Pfizer: Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in Children 5 Through 11 Years of Age

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a 10-µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 5 through 11 years of age. Pending recommendation from the Centers for Disease Control and Prevention (CDC), 10-µg doses will be shipped immediately.

“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 U.S.,” said Albert Bourla, Chairman and Chief Executive Officer, 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, M.D., 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.”

The authorization of the bivalent COVID-19 vaccine for children 5 through 11 years of age 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. Booster vaccinations for individuals 5 through 11 years of age are anticipated to start subject to and after the CDC endorses a potential recommendation. 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.

Pfizer and BioNTech have submitted an application to the European Medicines Agency (EMA) requesting a variation of the companies’ marketing authorization in the European Union to include a 10-µg booster dose of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in this age group. Similar applications are planned for submission with regulatory authorities around the world in the coming weeks.

A Phase 1/2/3 pediatric study is currently underway to evaluate different dosing regimens and dose levels of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine across age groups.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (COMIRNATY®) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.