Moderna asks the FDA to authorize omicron Covid boosters for children under the age of 6

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

Mike Blake | Reuters

Moderna has asked the Food and Drug Administration to authorize its booster shots of omicron for children, the company announced on Friday.

Moderna has filed two separate clearance applications with the FDA, one for teens ages 12 to 17 and another for kids ages 6 to 11. The Boston-based biotech company said it will also ask the FDA to authorize younger children, ages 6 months to 5 years – old, by the end of the 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 advisory committee earlier this month that it plans to ask the FDA to authorize omicron boosters for children ages 5 to 11 in early October.

Earlier this month, US health authorities cleared Moderna’s Omicron adult boosters. Pfizer’s boosters were licensed for people 12 years of age and older.

The new shots target the omicron BA.5 sub-variant and 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 infection and disease because target the most common omicron sub-variant.

Older vaccines, designed to fight the original Covid strain, no longer provide significant protection against mild infections and diseases because the virus has mutated so much. There is also concern that the effectiveness of the original shots in preventing hospitalization and serious illness is starting 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. The shots were cleared with no data from human clinical trials

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