The European Commission has approved Sanofi’s quadrivalent recombinant influenza vaccine Supemtek for the prevention of flu in adults aged 18 years and older.
Sanofi’s Supemtek is the now first and only recombinant influenza vaccine to be approved within the European Union.
The French pharma giant developed Supemtek using recombinant technology, which allows an exact match to the key component of the flu strains recommended by the World Health Organization (WHO).
The EU approval is based on data from two phase 3 clinical trials involving over 10,000 participants in total. When evaluated in these trials, Supemtek reduced the risk of flu by an additional 30% in adults aged 50 years and older compared to a standard-dose egg-based quadrivalent influenza vaccine.
Global influenza-associated deaths range from between 290,000 to 650,000 each year, with around ten million influenza-related hospitalisations also reported every year.
Sanofi expects the first European launches of Supemtek for the 2022/2023 flu season and a possible fast-track of doses to be delivered by the 2021/2022 season in certain countries.
“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 an increased ability to prevent influenza and its potentially severe complications, as well as the burden this places on healthcare systems,” he added.
Sanofi is also utilising its recombinant technology to develop a COVID-19 vaccine, which will be combined with an adjuvant from GlaxoSmithKline (GSK).
In September, Sanofi and GSK announced that they were launching clinical testing of the vaccine candidate and that they expect the first results from the study in early December.
Sanofi and GSK first announced their partnership in April, and at that time the companies said they expected to complete the development required for availability by the second half of 2021.
In addition to the GSK partnership, Sanofi also signed an agreement with Translate Bio to develop an mRNA-based COVID-19 vaccine.
Preclinical studies of the flu vaccine, published in October, found that it induced high antibody levels and produces neutralising antibodies in mice and macaques.