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# Moderna to Seek EUA for Infant Covid Vax
- URL: https://www.fdaweb.com/moderna-to-seek-eua-for-infant-covid-vax/
- Published: 2022-03-23T12:00:00.000Z
- Updated: 2026-09-14T17:37:42.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5151432

Moderna says it will ask FDA for an emergency use authorization (EUA) for its mRNA-1273 Covid-19 vaccine dosed for children 6 months to under 6 years old. The company [says](https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-its-COVID-19-Vaccine-Phase-23-Study-in-Children-6-Months-to-Under-6-Years-Has-Successfully-Met-Its-Primary-Endpoint/default.aspx?ref=fdaweb.com) it also has started a submission with FDA for a Covid-19 vaccine EUA for children 6 to 12 years old.

The company says children 6 months to under 6 years were given one-quarter of the adult vaccine dose in a two-dose series. The statement says that in the KidCOVE study, that dosing met the primary endpoint with robust neutralizing antibodies similar to the adult response. It also says the vaccine was generally well-tolerated in the age group.

With the omicron variant predominant during the KidCOVE study, Moderna found there was 44% vaccine efficacy in children 6 months to 2 years and 38% efficacy in those 2 to under 6 years. The company says it will evaluate the potential of a booster dose for all pediatric populations.