The European Commission gave permission for a new vaccination schedule of 2+1 doses for Hexyon, a novel 6-in-1 pediatric DTaP-IPC-HB-Hib vaccine,
Sanofi Pasteur MSD said Thursday.
The decision to approve the new 2+1 schedule calls for two doses and then one-dose booster vaccine. The child receives these shots at approximately 1 year old.
The previous vaccination schedule called for three doses of the vaccine and then a booster dose, making a total of four doses. This new schedule simplifies the administration of Hexyon to just three doses.
In February, the European Medicines Agency (EMA) gave a positive report about Hexyon, which helped Sanofi gain approval for the new vaccination schedule. EMA looked at a multicenter Phase III clinical trial of 546 infants before giving its positive report.
The study compared the new vaccine to another licensed combination vaccine. The results showed that Hexyon’s 2+1 vaccination schedule is safe and effective in protecting children against the six illnesses in the vaccine strains.
The new schedule will be implemented in Sweden, Norway, Denmark, France, Italy and Austria.
"This approval from the European Commission is another demonstration of Hexyon's good immunogenicity and safety profile,” Sanofi Pasteur Vice-President Development Stephen Lockhart said. "We are delighted to be able to offer Hexyon with this new schedule, which means that Hexyon can be made available to more infants in the European Union.”