Moderna Seeks EUA for COVID-19 Vaccine for Children Under Six Years Old

On Thursday, Moderna announced it is requesting a formal emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its mRNA COVID-19 vaccine for use in children ages six months to under six years. Moderna seeks an EUA for a low-dose version of its vaccine based on a study of approximately 6,700 children finding that two doses of the vaccine administered 28 days apart to children under six years old triggered levels of antibodies equivalent to those seen in older children and adults.

The vaccine appears to be approximately 51 percent effective for children ages six months to less than two years, and 37 percent effective for those ages two to less than six years. Company officials indicate that while the level of effectiveness is lower than anticipated, it is not surprising given the study was conducted when Omicron became the dominant variant.

Recall, earlier this year, Pfizer-BioNTech sought an EUA from the FDA for its COVID-19 vaccine for young children under five years old. However, after new data emerged indicating two doses of vaccine were ineffective, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) postponed its consideration of the request.

The FDA is anticipated to consider Moderna’s request over the coming weeks. Additional information is available here.