On Tuesday, the U.S. Food and Drug Administration approved the COVID-19 vaccine booster for children ages 5 to 11. The FDA approved a single booster of the Pfizer-BioNTec vaccine for children who have been fully vaccinated for at least five months.
Approval was granted based on a small study demonstrating that a third shot is safe and can significantly boost antibodies, countering waning immunity and providing added protection against the virus, including the more contagious omicron variant.
Until now, only children ages 12 and older and adults were eligible for a booster.
“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,” says FDA Commissioner Dr. Robert Califf.
On January 3, the FDA authorized the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for youth ages 12 through 15.
“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, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. He says the FDA has determined that the known and potential benefits of a single booster dose of the Pfizer vaccine for children 5 through 11 years of age “outweigh its known and potential risks.
Until now, only children ages 12 and older and adults were eligible for a booster.
It remains unclear how much of a demand there will be for the boosters. Less than a third of children ages 5 to 11 are fully vaccinated, and only about a quarter of adolescents have received a booster.
The FDA says it didn’t ask its outside advisers for input on the decision because the committee had previously discussed the issues and no new questions were raised.
The Centers for Disease Control and Prevention’s advisers on vaccine practices will meet Thursday and are expected to discuss implementing a booster dose for young children.
