Germany's BioNTech gains emergency US approval for Omicron booster

The US FDA granted emergency use authorisation for a 30-microgram booster dose of the Pfizer-BioNTech Covid-19 vaccine, bivalent and Omicron BA.4/BA.5, for individuals aged 12 years and above

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 US.

The US Food and Drug Administration (FDA) granted emergency use authorisation for a 30-microgram booster dose of the Pfizer-BioNTech Covid-19 vaccine, bivalent and Omicron BA.4/BA.5, for individuals aged 12 years and above, 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 aged 12 years and above 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 Immunisation 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 aged between 5-11 years 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 aged between six months to 4 years.

--IANS

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