Human medicines European public assessment report (EPAR): Supemtek, trivalent influenza vaccine (recombinant, prepared in cell culture), Status: Opinion

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Source: EMA New Medicines

Original: https://www.ema.europa.eu/en/medicines/human/EPAR/supemtek...

Published: Fri, 30 Jan 2026 12:00:00 +0100

Supemtek is a trivalent recombinant influenza vaccine, prepared in cell culture, intended for active immunization of adults 18 years of age and older to prevent influenza disease.[1] The application for registration was submitted by the manufacturer Sanofi Pasteur on October 4, 2019 through a centralized procedure pursuant to Regulation (EC) No. 726/2004.[1] The vaccine protects against two subtypes of virus A and two types of virus B according to official recommendations.[1][3] In two main studies involving more than 10,000 adults, Supemtek Tetra was at least as effective as a comparator vaccine in protecting against influenza and stimulating antibodies.[3] Another study with approximately 1,300 individuals demonstrated that in children and adolescents from 9 years of age, the immunogenic response is at least the same as in adults.[3] The safety profile is similar to other influenza vaccines, with mostly mild to moderate side effects.[3] The report is in the CHMP opinion phase.[1]