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


Following CDC approval for vaccinations for children ages 6 months to 5 years, Eleanor Kahn, 4, sits with her father Alex, while nurse Jillian Mercer administers the Moderna coronavirus vaccine ( COVID-19) at Rady Children’s Hospital in San Diego, California, United States, June 21, 2022.

Mike Blake | Reuters

Moderna has applied to the Food and Drug Administration to clear its omicron booster shots for children, the company announced Friday.

Moderna has filed two separate clearance applications with the FDA, one for adolescents 12 to 17 years old and another for children 6 to 11 years old. The Boston biotech company said it would also ask the FDA to allow injections for younger children, 6 months to 5 years old. -old, later this year.

The Centers for Disease Control and Prevention, in a paper released Tuesday, said it expects children to become eligible for omicron boosters by mid-October pending FDA clearance. The CDC’s Vaccine Advisory Committee has meetings scheduled for October 19 and 20.

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

US health regulators cleared Moderna’s omicron boosters for adults earlier this month. Pfizer boosters were allowed for people 12 and older.

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

Older vaccines, which were designed to combat the original strain of Covid, no longer offer significant protection against infections and mild illnesses because the virus has mutated so much. There are also concerns that the effectiveness of the original injections in preventing hospitalization and serious illness is beginning to decline.

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

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