As expected, regulators in Europe have given the green light to Sanofi's six-in-one paediatric vaccine Hexyon/Hexacima.
The European Commission has approved the French drugmaker's Sanofi Pasteur unit’s Hexyon, the only fully liquid, ready-to-use, six-in-one vaccine to protect infants against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b. The thumbs-up comes after the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion earlier this year based on studies involving 5,000 infants comparing Hexyon to licensed combination vaccines.
The new vaccine will be sold as Hexyon in western European countries by the firm's joint venture with Merck Sharp and Dohme - Sanofi Pasteur MSD - and as Hexacima in eastern Europe by the French company. Olivier Charmeil, chief executive of Sanofi Pasteur, said the six-in-one "will raise the standard of care of vaccination for millions of children" as it reduces the number of visits for infants "and it is more convenient for parents to complete the recommended vaccination schedule".