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3 changes to children’s vaccine recommendations announced

February 4, 2012 By Leave a Comment

MyHealthNewsDaily, Cari Nierenberg

New Vaccine Recommendations

The nation’s largest pediatrician group today released its new schedule of recommended childhood vaccinations. It made three major changes to its previous recommendations, after a federal advisory panel of experts reviewed recent evidence from vaccine studies.

The biggest change is the new recommendation that boys should be vaccinated against human papillomavirus (HPV). Since 2006, the HPV vaccine has been recommended for girls, primarily to help prevent cervical cancer, and in 2009, the experts advised that boys “could” be given the shots, too.

The stronger wording in the new recommendations, that boys “should” be given the shots, came about because new data showed giving boys the vaccine can help lessen the odds of HPV-associated cancers in men and in women, said Dr. H. Cody Meissner, chief of pediatric infectious disease at the Floating Hospital for Children at Tufts Medical Center in Boston.

Read the entire article here.

 

Filed Under: Cervical Cancer, HPV Vax, Science & Medicine, The United States, Vaccine Science, Vaccines and the Media Tagged With: , , ,

Your Doctor Cannot Tell You That Gardasil HPV Vaccine Or Cervarix Is Effective

February 3, 2012 By 1 Comment

The safety of the gardasil hpv vaccine and Cervarix hpv vaccine has come into question with countless vaccine injury’s, vaccine side effects and even dozens of deaths related to cervarix and gardasil hpv vaccine.   Now, a practitioner might tell you the risk outweighs the benefits, the problem is, your doctor cannot tell you that gardasil hpv or the cervarix  hpv vaccine is effective, for one simple reason…there is no evidence based medicine behind its trials.

You see, cervical cancer can take 20 to 40 years to develop after the time of HPV infection, andGardasil HPV follow up tests have only been done for a maximum of 5 years and ceravax for just a little over 8 years, so it is basically all just theory with some dire risks.

Canadian researchers Lucija Tomljenovic, PhD, and Christopher Shaw, PhD, from the Neural Dynamics Research Group, University of British Columbia, in Vancouver, point out that there is a major discrepancy in claims regarding the safety and efficacy of Gardasil (Merck & Co) and Cervarix (GlaxoSmithKline) — the 2 HPV vaccines that are currently on the market.

Read the entire article here.

 

 

 

 

 

 

Filed Under: HPV, HPV Vax, Vaccine Science Tagged With: , , , , ,

Gardasil HPV Vaccine Now Being Promoted For HPV Of The Mouth

February 3, 2012 By Leave a Comment

Original post: AwareAndPrepare.com

Gardasil Marketing?

As we have reported before, it seems the MO for many vaccine manufacturers is to get a vaccine approved for one population, and then increase the use of the vaccine to as many more patient populations as possible, regardless of whether it is safe and effective or they need it or not.  Even with wide spread vaccine side effects, vaccine injury and even vaccine death related to the Gardasil HPV vaccine, attempts are being made for mandatory vaccinations of teenage boys, women over 40, and now, anyone with a mouth.

This will be used to promote the Gardasil HPV vaccine, even though it is only effective against a few strains of HPV while there are many strains of HPV.  People must do their due diligence when it comes to the thought of “to vaccinate or not”, benefit vs risk scenarios are often not optimally delivered by medical personal which often leads to vaccine side effects, vaccine injury and even vaccine death, whether we are dealing with mandatory vaccinations or not.

Read the entire article here.

Filed Under: HPV, HPV Vax, Oral Cancer, Vaccine Marketing Tagged With: , , , ,

Mother seeking $200 000 after daughter’s death

February 1, 2012 By Leave a Comment

CJAD

800 AM
Canada

Posted By: Laura Casella lcasella@astral.com · 1/31/2012 12:58:00 PM

 

A family is seeking close to $200 000 from the sellers of the HPV vaccine because they believe it killed their teenage daughter.

