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FDA, CDC clear Pfizer, BioNTech's bivalent COVID-19 booster shots for ages 5 to 11 years old

COVID-19 booster vaccinations for individuals aged 5 to 11 years old have been cleared by the FDA and CDC.
Sandra Levy
Senior Editor
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The Centers for Disease Control and Prevention's director Rochelle Walensky, signed a decision memo expanding the use of updated (bivalent) COVID-19 vaccines to children aged 5 to 11 years old. 

This follows the Food and Drug Administration’s authorization of updated COVID-19 vaccines from Pfizer-BioNTech for children aged 5 to 11 years old, and from Moderna for children and adolescents aged 6 to 17 years old.

“As families across the country take part in fall festivities and plan for the upcoming holiday season, we aim to provide school-aged children with additional protection against the Omicron BA.4/BA.5 subvariants, which continue to account for more than 80% of cases in the United States,” said Albert Bourla, chairman and CEO of Pfizer. “Anticipating this need, we manufactured millions of booster doses, which will be made available, pending CDC recommendation, to help families stay up to date with COVID-19 vaccinations.”

“This milestone is important to be able to provide access to variant-adapted vaccines to a broader population,” said Prof. Ugur Sahin, CEO and co-founder of BioNTech. “In addition, we have started a clinical trial to evaluate the adapted vaccine based on the BA.4 and BA.5 subvariants in children six months through 11 years of age aiming to offer all age groups the opportunity to immunize against Omicron variants and subvariants.”

[Read more: Retailers begin offering bivalent COVID-19 booster vaccines]

The authorization of the bivalent COVID-19 vaccine for children aged 5 to 11 years old is supported by safety and immunogenicity data from Pfizer and BioNTech’s 30-µg Omicron BA.1-adapted bivalent vaccine, non-clinical and manufacturing data from the companies’ 10-µg Omicron BA.4/BA.5-adapted bivalent vaccine and pre-clinical data from the 30-µg Omicron BA.4/BA.5-adapted bivalent vaccine.

Clinical data from a Phase 2/3 trial showed a booster dose of Pfizer and BioNTech’s 30-µg Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the Omicron BA.1 subvariant compared to the companies’ original COVID-19 vaccine, with a favorable safety profile. Additionally, pre-clinical data showed a booster dose of the 30-µg BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against the Omicron BA.1, BA.2, BA.4 and BA.5 subvariants, as well as the original virus.

The companies will supply the original and bivalent vaccines under their existing supply agreement with the U.S. government.

[Read more: Retailers begin providing flu shots

Pfizer and BioNTech will begin shipping bivalent doses as directed by the U.S. government. Eligible U.S. residents will continue to receive the vaccine for free, consistent with the U.S. government’s commitment to free access to COVID-19 vaccines.