FDA advisers consider Moderna’s COVID shots for older kids

NEW YORK, June 14 (US): A government advisory panel met Tuesday to decide whether to recommend a second brand of the COVID-19 vaccine for school-aged children and teens, according to the Associated Press.

Outside experts at the Food and Drug Administration will vote on whether Moderna’s vaccine is safe and effective enough to give children ages 6 to 17.

If the committee approves the shot and the Food and Drug Administration approves, it would become the second choice for these children, to join the Pfizer vaccine.

The same panel of experts will meet on Wednesday to look at full-size shots from Moderna and Pfizer for young children, as young as 5.

Moderna’s COVID-19 vaccine has long been available to adults in the United States and elsewhere, and dozens of countries are offering it to children as well.

In the United States, children ages 12 to 17 get two full doses; Children 6 to 11 years old will receive half-size doses.

The U.S. Food and Drug Administration halted Moderna’s teen vaccine for several months while it was investigating a rare side effect, carditis.

This is mostly a risk to teens and young adults, and it can also happen with the Pfizer vaccine. Moderna has come under more scrutiny because its doses are much higher.

FDA scientists said in their review that there were no confirmed cases of carditis in Moderna’s pediatric studies.

But experts say the studies may have had too few participants to show rare side effects like this one.

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As for other side effects, FDA officials said nothing worrisome were reported — mainly sore arms, headaches, and fatigue.

A U.S. Food and Drug Administration (FDA) analysis concluded that two doses of Moderna are effective in preventing symptomatic COVID-19 disease in adolescents and younger children, with virus-fighting antibody levels similar to those developed in adults.

The vaccine’s effectiveness was estimated at 93% for the 12-17 group, and 77% for the smaller group, according to an FDA analysis.

However, the research was conducted when previous versions of the coronavirus caused the most infections in the United States, and it’s not clear how well they have handled modern variants.

It’s also based on a limited number of COVID-19 cases, which makes the estimates a bit rough.


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