Sanofi Pasteur have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended market approval for their 6-in-1 paediatric vaccine Hexyon/Hexacima.
The vaccine would be marketed as Hexyon in Western Europe, where it is a joint venture between Sanofi Pasteur and Merck & Co, and Hexacima in Eastern Europe, where it will be marketed only by Sanofi Pasteur.
The new vaccine would be the only fully liquid, ready-to-use, 6-in-1 vaccine to protect infants against diphtheria, tetanus, pertussis, Hepatitis B, poliomyelitis and haemophilus influenza b.
"Availability of Hexyon/Hexacima ready-to-use, 6-in-1 pediatric vaccine will raise the standard of care of vaccination for millions of children. It reduces the number of vaccination visits for infants and it is more convenient for parents to complete the recommended vaccination schedule and thus better protect their children against six major childhood diseases," said Olivier Charmeil, president and chief executive of Sanofi Pasteur, adding: "Upon licensure, we intend to introduce Hexyon/Hexacima vaccine in countries that are looking for improved and effective solutions for public immunization programs."
The three key benefits of the 6-in-1 vaccine, according to Sanofi, would be:
1. Hexyon/Hexacima is a fully liquid, ready-to-use vaccine. Therefore, no reconstitution would be needed prior to administration.
2. As a combined vaccine, this reduces the number of injections required and thus improves comfort and vaccination compliance for infants.
3. The use of acP (acellular pertussis) antigens and IPV (inactivated poliovirus vaccine) improves safety and reduces reactogenicity as compared to wcP (whole cell pertussis)-containing vaccines and OPV (oral polio vaccine).
Hexyon/Hexacima would compete with GlaxoSmithKline's (GSK) Infanrix Hexa.
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