Moderna Seeks EUA for COVID-19 Vaccine for 6 Months to 6 Years

Moderna is seeking emergency use authorization (EUA) from the FDA for its COVID-19 vaccine (mRNA-1273) in children ages 6 months to 6 years.

Meanwhile, Pfizer and BioNTech are seeking FDA EUA for a booster dose of their COVID-19 vaccine for children ages 5 through 11. The FDA granted Pfizer and BioNTech an EUA for the 5 to 11 age group in October 2021.

The pharma makers delayed seeking emergency authorization earlier this year after their trial showed that two doses were less than 50% effective against symptomatic disease, The New York Times said.

Moderna’s EUA application includes data from the Phase 2/3 clinical trial in children ages 5 through 11 years who received a booster dose about six months after the second dose of the Pfizer-BioNTech COVID-19 Vaccine 10-µg two-dose primary series, Moderna said in a news release.

Data from this study demonstrated a strong immune response in this age group following a booster dose of the Pfizer-BioNTech COVID-19 vaccine with no new safety signals, according to Moderna.

Stéphane Bancel

“We believe mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19 and will be especially welcomed by parents and caregivers,” said Stéphane Bancel, chief executive officer of Moderna.

The FDA has not yet cleared the COVID-19 vaccine for children under the age 5 because the vaccine manufacturers have not finished their applications, according to Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, The New York Times reported.

Despite growing pressure, including from Congress, the FDA might not rule on whether to authorize a pediatric vaccine dose for that group until June, administration officials have said, per The New York Times.

Still, Moderna said its phase 2/3 KidCOVE study showed a robust neutralizing antibody response in the 6 months to under 6 years of age group after a two-dose primary series of mRNA-1273, along with a favorable safety profile.

The previously announced results included a supportive preliminary efficacy analysis on cases mostly collected during the Omicron wave, including home testing for COVID-19.

When the analysis is limited only to cases confirmed positive for SARS-CoV-2 by central lab RT-PCR, vaccine efficacy remained “significant” at 51% for 6 months to under 2 years and 37% for 2 to under 6 years, Moderna said.

“These efficacy estimates are similar to vaccine efficacy estimates in adults against Omicron after two doses of mRNA-1273,” according to Moderna.

The EUA submission for children ages 6 months to under 6 years will be complete next week. Moderna is also currently studying booster doses for all pediatric cohorts.