NEW YORK: Germany's BioNTech SE and its US associate conglomerate Pfizer Inc. have gained emergency approval from the United States for their booster vaccination for the Omicron variant of the coronavirus in the US.
The Pfizer-BioNTech Covid-19 vaccine, bivalent and Omicron BA.4/BA.5, has been approved for emergency use by the US Food and Drug Administration (FDA) for individuals 12 years of age and older to receive a 30-microgram booster dosage.
According to their existing supply contract with the US government, the companies emphasised that they will provide both the original and bivalent vaccinations.
A proposed recommendation by the Advisory Committee on Immunization Practices is likely to be endorsed by the Centers for Disease Control and Prevention (CDC) before and after booster immunizations for those 12 years of age and older begin.
As instructed by the US government, Pfizer and BioNTech announced that they will start supplying bivalent doses.
In keeping with the US government's commitment to providing free access to Covid-19 vaccinations, eligible US citizens will continue to receive the vaccine without charge. The FDA will receive an application for an Omicron-adapted bivalent vaccine for kids between the ages of 5 and 11 in the first few days of October, the company said.
The companies are working with the FDA to prepare an application for an Omicron-adapted bivalent vaccine in children aged between 6 months to 4 years.