Linda Morin says while she approved of her 14-year-old daughter Annabelle getting the vaccine, she didn’t know when she’d receive it.

So when Annabelle was rushed to the hospital one night for constant vomiting and a loss of memory, Morin says she didn’t know it was just days following a first dose of Gardasil.

Doctors also couldn’t make the link and diagnosed it as a simple migraine.

Annabelle then went on to get a second dose of the vaccine and a few days after that in December 2008, was found dead in the bathtub.

“I was shocked. I didn’t know what to do,” Morin says.

The family is now seeking $197 000 in damages from Merck Frosst, which markets the vaccine, and from three doctors who treated Annabelle after her first dose.

Merck Frosst refused comment when contacted by CJAD news.

Read more here…. http://www.journaldemontreal.com/2012/01/30/une-famille-reclame-197-000-

Filed Under: Canada, Canadian Concerns, Death, Gardasil / Silgard Tagged With: , , , ,

SaneVax Open Letter to Kathleen Sebelius, Secretary of Health and Human Services

January 31, 2012 By 12 Comments

31 January 2012, Open Letter

To:  Kathleen Sebelius, Secretary of Health and Human Services – Kathleen.Sebelius@hhs.gov

Subject: Rescind approval of Gardasil® due to lack of efficacy during post-licensure monitoring

Dear Ms. Sebelius:

The quadrivalent human papillomavirus (HPV) vaccine, Gardasil® was approved for marketing as a drug to prevent cervical cancer under the fast track drug development program despite the fact the proposed vaccine did not qualify to use this program under FDA regulations. Since it was ‘fast-tracked,’ the manufacturer was allowed to use self-reversible precancerous lesions as surrogate endpoints for the evaluation of its efficacy to potentially prevent cervical cancer 30-40 years down the road. As you know, Fast Track Drug Development Programs are governed by the following stipulation:

“Where an accelerated approval is based upon a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity, post-marketing studies are ordinarily required “to verify and describe the drug’s clinical benefit and to resolve remaining uncertainty as to the relation of the surrogate endpoint upon which approval was based to clinical benefit, or the observed clinical benefit to ultimate outcome” (57 FR 58942, December 11, 1992).”

In compliance with the required post-marketing monitoring surveys, the CDC published the following guideline:

“While there are well established cancer registries in the United States, it will take decades before the impact of vaccine on cervical cancer is observed. More proximal measures of vaccine impact include outcomes such as prevalence of HPV vaccine types, incidence of cervical pre-cancers and genital warts.” [1]

According to a recently published, industry-sponsored study conducted on 12,852 young women, HPV vaccination was found to reduce 0.6% of HPV-16 infections, while increasing the rate of other high-risk (carcinogenic) HPV infections among the vaccinated women by 2.6-6.2% compared to the non-vaccinated women. The latter increased rate of infections caused by carcinogenic HPVs other than HPV-16 and HPV-18 in vaccinated women is 4 to 10 times higher than the reduced rate in HPV-16 infection. [2]

In the interest of public health and safety, due to this demonstrated lack of efficacy among consumers during post-licensure monitoring that used CDC recommended ‘more proximal’ measures to monitor vaccine impact, we hereby request the Secretary take immediate action to rescind the approval of Gardasil® for marketing in the United States until additional post-licensure data is available to support the efficacy of this new drug.

Thank you for your kind attention to this matter.

Respectfully,
Norma Erickson, President
SANE Vax Inc.
 
