Vaccine developer Pfizer and German partner BioNTech are asking the Food and Drug Administration to authorize its omicron-targeting COVID-19 booster for school-age children, the companies announced Monday.
Pfizer-BioNTech submitted an application for emergency use authorization of its BA.4/BA.5-adapted bivalent vaccine for children 5 to 11 years old at a 10-microgram dose, according to the news release.
The companies’ bivalent booster is currently authorized by the FDA at 15 micrograms to anyone 12 years old and older at least two months after any previous COVID-19 shots.
Pfizer-BioNTech based their most recent request in school-age children on clinical trial data with a bivalent booster targeting the original omicron variant – not the BA.4/BA.5. The new booster was tested on mice, but studies in people are not complete.
The companies said they planned to submit a similar application to the European Medicines Agency “in the coming days.”
Moderna’s omicron-targeting bivalent booster also was authorized by the FDA at the end of August for Americans 18 and older. It is unclear when the company plans to submit an EUA for younger age groups.
Both Moderna and Pfizer’s bivalent boosters combine the original COVID-19 vaccine, which targeted the spike protein on the virus’s surface, along with a reformulation that targets the mutated spike protein found on the BA.4 and BA.5 versions of the omicron variant.
About 4.4. million people have received a bivalent COVID-19 booster since the start of the month, representing only 1.5% eligible Americans, according to data released Thursday by the Centers for Disease Control and Prevention.
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Health experts say it is too early to predict whether demand would match the 171 million doses of the new boosters the U.S. ordered for the fall. But they’re urging people to stay updated with vaccines, as COVID-19 cases are expected to surge again this fall and winter, as they have both previous years of the pandemic.
The U.S. continues to report more than 30,000 COVID-19-related hospitalizations, and about 500 deaths a day as the country heads into the fall, according to Johns Hopkins University data.
“No one can predict COVID-19’s next turn,” according to a statement by the Infectious Diseases Society of America. “Success in controlling the pandemic is the result of ongoing preventive measures, and we must not let our guard down.”
Contributing: Karen Weintraub, USA TODAY; Associated Press. Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
