EMA Backs Fluad Tetra for Influenza Prophylaxis in the Elderly

Megan Brooks


March 31, 2020

The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has recommended granting marketing authorization for Fluad Tetra (Seqirus Netherlands BV), an adjuvanted quadrivalent influenza vaccine.

Fluad Tetra is indicated for prophylaxis of influenza in the elderly (aged 65 years or older). The vaccine will be available as an injectable suspension in prefilled syringes.

"The active substance of Fluad Tetra is influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, from four different influenza virus strains (two A subtypes and two B types)," the EMA said in a statement.

The vaccine contains the adjuvant MF59C.1 (MF59), "which is designed to increase and broaden the antigen-specific immune response and to extend the duration of the immune response," the EMA said.

Fluad Tetra induces an immune response similar to that of the previously approved adjuvanted trivalent vaccine, "with the added benefit of potentially protecting against both circulating type B viruses," the EMA said. The most common side effects are pain at the injection site, headache, and fatigue.

The summary of product characteristics will include detailed recommendations for use of Fluad Tetra and will be published in the European public assessment report, which will be made available in all official European Union languages after the European Commission grants marketing authorization.

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