Thursday, December 08, 2022

Moderna wants to be the first with COVID shots for the youngest children

Moderna wants to be the first with COVID shots for the youngest children

Moderna on Thursday asked US regulators to authorize reduced doses of its COVID-19 vaccine for children under 6 by the summer, a long-awaited step toward potential early shots for millions of tots .

Desperate families wait impatiently to protect the nation’s youngest children as people around them wear masks and other public health precautions – even as highly contagious coronavirus mutants continue to spread.

Moderna has submitted data to the Food and Drug Administration that it hopes the two low-dose shots can protect infants, toddlers and preschoolers — albeit not as effectively in the pandemic as before during the Omicron surge.

Moderna’s chief medical officer, Dr. Paul Burton, told the Associated Press: “There is a significant unmet medical need here with these youngest children.” Two kid-sized shots will “safely protect them.” I think it is likely that over time they will need additional doses. But we are working on that.”

Now, only children 5 years of age or older can be vaccinated in the US using rival Pfizer’s vaccine, leaving 18 million young children vulnerable.

Moderna’s vaccine isn’t alone in the race. Pfizer is expected to announce soon whether its three lower-dose shots work for the youngest children, months after the disappointing discovery that two doses weren’t strong enough.

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

While questions swirled about what’s taking so long, Marks told lawmakers earlier this week that the FDA can’t evaluate a product until a manufacturer has completed its application. In a statement Thursday, the FDA said Moderna would still have to submit some additional data to satisfy its request, but the agency would schedule a meeting with its scientific advisors to publicly debate the evidence. .

“It is critically important that we have a proper evaluation so that parents can have confidence in any vaccines that we authorize,” Marks told a Senate committee.

If the FDA approves vaccinations for the youngest children, the Centers for Disease Control and Prevention will have to recommend who needs them — all tots or just those who are at greater risk from COVID-19.

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