The FDA expanded an emergency use authorization (EUA) today, allowing the Pfizer-BioNTech COVID-19 booster shot for children ages 5 to 11 who are at least 5 months out from their first vaccine series.
for an amended authorization in April, after submitting data showing that a third dose in children between 5 and 11 raised antibodies targeting the Omicron variant by 36 times.
“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer-term effects, even following initially mild disease,” FDA Commissioner Robert M. Califf, MD, said in a news release.
To some experts, this data suggests an even greater need for children under 12 to be eligible for a third dose. “Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations,” says Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research.
The CDC still needs to sign off on the shots before they can be allowed. The agency’s Advisory Committee on Immunization Practices isto discuss allowing Pfizer’s and Moderna’s COVID-19 vaccines for children under 6 years old.Pfizer: “Pfizer and BioNTech Granted U.S. Emergency Use Authorization for Booster Dose of Their COVID-19 Vaccine in Children 5 Through 11 Years of Age.
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