Pharma Focus Europe

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years

Friday, December 09, 2022

Pfizer Inc. and BioNTech SE announced the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age. Children in this age group can receive a primary series consisting of two 3-µg doses of the original Pfizer-BioNTech COVID-19 Vaccine followed by a third 3-µg dose of the bivalent vaccine to complete the primary series. Vaccine doses can be delivered immediately upon receipt of a recommendation from the U.S. Centers for Disease Control and Prevention ("CDC").

On top of a persistent stream of COVID-19 cases, surging seasonal respiratory illnesses in young children are straining health systems across the U.S., with many states reporting more than 90% of their pediatric hospital beds are occupied.iii Updated COVID-19 vaccines may improve protection against severe illness and hospitalization caused by SARS-CoV-2 in this age group.

“This authorization offers an opportunity for parents to help better protect their young children against COVID-19, including disease caused by Omicron sublineages,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Nearly 40 million Americans have received a booster dose of an updated vaccine. It is critical that we all continue to do our part to help protect ourselves by staying up to date with COVID-19 vaccinations, as recommended by public health authorities, especially now as we plan to gather for the holidays and head into the winter season.”

“As the virus evolves it remains our goal to be able to provide access to variant-adapted vaccines against COVID-19 to a broader population,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “With this authorization, the adapted vaccine based on the Omicron sublineages BA.4 and BA.5 can become an important part of the primary vaccination series for young children."

The amendment to the EUA is supported by clinical data from adults who received the Omicron BA.4/BA.5-adapted bivalent vaccine, post-authorization experience with this bivalent vaccine among ages 5 years and older, and post-authorization experience with the original Pfizer-BioNTech COVID-19 Vaccine as a three-dose primary series for children 6 months through 4 years of age. Additional support is provided by clinical data from the companies’ Omicron BA.1-adapted bivalent vaccine in adults as well as pre-clinical and manufacturing data from the companies’ 3-µg Omicron BA.4/BA.5-adapted bivalent vaccine. The Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is currently authorized as a booster dose for ages 5 years and older in the U.S. and European Union (EU).

An application to extend Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine marketing authorization in the EU to include children ages 6 months through 4 years is under discussion with the European Medicines Agency (EMA).

The Pfizer-BioNTech COVID-19 Vaccines (COMIRNATY®) are based on BioNTech’s proprietary mRNA technology and were developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 Wild Type and BNT162b2 Bivalent (Original/Omicron BA.4/BA.5) 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.

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