Moderna's two dose 25 microgram vaccine for children 6 months to 6 years has met its primary endpoint!
This was an immunobridging trial, so the primary endpoint was non-inferior neutralizing antibody levels as compared to an 18-25 year old adult cohort that received the two dose 100 microgram adult vaccine. The Geometric Mean Ratio (GMR) was 1.3 (95% Cl: 1.1, 1.5) for the 6 months to 2 years old group and was 1.0 (95% Cl: 0.9, 1.2) for 2 years old to 6 years old. >1 indicates higher neutralizing antibody levels than the adult cohort.
The vaccine had no safety issues with no myocarditis cases observed. About 6,700 children were in the trial.
Moderna still doesn't have any vaccine with an EUA for those under 18. They'll be submitting for an EUA for this age group and for children 6-12 as well. They've already submitted for an EUA for 12-18 year olds.
Hopefully we can get a vaccine approved for this age group at some point this spring.