Moderna asks FDA to authorize omicron Covid boosters for children as young as 6 years old

Following CDC approval for vaccination of children aged 6 months to 5 years, 4 year-old Eleanor Kahn sits with her father Alex, as nurse Jillian Mercer administers the Moderna vaccine for the coronavirus disease (COVID-19) at Rady Children’s Hospital in San Diego, California, U.S., June 21, 2022.
Mike Blake | Reuters
Moderna has asked the Food and Drug Administration to authorize its omicron booster shots for children, the company announced on Friday.

Moderna filed two separate FDA authorization requests, one for adolescents ages 12 to 17 and another for kids ages 6 to 11. The Boston biotech company said it will also ask the FDA to clear the shots for the youngest children, 6 months through 5-years-old, later this year.

The Centers for Disease Control and Prevention, in a document published Tuesday, said it expects children to become eligible for the omicron boosters by mid-October pending authorization by the FDA. The CDC’s vaccine advisory committee has meetings scheduled for October 19 and 20.

Pfizer told the CDC advisory committee earlier this month that it expects to ask the FDA to authorize omicron boosters for children ages 5 to 11 in early October.

U.S. health regulators cleared Moderna’s omicron boosters for adults earlier this month. Pfizer’s boosters were authorized for people ages 12 and older.

The new shots target the omicron BA.5 subvariant as well as the original strain of Covid that first emerged in China in late 2019. The FDA and CDC expect the new boosters to provide superior protection against infection and disease because they target the most common omicron subvariant.

The old vaccines, which were designed to fight the original Covid strain, are no longer providing meaningful protection against infection and mild illness because the virus has mutated so much. There is also concern that the original shots’ effectiveness at preventing hospitalization and severe illness is starting to decline.

Public health officials are confident in the new omicron BA.5 boosters, though it’s unclear just how effective they will be in the real world. The shots were authorized without data from human clinical trials

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