Moderna asks FDA to authorize COVID-19 shot for young children

Moderna on April 28 said it has submitted an emergency use authorization request to the FDA for its two-dose COVID-19 vaccine regimen in children under 6, the only remaining age group not yet eligible for vaccination. 

The request is based on interim trial results that found the vaccine was 51 percent effective at preventing illness among children 6 months to 2 years old, and 37 percent effective against infection among 2- to 6-year-olds. Physicians expect the protection against severe illness to be stronger, though no conclusions could be drawn regarding the vaccine's effectiveness against hospitalization and deaths since there were no severe outcomes among children in the trial, The Washington Post reports. 

A top Moderna official said the company would finish submitting data on its vaccine for young children to federal regulators by May 9, according to The New York Times. The drugmaker has also requested authorization of its vaccine for children aged 6-11 and 12-17. A company spokesperson said Moderna plans to submit complete data for those requests in about two weeks, according to the Times. 

During an April 26 FDA oversight hearing, Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, suggested the agency has not yet cleared a vaccine for children under 5 because drugmakers have not yet submitted complete data, the Times reported. 

"Just remember, we can't actually finish our reviews until we actually have complete data," he said. 

Federal officials earlier this month said vaccines for children under 5 could become available in June. Pfizer has said it expects to have clinical trial results of its three-dose vaccine regimen for children under 5 ready to share with the FDA in early May. 

 

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