Hexyon 6-in-1 Paediatric Vaccine Approved in Europe

Hexyon is Europe’s only fully liquid, ready-to-use hexavalent paediatric vaccine

Lyon, 25th April 2013 – Sanofi Pasteur MSD,  the joint venture between MSD and Sanofi Pasteur in Europe, announced today that the European Commission has granted a community marketing authorisation for Hexyon^TM, an innovative new 6-in-1 paediatric vaccine.

Hexyon^TM is the only fully liquid, ready-to-use 6-in-1 vaccine to protect infants against six World Health Organization (WHO) priority diseases: diphtheria, tetanus, whooping cough, Hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.

Hexyon^TM has a unique advantage for healthcare professionals in that it is fully liquid (with all components in one syringe) and does not require any reconstitution, so making administration simple and limits the risk of error. The vaccine is indicated for primary and booster vaccination of infants from six weeks to 24 months of age in accordance with official recommendations in each European nation.

“We are very pleased that Hexyon is now approved for use in Europe. It clearly demonstrates Sanofi Pasteur MSD’s  commitment to provide innovative advances in vaccines to enhance public health in Europe.” said Jean-Paul Kress, President of Sanofi Pasteur MSD. “With this approval we can now give healthcare professionals an effective vaccine for infants with a unique ready-to-use formulation that will make administration simpler and  more secure.”

The EU Commission’s decision follows the recent recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), and is supported by the results of multi-center clinical studies involving approximately 5,000 infants. These studies compared Hexyon^TM with other licensed combination vaccines and  demonstrated that Hexyon^TM has a good safety profile and induces a robust immune response against all six targeted diseases.

The new hexavalent vaccine, developed by Sanofi Pasteur, will be commercialised in Europe under two brands names – in Western Europe* by Sanofi Pasteur MSD under the brand name Hexyon^TM and in Eastern Europe by Sanofi Pasteur under the brand name Hexacima^®.

 

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* France, Germany, UK, Spain, Italy, Belgium, Netherlands, Austria, Portugal,  Norway, Sweden, Denmark, Finland, Ireland, Greece, Iceland, Luxembourg, Liechtenstein

 

About Sanofi Pasteur MSD

Sanofi Pasteur MSD is a joint venture between Sanofi Pasteur, the vaccine division of Sanofi, and Merck, known as MSD outside the USA and Canada. Combining innovation and expertise, Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of Sanofi Pasteur and Merck to focus on the development of new vaccines to improve disease prevention across Europe.

 

For further information please contact: 

Caroline Ashe
Senior Director External Communications Europe
Sanofi Pasteur MSD
Tel : +33 4 37 28 4040
Mob :+33 6 33 46 1365
CAshe@spmsd.com

Download the press release in PDF format here:

 Hexyon 6-in-1 Paediatric Vaccine Approved in Europe

Sanofi Pasteur MSD Submits Quadrivalent Influenza Vaccine for European Licences

Addition of fourth influenza virus strain aims to increase protection against influenza

Lyon, 11 April 2013 – Sanofi Pasteur MSD, the joint venture between MSD and Sanofi Pasteur, announced today that it has submitted a decentralized marketing authorization application in Europe for a ‘Quadrivalent’ influenza vaccine, a new advanced seasonal flu vaccine.

The ‘Quadrivalent’ vaccine, developed by Sanofi Pasteur, is expected to help protect people from four different strains of seasonal influenza viruses. Currently available flu vaccines protect against three strains of flu viruses. By including a fourth influenza strain, the new seasonal flu vaccine could help further reduce influenza disease and influenza-related complications, hospitalizations and deaths.

“This filing clearly demonstrates our commitment to providing advanced vaccine solutions to help improve disease prevention in Europe,” said Jean Paul Kress, President of Sanofi Pasteur MSD. “We believe that quadrivalent flu vaccines will become the new standard for the prevention of seasonal flu.”

The new flu vaccine has been submitted for licences in Europe under the decentralized approval process, with France acting as the “Reference Member State” for the review of the licence dossier.

Once approved, the new quadrivalent vaccine will be commercialized in Western European countries by Sanofi Pasteur MSD and in Eastern European countries by Sanofi Pasteur, the vaccine division of Sanofi.

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About Sanofi Pasteur MSD
Sanofi Pasteur MSD is a joint venture between Sanofi Pasteur, the vaccine division of Sanofi, and Merck, known as MSD outside the USA and Canada. Combining innovation and expertise, Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of Sanofi Pasteur and Merck to focus on the development of new vaccines for Europe to improve the acceptability, efficacy and tolerability of vaccination.

For further information please contact:

Caroline Ashe
Senior Director External Communications Europe
Sanofi Pasteur MSD
Tel : +33 4 37 28 4040
Mob :+33 6 33 46 1365
CAshe@spmsd.com

Download the press release in PDF format here:

 Sanofi Pasteur MSD Submits Quadrivalent Influenza Vaccine for European Licenses