Initiative Citoyenne: More negative vaccine information uncovered

[SaneVax: Belgian watchdog group, Initiative Citoyenne, has uncovered  information showing that their country’s health officials apparently think deaths, lack of efficacy and adverse neurological outcomes after the use of Prevnar 13 are nothing the public needs to know.

In a second press release issued by the same group a couple of days later, Initiative Citoyenne asks some questions everyone should be asking. Why was GSK’s Synflorix vaccine withdrawn from the Belgian market after less that two years of use? Medical consumers throughout Belgium need to know.

Initiative Citoyenne demands an end to the code of silence surrounding vaccines. They are calling upon all citizens, politicians, journalists, doctors and other medical professionals to open their eyes to the total ethical, moral and safety disaster represented by the current practice of BLIND and systematic vaccination of infants. The time has come for an honest scientific assessment of vaccines, vaccine ingredients and vaccination practices. Nothing less is acceptable.]

Confidential Documents on the Prevenar 13 Vaccine: Proof that BOTH the Manufacturers AND the Health Authorities KNOW why we are Concerned!

Initiative Citoyenne, 20 Dec 2012 – Press Release

Prevnar 13 Concerns

Prevnar 13 Concerns

On the 8th of December, articles in the press reported on the contents of a substantial 1,271-page confidential GSK document leaked to us by contacts at the Belgian Medicines Agency.  This shocking document on the pharmacovigilance of the Infanrix Hexa vaccine revealed serious safety problems evidenced by a whole range of serious complications, including 36 deaths (over a 2-year period).  None of this information had ever been communicated to parents, representing a clear breach of Belgian law of the 22nd August 2002 on patient information.

We have now received more confidential documents on the safety of another paediatric vaccine very commonly used on infants and administered alongside the Infanrix Hexa hexavalent vaccine: the Prevenar 13, a pneumococcal vaccine manufactured by Wyeth/Pfizer.

This is an injection targeting 13 different strains of the bacterium and reputed to be an improved version of the old Prevenar (targeting only 7 strains).  It was in fact rushed to market in 2010 to replace the older vaccine, presumably an attempt to cover up the fiasco of its predecessor: the original Prevenar had disappointingly resulted in an increase in serious infections making it totally counterproductive.

OK, so the vaccine is not as effective as they tell us but is it at least safe for such tiny babies?

It would appear, according to recent confidential Wyeth (Pfizer) documents and to a reply from the European Medicines Agency (EMA) that both the manufacturer and the agency are aware of a significantly higher number of adverse neurologic effects in children vaccinated with BOTH Prevenar 13 AND Infanrix Hexa, as per the Belgian vaccination schedule at ages 2 and 4 months.

On the 4th of January this year, at the end of the required 6-week period, two Pfizer group Regulatory Affairs Directors, Mary Allin and Helen Edwards, sent a response to Dr. S. Spinosa of the European Medicine Agency on the topic of “higher number of neurologic events reported in Italy following the co-administration of Prevenar 13 and hexavalent vaccines”.  The two directors specified at the end of this letter that based on data supplied, they did not feel there was any need to modify the vaccine’s reference safety information (RSI), in other words its package insert.

GSK Synflorix Vaccine Withdrawn in a Hurry: Will We Ever Know Why?

Initiative Citoyenne, 22 Dec 2012 Press Release

GSK’s Synflorix vaccine was authorized for use in Europe in 2009 and arrived on the Belgian market in 2010.  This vaccine, a competitor for Wyeth’s very lucrative and much used Prevenar, was designed to protect against 10 different strains of pneumococcal disease and had received a stamp of approval in October 2010 from our experts at the Belgian Conseil Supérieur de la Santé (Supreme Health Council) as well as in May of 2011 from the Centre Fédéral d’Expertise des Soins de Santé (KCE) (Federal Healthcare Expertise Centre). Less than a year later, we learn from the Belgian Pharmacotherapeutic Information Centre (CBIP) website as well as from the Belgian Medicines Agency, that the Synflorix vaccine has been withdrawn from the Belgian market in early December 2012.

Strangely, to our knowledge no internet article specifies the TRUE REASONS behind this very hasty withdrawal from the market since the vaccine will only have ‘existed’ for two years but during that time, how many children will it have killed and damaged?  (Cf the various reports of children dying after receiving Infanrix Hexa + Synflorix in the recent GSK confidential document on the Infanrix Hexa vaccine).

It is nonetheless shocking to think that, in comparison, when we find a defect potentially jeopardising the safety of a particular model of car, all owners are duly informed and their cars are recalled as soon as possible for elementary checks.  Somehow, for vaccines, it is different: withdrawals take place in secret, without any consideration for the people who may have received the product; all of this because the hallowed image of vaccination must never be tarnished, and rightly so because the manufacturers still have close on 300 new vaccines they plan to launch in the years to come!

Take Sanofi’s Hexavac, withdrawn in 2005 under false pretenses and with the support of the European Medicines Agency.  In fact, the EMA helped the manufacturer to explain that the vaccine’s withdrawal was due to insufficient effectiveness of one of the valences in the cocktail when it really had to do with safety: according to journalist Virginie Belle in her recent book Faut-il Faire Vacciner Son Enfant? (Should You Vaccinate Your Child?) Infants had died from cerebral oedema following vaccination with this product.

Read the entire article with references here.



  1. Anna Paulina Eklöf says:

    This is unbelievable and shocking. Currently Infanrix Hexa is tested on 800 infants in Finland. The parents invited to join the test are only told there are only minor or no risks involved! The vaccine should be called INFAM RISK!

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