Sanofi's Six-In-One Pediatric Vaccine Recommended for European Approval

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended Sanofi's six-in-one pediatric vaccine for marketing authorization. The hexavalent vaccine (DTaP-IPV-Hib-HepB vaccine) was developed by Sanofi Pasteur, the vaccines division of Sanofi. Once approved, the vaccine will be commercialized under two brands names: Hexyon in Western Europe and Hexacima in Eastern Europe. The vaccine will also be available in international markets under the trade name Hexaxim.

Hexyon /Hexacima will be indicated for primary and booster vaccination of infants from six weeks of age in accordance with official recommendations. It is the only fully liquid, ready-to-use, six-in-one vaccine in Europe to protect infants against diphtheria, tetanus, pertussis (whooping cough), Hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.

"Availability of Hexyon/Hexacima ready-to-use, six-in-one 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 CEO of Sanofi Pasteur in a press statement. "Upon licensure, we intend to introduce Hexyon/Hexacima vaccine in countries that are looking for improved and effective solutions for public immunization programs."

The formulation does not require reconstitution prior to administration, which makes it convenient for healthcare professionals. It is a fully liquid, ready-to-use vaccine, available in vial and pre-filled syringe presentations. Another key benefit is that the combination of six vaccines into one reduces the number of injections, hence improving comfort and vaccination compliance for infants. Moreover, the use of acP (acellular pertussis) antigens and IPV (inactivated poliovirus vaccine) improves safety and reduces reactogenicity compared with wcP (whole cell pertussis)-containing vaccines and OPV (oral polio vaccine).

The CHMP’s positive opinion is supported by clinical data from multicenter trials involving approximately 5000 infants. Results from Phase III studies comparing Sanofi’s vaccine to licensed combination vaccines demonstrated that Hexyon/Hexacima is safe and induces a robust immune response against all six targeted diseases.