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Parliamentary questions
2 June 2017
P-003716-17
Question for written answer
to the Commission
Rule 130
Piernicola Pedicini (EFDD)

 Subject:  Pharmacovigilance and public disclosure of information concerning the safety of the hexavalent vaccine Infanrix Hexa
 Answer(s) 

An official document (10 May 2017) of the Italian Medicines Agency, AIFA, has published data concerning reports of suspected adverse reactions to GlaxoSmithKline’s hexavalent vaccine Infanrix Hexa.

From 2014 to 2016, 3 551 reports of various general diseases were recorded, such as psychiatric disturbances, diseases of the nervous system, skin, etc. Five deaths were also reported.

The AIFA affirms that there is no relationship between exposure to vaccines and SIDS (sudden infant death syndrome) and that just because a case of SIDS can occur shortly after vaccination, this does not mean there is a cause-effect relationship, citing two studies conducted respectively in Italy (Hera study) and Germany (Token study).

Given the serious nature of this information, can the Commission say:

Whether there are any more recent meta-analyses — and if so, they should be made available to the public — referring to the data which has emerged from the reports received by the AIFA and proving that there is no cause-effect relationship between the administration of Infanrix Hexa and sudden deaths;
Whether, if such studies do not exist, it will fulfil its pharmacovigilance tasks by commissioning a meta-analysis which proves that Infanrix Hexa is safe, in compliance with the precautionary principle?

Original language of question: IT 
Last updated: 9 June 2017Legal notice