Sanofi Pasteur announced today that its 6-in-1 paediatric vaccine Hexyon / Hexacima has been approved by the European Commission (EC).

The vaccine is the only fully liquid form of its kind and is designed to be given to infants from six weeks of age as a primary and booster vaccination against diphtheria, tetanus, pertussis (whooping cough), Hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.

Sanofi combined the six vaccinations in one to reduce the number of injections needed.

"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.

"We will introduce Hexyon / Hexacima vaccine in countries that are looking for improved and effective solutions for public immunisation programmes."

The EC’s decision comes after the European Medicines Agency supported the results of a multi-centre clinical study involving approximately 5,000 infants.

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The Phase III study comparing Hexyon / Hexacima to licensed combination vaccines and demonstrated that the drug is safe and induces a robust immune response against all six targeted diseases.

Hexyon / Hexacima has been included in the immunisation programme of over 30 countries, and it has already been distributed in over 100 countries with 180 million doses administered.

Image: The EC’s decision comes after the European Medicines Agency supported the results of a multi-center clinical study involving approximately 5,000 infants. Photo: Courtesy of Brian Hoskins.