The European Medicines Agency (EMA), as part of a procedure designed to evaluate medicinal products intended for markets outside the European Union, has granted positive scientific opinion for  Sanofi Pasteur's vaccine Hexaxim (DTaP-IPV-Hib-HepB vaccine).

This is the first time the EMA gives a positive scientific opinion to a vaccine following that procedure. Hexaxim is the only fully liquid, ready to use 6-in-1 vaccine to protect infants against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.

“Our goal is to provide access to children throughout the world to the same standard of care for childhood immunization. Availability of Hexaxim  ready to use 6-in-1 paediatric vaccine will raise the standard of care of vaccination for millions of children,” said Olivier Charmeil, President and CEO of Sanofi Pasteur. “Upon licensure we intend to introduce Hexaxim in countries looking for improved and effective solutions in particular for public immunization programmes.”

The EMA scientific opinion is based on the review of a dossier submitted by Sanofi Pasteur through the “Article 58” procedure. The EMA assessment was conducted with the participation of experts from the World Health Organization (WHO) according to the same quality, safety and efficacy criteria as vaccines authorized for the European Union. Many countries in Latin America, Africa, the Middle East and Asia grant market authorization based on the EMA scientific opinion.

“A 6 in 1 paediatric vaccine reduces the number of vaccination visits for infants. It is more convenient
for parents to complete the recommended vaccination schedule and thus better protect their children against 6 major childhood diseases,” said Dr Pio Lopez, Paediatriciannnn, Infectologist, Professor at the Universidad del Valle in Cali and President of the Vaccines Chapter of the Colombian Association of Infectious Diseases (ACIN), and principal investigator for a clinical study of the vaccine in Colombia. “Hexaxim also includes inactivated poliovirus vaccine which is an important step to ensure communities remain polio-free.”

Key benefits of Hexaxim vaccine: Hexaxim is a fully liquid, ready to use vaccine; no reconstitution is needed prior to administration which improves convenience for health care professionals. It is available in vial and/or syringe presentations; By combining six vaccines into one, Hexaxim reduces the number of injections, which improves comfort and vaccination compliance for infants;  The use of acP (acellular pertussis) antigens and IPV (inactivated poliovirus vaccine), both commonly used in North America and Europe, improves safety and reduces reactogenicity as compared to wcP (whole cell pertussis)-containing vaccines and OPV (oral polio vaccine).

Upon approval, Hexaxim would be indicated for primary and booster vaccination of infants from six weeks of age in accordance with official recommendations.

The EMA positive opinion is supported by results of multi-center clinical studies involving approximately 4,000 infants in Argentina, Peru, Mexico, South Africa, and Thailand. Phase III clinical studies comparing Hexaxim to licensed combination vaccines demonstrated that Hexaxim is safe and induces a robust immune response against the six targeted diseases.

Hexaxim complements Sanofi Pasteur’s Acxim family of acP-IPV (acellular pertussis vaccine, inactivated poliovirus vaccine) combination vaccines. To date, more than 180 million doses of Sanofi Pasteur’s acP-IPV containing vaccines have been distributed in over 100 countries and have been included in the national immunization programs in over 30 countries. Hexaxim combines the same antigens included in the well-established vaccines Tetraxim/Tetravac (DTaP-IPV vaccine) and Pentaxim/Pentavac (DTaP-IPV-Hib vaccine), with Sanofi Pasteur’s new hepatitis B antigen.