Pfizer (NYSE: PFE) and its COVID-19 vaccine partner BioNTech (Nasdaq: BNTX) today announced they’ve submitted a EUA application with the FDA for an omicron COVID-19 booster for children under 5.
The companies are seeking authorization for their omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age.
The U.S. is presently grappling with a “tripledemic” of COVID-19, flu and RSV, which can each cause respiratory distress in children. Pfizer and BioNTech said today that updated COVID-19 vaccines may help prevent severe illness and hospitalization.
If authorized, children in this age group would still receive a primary series consisting of two 3-µg doses of the original Pfizer-BioNTech COVID-19 vaccine. After that, they would receive a third 3-µg dose of the omicron BA.4/BA.5-adapted bivalent vaccine.
Pfizer and BioNTech are seeking a similar authorization from the European Medicines Agency (EMA) in the EU, which is also grappling with COVID-19, influenza and RSV.
The omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine already has authorization in the U.S. and UE as a booster dose for children 5 and up.