The omicron-targeting COVID-19 booster for school-age children is being requested by vaccine producer Pfizer and its German partner BioNTech, the firms said on Monday.
According to a news release, Pfizer-BioNTech submitted an application for emergency use permission of their bivalent vaccine, BA.4/BA.5-adapted, for children aged 5 to 11 at a dose of 10 micrograms.
The FDA has approved the firms’ bivalent booster at 15 micrograms for anyone 12 years of age and older at least two months after receiving any prior COVID-19 doses.
Based on clinical trial data with a bivalent booster targeting the original omicron variation and not the BA.4/BA.5 strain, Pfizer-most BioNTech’s recent request in school-aged children was made. The new booster was tested on mice, but human tests are still inconclusive.
The businesses declared they will send the European Medicines Agency a similar proposal “in the next days.”
At the end of August, the FDA also approved American adults aged 18 and older to use Moderna’s omicron-targeting bivalent booster. When the business intends to submit an EUA for younger age groups is unknown.
The bivalent boosters from Moderna and Pfizer combine the initial COVID-19 shot, which focused on the virus’s spike protein, with a reformulation that focuses on the mutant spike protein present on the BA.4 and BA.5 variants of the omicron variety.
According to data provided on Thursday by the Centers for Disease Control and Prevention, only 1.5% of eligible Americans—or around 4.4 million people—have obtained a bivalent COVID-19 booster since the beginning of the month.
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