The hexavalent contaminated: UPDATE

As mentioned in the article Saturday, October 13 The hexavalent contaminated , some batches of Infanrix Hexa produced by GlaxoSmithKline and used on newborns in different countries of the world, they have been recalled “voluntarily” by the company in via “precautionary” for the suspect / confirmed of microbial contamination from “Bacillus Cereus”.

No official statement was issued by the Italian authorities; in the late evening it is finally out a note from the Pharmacovigilance AIFA .

The Ministry of Health, contacted by the undersigned Office VIII [administrative activities for the payment of compensation under the law 25 February 1992 n. 210: state jurisdiction functions concerning the compensation to persons injured by compulsory vaccination and infection with infected blood or derivatives] with whom I have had telephone contact regarding the practice of my son, replied: ” The lots are sold by us “.

On Saturday evening, October 13, I had forwarded an extensive mail to pharmacovigilance Glaxo [ drugsurveillance-italy@gsk.com ], full of references cited in the previous article.

Monday afternoon I received reply from Mrs. AC [not carry the name for obvious privacy issues] of Glaxo Italy Pharmacovigilance Service, for granting me a clarifying phone call. All this happened this afternoon.

Publicly thank the representative of the drug giant for giving attention and cooperation to a simple citizen and, as is often said in these cases, ” the messenger not worth door: let’s take this circumstance response “.

We are aware of the issue of microbiological contamination.

The contamination has affected the area of ​​production of vaccines but no contamination has affected the finished products, or vaccines.

For Europe, the vaccines are “all” products in Belgium. The affected lots are not used on the national territory.

Ours is extreme precaution.

There are no reported adverse events.

The countries concerned are about 19

I try to ask what are the other 13 countries. In addition to the six aforementioned countries [Spain, France, Germany, Slovakia, Canada and Australia] are added: Great Britain, Belgium, Netherlands, Greece, Czech Republic, Albania, Malaysia, Vietnam, Qatar, Romania, Lebanon, Brazil, Malta.

We are the miracles?

Overflight that vaccines are produced all in Belgium as from the German Health Ministry document shows that things are not really so:

Workshops / “external parallel” distributors and lot numbers affected by the measure:

  • Emra-Med, Kohlpharma, Pharma Westen, Veron Pharma: A21CB187B
  • CC-Pharma: A21CB337A
  • Pharma Westen, Emra-Med, Kohlpharma, Veron Pharma: A21CB187C
  • ACA Müller: A20CA742A , A20CA743A

… So if these companies are all in Belgium I think you need review the geography, given that the other 5 batches withdrawn [ A21CB191C , A21CB193A , A21CB193B , A21CB193C , A21CB194A ] are produced right from Glaxo Germany!

Meanwhile the local health authorities receive phone calls from parents understandably concerned. We too have received e-mails from all over Europe where, unfortunately, in many cases, the withdrawn vaccine had been administered to children. Rather than reassure and advise people on how to behave, as well as submit a complaint to the competent judicial authorities, we could not do.

It was still reasonable to expect greater interest and timeliness by the health authorities responsible for pharmacovigilance, in compliance with the EMEA rules on withdrawals from the market products and managing non-compliance

“The defects of Class I defects are potentially life threatening. A rapid alert notification to be sent to all the contacts in a list in charge of the service of notice, regardless of whether the game has been exported to that country . “

The behavior can not be justified: despite being aware of the problem, they thought to remain silent until they were pressed with alerts sent through any means of communication.

But in fact, to our questions, we have not received an answer:

  1. if ” no contamination was found in the products “, because withdraw them?
  2. if ” no contamination was found in the products “, because it was attributed to the defect classification of CLASS?

When in doubt, however, take note of the affected lots and expect [remember that it is your right] to know the lot number of the vaccine that is given to your child or your daughter.

For greater clarity should be available the lot numbers of all countries concerned by the measure!

Instead, this uncertainty is worse than roulette. A roulette wheel that is played on unaware of newborns skin and that, regardless of the fact that the lots are not marketed in Italy, could become material to an exposed in some Attorney [for example starting from Turin in which there is Dr.. Guariniello] .

As rightly gives the Dr. Montanari in recent comments:

  1. I believe you can not make the fish in a barrel. That vaccines do not give now the problem can no longer be denied, at risk of ridicule. Taking for granted, at least temporarily, honesty, overseers must act to control, and to do so, they must have who knows how to be serious, because so far it was considered nothing more than a pure performance bureaucratic and that all was well regularly was an act of faith that it was a sin to doubt. If, for whatever reason, the people in charge of control are not up, it should be replaced without delay because here we are talking about health and, in some cases, life or death. For its part the pharmaceutical industry has a duty to review the controls. If until now was allowed to settle for the bureaucracy, should now begin work in scientific terms according to what current science prescribes. About drugs in general, and the even more vaccines, there can be no doubt at least as regards the content, content that should be clearly stated, which, at the time, certainly not. My suspicion, perhaps confirmed by those withdrawals, is that even equipment and work environments are not what should be, which would explain the presence of non-biodegradable inorganic powders and not biocompatible in all vaccines that we have analyzed. Finally, it is imperative that physicians, and pediatricians in particular, recall that they have vowed to Hippocrates to do only the welfare of their patients.
  2. Apparently we always talk about bacterial contamination but I wish it was focusing attention on contamination by micro- and nanopowder. These can present a great aggressiveness because the body has no weapon to defend himself, contrary to what occurs for most of the bacteria. I think it is worrying to note that for this kind of pollution there is no monitoring.

We hope not to have to find out in a few months that among these countries also includes Italy.

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