Pfizer seeks EUA for omicron booster in young children

Pfizer and BioNTech are seeking an emergency use authorization from the FDA for omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines in children aged 6 months to 4 years.

The companies announced in a press release that they are suggesting a primary series consisting of two 3-µg doses of their original COVID-19 vaccine, followed by a third, 3-µg dose of the omicron BA.4/BA.5-adapted bivalent vaccine.

“With the high level of respiratory illnesses currently circulating among children under 5 years of age, updated COVID-19 vaccines may help prevent severe illness and hospitalization,” the companies said in the release.

In mid-October, the FDA granted EUAs for Pfizer-BioNTech and Moderna’s omicron boosters for older children and teens.

As of Nov. 30, the CDC reported that 1.8 million children aged 6 months to 4 years in the United States had received a single dose of a COVID-19 vaccine, representing 10% of that population. About 15.3 million children in that age group have yet to receive their first dose.

According to the AAP, 28,604 new pediatric COVID-19 cases were reported in the U.S. during the week ending Dec. 1, representing 10.8% of all weekly reported cases. This amount brings the total number of child cases reported to 15,036,663.

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 Dec. 1, 2022. Accessed Dec. 5, 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 Nov. 30, 2022. Accessed Oct. 12, 2022.