WASHINGTON — Pfizer and BioNTech announced Monday that they have submitted an application to the U.S. Food and Drug Administration for emergency use authorization of a booster dose of their bivalent COVID-19 vaccine for children ages 5 to 11.
We completed, together with @Pfizer, the submission to the @US_FDA requesting Emergency Use Authorization (EUA) of a 10-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children aged 5-11. https://t.co/R6A2LfZtgb pic.twitter.com/QEVl2ChCmf
— BioNTech SE (@BioNTech_Group) September 26, 2022
The request “is supported by safety and immunogenicity data from the companies’ Omicron BA.1-adapted bivalent vaccine, nonclinical and manufacturing data from the companies’ 10-microgram Omicron BA.4/BA.5-adapted bivalent vaccine, and preclinical data from the companies’ Omicron BA.4/BA.5-adapted bivalent vaccine,” the companies said in a news release posted shortly before 7 a.m. EDT.
Pfizer and BioNTech added that they also will submit an application to the European Medicines Agency to approve the bivalent booster for the same age group “in the coming days,” according to the release.
The companies went on to say they have begun a study “to evaluate the safety, tolerability and immunogenicity of different doses and dosing regimens” of their adapted bivalent vaccine for children ranging in age from 6 months to 11 years old.
“This pediatric study is consistent with regulatory guidance and follows a previous Phase 1/2/3 trial involving these age groups that demonstrated the original Pfizer-BioNTech COVID-19 vaccine is well-tolerated and offers a high level of protection against COVID-19, measured at a time when the Omicron BA.2 strain was highly prevalent,” the release said.
Earlier this month, the Centers for Disease Control and Prevention endorsed the reformulated COVID-19 vaccine booster by Pfizer and BioNTech for emergency use in people ages 12 and older. The agency also endorsed the use of Moderna’s bivalent booster in adults ages 18 and older.
Monday’s announcement came as the rate of new COVID-19 cases appeared to be declining both domestically and globally, according to The New York Times. As of Sunday, the U.S. was averaging 54,239 new cases per day, down 18% from two weeks earlier, the newspaper reported. Meanwhile, the worldwide average was 441,264 new cases per day, down 10% in the same period.
As for fatalities, the U.S. averaged 432 deaths per day – an increase of 15% from two weeks earlier, the newspaper reported. The global average was 1,530 daily deaths, down 15% from 14 days earlier.
The CDC reported Sunday that 67.8% of the U.S. population is considered fully vaccinated against COVID-19. About 48.7% of fully vaccinated residents have received a booster dose of a coronavirus vaccine, the agency said.
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