The authorization makes it the first COVID-19 booster cleared for children younger than 12, according to a news release. All children in that age group who received their second shot at least five months ago are eligible to receive the third shot.
“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.
“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,” he said.
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