FDA Advisers Endorse Moderna's COVID Vaccine for Older Children; Says Jab is Safe for Kids 6-17

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By Joel Brussels , Parent Herald Jun 15, 10:27 am

Photo: (Photo : EUGENE HOSHIKO/POOL/AFP via Getty Images)

A government advisory panel endorsed on Tuesday, June 14, a second brand of COVID-19 vaccine for school-age kids and teens. The outside experts of the Food and Drug Administration (FDA) voted unanimously that Moderna's COVID vaccine is safe and effective enough to be given to children ages 6 to 17. If the FDA agrees, it will become the second option for those kids, joining the vaccine of Pfizer for children.

The same expert panel of the FDA will meet on Wednesday, June 15, to consider tot-sized shots from Pfizer and Moderna for the littlest kids, those under the age of 5, according to the Associated Press.

Moderna seeking clearance for two doses of COVID vaccine

Moderna's COVID vaccine has long been available for adults in the United States and elsewhere, and more than three dozen countries offer it to kids as well. If the FDA authorizes Moderna's shot for teenagers and younger children, the Centers for Disease Control and Prevention (CDC) will next decide whether to recommend the vaccine.

The Massachusetts company is seeking clearance for two doses of the COVID vaccine and plans to offer a booster later. The vote that happened on Tuesday was only for two doses - full-strength for those ages 12 to 17 and half-sized doses for kids ages 6 to 11.

CDC's Dr. Melinda Wharton, a member of the panel, told NBC News that according to the data, the benefits outweigh the risks for both of these doses in both age groups. The FDA held up the teen vaccine of Moderna for months while it investigated a rare side effect of the shot, which is heart inflammation.

That is mostly a risk for young men and teen boys and also can occur with Pfizer's vaccine. Moderna got extra scrutiny, though, because its shots are a far higher dose. FDA scientists said in their review that there were no confirmed cases of heart inflammation in Moderna's kid studies. Experts say, however, that the studies may have had too few participants for a rare side effect like that to appear.

Heart inflammation side effect needs to be watched closely

Dr. Mark Sawyer, a panel member from the University of California, San Diego's medical school, said that side effect needs to be watched closely going forward as the use of the vaccine expands.

FDA officials said nothing worrisome was reported. Other side effects were mainly sore arms, headache, and fatigue. The FDA analysis concluded that two doses of Moderna are effective in preventing symptomatic COVID illness in teens and younger children, with the levels of coronavirus-fighting antibodies comparable to those that developed in young adults.

According to the FDA analysis, vaccine effectiveness was estimated at 93 percent for teens and 77 percent for younger children. However, the said research was done when earlier versions of COVID-19 were causing most of the infections in the U.S., and it is unclear how well the shots would work against recent more contagious variants, according to Politico.