NEW YORK – A government advisory panel met Tuesday to decide whether to recommend a second COVID-19 vaccine for school-age children and adolescents.
Outside experts at the Food and Drug Administration will vote on whether Moderna’s vaccine is safe and effective enough to give to children ages 6 to 17. If the panel backs the vaccine and the FDA agrees, it would become the second choice for those children, joining Pfizer’s vaccine. .
The same panel of experts will meet Wednesday to consider small takes from Moderna and Pfizer for the youngest kids, those under 5.
Moderna’s COVID-19 vaccine has long been available to adults in the US and elsewhere, and dozens of countries are also offering it to children. In the US, children ages 12 to 17 would receive two full doses; ages 6 to 11 would receive half-size doses.
The FDA held Moderna’s teen vaccine for months while it investigated a rare side effect, inflammation of the heart. That’s primarily a risk for teens and young men, and it can also happen with the Pfizer vaccine. Moderna has received additional scrutiny because its injections are a much higher dose.
In their review, the FDA scientists said there were no confirmed cases of heart inflammation in Moderna’s children’s studies. But experts say the studies may have had too few participants for a rare side effect like that to show up.
The FDA request is for two doses of your vaccine.
“There just aren’t enough people in clinical trials to catch” the problem, if it’s occurring, Georgetown University’s Dr. Jesse Goodman, the former FDA chief of vaccines, said in a call with reporters earlier this week. .
The FDA analysis concluded that two doses of Moderna are effective in preventing symptomatic COVID-19 illness in adolescents and young children, with virus-fighting antibody levels comparable to those developed in young adults.
Vaccine efficacy was estimated at 93% for the 12-17 year old group and 77% for the younger group. However, the research was done when earlier versions of the coronavirus were causing the majority of infections in the US and it’s unclear how well they work against newer variants.
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The FDA review said a booster shot would likely be needed, as is now recommended for children vaccinated with Pfizer injections, as well as all adults.
It’s unclear how much demand there will be for Moderna’s drinks. Teenagers became eligible a year ago for Pfizer’s vaccine, which uses the same technology, and only 60% received two doses. Immunizations for the youngest children began in November; about 29% have been vaccinated, according to the Centers for Disease Control and Prevention.
If the FDA licenses Moderna’s shots for teens and school-age children, the matter goes to the CDC, which makes vaccine recommendations to doctors and the public. A CDC spokesman said the agency is not expected to address the issue until later this month.
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