Posted by Michael Wonder on 01 Mar 2023
Pfizer and BioNTech submit for US emergency use authorisation of Omicron BA.4/BA.5 adapted bivalent COVID-19 booster in children under 5 years
1 March 2023 - Pfizer and BioNTech today submitted an application to the US FDA for emergency use authorisation of a booster (fourth) dose of the companies’ Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine in children 6 months through 4 years of age (also referred to as under 5 years).
The Omicron BA.4/BA.5-adapted bivalent vaccine is currently authorised as the third dose of the three-dose primary series for children in this age group. Authorisation of a booster dose would give families the option to further protect their young children against more recently circulating Omicron sub-lineages.
