Children ages 5-11 who completed their primary COVID-19 vaccine series at least five months ago are now eligible to receive Pfizer's booster shot.
The U.S. Food and Drug Administration granted an emergency use authorization Tuesday. In April, Pfizer and BioNTech had submitted data showing their shot increased omicron-specific antibodies by 36 times in this age group.
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No major safety concerns were reported with the booster dose. The most common side effects were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain, and chills and fever.
Previous studies from the New York State Department of Health and the U.S. Centers for Disease Control and Prevention found concerning drops in the effectiveness of Pfizer's vaccine during the omicron surge last fall.
The effectiveness of the original two-dose series fell from 68% to about 12% among children ages 5-11 when the omicron became the dominant variant in the United States, the New York study found. That reduction was much more drastic than the one seen in children ages 12-17. Still, the two doses continued to protect against severe illness and hospitalization.
In the CDC study, the vaccine reduced the risk of omicron infection by 31% among those 5 to 11, compared with a 59% reduction in risk among those 12-15.
"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 Dr. Robert Califf said.
Now, anyone age 5 or older is eligible for at least one booster dose. People who are 50 and older and people 12 and older who are immunocompromised are eligible for two booster doses.
According to the New York Times, many parents remain reluctant to have their young children vaccinated at all. Children ages 5-11 have been eligible for COVID-19 shots since November, but only 29% have received two doses and another 6% have received one.
The CDC's Advisory Committee on Immunization Practices is scheduled to meet Thursday to discuss COVID-19 vaccine boosters. Moderna has requested FDA authorization for a second COVID-19 booster shot for everyone 18 and older; a decision is still pending.