Moderna asks the FDA to authorize omicron Covid boosters for children 6 years and older

Following the CDC’s approval for vaccination of children ages 6 months to 5 years, Eleanor Kahn, 4, sits with her father Alex as nurse Jillian Mercer administers the Modern 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 license its omicron booster vaccines for children, the company announced Friday.

Moderna filed two separate FDA clearance applications, one for adolescents ages 12 to 17 and one for children ages 6 to 11. The Boston biotech company said it will also ask the FDA to approve vaccines for younger children, ages 6 months to 5 years. – Old, at the end of this year.

The Centers for Disease Control and Prevention, in a document released Tuesday, said they expect children to be eligible for omicron boosters in mid-October pending FDA clearance. The CDC’s vaccine advisory committee has meetings scheduled for October 19-20.

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.

US health regulators approved Moderna’s omicron boosters for adults earlier this month. Pfizer boosters were licensed 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 hope the new boosters will provide superior protection against infections and diseases because they target the most common omicron. subvariant

Older vaccines, which were designed to fight the original strain of covid, no longer provide significant protection against mild infections and illnesses because the virus has mutated so much. There is also concern that the effectiveness of the original injections in preventing hospitalization and serious illness is beginning to wane.

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

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