European Commission approves Supemtek (quadrivalent recombinant influenza vaccine) for the prevention of influenza - Sanofi

The European Commission has granted a marketing authorization for Supemtek, a quadrivalent (four-strain) recombinant influenza vaccine, from Sanofi, for the prevention of influenza in adults aged 18 years and older. Supemtek is the first and only recombinant influenza vaccine now approved in the European Union. Supemtek is produced using recombinant technology, which allows an exact match to the key component of the influenza strains recommended by the World Health Organization, avoiding the risk of viral mutations. Supemtek also contains three times more antigen than both egg-based and cell-based standard-dose vaccines. This increased amount of antigen and the use of recombinant technology provide improved protection against influenza, particularly in those aged 50 and older. In comparison with a standard-dose egg-based quadrivalent influenza vaccine, Supemtek reduced the risk of influenza by an additional 30% for adults aged 50 years and older. The authorization is based on clinical data demonstrating safety, immunogenicity and efficacy of Supemtek in two Phase III randomized controlled trials, involving more than 10,000 patients in total. Specifically, the relative efficacy of Supemtek was demonstrated in a Phase III multicenter (40 outpatient centers in the US, involving more than 9,000 adults), randomized controlled efficacy trial.