Cell-Based Quadrivalent Flu Vaccine Recommended by EMA Panel

Troy Brown, RN


October 19, 2018

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting marketing authorization for Flucelvax Tetra (Seqirus Netherlands BV), a quadrivalent cell-based influenza vaccine, on October 18, 2018. Its full indication is for prophylaxis of influenza in adults and children aged 9 years and older; it should be used according to official recommendations.

The US Food and Drug Administration approved the trivalent influenza vaccine Flucelvax for adults aged 18 years and older on November 21, 2012.

The trivalent vaccine was granted marketing authorization for use in adults in the European Union on June 1, 2007 under the trade name Optaflu (Seqirus GmbH). The marketing authorization expired in 2012; the company renewed it at the time but declined to renew it again in 2017, citing commercial reasons.

Flucelvax Tetra will be sold as an injectable suspension in prefilled syringes. "The active substance of Flucelvax Tetra consists of influenza virus surface antigens (hemagglutinin and neuraminidase), inactivated and prepared in cell cultures, of four different influenza virus strains (two A subtypes and two B types)," according to an EMA news release.

The vaccine protects against influenza by induction of humoral antibodies against the hemagglutinins, neutralizing influenza viruses. Its benefits are the fact that it induces an immune response similar to the previously approved trivalent cell-based vaccine and also potentially protects against both circulating influenza type B viruses.

The most frequently seen adverse effects are injection site pain, headache, fatigue, myalgia, erythema, and induration.

The summary of product characteristics will include detailed recommendations for use of the product 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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