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Pfizer-BioNTech, Moderna Seek FDA EUA for Bivalent Vaccine Boosters in Pediatric Population

These vaccines target the wild strain as well as the Omicron BA.4/BA.5 variants.


Pfizer-BioNTech announced yesterday they had submitted their application for an FDA emergency use authorization (EUA) for their 10-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age.

According to the Pfizer-BioNTech, the companies’ submission is supported by safety and immunogenicity data from the companies’ bivalent Omicron BA.1-adapted vaccine, non-clinical and manufacturing data from the companies’ 10-µg bivalent Omicron BA.4/BA.5-adapted vaccine, and pre-clinical data from the companies’ Omicron BA.4/BA.5-adapted vaccine in their decision.

In addition, an application to extend the Omicron BA.4/BA.5-adapted bivalent vaccine marketing authorization to include children ages 5 through 11 years will be submitted to the European Medicines Agency (EMA) in the coming days.

Pfizer-BioNTech also announced that they had initiated a phase 1/2/3 study to evaluate the safety, tolerability, and immunogenicity of different doses and dosing regimens of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 11 years of age.

This follows the news of Moderna’s recent submission. That company announced on Friday they had filed their request for an EUA for their Omicron-targeting bivalent COVID-19 vaccine, mRNA-1273.222, in children and adolescents 12 to 17 years of age. They also said their EUA submission for children ages 6 to 11 years old was also completed.

The companies have been closely aligned in the timing of authorizations and approvals for their COVID-19 vaccines.