gruber, Pfizer’s senior vice president for vaccine clinical research and development.

As with Pfizer’s shot for teens and adults, the version for children also requires two doses spaced three weeks apart. The dosage for the younger age group is much smaller: 10 micrograms for kids, compared to 30 micrograms for adults.

Data from Pfizer that was analyzed by FDA regulators indicates that the company’s vaccine would offer strong protection. The two-shot regimen had a 90.7 percent efficacy rate in preventing symptomatic COVID-19 in a clinical trial of children ages 5 to 11, with similar side effects to those in adults, such as headache and fever.

One risk weighed by the vaccine panel Tuesday was myocarditis, a rare condition involving inflammation of the heart muscle that has been linked to the Pfizer and Moderna vaccines in older boys and young men. A COVID-19 infection also carries a risk of triggering myocarditis. 

The FDA’s analysis evaluated the chance of that rare inflammation against several scenarios in order to compare the number of COVID-19 hospitalizations prevented by a vaccine against the number of potential myocarditis cases.

In nearly all of those scenarios, the hospitalizations and deaths prevented outnumbered the potential instances of myocarditis. At a very low rate of community spread of the virus, that tradeoff flipped. 

However, analysts said the model relies on a rate of myocarditis that occurs in older children, and that rate is likely higher than what will be seen in younger children.

FDA officials also reiterated the intense safety surveillance systems that the agency uses to identify any adverse reactions that may occur.

One unanswered question from the hearing is whether kids also will eventually need a booster shot, like the ones recently approved for adults six months after their second dose.

Pfizer’s officials said they will be gathering data on the antibody response at six months after inoculation.