The European Commission (EC) has approved a six-in-one (hexavalent) paediatric vaccine developed by the Sanofi Pasteur MSD joint venture.
Hexyon/Hexacima is the only full liquid, ready-to-use vaccine of its type on the EU market, according to Sanofi Pasteur, and provides protection against diphtheria, tetanus and pertussis (DTP) as well as hepatitis B, polio and Haemophilus influenzae type B (Hib), a cause of meningitis.
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 under the brand name Hexacima in eastern European by Sanofi Pasteur.
Olivier Charmeil, chief executive of Sanofi Pasteur, said the therapy “will raise the standard of care of vaccination for millions of children”, adding that it will be an “important growth driver” for the company in 2013 and beyond.
Hexyon/Hexacima can be used for primary and booster vaccinations from the age of six weeks and comes onto the market as a competitor to GlaxoSmithKline’s Infanrix Hexa, part of the pharma company’s Infanrix/Pediarix range which made around £775m ($1.18bn) in sales last year.
Infanrix Hexa has been on the market since 2000 and has had the hexavalent paediatric vaccine category to itself since 2005, when a European Commission review of short and long-term protection afforded by recombinant hepatitis B vaccines led to the temporary suspension of Sanofi Pasteur MSD’s rival Hexavac product.
Hexavac was not returned to the market after the suspension was lifted for commercial reasons, according to the vaccines joint venture, and its marketing authorisation was officially withdrawn last year.
Meantime, however, GSK has run into some problems of its own with Infanrix Hexa and was forced to recall batches of the product in around 20 countries last year after some were found to be contaminated with bacteria.
Sanofi Pasteur MSD says it now has a hexavalent product that reduces the number of injections given to infants and is easier for healthcare practitioners to administer as it does not need reconstitution.
Hexyon/Hexacima also uses a cellular pertussis and inactivated poliovirus components, which are safer and better tolerated than products that use whole-cell pertussis (wcP) or oral polio vaccine (OPV).
The EC decision is based on the results of clinical trials involving approximately 5,000 infants, which compared Hexyon/Hexacima to licensed combination vaccines and showed the new product was safe and induced an immune response against all six targeted diseases.