Moderna asks FDA to authorize omicron booster shots for kids as young as 6

 Moderna on Friday said it has asked the Food and Drug Administration (FDA) to authorize its COVID-19 bivalent booster shot for adolescents and children as young as 6 years old.

The application for children ages 6 months to under 6 years is expected to be completed later this year, the company said.

The announcement was made on Twitter, with no additional details.

Moderna’s booster shot is currently authorized for adults, while the bivalent booster from Pfizer/BioNTech is authorized for adolescents as young as 12. They have not yet asked FDA to authorize the shot for younger kids.

In a document published earlier this week, the Centers for Disease Control and Prevention said it anticipates a recommendation for bivalent COVID-19 boosters for young children in early- to mid-October, pending FDA authorization.

The agency said it expects that if bivalent boosters are authorized for individuals aged 5 years and older as a booster, the original mRNA COVID-19 vaccines may no longer be authorized as booster doses, only as an initial vaccine series. 

Bivalent boosters contain mRNA targeting the original strain of SARS-CoV-2 as well as the BA.4/BA.5 subvariants of the Omicron strain, which are currently the most prevalent versions of the virus circulating.

The Biden administration has procured over 170 million doses of bivalent COVID-19 vaccine for distribution and administration, enough to “ensure a robust and complete national booster vaccination campaign through the fall and early winter,” CDC said. 

Doses of bivalent Moderna vaccine for children aged 6 to 17 are expected to come from the same vials currently in the field that are being used to vaccinate adults.

The Moderna bivalent vaccine for adolescents and teenagers aged 12 to 17 years is expected to be the same volume and dosage as is currently authorized for adults, while the vaccine for kids ages 6 to 11 is expected to be half the volume and dosage that is currently authorized for adults.

https://thehill.com/policy/healthcare/3658319-moderna-asks-fda-to-authorize-omicron-booster-shots-for-kids-as-young-as-6/