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Parliamentary questions
7 July 2017
Answer given by Mr Andriukaitis on behalf of the Commission

The benefit/risk profile of Infanrix Hexa for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b is considered to be favourable by the European Medicines Agency (EMA).

The Commission is not aware of any recent meta-analysis(1). It should be noted that any reports received by the Italian Medicines Agency are also transmitted to an EU safety database called EudraVigilance(2) (the system for managing and analysing information on suspected adverse reaction to medicines). EMA performs regular signal detection activities using this data. Moreover, risk-benefit evaluation is conducted during periodic safety assessments of authorised products.

The latest evaluation of Infanrix Hexa ended in June 2015 and concluded that the data are globally reassuring with no clear indication of a signal for sudden deaths.

In addition to the routine pharmacovigilance activities performed by the marketing authorisation holder (MAH), the Pharmacovigilance Risk Assessment Committee of EMA requested the MAH to continue monitoring sudden death cases and to update the literature review and the observed versus expected analyses (including sensitivity analyses).

The next periodic assessment is due in January 2018. So far, no valid signal was identified; therefore further research (such as e.g. a meta-analysis) has not been required.

(1)Based on PubMed search

Last updated: 11 July 2017Legal notice