Signed on behalf of the Board of Directors, SANE Vax, Inc.
Leslie Carol Botha, Vice President of Public Relations
Janny Stokvis, Vice President of Research
Rosemary Mathis, Vice President of Victim Support
Freda Birrell, Secretary
Linda Thompson, Treasurer

References

  1. Markowitz LE, Hariri S, Unger ER, Saraiya M, Datta SD, Dunne EF. Post-licensure monitoring of HPV vaccine in the United States. Vaccine. 2010; 28:4731-7.
  2. Wright TC Jr, Stoler MH, Behrens CM, Apple R, Derion T, Wright TL. The ATHENA human papillomavirus study: design, methods, and baseline results. Am J Obstet Gynecol. 2012;206:46.e1-46.e11. (See Table 3)
  3. Human papillomavirus (HPV) vaccine policy and evidence-based medicine:
    Are they at odds? Lucija Tomljenovic, Ph.D., Christopher A. Shaw,
    Ph.D., Annals of Medicine, Jan. 2011
Cc: Dr. Margaret Hamburg, FDA Director – margaret.hamburg@fda.hhs.gov
Dr. Lauri Markowitz, CDC Epidemiologist – lauri.markowitz@cdc.hhs.gov 
 
 
Filed Under: United States Concerns Tagged With: , , , ,

Post-Gardasil Syndrome in Quebec Followed Vaccination Sans Consent

December 13, 2011 By Leave a Comment

Age of Autism

December 10, 2011

Camille from Quebec

After much research and discussion, my daughter and I had both signed the required form to refuse the Gardasil vaccine currently being administered in Quebec. In order to assure there would be no problem, I also phoned the school the morning the first dose of Gardasil was to be offered and spoke to the school nurse to inform her that my daughter would not be receiving this vaccine. The nurse assured me there would be no problem.

On 28 September 2011, my daughter presented the signed vaccine waiver and informed the school nurse that she would not receive the HPV vaccine. The nurse then set aside 15 minutes to inform Camille about the benefits of the vaccine.

After the discussion, Camille repeated her decision to refuse the Gardasil injection. The nurse then handed her additional informational documents and told Camille that if she changed her opinion, she could always inform the other nurse.

Subsequently, Camille met with a second nurse, this one outraged that my daughter refused the vaccine. She had set aside 10 minutes of her time to try to convince Camille again. The only side effect she mentioned was headache. This nurse pointed out that Camille would be the only one in the school to refuse Gardasil. She told her the consequence of refusing meant she could get cancer and die, only because she was being stubborn. She continued on until Camille finally granted her consent.

At that point, the nurse told her not to show her health record to her mother in order to avoid any discussion on this at home.

My daughter was pressured until she agreed to be vaccinated. Her ‘consent’ was neither freely given, nor appropriately informed. Camille’s consent was obtained through intimidation. A 14-year old girl does not have the experience to deal with authority figures in the same manner as an adult.

In my opinion, the way Camille was treated was an abuse of power and a breach of my trust in school health authorities.

Without my consent, or knowledge, Camille received her first Gardasil injection at 3:45 pm on that day. By 4:00 pm she was on the bus to come home. She already had a stomach ache and a headache. She decided to try and rest during the 45 minute drive home. She lost consciousness. Students noticed and tried to wake her up, but when they did she acted confused. They informed the bus driver, who promptly stopped the bus and called an ambulance.

She was admitted to St-Jérômes Hospital barely 2 hours after her injection. She has no memory of how she got to the hospital other than she recalls waking up in the ambulance. The hospital staff said there was no link between her condition and the vaccine. They recommended consulting an allergist.

The future brought fever, rash, fainting, fatigue, weakness, headaches, stomach pains and more consultations. She is now being treated for a urinary infection, abscesses in her mouth and oral candidose.

No link?

I lodged a formal complaint to the Order of Nurses of Québec. Teenage girls must be informed and warned of all possible side effects – not be left in the dark.

Today, nearly two months after the first shot of Gardasil, my daughter still has headaches that will not go away. Day after day she has to deal with them. She has no more appetite and has lost weight. This girl, who has been to an ophthalmologist every year since she was two years old and exhibited perfect vision, has now been told she will have to wear glasses because of her deteriorating vision.

For 11 years her vision was perfect, no longer – no link?

