Moderna seeks OK to vaccinate kids under 6

FDA will look at data from two low-dose shots.

Moderna on Thursday asked U.S. regulators to authorize low doses of its COVID-19 vaccine for children younger than 6, a long-awaited move toward potentially opening shots for millions of tots by summer.

Frustrated families are waiting impatiently for a chance to protect the nation’s littlest kids as all around them people shed masks and other public health precautions — even though highly contagious coronavirus mutants continue to spread. Already about three-quarters of children of all ages show signs they’ve been infected at some point during the pandemic.

Moderna submitted data to the Food and Drug Administration that it hopes will prove two low-dose shots can protect babies, toddlers and preschoolers — albeit not as effec- tively during the omicron surge as earlier in the pandemic. “There is an important unmet medical need here with these youngest kids,” Dr. Paul Burton, Moderna’s chief medical officer, told The Associated Press. Two kid-size shots “will safely protect them. I think it is likely that over time they will need additional doses. But we’re working on that.”

Now, only children ages 5 or older can be vaccinated in the U.S., using rival Pfizer’s vaccine, leaving 18 million younger tots unprotected.

Moderna’s vaccine isn’t the only one in the race. Pfizer is soon expected to announce if three of its even smaller-dose shots work for the littlest kids, months after the disappointing discovery that two doses weren’t quite strong enough.

Whether it’s one company’s shots or both, FDA vaccine chief Dr. Peter Marks said the agency will “move quickly without sacrificing our standards” in deciding if tot-sized doses are safe and effective.

While questions are swirling about what’s taking so long, Marks told lawmakers earlier this week the FDA can’t evaluate a product until a manufacturer completes its application. In a statement Thursday, the FDA said it will schedule a meeting to publicly debate Moderna’s evidence with its independent scientific advisers but that the company still must submit some additional data. Moderna expects to do so within weeks.