12/09/2011

Call for Review of Contaminated Gardasil Vaccine

 

The Ministry of Health must immediately recall and review the potentially life threatening Gardasil vaccine as six New Zealand batches have tested positive for the synthetic recombinant Human Papilloma Virus (HPV) DNA [1] [2]. This finding is highly concerning as the Health Authorities were told that all viral DNA had been removed from the vaccine through purification.

The Merck Sharpe and Dohme (NZ) HPV Virus vaccine Gardasil has been linked to adverse reactions leading to hospitalisation and persisting disability. [3]

The U.S. Federal Drug Administration (FDA) [4] vaccine events reporting site (VEARS) has 12,424 reports of adverse events following Gardasil vaccination. Of these, 772 were reports of serious events (6.2% of the reports) and the remaining 11,652 (93.8%) were classified as non-serious. In New Zealand 1 death has so far been attributed to the vaccine.

The discovery that some batches contain HPV DNA contradicts the Medsafe data sheets [5] statement that the vaccine does not contain viral DNA."

"virus-like particles are adsorbed onto an aluminium-containing adjuvant (amorphous aluminium hydroxyphosphate sulfate, or AAHS)… because the virus-like particles contain no viral DNA, they cannot infect cells or reproduce.”

“The finding raises concerning issues around the safety of such genetically engineered vaccines and the purification processes they undergo, as many are produced from virus-like particles bonded to aluminium salts,” said Claire Bleakley president of GE-Free NZ.

“It is now apparent that the method used to detect whether functional HVP DNA is transferred into the vaccines is defective.”

Dr. Sin Hang Lee [6] a pathologist at the Milford Hospital pathology laboratory US , is quoted as saying that "once a segment of recombinant DNA is inserted into a human cell, the consequences are hard to predict. It may be in the cell temporarily or stay there forever, with or without causing a mutation. Now the host cell contains human DNA as well as genetically engineered viral DNA.”

SANE Vax Inc who investigated and discovered this contamination event after testing the blood of an adolescent girl two years post -vaccination, have expressed concern over the prolonged circulation of the foreign recombinant (GE) DNA as the natural virus is short lived. The vaccine was genetically engineered to produce “virus like” particles to stimulate immunity. It is not known if GE DNA has used the body’s cellular mechanisms as a host to keep replicating with unknown results.

“This serious revelation has highlighted that the regulatory authorities rely too much on industry based findings and not independent science. There are increasing reports of auto immune diseases such as juvenile arthritis and Guillian-Barre Syndrome occurring after the use of recombinant vaccines [7], raising questions about the impact of genetically engineered foreign proteins present in food and vaccines,” said Claire Bleakley.

“The Ministry of Health must immediately recall and retest all vaccines that are made from genetically engineered (recombinant) DNA to check that the purification process has removed all recombinant DNA that could be associated with increasing the risk of serious health problems.”

ENDS:

Claire Bleakley 06 -3089842 / 027 3486731

References:

[1] http://sanevax.org/wp-content/uploads/2011/09/Gardasil-Vaccine-Lots-by-country.pdf

[2] http://sanevax.org/sane-vax-to-fda-recombinant-hpv-dna-found-in-multiple-samples-of-gardasil/

[3] http://carm.otago.ac.nz/pdfs/HPV_%20AEFI%20summary_December%202009.pdf

[4] http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm179549.htm

[5] http://www.medsafe.govt.nz/profs/Datasheet/g/Gardasilinj.pdf

[6] http://sanevax.org/sane-vax-inc-discovers-potential-bio-hazard-contaminant-in-merck%E2%80%99s-gardasil%E2%84%A2-hpv-4-vaccine/

[7] Choe YJ, Cho H, Kim SN, Bae GR, Lee JK. (2011) Serious adverse events following receipt of trivalent inactivated influenza vaccine in Korea , 2003-2010. http://www.ncbi.nlm.nih.gov/pubmed/21827815

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