(AOF) – Pfizer Inc. and BioNTech today announced that they have filed an application with the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for a booster dose. of 10 micrograms of the bivalent Omicron BA.4/BA.5 vaccine suitable for Covid-19 for children aged 5 to 11 years.
The emergency use authorization request for the Omicron BA.4/BA.5 adapted bivalent vaccine in this age group is supported by data on the safety and immunogenicity of the Omicron BA.1 adapted bivalent vaccine. -, non-clinical and manufacturing data of the 10 microgram Omicron BA.4/BA.5 adapted bivalent vaccine and preclinical data of the Omicron BA.4/BA.5 adapted bivalent vaccine.
An application to extend the marketing authorization of the adapted bivalent vaccine Omicron BA.4/BA.5 in the European Union to include children aged 5-11 years will be submitted to the European Medicines Agency (EMA) in the next few days.
The companies have also initiated a Phase 1/2/3 study (NCT05543616, C4591048) to assess the safety, tolerability and immunogenicity of different doses and dosing regimens of the bivalent Omicron BA.4/BA.5 COVID-specific vaccine. -19 in children aged 6 months to 11 years.
This pediatric study complies with regulatory guidelines and follows a previous Phase 1/2/3 trial involving these age groups which demonstrated that the original Pfizer-BioNTech COVID-19 vaccine is well tolerated and provides a high level of protection against COVID-19, measured at a time when the Omicron BA.2 strain was highly prevalent.