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Pfizer and BioNTech request Emergency Use Authorization for Omicron booster

Pfizer and BioNTech have applied to the FDA for Emergency Use Authorization of their Omicron BA.4/BA.5-adapted bivalent vaccine booster for use in pediatric patients aged 3 to 11 years.

Pfizer and BioNTech SE have submitted an application for an Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA) for a 10-µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in pediatric patients aged 5 through 11 years.

Safety and immunogenicity of the booster has been supported in nonclinical and manufacturing data from the companies, along with data on prior Omicron vaccines they have produced. 

A phase 1/2/3 study has also tested safety, tolerability, and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in pediatric patients aged 6 months to 11 years. This study follows regulatory guidance and comes after a previous phase 1/2/3 study showing tolerance and protection from the companies’ original Pfizer-BioNTech COVID-19 vaccine in the same age group.

The study will be divided into 4 substudies. In the first, 3-µg, 6-µg, and 10-µg doses will be analyzed. In the second substudy, participants who had received 2 doses of COVID-19 vaccination will receive a third and fourth 3-µg dose of the bivalent vaccine.

In the third substudy, 6-µg and 10-µg doses will be analyzed in a fourth dose based on phase 1 findings. In the final substudy, the bivalent vaccine will be administered as a third or fourth dose.

Currently, both the original and Omicron BA.4/BA.5 bivalent vaccines have been given EUA by the FDA for individuals aged 12 years and older. It is offered as a single dose which patients can receive at least 2 months after completion of initial COVID-19 vaccination series or receipt of the most recent approved booster.

Reference

Pfizer and BioNTech submit application to US FDA for Emergency Use Authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster in children 5 through 11 years of age. Pfizer. September 26, 2022. Accessed September 28, 2022. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-application-us-fda-emergency-0