FDA Advisers Support Moderna COVID-19 Vaccine for Older Children

On Tuesday, a government advisory panel approved a second brand of COVID-19 vaccine for school-age children and teens.

External experts from the Food and Drug Administration voted unanimously that the Moderna vaccine is safe and reasonably effective in children aged 6 to 17. If the FDA agrees, she will become a second option for these children, joining the Pfizer vaccine.

The same panel of FDA experts will meet on Wednesday to review Moderna and Pfizer’s childhood shots for the youngest children under 5.

Moderna’s COVID-19 vaccine has long been available for adults in the US and other countries, and more than three dozen countries offer it to children as well. If the FDA approves the Moderna vaccine for teens and young children, the Centers for Disease Control and Prevention will then decide whether to recommend vaccinations.

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The Massachusetts company is seeking approval for two doses and plans to offer a booster later. Tuesday’s vote was for only two doses – a full dose for 12-17 and a half dose for 6-11.

“The data do support that the benefits outweigh the risks for both of these doses in both of these age groups,” said Dr. Melinda Wharton of the CDC, a member of the panel.

The Food and Drug Administration (FDA) suspended development of Moderna’s teenage vaccine for several months while a rare side effect, heart inflammation, was studied. This is mostly a risk for teenage boys and young men and can also happen with the Pfizer vaccine. Moderna has come under extra scrutiny because its shots have a much higher dose.

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

“Obviously this needs to be closely monitored going forward as we expand the use of the vaccine,” said Dr. Mark Sawyer, a team member at the University of California, San Diego School of Medicine.

As for other side effects, FDA officials said there were no alarming reports – mostly arm pain, headache and fatigue.

An FDA analysis concluded that two doses of Moderna are effective in preventing symptomatic COVID-19 disease in adolescents and young children, with virus-fighting antibody levels comparable to those produced in young adults.

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According to an FDA analysis, the vaccine is estimated to be 93% effective for teenagers and 77% for young children. However, the study was done when earlier versions of the coronavirus were causing most infections in the US, and it’s not clear how well they work against later, more contagious variants. It is also based on a limited number of COVID-19 cases, which makes the estimates a little rough.

An additional shot has been added to the studies, Moderna said, and data is expected around next month. Booster shots are now recommended for children vaccinated with Pfizer shots, as well as for all adults.

It is not yet clear how much Moderna’s footage will be in demand. A year ago, teenagers became eligible for Pfizer’s vaccine, which uses the same technology, and only 60% received two doses. Vaccinations for young children began in November; About 29% have been fully vaccinated, according to the CDC.

A CDC spokesperson said that if the FDA allows Moderna vaccines for teenagers and schoolchildren, the agency will not review a vaccine until the end of this month.

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