Therapy Areas
Pfizer and BioNTech seek FDA approval of new Omicron-tailored COVID-19 booster for children
26 September 2022 -

US biopharmaceutical company Pfizer Inc (NYSE: PFE) and its partner, German biotechnology company BioNTech SE (Nasdaq: BNTX), announced on Monday that they have applied to the US Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children aged between 5 and 11 years.

The EUA request in this age group is supported by safety and immunogenicity data from Pfizer and BioNTech's bivalent Omicron BA.1-adapted vaccine, non-clinical and manufacturing data from their 10-µg bivalent Omicron BA.4/BA.5-adapted vaccine, and pre-clinical data from their Omicron BA.4/BA.5-adapted vaccine, the two companies said.

A similar application will be submitted to the European Medicines Agency (EMA) in the coming days.

Pfizer and BioNTech have also initiated a Phase 1/2/3 study to evaluate the safety, tolerability and immunogenicity of different doses and dosing regimens of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children aged between 6 months and 11 years. This follows a previous Phase 1/2/3 trial involving these age groups that demonstrated the original Pfizer-BioNTech COVID-19 vaccine is well-tolerated and offers a high level of protection against COVID-19, measured at a time when the Omicron BA.2 strain was highly prevalent.

Login
Username:

Password:


Related Headlines