Europe. The European Medicines Agency has recommended the suspension of the marketing authorization for Hexavac. This is a precautionary measure taken amidst concerns about the vaccine's long-term protection against hepatitis B following the identification of a decreased immunogenicity of the hepatitis B component in the vaccine. Hexavac is a vaccine for infants and children against diphtheria, tetanus, whooping cough (pertussis), hepatitis B virus, polio virus and Hemophilus influenzae type b.

The current concern does not affect the protection against diphtheria, tetanus, whooping cough, polio and Hemophilus influenzae type b. Sanofi Pasteur MSD, the marketing authorization holder, has been directed to design a specific surveillance programme to determine whether infant and children, already vaccinated with Hexavac, would need to be revaccinated at a later stage, to ensure long-term protection against hepatitis B.

Reference:

Press release. European Medicines Agency, 15 September 2005 (http://www.emea.eu.int).