Sanofi says pediatric vaccine Hexyon/Hexacima approved in Europe

The European Commission has approved French drug major Sanofi (Euronext: SAN) subsidiary Sanofi Pasteur’s 6-in-1 pediatric vaccine Hexyon/Hexacima (DTaP-IPV-Hib-HepB vaccine) for primary and booster vaccination of infants from six weeks of age.

The EC decision follows the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommendation supported by the results of multi-center clinical studies involving around 5,000 infants (The Pharma Letter February 22). Phase III clinical studies comparing Hexyon/Hexacima to licensed combination vaccines demonstrated that the product is safe and induces a robust immune response against all six targeted diseases

Hexyon/Hexacima 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.