Germany's BioNTech gains emergency US approval for Omicron booster
New York, 31 August 2022 (dpa/MIA) - Germany's BioNTech SE and its US partner Pfizer Inc have gained emergency US approval for their booster vaccination for the Omicron variant of the coronavirus in the United States.
The US Food and Drug Administration (FDA) granted emergency use authorization for a 30-microgram booster dose of the Pfizer-BioNTech Covid-19 vaccine, bivalent and Omicron BA.4/BA.5, for individuals ages 12 years and older, Pfizer and BioNTech said in a statement on Wednesday.
The companies noted that they will supply the original and bivalent vaccines under their existing supply agreement with the US government.
Booster vaccinations for individuals 12 years of age and older are anticipated to start subject to and after the Centers for Disease Control and Prevention (CDC) endorse a potential recommendation by the Advisory Committee on Immunization Practices.
Pfizer and BioNTech said that they will begin shipping bivalent doses as directed by the US government.
Eligible US residents will continue to receive the vaccine for free, consistent with the US government's commitment to free access to Covid-19 vaccines.
The companies stated that an application for an Omicron-adapted bivalent vaccine for children 5 through 11 years of age is planned for submission to FDA in early October.
The companies are working with the FDA to prepare an application for an Omicron-adapted bivalent vaccine in children 6 months through 4 years of age.