Pfizer, BioNTech Submit Application for EUA of Omicron Bivalent Booster in Children Aged 5 Through 11

Pfizer and BioNtech have completed a submission to the FDA for emergency use authorization (EUA) of a 10-µg booster dose of the Omicron-specific bivalent COVID-19 vaccine for children 5 through 11 years of age.

The booster vaccine is an adaptation of the BA.4 and BA.5 vaccines, and the EUA request is supported by safety and immunogenicity data from the bivalent Omicron BA.1-adapted vaccine, non-clinical and manufacturing data from the 10-µg bivalent Omicron BA.4/BA.5-adapted vaccine, and pre-clinical data from the Omicron BA.4/BA.5-adapted vaccine. An application will also be submitted to the European Medicines Agency for the same age group.

Pfizer and BioNTech have also initiated a phase 1/2/3 study evaluating the safety, tolerability, and immunogenicity of different doses and dosing regimens with the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 11 years of age. The study follows a previous phase 1/2/3 trial involving these age groups, which demonstrated that the original Pfizer-BioNTech COVID-19 vaccine is well-tolerated and offers a high level of protection against COVID-19.

The new trial will have 4 substudies examining different bivalent vaccine dosing regimens, dose levels, and age groups:

• Substudy A will include participants 6 through 23 months of age who are COVID-19 vaccine-naïve. The phase 1 dose-finding study will evaluate 3-µg, 6-µg, and 10-µg dose levels. Based on the phase 1 results, participants in phases 2 and 3 will receive the selected dose as a 3-dose primary series, followed by a booster dose.
• Substudy B will include participants 6 months through 4 years of age who had previously received 2 to 3 doses of the original COVID-19 vaccine. Those who received 2 doses of the original vaccine prior to enrollment will receive a third and fourth 3-µg dose of the bivalent vaccine. Participants who have previously received 3 doses of the original vaccine will receive a 3-µg booster dose.
• Substudy C will include participants 6 months through 4 years of age who had previously received 3 doses of the original COVID-19 vaccine. A phase 1 dose-finding study will evaluate 6-µg and 10-µg dose levels of the bivalent vaccine for a fourth dose. Based on these results, phase 2/3 will receive the selected dose as a fourth dose.
• Finally, Substudy D will include participants 5 through 11 years of age who had previously received 2 to 3 doses of the original vaccine. Participants will receive the bivalent vaccine as either a third or fourth 10-µg booster dose.

In August, the FDA authorized Pfizer-BioNTech’s bivalent COVID-19 vaccine for use a single booster dose at least 2 months following primary booster vaccination in individuals 12 years of age and older. The BA.4 and BA.5 lineages of the Omicron variant are currently causing most cases of COVID-19 in the United States and are expected to circulate in the fall and winter.

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. News release. Pfizer; September 26, 2022. Accessed September 26, 2022. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-application-us-fda-emergency-0