EMA approves immunization schedule for pediatric 6-in-1 vaccine

The European Medicines Agency has approved a “2+1” immunization schedule for Hexyon, a pediatric vaccine that protects against multiple viruses, including hepatitis B virus infection, according to a press release.

Hexyon (DTaP-IPV-HB-Hib, Sanofi) is a vaccine containing active substances derived from diphtheria, tetanus, pertussis and Haemophilus influenzae type-b bacteria, HBV and inactivated polioviruses, according to the EMA website. The vaccine is used in children from age 6 weeks to 2 years to protect against diphtheria, HBV, tetanus, pertussis, poliomyelitis and invasive diseases caused by H. influenzae type-b bacteria.

The “2+1” schedule is based on a primary immunization with two doses followed by one booster vaccination around 1 year of age, according to the release. The new schedule consists of a total of three doses, as compared with other approved schedules that include four doses: three of primary vaccine and one booster.

“This approval from the European Commission is another demonstration of Hexyon's good immunogenicity and safety profile,” Stephen Lockhart, vice president of development of Sanofi Pasteur MSD, the vaccine division of Sanofi, said in the release. “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.”

European countries seeking approval of the vaccine include France, Italy, Austria, Denmark, Norway and Sweden, according to the release.

The approval of the new immunization schedule follows the EMA’s positive opinion of the vaccine, which was granted in February based on results from a phase 3 clinical trial with 546 infants. Results demonstrated that Hexyon administered in a “2+1” immunization schedule is safe and projected protective immune responses against all six infectious diseases.

Editor’s Note: A correction was issued to the full name of the EMA. The Editors regret this error.