Pfizer, BioNTech to Ask FDA to Authorize COVID Recall for Healthy Children Aged 5-11
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Pfizer and BioNTech said on Tuesday that they will ask the Food and Drug Administration (FDA) to authorize a booster dose of their coronavirus vaccine for emergency use in healthy children aged 5 to 11.
Vaccine makers said new data shows children in that age group could benefit from another injection.
In a subanalysis of 30 children, there was a 36-fold increase in neutralizing antibody titers from levels seen after two doses of the Pfizer-BioNTech COVID-19 vaccine.
“A robust response was observed regardless of previous SARS-CoV-2 infection”, Observes the note.
The data have not been published or checked by independent experts.
Health officials already urge all 12-year-olds to receive a booster dose and recently recommended a second booster for U.S. adults 50 years and older.
Pfizer and BioNTech also plan to share data with the European Medicines Agency (EMA) and other regulatory agencies around the world.
Pfizer tested the children’s booster during the winter omicron peak.
Vaccinations are largely less effective against the variant than previous versions of the coronavirus, but still offer strong protection against serious illness.
Children between the ages of 5 and 11 receive one third of the dose given to those aged 12 years or older.
Pfizer shots are only available to children in the United States, and just over a quarter of the younger age group has received two doses.
The United States has not yet allowed filming for children under 5.
The Associated Press contributed to this report.