The doctor from the Canadian Health Agency told us there was no link between her symptoms and Gardasil. Furthermore, she said that Camille was sick and had all of those symptoms prior to vaccination. How can she say that?

I swear to God, my daughter’s health was in perfect condition BEFORE she got this shot.

Read Full Article here……http://sanevax.org/victims-2/

Filed Under: Canadian Concerns, Gardasil / Silgard Injuries, SANE Vax Press Releases Tagged With: , , , , ,

Wollongong University Researcher Writes to Australian Government Officials

October 20, 2011 By Leave a Comment

Sent: Wednesday, October 19, 2011 11:41 AM
To: Honourable Nicola Roxon
Cc: peter.collignon@act.gov.au; attorney@ag.gov.au; Anna Salleh; enquiries@sweetcommunication.com.au; bitan@theaustralian.com.au;r.manne@latrobe.edu.au; senator.bob.brown@aph.gov.au; andrew.wilkie.mp@aph.gov.au; pbarr@rtrfm.com.au; mediawatch@your.abc.net.au;complaintsinfo@humanrights.gov.au; cathy.oleary@wanews.com.au; julian@jjlaw.com.au
Subject: Steven Hambleton President of the AMA
Importance: High

To the Federal Health Minister,

I am writing in response to the article ‘A Noble Cause’ aired on Background Briefing on the ABC radio 16.10.11. In this article the President of the AMA, Dr. Steven Hambleton, made his position on the transparency of government health policies crystal clear. He stated that:

 ‘A register could jeopardise the reputations of the doctors on it’. In another words, the public interest is not a priority. The need for ‘balanced, unbiased and evidence-based science’ is clearly not a goal to be achieved by the AMA.

This statement was made with respect to the following activities of doctors and institutions:

  • doctors being paid to give presentations using pharmaceutical company slides and pharmaceutical funded research and statistics
  • doctors given free international trips and paid to give presentations for drugs
  • Pharmaceutical sales representatives given large bonuses to sell a drug even after concerns were raised about the side-effects of the drugs
  • The hidden industry ties of academics in universities and similarly in government advisory boards.
  • The conflicts of interest in the media presentation of drugs and their side-effects
  • The conflicts of interest in Australia’s National Immunisation Conference presented by the Public Health of Australia (PHAA) and fully funded by the pharmaceutical companies
  • The hidden ties between industry and the chief-editors on peer-reviewed journals, who are selecting against articles with negative findings on drugs/vaccines.
  • Little research funding being provided for research in the public interest. In particular, the possibility that the chemicals in the 13 vaccines now recommended to infants under 12 months of age, are causing the steep increase in chronic illness in our children.

These activities of the health department are all occurring without an adequate surveillance system for adverse reactions to drugs and in particularto vaccines (which are for healthy people). Australia has a passive post-marketing surveillance system for adverse reactions that is not designed to determine causal relationships with the vaccine. This is a significant failing of the health system and means that chronic illness in the population will continue to increase - despite all the money that is being put into healthcare. It also means we will need to put millions of dollars into disability insurance schemes for long-term carers created by a fraudulent health system. Please contact Professor Peter Collignon (ANU) for confirmation of the inadequate surveillance system set up for determining the rates and causal links for adverse events to vaccines.

If you (as the Health Minister) are unaware of the ingredients of vaccines and if you have never used 13 vaccines in yourself in a one year time frame, can I please ask why you would be recommending that 13 should be used in a developing infant? These questions have been put to Professor Fiona Stanley and the Telethon Institute but they have not been answered. Instead the academics and scientists who are speaking out on this issue are being attacked by faceless people on twitter and blogs. The consumers are wanting this policy supported by evidence-based science but consumer organisations have become toothless as advocates and health professionals protect their jobs.

I have attached a picture for you to see the implications of the current immunisation schedule and in the words of Professor Fiona Stanley ‘many educated people are no longer vaccinating their children’.

