First recombinant influenza vaccine approved in the European Union

pharmafile | November 20, 2020 | News story | Medical Communications, Sales and Marketing Europe, influenza, pharma 

The European Commission (EC) has just approved its first recombinant influenza vaccine for the European Union, awarding marketing authorisation to Sanofi Pasteur’s quadrivalent recombinant influenza vaccine Supemtek to prevent influenza infection in patients aged at least 18 years old.

The vaccine is built on an exact match of WHO-recommended flu strains, which, according to the company, avoids the risk of viral mutations. The therapy also provides increased protection to patients over the age of 50 because it contains three times the antigen levels of egg- and cell-based standard-dose vaccines; Supemtek drove a reduction in these patients of 30% in the relative risk of influenza-like illness.

The EC’s decision to approve the therapy was based on two Phase 3 studies covering over 10,000 participants, where it demonstrated non-inferiority to standard-dose, egg-based quadrivalent-inactivated influenza vaccines in terms of immunogenicity, tolerability and safety.

“Supemtek is the first and only flu vaccine to use recombinant technology, and demonstrates Sanofi Pasteur’s commitment to continued innovation,” said Hugo Fry, General Manger at Sanofi Pasteur UK & Ireland “We are in the middle of a second wave of COVID-19, and more than ever, it is critical that flu vaccination uptake is high in priority populations to reduce a double burden applying pressure on an already-stretched NHS. Moving forward, Supemtek could provide UK health authorities with an important new option to prevent influenza and reduce the burden on public health and the NHS.”

Flu causes around 17,000 deaths in the UK on average each year, and can increase heart attack risk by up to ten times.   

Matt Fellows

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