Saturday, January 25, 2025

PFİZER and BioNTech Granted FDA Approval for COVID-19 Vaccine for 2023-2024 Season

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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).

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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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