Sanofi’s four-strain (quadrivalent) influenza vaccine Vaxigrip has been accepted by the European Medicines Agency (EMA) for review for approval in the EU.
The news comes a week after GlaxoSmithKline was granted marketing approval in Germany and the UK for its own four-strain vaccine Influsplit/Fluarix Tetra, while AstraZeneca’s FluMist Quadrivalent is also available in the US.
These quadrivalent vaccines provide protection against two A strains and two B strains of influenza, and are becoming an increasingly popular alternative to the current standard trivalent seasonal influenza vaccines, which only cover one influenza B virus.
This is because during a typical influenza season, there may be two different influenza B strains circulating, or the B strain selected for inclusion in the trivalent influenza vaccine may not be the influenza B strain that eventually circulates causing illness.
“The inclusion in the seasonal influenza vaccine of the four influenza viruses anticipated to circulate in the forthcoming season has the potential to reduce the risk of influenza disease and influenza-related complications, specifically hospitalisations and deaths among those at risk who contract the disease,” said Olivier Charmeil, president and CEO of Sanofi’s vaccine division Sanofi Pasteur.
The application covers the vaccines use in children and adults from 9 years of age.
If approved, Vaxigrip will be commercialised in Western European countries by Sanofi Pasteur MSD – a joint venture between MSD and Sanofi Pasteur – and in other countries, including Eastern Europe, by Sanofi Pasteur.
In the US, the FDA is currently reviewing a quadrivalent version of Sanofi’s flu vaccine Fluzone.
Sanofi upscale manufacturing efforts in malaria
Sanofi also announced it is to launch a large-scale production line in Italy to manufacture semisynthetic artemisinin, a key ingredient of malaria treatments.
The company will partner with PATH, an international non-profit organisation in global health innovation, to produce the compound, demand for which has increased since the World Health Organization (WHO) identified artemisinin-based combination therapies (ACTs) as the most effective malaria treatment available.
The partnership is part of the OneWorld Health programme funded by the Bill & Melinda Gates Foundation, which launched a project nine years ago to develop a commercial-scale alternative manufacturing process to produce artemisinin due to the inconsistencies of the existing botanical supply.
Sanofi said it will produce the ingredient using a “no-profit, no-loss production model”, which is intended to help to maintain a low price for developing countries.