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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

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

By AP News
Published - Oct 12, 2022, 10:32 AM ET
Last Updated - Jul 17, 2024, 02:12 AM EDT

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Oct 12, 2022--

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.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221011006028/en/

“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.”

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