Monday, September 19, 2011

Gardasil Contamination: EMA Steps Up to the Plate, FDA drops the Ball

By Norma Erickson, President
16 September 2011, in response to an inquiry about SANE Vax’s recent discovery of genetically engineered HPV DNA in Gardasil™[i], the following announcement was broadcast on radio out of Clonmel, County Tipperary, Ireland:

“The IMB (Irish Medicines Board) and European Medicines Agency (EMA) are aware of the recent communication from Sane Vax and following on from this, the EMA requested the marketing authorisation holder conduct an immediate assessment of the risk of contamination.

The IMB, through its participation in EU Scientific Committees is contributing to the ongoing EU assessment of this issue and will continue to do so at further EU meetings scheduled over the coming week. Any updates on the outcome of these discussions and any recommendations will be highlighted, as appropriate. At present, the balance of risks and benefits for the vaccine remains positive.

The Gardasil vaccine has been licensed for use in the EU since 2006. The IMB together with the EMA continue to monitor the benefit-risk profile of Gardasil.”

This is particularly good news for medical consumers in the 27 countries belonging to the European Union (Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom). An ‘immediate risk assessment’ should mean the marketing authorisation holder must now:

Determine the extent of the contamination
Determine any potential health risk that could result from HPV rDNA attached to aluminium adjuvant being injected into the human body
The critical issue here is not that the vaccine has residual DNA in it, but that the contaminating HPV DNA is genetically modified and firmly attached to the aluminium adjuvant – making it an unknown quantity as far as potential health risks.

Is recombinant (genetically engineered) HPV DNA, or adventitious DNA, capable of altering human DNA potentially initiating cancer, or a host of autoimmune disorders?

The manufacturer of Gardasil™, Merck, went to great lengths to assure government health authorities around the world there was no viral DNA in the vaccine.[ii] [iii] Merck repeatedly told health authorities that this vaccine only contained virus-like particles manufactured from the L1 protein – NO HPV DNA. Recognizing the potential health risks of residual DNA, government health officials relied on this assurance when they approved the vaccine for use in their countries.

The SANE Vax team believes the solution is simple. Gardasil™ does not meet the specifications the manufacturer put forth to gain approval for the use of their HPV vaccine. Therefore, Gardasil™ use should be discontinued until such time as the manufacturer can either remove all residual HPV DNA from the vaccine, or prove the residual HPV rDNA attached to the aluminium adjuvant poses no health risks when injected into the human body.

SANE Vax Inc would like to thank the EMA and IMB for ‘stepping up to the plate.’ We believe demanding an immediate risk assessment be performed by the authorisation holder is the only reasonable avenue available. Medical consumers around the globe will be watching and anxiously awaiting the outcome of your investigations into this matter.

SANE Vax Inc notified the FDA about the discovery of HPV rDNA contaminants in Gardasil™ before anyone else was informed.[iv] Why does this government agency remain strangely silent regarding the contamination of Gardasil™? Has the Food and Drug Administration in the United States ‘dropped the ball’?

Could it be that since the FDA failed to require the manufacturer to test for, evaluate and quantify the risks of residual recombinant HPV DNA in Gardasil™ before granting approval for marketing the vaccine, they just decided to take their toys and go home?

Medical consumers deserve better than that.


[i] SANE Vax Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil

[ii] Vaccines and Related Biological Products Advisory Committee (VRBPAC) Briefing Document-Gardasil

[iii] JVCI Statement on Human papillomavirus Vaccines

[iv] SANE Vax to FDA: Recombinant HPV DNA found in multiple samples of Gardasil

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