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FDA authorizes COVID vaccine boosters for children ages 5-11

May 17, 2022

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The Food and Drug Administration (FDA) has authorized COVID-19 vaccine boosters for children ages 5-11 years.

The extra dose of Pfizer-BioNTech vaccine could be given at least five months after the primary series, according to the emergency use authorization. The Centers for Disease Control and Prevention (CDC) will make its own recommendation on boosters for children. Its Advisory Committee on Immunization Practices meets Thursday, but an agenda has not been released.

“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, M.D., said in a news release. “… Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe.”

The FDA based its decision on data from a randomized, placebo-controlled trial. Antibody levels against SARS-CoV-2 virus increased among 67 children ages 5-11 who received a booster seven to nine months after their two-dose primary series.

Among 400 children who received a booster five to nine months after their primary series, the most common side effects were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, and chills and fever.

A booster dose for this age group is 10 micrograms, the same as the dosage in the primary series. It is one-third of the adolescent and adult dose.

The booster authorization comes as COVID cases in children are rising. More than 93,000 cases were reported during the week ending May 12, a 76% increase over two weeks prior, according to data from the AAP and Children’s Hospital Association.

Children ages 5-11 years became eligible for COVID-19 vaccines in early November 2021. However uptake has been slow, and only 29% are fully vaccinated, according to CDC data.

Everyone ages 12 and older is already eligible for one booster. Adults ages 50 and older, people ages 12 and older who are immunocompromised and people who got two doses of Johnson & Johnson’s vaccine can get a second booster.



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