Moderna vaccine closer to approval for older kids

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

The Food and Drug Administration’s outside experts voted unanimously that Moderna’s vaccine is safe and effective enough for use in 6- to 17-year-olds.

If the FDA agrees, the Moderna vaccine will become the second option for that age group, joining Pfizer’s vaccine.

The same FDA expert panel will meet Wednesday to consider tot-size shots from Moderna and Pfizer for kids under 5.

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

The Massachusetts company is seeking clearance for two doses and plans to later offer a booster. Tuesday’s vote was for two doses: fullstrength for ages 12 to 17 and half doses for those 6 to 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 advisory panel.

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 youth studies. But experts say the studies may have had too few participants for such a rare side effect 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.

The FDA analysis concluded that two doses of Moderna’s vaccine are effective in preventing symptomatic COVID-19 illness in teens and younger kids, with the levels of virus-fighting antibodies comparable to those developed in young adults.

Vaccine effectiveness was estimated at 93% for teens and 77% for the younger children, according to the FDA. However, the research was conducted when earlier versions of the coronavirus were causing most U.S. infections; it’s not clear how well they work against the more contagious Omicron variant and its even more transmissible subvariants.

The analysis is also based on a limited number of COVID-19 cases, making the estimates a bit rough.

A booster shot has been added to the studies, and data are expected in about a month, Moderna officials said. Booster shots are now recommended for children who have been vaccinated with Pfizer’s shots, as well as for all adults.

How much demand there will be for Moderna’s shots isn’t clear. Teens became eligible a year ago for Pfizer’s vaccine, which uses the same technology, and only 60% have gotten two doses. Shots for younger kids started in November; about 29% have been fully vaccinated, according to the CDC.

If the FDA authorizes Moderna shots for teens and schoolchildren, the CDC is not expected to review the vaccine until later this month, according to an agency spokesperson.