A third dose of Pfizer/BioNTech’s COVID-19 vaccine is authorized for kids ages 5 to 11 years, the FDA announced on Tuesday.
The third 10 μg dose may be administered to children at least 5 months after the initial primary series under the terms of the emergency use authorization (EUA), the agency said.
“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,” said FDA Commissioner Robert M. Califf, MD, in a statement.
The agency cited data from ongoing trials that supported the initial EUA of the vaccine in this age group. In 67 study participants who received a booster dose 7 to 9 months after their initial primary series, “the antibody level against the SARS-CoV-2 virus one month after the booster dose was increased compared to before the booster dose,” they noted.
Pfizer/BioNTech previously shared top-line data in April from the phase II/III clinical trial on 140 children ages 5 to 11 who received a booster dose after their two-dose primary series, and a subgroup of 30 kids in whom response against Omicron was studied specifically. In this subgroup analysis, there was a 36-fold increase in neutralizing antibody titers compared with levels seen after the two-dose primary series, the companies reported.
There were no new safety signals observed among 401 children with booster readout data at least 5 months after a primary series (86.8% received the booster 8 months after their second dose, according to the revised EUA), with the most common systemic adverse events being fatigue, headache, muscle or joint pain, and fever.
FDA noted that they did not convene the Vaccines and Related Biological Products Advisory Committee prior to this EUA, as the agency “concluded that the request did not raise questions that would benefit from additional discussion by committee members.”
CDC’s Advisory Committee on Immunization Practices is scheduled to meet on Thursday, likely to discuss recommendations for the vaccine in this population.