European Commission approves Sanofi’s recombinant influenza vaccine

By Rachel Arthur contact

- Last updated on GMT

Supemek - Flublok Quadrivalent in the US - is the only recombinant influenza vaccine approved in these regions Pic:getty/moussa81
Supemek - Flublok Quadrivalent in the US - is the only recombinant influenza vaccine approved in these regions Pic:getty/moussa81

Related tags: Sanofi, Influenza vaccine, COVID-19 vaccine

The European Commission has granted a marketing authorization for Sanofi’s Supemtek, a quadrivalent (four-strain) recombinant influenza vaccine: representing the first and only recombinant influenza vaccine approved in the European Union.

The vaccine is already approved in the US under the tradename Flublok Quadrivalent (where it is also the only recombinant influenza vaccine). The first European launches could become available for the 2021-2022 influenza season in certain countries; with the main launch set for the 2022-2023 season.

The flu vaccine's new recombinant technology is also being used in Sanofi’s lead COVID-19 vaccine candidate with GSK: which is expecting to launch a pivotal Phase 3 study before the year is out. This could be followed by a request for regulatory approval in the first half of 2021.

Recombinant tech

Recombinant technology is a new way of producing influenza vaccines which ‘differs significantly’ to the egg-based and cell-based technologies currently used.

These current technologies require the influenza virus to be replicated via the egg-based or cell-based methods: a process that leaves room for mutations to occur, meaning the virus produced for the vaccine may have disparities to the viruses circulating in the population and thus lower its efficacy.

In contrast, recombinant technology - which only replicates the portion of the virus' genetic makeup necessary to prevent flu - does not rely on the influenza virus replicating itself. 

In an independent systematic review published in October 2020 for Supemtek, the European Center for Disease Prevention noted that “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”.

Improved protection for older people

Supemtek has been approved for use in adults aged 18 years and older in the EU: with Sanofi championing improved protection particularly in those aged 50 and over.

A Phase 3 trial demonstrated that it improved protection against influenza compared to a standard-dose egg-based quadrivalent influenza vaccine, reducing the risk of influenza by an additional 30% in adults over 50 years old.

“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,"​ states Sanofi. "Supemtek also contains three times more antigen than both egg-based and cell-based standard-dose vaccines.”

While the focus may be on COVID-19 vaccines this year, Sanofi notes that influenza-associated deaths range from 290,000 to 650,000 a year worldwide, with influenza cases increasing pressure on health systems through cases themselves and an increase in heart attack and stroke risks.

“In the context of the COVID-19 pandemic, preventing influenza remains a public health priority,” ​said Thomas Triomphe, Head of Sanofi Pasteur. “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.”

Sanofi Pasteur, the vaccines global business unit of Sanofi, is upping delivery of flu vaccines by 20% this year: reaching a new high of 250 million doses.

In the works: Sanofi/GSK COVID-19 vaccine candidate

  • An adjuvanted recombinant protein-based COVID-19 vaccine
  • Currently in a Phase 1/2 study in the US with 440 participants aged 18+
  • First results from Phase 1/2 study expected in early December; with a Phase 3 trial set to start by the end of the year
  • Request for regulatory approval could follow in the first half of 2021

Related topics: Bio Developments, COVID-19

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