The EC authorisation is based on clinical data from two Phase 3 trials in a total of more than 10,000 patients, which established the safety, immunogenicity and efficacy of Supemtek
France-based Sanofi has secured the European Commission (EC) approval to market its quadrivalent recombinant vaccine Supemtek, against influenza in adults aged 18 years and above.
The French pharmaceutical firm said that Supemtek is the first and only recombinant influenza vaccine approved in the European Union (EU).
Supemtek is manufactured using recombinant technology, which ensures the use of components exactly similar to that of the influenza strains, as recommended by the World Health Organization (WHO)
The recombinant technology is an advanced way of producing influenza vaccines, which eliminates the risk of viral mutations that potentially reduce vaccine efficacy.
Also, the quadrivalent recombinant vaccine is said to contain three times more antigen compared to both egg-based and cell-based standard-dose vaccines.
The enhanced amount of antigen and recombinant technology would offer improved protection against influenza, particularly in people aged 50 years and above, said the company.
European Centre for Disease Prevention said: “The recombinant haemagglutinin was found to provide a greater protective effect against overall influenza compared with no vaccination and with traditional influenza vaccination.
“This effect may be attributable to either the restriction of mutations seen with egg-based vaccines or the higher dose of antigen seen in this type of influenza vaccine”.
The EC authorisation is based on clinical data from two Phase 3 trials in a total of more than 10,000 patients, which established the safety, immunogenicity and efficacy of Supemtek.
A Phase 3 multicentre randomised controlled efficacy trial demonstrated the relative efficacy of Supemtek, in more than 9,000 adults, at 40 outpatient centres in the US.
Supemtek has reduced the risk of influenza by an additional 30% for adults aged 50 years and older when compared to standard-dose egg-based quadrivalent influenza vaccine.
The French drugmaker intends to introduce the product in European Union in the 2022/2023 influenza season, and accelerate the availability of doses as early as the 2021/2022 season in certain countries.
Furthermore, Supemtek is also approved outside of the EU, in the US under the brand name Flublok Quadrivalent.
Sanofi Pasteur head Thomas Triomphe said: “In the context of the COVID-19 pandemic, preventing influenza remains a public health priority. 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.”