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FDA advisers are considering Moderna’s COVID shots for older children

NEW YORK – A government advisory panel met on Tuesday to decide whether to recommend a second brand of COVID-19 vaccine for school-age children and young people.

The outside experts from the Food and Drug Administration will vote on whether Moderna’s vaccine is safe and effective enough to help children ages 6 to 17. If the panel endorses the vaccine and the FDA agrees, that would be the second option for these children, joining Pfizer’s vaccine.

The same panel of experts will meet on Wednesday to consider it Small snapshots of Moderna and Pfizer for the little onesthose under 5.

Moderna’s COVID-19 vaccine has long been available to adults in the United States and elsewhere, and dozens of countries are also offering it to children. In the US, children ages 12 to 17 would be given two full-strength doses; 6 to 11 years of age would receive half-size doses.

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The FDA withheld Moderna’s teenage vaccine for months while it investigated a rare side effect, heart inflammation. This is a particular risk for teenagers and young men and can also occur with the Pfizer vaccine. Moderna came under more scrutiny because its recordings have a far higher dose.

In their review, FDA scientists said there were no confirmed cases of heart inflammation in Moderna’s child studies. However, experts say the studies may have had too few participants for a rare side effect like this to occur.

“There just aren’t enough people in the clinical trials to recognize the problem” when it occurs, said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief, speaking to reporters earlier this week.

The FDA analysis concluded that two doses of Moderna are effective in preventing symptomatic COVID-19 in teenagers and younger children, with levels of virus-fighting antibodies comparable to those developed in young adults.

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The effectiveness of the vaccine was estimated at 93% for the 12-17 year old group and 77% for the younger group. However, the research was conducted when earlier versions of the coronavirus caused most US infections, and it’s not clear how well they work against newer variants.

The FDA review said it was likely a booster shot would be required as is now recommended for children vaccinated with Pfizer shotsas well as for all adults.

How big the demand for Moderna’s recordings will be is not clear. Teenagers were eligible for Pfizer’s vaccine, which uses the same technology, a year ago and only 60% got two doses. Recordings for younger children began in November; about 29% were vaccinated, according to the Centers for Disease Control and Prevention.

If the FDA approves Moderna shots for teens and schoolchildren, the matter moves on to the CDC, which makes vaccination recommendations to doctors and the public. A CDC spokesman said the agency is not expected to take up the issue until later this month.

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https://www.local10.com/health/2022/06/14/fda-advisers-consider-modernas-covid-shots-for-older-kids/ FDA advisers are considering Moderna’s COVID shots for older children

Sarah Y. Kim

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