Until now, only children ages 12 and older and adults were eligible for a booster.
The companies requested the authorization based on a small study that the companies and FDA said demonstrated a third shot is safe and can significantly boost antibody levels, countering waning immunity and providing added protection against the virus, including the more contagious omicron variant.
“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.
But others are skeptical, saying two shots are still providing strong protection against serious disease and death, and the it remains unclear how much added protection a third shot will provide or how long it will last. The FDA didn’t ask its outside advisers for input on the decision because the agency said the committee had previously discussed the issues and no new questions were raised.and are expected to discuss implementation of a booster dose for this age group.
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