LYON, France, April 22, 2013 /PRNewswire/ --
Hexyon is Europe's only fully liquid, ready-to-use hexavalent paediatric vaccine
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®.
* France, Germany, UK, Spain, Italy, Belgium, Netherlands, Austria, Portugal, Norway, Sweden, Denmark, Finland, Ireland, Greece, Iceland, Luxembourg, Liechtenstein
About Sanofi Pasteur MSD http://www.spmsd.com
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.
SOURCE Sanofi Pasteur MSD