Pfizer and BioNTech announced Monday that they had submitted a request for Emergency Use from the U.S. Food and Drug Administration for vaccine booster doses tailored to the omicron variant of COVID-19 for children ages 5 to 11.
In late August, the FDA approved Pfizer BioNTech and Moderna bivalent “updated booster” vaccines for use in adults age 18 and older.
Both of these vaccines contain two messenger RNA (mRNA) components of SARS-CoV-2 virus that causes COVID-19 infections, said the FDA. One is the original strain of SARS-CoV-2 and the other one addresses the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.
“Pfizer and BioNTech’s bivalent vaccine contains 15 [micrograms] of mRNA encoding the wild-type spike protein of SARS-CoV-2, which is present in the Original Pfizer-BioNTech COVID-19 Vaccine, and 15 [micrograms] of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants,” said the companies.
Pfizer BioNTech’s bivalent vaccine for children is 10 micrograms.
“The request for Emergency Use Authorization of the Omicron BA.4/BA.5-adapted bivalent vaccine in this age group is supported by safety and immunogenicity data from the companies’ bivalent Omicron BA.1-adapted vaccine, non-clinical and manufacturing data from the companies’ 10 [microgram] bivalent Omicron BA.4/BA.5-adapted vaccine, and pre-clinical data from the companies’ Omicron BA.4/BA.5-adapted vaccine in their decision,” said a Monday press release from Pfizer. It also plans to submit marketing authorization for the vaccine in Europe this week.
A study to evaluate “the safety, tolerability, and immunogenicity of different doses and dosing regimens” of the omicron-targeting vaccines in children 6 months to 11 years old has been initiated, according to Pfizer.
‘The Phase 1/2/3 pediatric clinical study will have four substudies examining different bivalent vaccine dosing regimens, dose levels and ages,” the company said.
During the “Breaking Down the Bivalent Boosters” event last week, Dr. Peter Marks – director of the FDA’s Center for Biologics Evaluation and Research – said that he is confident the administration will approve new boosters for the 5 to 11-year-old age group soon.
As of Sept. 21, 35.5% of people in the U.S. had received two booster doses of COVID-19 vaccine in addition to their primary series vaccinations and more than 1 million children have received at least one COVID-19 vaccine dose. Information about doses and boosters is available through the U.S. Centers for Disease Control and Prevention.
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