EMA clarification request on cradle deaths deleted from GlaxoSmithKline reports

EMA clarification request on cradle deaths deleted from GlaxoSmithKline reports

The PSUR (Periodic Safety Update Report) is a periodic evaluation of the benefit-risk ratio of a medicine and provides an analysis of its safety and efficacy during its life cycle. The submission of a PSUR to the competent authority is regulated and must follow the relative procedures and timescales established at European level in compliance with EU regulations. As you can imagine it is an element of enormous importance, the manufacturer of an approved medicine in Europe has the obligation to submit a periodic update report on the safety of his medicine and the control body, the European Medicines Agency or the The National Medicines Agency checks the compliance of these relationships to guarantee constant safety over time.

In 2018 we had published a series of awareness campaigns, 1 to be precise, five, which were intended to inform the population on certain issues and one of these campaigns concerned a publication of two Indian doctors, Dr. J. Puliyel and Dr. Sathyamala, 2 where it was found that in the latest Infanrix Hexa vaccine safety report (PSUR 19) submitted by GlaxoSmithKline in 2015 to EMA, SIDS deaths related to hexavalent vaccination had been cleared so it would seem that the observed deaths were included in those waits and fall within the safe range of the vaccine. What for our association was worthy of attention regarding this publication, in addition to the fact that it was Dr. Loretta Bolgan herself who had detected the omission at the time and communicated it to the Indian researchers, was that the EMA, the body responsible for checking that particular PSUR, had absolutely not noticed.

We quote an emblematic phrase of the research:

"If these deaths weren't cleared, the deaths after vaccination would have been significantly higher than expected ... The manufacturer would have had to admit to the EMA that their vaccine was the cause of those excess deaths."

After a year, after having dealt with discrete results in the access to the files (FOIA) to find out the number of victims of vaccine indemnified at regional and national level, we have resumed the issue of PSUR omissions by GSK and the lack of control by the EMA, by recording a formal request for clarifications and checks to the European Medicines Agency and we are determined and convinced that in the short to medium term we may have more data on this omission. Certainly after this first formal phase, in the absence of clear and decisive responses, a whole series of complaints may result from the competent bodies at European and international level. This request, being the Infanrix Hexa vaccine approved in Italy with mutual recognition, will also be registered with the Italian Medicines Agency.

It is plausible to us, after seeing us rebound in half of Europe for the analysis question, that also the documentary verification on the safety of drugs (including vaccines) is highly deficient, at least enough to ask a doubt and seek clarity.

For this reason we do not rule out opening a new project: an in-depth analysis of all PSURs of all vaccines marketed in Europe and, in collaboration with our foreign partners, open a long and interesting period of complaints for any documented non-compliance found !

We also remind Italian politics that for the umpteenth time a small group of parents is complying with a specific request, unanswered to date, by the Italian Parliament; requests received by written answer question No. 4-17956, presented by the former Vice-President of the Commission "Depleted Uranium" Honorable Ivan Catalano, on 28 September 2017.

Note: in the same formal request to the EMA, we found it appropriate to ask some specific questions also on a second article by Dr. Puliyel, published with peer review, 3 in which a very critical aspect is raised regarding the classification of adverse reactions which can contribute worryingly to their underestimation reported to the Agency. We will be happy to update you also on this aspect.

Covelva Staff


  2. Puliyel J, Sathyamala C. Infanrix hexa and sudden death: a review of the periodic safety update reports submitted to the European Medicines Agency. Indian J Med Ethics. 2018 Jan-Mar; 3 (1) NS: 43-7. DOI: 10.20529 / IJME.2017.079
  3. Puliyel J and Naik P. Revised World Health Organization (WHO) 's causality assessment of adverse events following immunization - a critique
    F1000Research 2018, 7: 243 (doi: 10.12688 / f1000research.13694.2)

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