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. A CDC study published in March also showed that the Pfizer series reduced the risk of Omicron by 31% in children 5 to 11, a significantly lower rate than for kids 12 to 15, who had a 59% risk reduction after receiving two doses.
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 administered. The agency’s Advisory Committee on Immunization Practices is set to meet on Thursday to discuss boosters in this age group.
FDA advisory panels plan to meet next month to discuss authorization of Pfizer’s and Moderna’s COVID-19 vaccines for children under 6 years old.