Although there are is no proven causal relationship between this extraordinary event and the application of one batch of the vaccine, the holder of the registered vaccine, GlaxoSmithKline Biologicals S.A. of Rixensart in Belgium and the State Institute for Drug Control (SÚKL) have decided to implement this preventive suspension. This was based on a report identifying an undesired side-effect which has caused the death of a child on the day of vaccination.
None of the 10 European Union States to which similar batches related to batch A21CC054A were distributed have reported any life-threatening side-effects.
Further, it should be noted that the State Institute for Drug Control has not recorded any exceptional number of reports regarding the side-effects associated with this particular batch.
The INFANRIX HEXA vaccine has been registered in the European Union in 2000. Since, 2007, the vaccine has become a part of the vaccination calendar here in the Czech Republic. Each year, approximately 400,000 children are vaccinated by application of three doses and 1 supplementary supportive dose. All in all, approximately 3,000,000 doses of this vaccine have been applied in the Czech Republic alone.
The INFANRIX HEXA A21CC054A batch was introduced to the Czech market in February 2014 and distributed to medical facilities in May-August 2014. The batch itself included 6,171 packages amounting to 61,710 doses of the vaccine. This batch has already been distributed to medical facilities. This measure aims to stop the distribution, sale and medical application of the batch in question.
Prior to the introduction of batch A21CC054A to the market, an independent quality check was carried out by the Scientific Institute of Health in Belgium. The quality of the vaccination was assessed to be in full accordance with the documentation provided during its registration.
The safety of all vaccines is constantly monitored across the entire European Union and all reported suspect cases are carefully assessed and weighed according to the benefits of the vaccination versus possible risks. The weight of the benefits in the prevention of serious infectious diseases and currently associated risks for the INFANRIX HEXA vaccine remains positive in nature.
Press and Information Department
23. 9. 2014