Please could you address these issues in your department as consumers would like some accountability. I am happy to provide references for any of the claims made in this email. I will forward this email to the community.

Kind regards, 
Judy Wilyman
PhD researcher
Wollongong University

 

Filed Under: Australian Concerns Tagged With: ,

Canadian Mum Writes Letter of Concern about Gardasil to Prime Minister

October 9, 2011 By 1 Comment

The following letter was written by a Canadian mum to express her concerns about Gardasil® to the Prime Minister of Canada:

Subject: Gardasil Safety

Hello,

My name is Heather Martin and I am writing to ask you questions regarding information I received that the vaccine Gardasil (HPV – Human Papilloma Virus) has been tested in the United States, Australia, Poland and elsewhere and has tested positive for rDNA contamination.  It is unclear whether this rDNA poses a risk to human health (Cancer, rheumatoid arthritis, etc..), but given the numerous cases of serious adverse reactions to this vaccine it would seem prudent to firstly be aware of the potential risk and to secondly, cease the administration of this vaccine until further testing can be done.

A physician in the US named Dr. SH Lee, has been testing this vaccine at the Milford Hospital at a lab there.  In the days prior to a visit from FDA officials to confirm his results, the hospital locked the doors to his lab and fired him on the spot.  His hope was to reason with the directors of Milford Hospital and that it would all blow over.  However, several months have passed and Dr. Lee has been subject to slander, humiliation and has not been able to complete his work or provide the FDA with the information it has requested of him regarding the vaccine.  He has since retained council and has proceeded to file a case against the hospital.

Dr. Lee is an internationally respected pathologist who was contracted by SaneVax to investigate and test Gardasil due to injury and wrongful death complaints by parents whose children had received the vaccine.  Dr. Lees results have been published in peer reviewed journals and he is considered an expert in the purification and methods of detection of DNA and rDNA in the lab.

The case of Dr. Lee brings me to my question:  Has similar testing been conducted on the batches of Gardasil administered here in Canada?  Will there be a moratorium on the administration of Gardasil until the results of such testing can be concluded by an independent lab here in Canada?  And if not, why not?

I concede that I am not a professional scientist, but I am a mother of girls and would like to be reassured (as would all mothers) that the vaccine we are giving them will be safe in the short and long term.

I resent the public health systems inference that parents who sign the ‘opt out’ form for their daughters grade 6 HPV shot are somehow negligent.  To me, pharmaceutical companies who do not properly test their products before selling them to the government and the public are negligent.  Therefore the Canadian government is equally negligent under its own Consumer Products Safety Act if it does not investigate this matter.

The reality is that people are suspicious of vaccines now more thanever and it is imperative that IF the public is expected to take these vaccines without question, that there be no question regarding safety of these vaccines.  Until the authorities that promote them can answer that, people will not comply.  It is my opinion that the duty of the Health Agency of Canada  investigate these allegations in order to do its job, which is to protect the health of Canadians.

Thank you for your time in answering these questions for me.

Sincerely,
Heather Martin

p.s.
The link to the SaneVax article can be found here: http://sanevax.org/sane-vax-inc-reports-human-papillomavirus-hpv-dna-contamination-in-gardasil%E2%84%A2-to-fda-requests-public-safety-investigation/

Reply:

From: “Prime Minister/Premier ministre” <pm@pm.gc.ca>
Date: October 3, 2011 10:25:07 AM CDT (CA)
To: “Heather Martin” 
Cc: “Leona Aglukkaq, P.C., M.P.” <minister_ministre@hc-sc.gc.ca>

Subject: Office of the Prime Minister / Cabinet du Premier ministre

Dear Ms. Martin:

Thank you for writing to the Prime Minister. In your e-mail, you raised an issue that falls within the portfolio of the Honourable Leona Aglukkaq, Minister of Health.

Please be assured that your comments have been carefully noted.  I have taken the liberty of forwarding your e-mail to Minister Aglukkaq. I am certain that the Minister will wish to give your views every consideration.

