Moderna has submitted a request to the Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for its COVID-19 vaccine, mRNA-1273, in children 6 months to under 6 years of age.
The submission is based on results from the phase 2/3 KidCOVE study (ClinicalTrials.gov Identifier: NCT04796896), which included 3 pediatric cohorts: children 6 months to less than 2 years old; children 2 to less than 6 years old; and children 6 to less than 12 years old. Children 6 months to less than 6 years of age received either two 25mcg doses of mRNA-1273 or placebo, separated by 28 days.
Results showed a robust neutralizing antibody response in this age group similar to the 100mcg two-dose primary series in adults 18 to 25 years of age (primary endpoint). The safety profile was also consistent with that observed in older groups.
Vaccine efficacy was reported to be 51% (95% CI, 21-69) for children 6 months to less than 2 years of age and 37% (95% CI, 13-54) for children 2 years to less than 6 years of age when the analysis was limited only to cases confirmed positive for SARS-CoV-2 by central lab RT-PCR. These efficacy estimates were similar to those seen in adults against Omicron after 2 doses of mRNA-1273.
“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 Company expects to complete the EUA submission for children 6 months to under 6 years of age by next week. Booster doses of mRNA-1273 for all pediatric cohorts are also currently being investigated.
In a press statement, the American Academy of Pediatrics (AAP) said it was eager to see data on a COVID-19 vaccine for young children. “We urge the FDA and CDC to move with all possible speed to review the data on the Moderna vaccine, and if it is safe and effective, to authorize it as soon as possible for this age group,” said AAP President Moira Szilagyi, MD, PHD, FAAP.
The organization continues to urge parents of children already eligible for the COVID-19 vaccine to make sure they are up to date on vaccinations.
Moderna files for authorization of its COVID-19 vaccine in young children six months to under six years of age. News release. Moderna, Inc. Accessed April 28, 2022. https://investors.modernatx.com/news/news-details/2022/Moderna-Files-for-Authorization-of-Its-COVID-19-Vaccine-in-Young-Children-Six-Months-to-Under-Six-Years-of-Age/default.aspxAmerican Academy of Pediatrics urges quick and transparent steps toward review of COVID-19 vaccine for youngest age group of children. News release. American Academy of Pediatrics. Accessed April 28, 2022. https://www.aap.org/en/news-room/news-releases/aap/2022/american-academy-of-pediatrics-urges-quick-and-transparent-steps-toward-review-of–covid-19-vaccine-for-youngest-age-group-of-children/