Vaccine makers seek FDA authorization for pediatric omicron boosters

Pfizer-BioNTech and Moderna have asked the FDA to authorize bivalent omicron COVID-19 booster vaccines for children.

Pfizer and BioNTech said Monday that they are seeking an emergency use authorization (EUA) for children aged 5 through 11 years. Like their booster that is already recommended for children aged 12 years and older, the adapted vaccine targets the original strain of SARS-CoV-2 and the omicron BA.4 and BA.5 subvariants, but in a 10-µg dose — one-third the size of the vaccine recommended for the older age group.

Moderna on Friday announced that it had submitted one EUA request for its omicron-targeting bivalent vaccine for children and adolescents aged 12 to 17 years, and another EUA request for children aged 6 to 11 years.

Moderna said it expects to complete an EUA application for children aged 6 months to under 6 years “later this year.”

Pfizer said it will be launching a phase 1/2/3 clinical study of the booster’s safety, immunogenicity, and effects among children aged 6 months through 11 years of age. Four substudies will group children by age and COVID-19 vaccination status: ages 6 through 13 months who are COVID-19 vaccine naive; aged 6 months through 4 years who have received two to three doses of the original COVID-19 vaccine; ages 6 months through 4 years who have previously received three doses of original COVID-19 vaccine; and ages 5 through 11 years who have received two to three doses of COVID-19 vaccine.

As of Sept. 14, the CDC reported that approximately 8.7 million children aged 5 to 11 years in the U.S. had received a full dosage of COVID-19 vaccine, representing just 31% of that population. An additional 2 million received one dose.

According to the AAP, more than 60,200 new pediatric COVID-19 cases were reported in the U.S. during the week ending Sept. 15 — a decline from more than 90,000 cases reported 2 weeks prior — bringing the total number of child cases reported to 14,682,832.

References:

AAP. Children and COVID-19: State-level data report. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/. Published Sept 15, 2022. Accessed Sept. 26, 2022.

AAP. Summary of data publicly reported by the Centers for Disease Control and Prevention. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-vaccination-trends/. Published Sept. 14, 2022. Accessed Sept. 26, 2022.