The U.S. Food and Drug Administration advisers recommended to authorize Moderna’s two-dose COVID-19 vaccine for children and teens aged 6 to 17 years, reports said.
The FDA is expected to authorize the Moderna vaccine for ages 6-17 soon as the agency generally follows the recommendations of its advisers, even though it is not obliged to do so.
The vaccine also requires the recommendation by the U.S. Centers for Disease Control and Prevention or CDC. A committee of CDC advisers is expected to meet Friday and Saturday for the decision.
The two-dose course of Moderna’s vaccine has long been available for people aged 18 and older. Moderna asked the FDA to authorize its vaccine for teenagers 12 to 17 in June 2021, and for the 6 to 11 age group in March this year.
Meanwhile, the FDA advisers’ two-day meeting started Tuesday to discuss mRNA vaccines in children. The committee on Wednesday will consider Moderna’s application for vaccine clearance for children under 6.
Last week, the FDA had said that Moderna’s vaccine is effective in children under 6 in preventing symptomatic infection without causing worrisome side effects. Moderna submitted its vaccine data for children 6 months through 5 years to the FDA in late April.
Certain reports said Moderna vaccine is at higher risk of heart inflammation at higher rates, and some European countries have limited its use for younger age groups.
The FDA committee will also consider the vaccine application by Pfizer and its German partner, BioNTech that sought emergency use authorization of their Covid-19 vaccine for children ages 6 months to 5 years. Pfizer vaccine also received recommendation from FDA advisers for use in children aged 6 months to under 5 years.
The Pfizer vaccine was authorized for children aged 5 to 11 in October, and its booster dose was authorized for the same age group in May.
Children younger than 5 years are the only age group who are not eligible for vaccination against Covid-19 in the U.S.
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