Moderna seeks OK for kids’ shot
Moderna asked U.S. regulators Thursday to authorize its COVID-19 vaccine for children younger than 6, a long-awaited move toward potentially making shots available for millions of kids by summer.
The company submitted data to the Food and Drug Administration that it hopes will prove that two low-dose shots can protect babies, toddlers and preschoolers, albeit not as effectively during the Omicron surge as earlier in the pandemic.
Frustrated families have waited for a chance to protect the nation’s littlest kids as people shed masks and other public health precautions — even though highly contagious coronavirus mutants continue to spread.
“There is an important unmet medical need here with these youngest kids,” said Dr. Paul Burton, Moderna’s chief medical officer. 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 kids 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 would “move quickly without sacrificing our standards” in deciding if doses for very young children are safe and effective.
While questions are swirling about what’s taking so long, Marks told lawmakers this week that the FDA can’t evaluate a product until a manufacturer completes its application. The FDA will publicly debate the evidence with its scientific advisors before making a decision, and Marks said meetings would be set to cover several expected applications.
“It’s critically important that we have the proper evaluation so that parents will have trust in any vaccines that we authorize,” Marks told a Senate committee.
If the FDA clears the vaccinations for the youngest of children, the Centers for Disease Control and Prevention would have to recommend who needs them — all children in that age group or just those at higher risk.