Big Move From Moderna on Shots for Youngest Kids

Pharma company submits data to FDA, asks regulators to OK COVID shots for under-6 set
By Newser Editors and Wire Services
Posted Apr 28, 2022 8:01 AM CDT
Big Move From Moderna on Shots for Youngest Kids
A health worker administers a dose of the Moderna COVID-19 vaccine during a vaccination clinic in Norristown, Pa., on Dec. 7, 2021.   (AP Photo/Matt Rourke, File)

Moderna on Thursday asked US 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. Now, only children ages 5 or older can be vaccinated in the US, using rival Pfizer's vaccine, leaving 18 million younger tots unprotected. 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 effectively during the omicron surge as earlier in the pandemic, per the AP.

"There is an important unmet medical need here with these youngest kids," says 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." 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-size doses are safe and effective.

With questions swirling on 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 advisers before making a decision. "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 vaccinations for the littlest, next the CDC will recommend who needs them—all tots or just those at higher risk from COVID-19. Many parents are desperate for whichever vaccine gets to the scientific finish line first. "We've been kind of left behind as everybody else moves on," says one mom whose 6-year-old daughter is vaccinated, but whose 3-year-old and 18-month-old sons are part of Pfizer's trial.

(More Moderna stories.)

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