For more information on the Government’s initiatives, you may wish to visit the Prime Minister’s Web site, at www.pm.gc.ca.

Once again, thank you for taking the time to write.

M.F. Bustos
Manager/Gestionnaire
Executive Correspondence Services
for the Prime Minister’s Office
Services de la correspondance
de la haute direction
pour le Cabinet du Premier ministre

Filed Under: Canadian Concerns Tagged With: , , ,

Freda Birrell, SANE Vax, letter to Committee for Medicinal Products for Human Use regarding Gardasil contamination

October 3, 2011 By 5 Comments

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?

 Freda Birrell

East Lothian – Scotland

Secretary Sane Vax Inc – www.sanevax.org

References:

http://www.parliament.uk/deposits/depositedpapers/2011/DEP2011-0706.pdf 1

(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

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000721/WC500024632.pdf 2

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.

Kind Regards,

Document & Information Services
European Medicines Agency
7 Westferry Circus
Canary Wharf
London
E14 4HB
United Kingdom

info@ema.europa.eu
http://www.ema.europa.eu

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 reply from Dr. Abadie, Chairman CHMP, here.

Read the EMA adopted response to SANE Vax concerns here. (online version)

Read SANE Vax response to the EMA here.

 

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.

Yours sincerely,
Sarah Walker
Customer Service Centre
Department of Health

Filed Under: Europe, UK Concerns Tagged With: , , , , , , ,

Irish Vaccine Safety Advocate Files Complaint Against Health Authorities re: Gardasil

September 20, 2011 By Leave a Comment
 
Superintendent,
Clonakilty Garda Headquarters,
McCurtain Hill,
Clonakilty,
Co. Cork.

 

Dear Superintendent,

I am lodging a formal complaint with you against the Irish Medicines Board, the Health Service Executive, and the Irish Government for failing to withdraw the Gardasil Vaccine Human Papilloma Virus(cervical Cancer vaccine) which is known to be contaminated.  I am also enclosing a letter that I have forwarded to the Convent of Mercy in Clonakilty and to a number other schools to alert them to the contamination.

They are continuing to allow girls to be vaccinated, through the school vaccination programme with a vaccine that is now under investigation. This vaccine poses a serious risk to the lives and health of girls and women. I have notified a number of secondary schools and will try to inform others. It is impossible to get this vital information to everyone. In many schools today, Monday, and during the coming weeks, girls are scheduled to receive the Gardasil vaccine.

The Gardasil contamination was uncovered after a young girl who had been vaccinated with the Gardasil vaccine developed severe juvenile Rheumatoid Arthritis. When she was examined the girl was found to have HPV DNA in her blood two years post Gardasil vaccination. As this finding was not normal, it was then decided to analyse a vial of Gardasil. It tested positive for genetically modified HPV DNA.

Subsequent tests of vials of the Gardasil vaccine manufactured by Merck, were selected from thirteen different lot numbers and from various countries worldwide.100% of the samples tested positive for the presence of genetically modified HPV DNA. The lots tested came from four separate manufacturing facilities.

Merck, has already stated officially that “Gardasil is not a live vaccine: It contains no viral DNA, and is therefore incapable of causing infection”.

Scientists have now confirmed that Gardasil is contaminated with viral DNA .

!00% contamination in the vials tested worldwide. This contamination potentially poses a very serious risk to girls who receive the vaccine.

The vaccination programme has now resumed in Irish schools. The Irish Medicines Board is fully aware of the findings by Sane Vax Inc. The IMB acknowledged this in a private e-mail and in a statement to Tipperary FM Radio.  Administering a vaccine that has proven to be 100 percent contaminated in the tests carried out to date, is reckless and negligent and constitutes a serious abuse of children.

Please acknowledge receipt of this complaint.

Yours sincerely,

xxxxxxxxx

 

Filed Under: Irish Concerns Tagged With: , , , , ,
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