Gardasil Contamination, FDA drops the Ball


Please see the latest breaking news below. The Irish Medicines Board
and the European Medical Agency have called for a formal risk
assessment of the contaminant discovered in Gardasil. Strangely, the
FDA is still silent on the issue. Please feel free to circulate this
far and wide. There has obviously got to be public pressure applied to
force the FDA to take some action to protect the medical consumers in
the United States.

Here is the link to the article on the web –

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

Please – help people become informed – our government is not taking
their responsibility seriously.

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

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
[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

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