Information on vaccination incidents in Japan

messages in brief | 08/03/2011

Prevenar (active ingredient: pneumococcal polysaccharides of serotype 4, 6B, 9V, 14, 18C, 19F and 23F, conjugated to CRM197 carrier protein, adsorbed) has been licensed since 2001 under the centralized procedure in all EU member states for children aged two months to five years. This pneumococcal vaccine protects against meningitis (meningitis), sepsis (blood poisoning), bacteremia (bacteria in the blood), pneumonia (pneumonia) and otitis media, which can be caused by the bacterium Streptococcus pneumoniae. The vaccine's mode of action is based on stimulating the body of the vaccinated to produce antibodies against the pathogens in question. In Japan, two million doses of Prevenar have been given since 2010, and a total of 360 million doses have been given worldwide in the last ten years since the vaccine was approved.


Incidents in JapanFour deaths have been reported from Japan that are temporally related to the vaccines administered. All cases involved children who received multiple vaccinations. Specifically, they received ActHIB (hemophilus influenza type B) and Prevenar (7-valent vaccine, pneumococcal), among others.


Situation in AustriaIn Austria, the follow-up product Prevenar 13 has been available since 2010. The Austrian vaccination schedule recommends four vaccinations with pneumococcal vaccine for immunization against pneumococci. In the pediatric vaccination program, this is currently done with the 10-valent pneumococcal vaccine Synflorix (for at-risk children). The vaccines have been approved through the centralized approval process via the European Medicines Agency (EMA). The benefit-risk ratio is positive.


AGES PharmMed / BASG continues to monitor the situation. However, there is currently no indication of a safety signal in connection with the vaccines Prevenar (7-valent vaccine) and ActHIB.


Further information:

Vaccination schedule 2011



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