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Moderna Wants to Be First to Provide COVID Vaccines to Youngest Kids

Moderna Wants to Be First to Provide COVID Vaccines to Youngest Kids

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

Now rival company Moderna has submitted data to the Food and Drug Administration (FDA) that it hopes will prove two low-dose shots can protect children younger than 6, although its effect wasn’t nearly as high in kids tested during the Omicron surge as earlier in the pandemic.

Moderna is seeking to be the first to offer the COVID-19 vaccine for the youngest American children, asking the Food and Drug Administration (FDA) Thursday to clear low-dose shots for babies, toddlers, and preschoolers. The company said two kid doses were about 40% to 50% effective at preventing symptomatic COVID-19, not a home run but for many parents, any protection would be better than none.

In a study of 6,700 kids ages 6 months through 5 years, two Moderna shots — each a quarter of the regular dose — triggered high levels of virus-fighting antibodies, the same amount proven to protect young adults. There were no serious side effects, and the shots triggered fewer high fevers than other routine vaccinations.

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

The FDA says it 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 next week.

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