The Food and Drug Administration Tuesday authorized the Pfizer-BioNTech COVID-19 vaccine booster dose for children ages 5 through 11, although the Centers for Disease Control and Prevention still needs to sign off on it.
If approved, this would be the first booster accessible to children within this age group, which has been hit hard with high infection rates for the omicron variant, a CDC report stated.
“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 in a statement.
“The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age to provide continued protection against COVID-19,” Califf said. “Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe.”
Boosters are currently available for those who are 12 and older in the U.S. for walk-ins or scheduled appointments at doctors' offices, pharmacies and local health departments, as listed on the Utah State website.
The effectiveness of the single booster shot for younger age groups is supported by “FDA’s analysis of immune response data in a subset of children from the ongoing randomized placebo-controlled trial.”
Close to 70 participants received a booster dose 7 to 9 months after the two primary doses, and their antibodies increased after the additional dose.
According to NPR, less than a third of the 28 million 5-to-11-year-olds in the U.S. have received two doses of the COVID-19 vaccine.
“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,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.
“The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups,” Marks said.
The Advisory Committee, CDC’s independent group of advisers, is expected to discuss the booster shot on Thursday, per NBC News.