Dear Mr Chairman and Vice-Chairman of the CHMP Committee
I am sending the undernoted to all the members of your Committee
The two Press Releases, the one attached above “Sane Vax Inc announces the discovery of Viral HPV DNA Contaminant in Gardasil and the following link to “Sane Vax Inc discovers potential biohazard contamination in Merck’s Gardasil HPV 4 Vaccine” have to both be read to be believed.
By accident and not by design, information was sent to Sane Vax Inc from a mother in Canada who advised us that her daughter was found to have HPV DNA in her blood 2 Years Post-Vaccination with Gardasil. This was verified by Dr Sin Hang Lee, Pathologist at the Milford Hospital Pathology Laboratory who found no reason to question the local laboratory’s findings.
As it was regarded that this discovery was ‘not normal’ it was decided to analyse a vial of Gardasil. This sample tested positive for recombinant (genetically engineered) viral HPV-11 and viral HPV-18 residues, both of which were firmly attached to the aluminium adjuvant. To make certain that this analysis could be replicated it was decided to obtain other vials, with different lots numbers from various countries around the world. The Gardasil vials with different lot numbers were from New Zealand, Australia, Spain, Poland, France and three states in the U.S. 100% of the samples tested positive for the presence of the genetically modified HPV DNA and the lots tested came from four separate manufacturing facilities.
As indicated above this discovery was by accident and not by design. However, it raises many serious issues which now have to be dealt with by our respective governments in London, in Edinburgh and by the European Parliament. We have been advised by the JCVI, by the European Parliament, by the FDA and by Merck that the HPV vaccines do not contain any viral DNA. This is recorded in links 1, 2 and 3 below and is the official wording from these organisations.
There are now many serious questions which have to be raised regarding this discovery:
- What action do the UK Government, Scottish Parliament and European Parliament intend to take on this matter?
- Gardasil is licensed in the UK and comes under the safety umbrella of our Government’s Agencies; Cervarix has been administered in our schools since 2008 (though there is speculation that it will be replaced in the UK by Gardasil) and it is imperative that the same type of analysis has to be carried out to ensure the safety of Cervarix;
- In the light of what has been discovered nothing can be taken for granted;
- How many adolescents who have suffered adverse reactions post Gardasil vaccination have HPV DNA in their blood?
- What are the medical ramifications if HPV DNA should remain in the blood stream for an extended period of time?
- Is the aluminium adjuvant a carrier for the HPV DNA?
- What happens if genetically engineered DNA enters a human host cell?
- Will it mutate the host cell leading towards cancer and other autoimmune disorders?
- The Medical profession and consumers need to have these questions answered NOW because of the new programme which starts again this September; otherwise serious repercussions could arise if no action is taken;
- Will proper checks be carried out on Cervarix to ensure that this vaccine does not contain any contaminations bearing in mind it is also a genetically modified vaccine produced by similar manufacturing techniques?
- Many reports and correspondence have been sent to the UK and Scottish governments informing them of girls who have become seriously ill after vaccination with Cervarix, very similar symptoms to girls who became ill after Gardasil; could these now come back to haunt them if this information is not taken seriously and proper investigations carried out?
East Lothian – Scotland
Secretary Sane Vax Inc – www.sanevax.org
(end of page 1 and beginning of page 2):
HPV vaccines are sub-unit vaccines made from the major protein of the viral-coat or capsid of HPV.Virus-like particles (VLPs) are prepared as recombinant proteins from either yeast or baculovirus infected cells that are derived from a type of moth. VLPs mimic the structure of the natural virus but do not contain any viral DNA.
This is a reference to both Gardasil and Cervarix – Joint Committee on Vaccination and Immunisation
See 5. Pharmacological Properties
5.1 Pharmacodynamic properties
….. Since the VLPs contain no viral DNA, they cannot infect cells, reproduce or cause disease. This is a reference to Cervarix, European Medicines Agency
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM231522.pdf 3
Page 12, 3.2
3.2 GARDASIL®- The Quadrivalent HPV (Types 6, 11, 16, 18) Vaccine
…. GARDASIL® is not a live virus vaccine; it contains no viral DNA, and is therefore incapable of causing infection.
Explanation of the word ‘Viral’
Viral is any DNA (whole or partial) that originally came from a virus, in this case the HPV virus, and that could include natural DNA, wild DNA or genetically engineered DNA
The European Medicine agency responded with the following email:
Dear Ms Birrell,
Please find herewith attached the response to your request.
Document & Information Services
European Medicines Agency
7 Westferry Circus
Frequently Asked Questions (FAQs) have now been published on the Agency’s website. It comprises answers to the most commonly asked questions submitted to the EMA. You are invited to consult it here: (see attachment below)
Read the EMA adopted response to SANE Vax concerns here. (online version)
Reply from the Department of Health:
Our ref: DE00000645764
Dear Mrs Birrell,
Thank you for your correspondence of 19 September to the ministers of the Department of Health about Gardasil. I have been asked to reply.
The Department is aware that this issue was recently considered by the European Committee for Medicinal Products for Human Use (CHMP) and its Biologics Working Party (BWP) at their September meetings.
The CHMP takes very seriously any potential contamination issue and has considered all the available evidence in relation to the statements made about Gardasil in relation to HPV DNA.
The CHMP concluded that the presence of recombinant DNA fragments does not represent a case of contamination and is not considered to be a risk to vaccine recipients. The current benefit-risk balance of Gardasil was not considered to be affected by this information and Gardasil is considered to remain safe and effective.
On 23 September, the European Medicines Agency posted the CHMP’s response to the concerns raised by Sane Vax on its website, which can be found at http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/09/WC500112851.pdf.
As with all vaccines and medicines, any emerging evidence relating to possible risks associated with the vaccine is carefully reviewed and, if appropriate, regulatory action is taken.
I hope this reply is helpful.
Customer Service Centre
Department of Health