CHMP positive for Flucelvax vaccine to prevent influenza

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Flucelvax, intended for the prevention of influenza disease in children and adults. The applicant for this medicinal product is Seqirus Netherlands B.V.

Flucelvax will be available as a suspension for injection in pre-filled syringes. Flucelvax is an influenza vaccine (ATC code: J07BB02). It contains haemagglutinin and neuraminidase surface antigens from 3 inactivated influenza virus strains, two A subtypes (H1N1 and H3N2) and a B type (Victoria lineage). Flucelvax provides protection against the influenza viruses it targets by inducing neutralising antibodies against viral haemagglutinin.

The benefit of Flucelvax is its ability to protect adults and children from 2 years of age against seasonal influenza, similar to previously authorised trivalent and quadrivalent vaccine. The most common side effects with Flucelvax are pain at the injection site, headache, fatigue, myalgia, erythema and induration