The European Commission has granted a marketing authorization for Supemtek, a quadrivalent (four-strain) recombinant influenza vaccine, 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 3 randomized controlled trials involving more than 10,000 patients in total. Specifically, the relative efficacy of Supemtek was demonstrated in a Phase 3 multicenter (40 outpatient centers in the US, involving more than 9,000 adults), randomized controlled efficacy trial.
“In the context of the COVID-19 pandemic, preventing influenza remains a public health priority,” said Thomas Triomphe, Head of Sanofi Pasteur. “Today’s approval of Supemtek supports our strong commitment in advancing influenza vaccine technology. With Supemtek, we provide European health authorities with an additional innovative solution that has demonstrated increased ability to prevent influenza and its potentially severe complications, as well as the burden this causes on healthcare systems.”
Each year, influenza-associated deaths range from 290,000 to 650,000 globally, and the burden on hospitals is around 10 million of influenza-related hospitalizations. Recent data also show that influenza can multiply the risk of heart attack by up to 10 times, and the risk of stroke by up to 8 times, in the week after influenza infection demonstrating that the burden of influenza goes beyond its well-known respiratory complications.
The first European launches are expected for the 2022/2023 influenza season, with a possibility of accelerating the availability of doses as early as the 2021/2022 season in certain countries. Outside of the EU, Supemtek is also approved in the U.S. under the tradename Flublok Quadrivalent