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Sanofi Pasteur’s Hexaxim vaccine gets EMA go-ahead

The positive report enables the French company to market the six-in-one vaccine in global markets outside Europe.

The European Medicines Agency has granted a positive scientific opinion for Sanofi Pasteur’s child vaccine Hexaxim, based on the results of multi-centre clinical studies involving approximately 4,000 infants in Argentina, Peru, Mexico, South Africa and Thailand.

Hexaxim is a liquid six-in-one vaccine that protects infants against diphtheria, tetanus, pertussis, Hepatitis B, poliomyelitis and invasive infections caused by haemophilus influenzae type b.

Sanofi Pasteur claims that by combining six vaccines in one, Hexaxim reduces the number of injections, which improves comfort and vaccination compliance for infants.

Olivier Charmeil, president and CEO of Sanofi Pasteur, said:

Our goal is to provide access to children throughout the world to the same standard of care for childhood immunisation. Availability of Hexaxim ready to use six-in-one pediatric vaccine will raise the standard of care of vaccination for millions of children. Upon licensure, we intend to introduce Hexaxim in countries looking for improved and effective solutions in particular for public immunisation programmes.