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The companies sought FDA EUA for Covid-19 booster vaccine usage in children aged five to 11 years. Credit: Arne Müseler / Flickr (Creative Commons).

Pfizer and BioNTech have submitted an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a 10µg booster of their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine in children.

The companies sought authorisation for booster vaccine usage in children aged five to 11 years.

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Their application is based on bivalent Omicron BA.1-adapted vaccine’s safety and immunogenicity findings, non-clinical and manufacturing data of 10µg bivalent Omicron BA.4/BA.5-adapted vaccine, as well as Omicron BA.4/BA.5-adapted vaccine’s pre-clinical findings.

A Phase I/II/III clinical trial of the Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine was initiated recently in children aged six months to 11 years.

The paediatric trial will assess the safety, tolerability and immunogenicity of varying vaccine doses and dosing schedules.

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It will have four substudies. Substudy A will enrol subjects aged six to 23 months who are naïve to the Covid-19 vaccine. 

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Substudy B and C will have subjects aged six months to four years who have received two-three and three doses of original vaccine doses, respectively.

Substudy D will enrol subjects aged five to 11 who have received two-three doses of the original vaccine.

This trial comes after a prior Phase I/II/III study, where the original Covid-19 vaccine was demonstrated to be well-tolerated.

Additionally, this vaccine was found to offer greater protection levels against the SARS-CoV-2 virus when its Omicron BA.2 strain was dominant.

The companies also intend to seek marketing authorisation from the European Medicines Agency for the Omicron BA.4/BA.5-adapted bivalent vaccine for use in children of this age group soon.

Earlier this month, the US FDA granted EUA for Pfizer-BioNTech’s bivalent Covid-19 vaccine booster.