Pfizer and BioNTech have gained FDA approval for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine, intended for individuals aged 12 and above. This season’s vaccine is designed as a single dose for most people aged 5 and older. Children under 5 may receive additional doses if they haven’t completed a three-dose series with previous vaccine formulations.
The decision comes after the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended an Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for the 2023-2024 fall and winter season. This updated vaccine aims to provide better protection against multiple Omicron-related sublineages, including XBB.1.5, BA.2.86 (Pirola), and EG.5.1 (Eris).
Pfizer and BioNTech are actively collaborating with pharmacies, hospitals, and clinics to ensure easy access to this season’s vaccine. The companies have been producing the 2023-2024 COVID-19 vaccine in preparation for increased demand during the fall and winter seasons.
The FDA’s approval is based on comprehensive evidence of safety and efficacy, including pre-clinical data showing improved responses against various Omicron XBB-related sublineages compared to earlier formulations. This updated vaccine aims to address the evolving landscape of COVID-19 variants and their seasonal patterns.
This COVID-19 vaccine will be available in various healthcare settings across the United States, with no out-of-pocket costs for most Americans. Similar regulatory submissions have been made in the European Union and other regions.
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