Pfizer Inc. and BioNTech SE have submitted a regulatory application to the European Medicines Agency (EMA) for the approval of their COVID-19 vaccine, COMIRNATY®, targeting the LP.8.1 strain for the 2025-2026 season. This submission follows the EMA's Emergency Task Force recommendation to update the vaccine composition to address the LP.8.1 strain. The vaccine, developed using BioNTech's proprietary mRNA technology, is aimed at enhancing protection against COVID-19 for individuals 12 years and older. The regulatory review is ongoing, and the companies are awaiting approval to proceed with distribution for the upcoming season.
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