Pfizer, BioNTech Submit Updated COVID-19 Vaccine for Children

The companies have also initiated a phase 1/2/3 study to evaluate different doses and dosing regimens of the BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 11 years of age.

Pfizer and BioNTech are requesting emergency use authorization (EUA) of a 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.

The request in this age group is supported by safety and immunogenicity data from the companies’ bivalent omicron BA.1-adapted vaccine, nonclinical and manufacturing data from the companies’ 10-µg bivalent omicron BA.4/BA.5-adapted vaccine, and preclinical data from the companies’ omicron BA.4/BA.5-adapted vaccine.

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.

The companies have also 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. The study will have four substudies examining different dosing regimens and ages. This includes:

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

Related: FDA Authorizes Pfizer, Moderna Updated COVID-19 Boosters

In August 2022, the FDA amended the emergency use authorizations of both the updated Moderna and the Pfizer/BioNTech COVID-19 booster vaccines that include the omicron variants. The updated boosters are bivalent vaccines and contain two messenger RNA (mRNA) components, one of the original strain of the SARS-CoV-2 and the BA.1, BA.4 and BA.5 omicron variant.