Pfizer-BioNTech Seek EUA for Omicron Booster in Children Aged Under 5 Years

Pfizer and BioNTech submitted an application to the US Food and Drug Administration (FDA) for emergency use authorization (EUA) of their omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the 3-dose primary series for children aged 6 months to 4 years.

On Monday, the companies announced 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,” said the companies in the December 5, 2022, statement.

In mid-October, the FDA amended the EUAs of the Moderna and Pfizer-BioNTech COVID-19 bivalent booster shots for use in older children and teenagers. Both company’s bivalent boosters can now be administered at least 2 months after primary or booster vaccination, the Moderna shot in children aged 6 to 17 years and the Pfizer counterpart in those aged 5 to 11 years.

According to an American Academy of Pediatrics (AAP) report drawing on data posted by the Centers for Disease Control and Prevention, as of November 30, 2022, 1.8 million children aged 6 months to 4 years have received at least 1 dose of COVID-19 vaccine, representing 10% of that population. Approximately 15.3 million children in this age group have yet to receive their first COVID-19 vaccine dose.