May 17, 2022 – The FDA expanded an emergency use authorization (EUA) today allowing the Pfizer-BioNTech COVID-19 booster shot for children between the ages of 5 to 11 who are at least 5 months out from their first vaccine series.
According to the most recent data from the Centers for Disease Control and Prevention, 28.6% of children in this age group have received both COVID-19 vaccines in the Pfizer-BioNTech series, and 35.3% have received their first dose.
Pfizer's vaccine trial involving 4,500 children showed that children under 12 tolerated the third dose well, with the booster having a similar safety profile to the first two-dose series, according to a company statement.
Pfizer asked the FDA for an amended EUA in April, after submitting data showing that a third dose in children between 5 and 11 raised Omicron-neutralizing antibodies 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, says in a news release.
A study done by the New York State Department of Health showed the effectiveness of Pfizer's two-dose vaccine series fell from 68% to 12% 4-5 months after the second dose was administered to children 5 to 11 during the Omicron surge.
