2nd vaccine for older kids gets panel's OK

NEW YORK >> A government advisory panel Tuesday endorsed a second brand of COVID-19 vaccine for school-age children and teens.

The Food and Drug Administration's outside experts voted unanimously that Moderna's vaccine is safe and effective enough to give kids ages 6 to 17. If the FDA agrees, it would become the second option for those children, joining Pfizer's vaccine.

The same FDA expert panel will meet Wednesday to consider tot-sized shots from Moderna and Pfizer for the littlest kids, those under 5.

Moderna's COVID-19 vaccine has long been available for adults in the U.S. and elsewhere and more than three dozen countries offer it to older children, too. If the FDA authorizes Moderna's vaccine for teens and younger children, the Centers for Disease Control and Prevention will next decide whether to formally recommend the shots.

The Massachusetts company is seeking clearance for two doses, and plans to later offer a booster. Tuesday's vote was only for two doses — full-strength for 12-17 and half-sized doses for those 6-11.

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

“I believe that this will provide families an important option” and may be particularly important for families who live in areas where coronavirus spread is increasing, said another panel member, Dr. Ofer Levy of Boston Children's Hospital.

The FDA held up Moderna's teen vaccine for months while it investigated a rare side effect, heart inflammation. That's mostly a risk for teen boys and young men, and also can occur with the Pfizer vaccine. Moderna got extra scrutiny because its shots are a far higher dose.

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

“That clearly needs to be watched closely going forward as we expand the use of the vaccine,” said Dr. Mark Sawyer, a panel member from UC San Diego's medical school.

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