Moderna Seeks FDA Approval for Vaccine for Kids Under 6

A similar immune response was shown in kids ages 6 months to 5 years as it did in adults.

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On Thursday, Modern requested authorization for low doses of its COVID-19 vaccine for kids under age 6. This long-awaited news comes as many parents hope to get the vaccine for their children by summertime.

The country’s littlest kids are still awaiting a vaccine, even as mask mandates and other rules and regulations have been lifted. Moderna submitted data to the Food and Drug Administration so that babies, toddler and preschoolers will be able to get two low-dose shots of the vaccine.

This comes after the company’s trials performed well with this age group.

The two 25-microgram doses of the vaccine for kids ages 6 months through five years old showed a similar response to the two 100-microgram doses given to adults ages 18-25. This showed that there is a benefit to the vaccine for kids in this age group.

The two doses of the vaccine are given 28 days apart and the data showed a “robust neutralizing antibody response in both age groups” the company said in a news release.

“We believe these latest results from the KidCOVE study are good news for parents of children under 6 years of age. We now have clinical data on the performance of our vaccine from infants six months of age through older adults,” said Stéphane Bancel, Chief Executive Officer of Moderna.

“Additionally, after consultation with the U.S. FDA we have initiated a submission for emergency use authorization of our COVID-19 vaccine in children ages 6 to 11 years old and are updating our submission to the FDA for emergency use authorization of mRNA-1273 in adolescents ages 12 to 17 years with additional follow-up data,” she said.

The data was based on a group of 6,900 children ages 6 months to 5 years old. The majority of adverse reactions to the vaccine were mild to moderate and occurred more often after the second shot. No deaths or myocarditis were reported.

The vaccine was not great at preventing COVID-19 infections caused by the Omicron variant. The efficacy for children ages 6 months through 1-year-old was 43.7 percent. For children ages 2 through 5, the efficacy was 37.5 percent. These numbers were consistent with how vaccinated adults responded to Omicron.

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