(RTTNews) - The U.S. Food and Drug Administration approved the supplemental Biologics License Application--COMIRNATY 2023-2024 Formulation--for individuals 12 years and older and granted emergency use authorization for individuals 6 months through 11 years of age for Pfizer Inc. (PFE) and BioNTech SE's (BNTX) Omicron XBB.1.5-adapted monovalent COVID-19 vaccine, the companies said in a statement on Monday.
This season's vaccine is indicated as a single dose for most individuals 5 years of age and older. Children under the age of 5 may be eligible to receive additional doses of this season's vaccine if they have not already completed a three-dose series with previous formulations of a COVID-19 vaccine.
Pfizer and BioNTech noted that they have been manufacturing the 2023-2024 COVID-19 vaccine at risk to ensure supply readiness ahead of the fall and winter season, when demand for COVID-19 vaccination is expected to increase in line with the seasonality period also seen with other respiratory viruses.
The companies said that the COVID-19 vaccine will be available in pharmacies, hospitals, and clinics across the U.S. following a recommendation by the Centers for Disease Control and Prevention.
In the European Union, the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (COMIRNATY Omicron XBB.1.5) has also received marketing authorization by the European Commission for individuals 6 months of age and older on August 31, 2023.
Pfizer and BioNTech have submitted data for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine to other regulatory authorities around the world.
For More Such Health News, visit rttnews.com
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
