CHMP recommends Flucelvax Tetra a quadrivalent cell-based influenza vaccine.-Seqirus/CSL
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting marketing authorization for Flucelvax Tetra from 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 FDA 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).
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