The U.S. Food and Drug Administration has approved a booster dose of Pfizer/BioNTech’s COVID-19 vaccine for children ages 5 to 11.
Drug-maker Pfizer provided company data last month indicating a third dose of the vaccine raised antibodies that battle the omicron variant by “36-fold” in that demographic.
“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 Califf said in a statement published Tuesday, explaining the FDA’s emergency use authorization.
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The FDA authorized a single booster for children ages 12 to 15 at the start of the year. Kids aged 5 through 11 years are eligible for boosters five months after completing their primary series of Pfizer-BioNTech COVID-19 vaccines. The FDA authorized vaccines for children as young as 5 years old in October.
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The safety of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine in the newly approved age group was observed in 400 children boosted at least five months after receiving an initial two-dose series, the FDA reports.
The most common side effects reported were pain, redness and swelling at the injection site, fatigue, headaches, muscle or joint pain and chills and fever.