The application follows an upsurge in the circulation of respiratory diseases among children under 5 years of age. It is thought the updated vaccine might help to prevent severe illnesses and hospitalisation.
The Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is currently authorised as a booster dose for ages 5 years and older in the US and European Union (EU). If this EUA application is authorised, children 6 months to under 5 years of age would receive a primary series consisting of two 3-µg doses of the original Pfizer/BioNTech COVID-19 Vaccine, followed by a third 3-µg dose of the Omicron BA.4/BA.5-adapted bivalent vaccine.
