Categories: Health

Moderna is making use of to the FDA for approval of omicron Covid boosters for youngsters ages 6 and older

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

Mike Blake | Reuters

Moderna has asked the Food and Drug Administration to approve its Omicron booster shots for children, the company said Friday.

Moderna submitted two separate FDA submissions, one for adolescents ages 12 to 17 and one for children ages 6 to 11. The Boston-based biotech said it would also ask the FDA to approve shots for the youngest children, ages 6 months to 5 years-old, later this year.

The Centers for Disease Control and Prevention said in a document released Tuesday that they expect children to be eligible for the Omicron boosters by mid-October, pending FDA approval. 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 seek FDA approval of Omicron boosters for children ages 5 to 11 in early October.

US health officials cleared Moderna’s Omicron boosters for adults earlier this month. Pfizer’s boosters have been approved for people aged 12 and over.

The new shots target the subvariant Omicron BA.5, 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 infection and disease because they target the most common omicron subvariant.

The old vaccines that were developed to fight the original Covid strain no longer provide meaningful protection against infection and minor illness because the virus has mutated so severely. There are also concerns that the effectiveness of the original vaccines in preventing hospitalization and serious illness is beginning to decline.

Public health officials are excited about the new omicron BA.5 boosters, although it’s unclear how effective they will be in the real world. The recordings were approved without human clinical trial data