Pfizer and BioNTech request Emergency Use Authorization for Omicron booster

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