Sanofi’s vaccines arm Sanofi Pasteur has received backing from European regulators for its multi-disease vaccine Hexyon-Hexacima in children.
A key advisory committee to the European Medicines Agency (EMA) recommended the vaccine be approved as both a primary and booster vaccination in children aged six weeks to 24 months against six conditions: diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b.
Sanofi said it will market the product under the brand name Hexyon in Western Europe, where the company will work with MSD (known as Merck & Co outside Europe) as part of the companies’ Sanofi Pasteur MSD joint venture.
In Eastern Europe, the product will be marketed under the brand name Hexacima by Sanofi Pasteur alone.
Commenting on the approval, Sanofi Pasteur’s president and CEO Olivier Charmeil said that Hexyon-Hexacima will “raise the standard of care of vaccination for millions of children”.
He said: “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.”
In its summary of opinion, the EMA’s Committee for Medicinal Products for Human Use (CHMP) said Hexyon-Hexacima had demonstrated a favourable benefit-to-risk balance for its ability to protect infants in its approved indications, with side effects including pain, swelling and vomiting.
The CHMP also said the vaccine should be given as three doses at least four weeks apart.
Data backing the recommendation came from several multi-centre phase III clinical studies involving around 5,000 children, which compared Hexyon-Hexacima to licensed combination vaccines.
According to Sanofi, benefits of the vaccine include its fully liquid, ready-to-use formulation, which makes the product easier to use for healthcare professionals.