CHMP issues positive opinion on new schedule for Sanofi Pasteur's Hexyon

The European Medicines agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on an additional schedule of administration for Hexyon, (DTaP-IPV-Hep B-Hib).

Hexyon, manufactured by Sanofi Pasteur, the vaccines division of French drug major Sanofi (Euronext: SAN), protects infants against: diphtheria, tetanus, whooping cough, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b. It has been recommended for two doses in primary vaccination and one as a booster dose. The European countries recommending the ‘2+1’ schedule for infant vaccination include France, Italy, Austria, Denmark, Norway and Sweden. It is already recommended in other European countries using a ‘3+1’ schedule.

Stephen Lockhart, vice president of development at Sanofi Pasteur, said:  “This positive opinion is another demonstration of Hexyon's good immunogenicity and safety profile. This positive evaluation of a new schedule is a key step towards making Hexyon available to more infants in the EU, in addition to infants in more than 20 countries around the world where the vaccine has already been used”