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FDA ANNOUNCES DNA FRAGMENTS - NO SAFETY RISK

October 28, 2011
by Norma Erickson, President www.sanevax.org

In response to the recent announcement by SANEVax Inc. of the discovery of genetically modified HPV DNA residue in multiplevials of Gardasil, the FDA posted the following page on their site, FDA Information on Gardasil – Presenceof DNA Fragments Expected, No Safety Risk. The FDA lists several ‘key facts’ in an obvious attempt to allay any fears which may have arisen over the discovery of foreign DNA in yet another ‘safe and effective’ vaccine.  Unfortunately, these ‘key facts’ raise more questions than answers.

In spite of the fact the FDA claims their mission is, helping the public get the accurate, science-based information they need to use medicines, there are no scientific references and no indication that these ‘key facts’ are anything more than damage control statements.  American medical consumers deserve better from an agency funded by taxpayers and entrusted with the mission of being responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices……(FDA mission statement)

According to the Consumer Justice Group, in the last 27 years, there have been 31 drugs approved ‘safe and effective’ by the FDA which were subsequently withdrawn from the market due to safety concerns not uncovered during clinical trials. No one will ever know the true cost in human suffering resulting from adverse reactions to these 31 FDA approved ‘safe and effective’ medications.

Medical consumers worldwide are not willing to risk their children’s health and perhaps their very lives on a vaccine that ‘might’ prevent cancer 20 to 30 years down the road. Parents are not willing to wait until the adverse events post Gardasil vaccination reaches the same numbers as Vioxx did before the vaccine is withdrawn from the market.

Medical consumers around the world are no longer willing to accept the FDA’s ‘word’ when it comes to HPV vaccines and their children’s health and safety. They are demanding scientific proof of the claims made by the FDA and vaccine manufacturers.

FDA ‘Key Facts,’ and questions raised by SANEVax Inc. on behalf of medical consumers:
Gardasil does contain recombinant HPV L1-specific DNA fragments, but these are not contaminants. DNA encoding the HPV L1 gene is used in the vaccine manufacturing process to produce the virus-like particles that make up the vaccine. The presence of these DNA fragments is expected, is not a risk to vaccine recipients, and is not a safety factor. DNA is the “blueprint” for the majority of living organisms and carries the genetic instructions for how cells function and grow.
Do these ‘expected’ DNA fragments contain plasmid?
Please explain why, if these HPV rDNA fragments are ‘expected,’ why did the manufacturer have to invent a patented process to remove them?
Please provide the DNA sequences of all ‘expected’ HPV DNA fragments in the vaccine.
Provide copies of all scientific studies that prove these DNA fragments are ‘not a risk to vaccine recipients.’
Do the  above referenced studies include studies regarding the potential safety concerns of these ‘expected’ DNA fragments being tightly bound to aluminum hydroxyphosphate micro-particles?

The vaccine manufacturing process is highly regulated under FDA’s current good manufacturing practice requirements, including inspections conducted by FDA of the manufacturing processes and facilities.

Please publish all reports of FDA inspections of the four manufacturing facilities from which the Gardasil samples tested at Milford Medical Laboratory originated since Gardasil’s FDA approval, including the DNA      sequences of the detectable residual HPV DNA molecules and the quantity of total HPV DNA per Gardasil dose.
Since the early development of Gardasil, FDA and the manufacturer (Merck and Co., Inc.) have known that after purification of the vaccine, small quantities of residual recombinant HPV L1-specific DNA fragments remain in the vaccine. Gardasil does not contain DNA from other HPV genes or any full-length infectious HPV genomes.

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THE HPV VACCINE - WHAT DO YOU REALLY KNOW ABOUT IT

(NaturalNews) If you are considering vaccinating your child with an HPV vaccine, what information have you read, and what questions have you asked?What do you KNOW about the human papillomaviruses (HPV) which the medical profession says causes cervical cancer?

If you are going to vaccinate your child on the word of the medical profession, and don’t want any further information, then stop right here. But be aware that ignorance is not bliss. And that the medical system has deliberately not told you everything you need to know about either the viruses, or the vaccine.

If you want to take responsibility for your own decisions, rather than hand over responsibility to the medical profession, then you might be interested in some of the following questions and answers, which deserve truthful answers that the vaccine industry doesn’t want to give you:

Question: Publicity for Gardasil says that girls should have this HPV vaccine before sexual intercourse, because they don’t catch this virus until they are sexually active. Is this correct?

No, this is not correct. Over the last 20 years, the medical profession has documented that human papillomaviruses can be transmitted during pregnancy, after pregnancy, from child to child, and adult to child.

Question: Why then are we told that these human papillomaviruses can only be contracted after sex?

Because adolescents are the market Merck was targeting, and to admit that the viruses can be acquired naturally before sex, doesn’t suit Merck. The medical literature for the last 20 years has also stated that to ignore the fact that HPV viruses can cause silent infection at any age ‘has implications for any vaccination programme,’ though those ‘implications’ have never been spelled out. However, they expect parents to naively believe that intelligent human papillomaviruses know they aren’t allowed to let themselves loose, until the first act of sexual intercourse. And for some reason, most parents believe this sort of nonsense statement.

Question: Are these viruses implicated in cervical cancers, and other cancers?

Yes they are – but primarily in people, whose innate immune system is struggling because they eat rubbish, drink alcohol, smoke cigarettes, don’t get enough sleep, and burn the candle at 12 ends. Much more than a virus is required for a woman to get cervical cancer.

Question: Doesn’t everyone get human papillomavirus infections?

Yes. Not only has ‘everyone’ but just about any species that breathes gets papillomavirus infections – even lizards. The medical literature shows that a good diet, correct mineral and vitamin intake, and living a healthy lifestyle, normally results in the recipient throwing off HP infections easier than a cold, and all they have to show for it, is lifelong natural immunity. Healthy lifestyles don’t fill Big Pharma bank balances, so you won’t be told about that.

Question: But I’ve been told this vaccine is so important! Is that wrong

This vaccine is very important for Merck’s accountants – vitally important. It’s ‘the’ product that is supposed to dig Merck out of its current financial woes.

But is it important for your child? No. The cervical smear programme stopped people dying of cervical cancer long before ‘fear-no-longer’ Gardasil came along. And because the vaccine only covers two types out of at least 20 supposedly carcinogenic HP virus types (amongst at least 300 different strains), people who have cancer phobia will still want to have smears anyway. Today, 90% of all deaths from cervical cancer occur in the third world countries which don’t have such a programme, or the ability to deal with abnormal smears even if they had a smear programme. The primary drivers of cervical cancer in third world countries are chronic malnutrition, and fundamentally atrocious living conditions, which happens to create the most susceptible population with the least resources.

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HEALTH AUTHORITIES ADMIT RECOMBINANT DNA IN GARDASIL

PRESS RELEASE - SANEVAX

October 14, 2011
by Norma Erickson, President

2 September 2011, SANE Vax Inc. posted a letter sent to Dr. Margaret Hamburg, FDA Commissioner, on their website to inform her that recombinant (genetically modified) HPV DNA firmly attached to the aluminum adjuvant had been discovered in Merck’s quadrivalent HPV vaccine, Gardasil™.

In what appears to be a worldwide coordinated response, SANE Vax Inc. and other advocacy groups have received the following replies:
22 September 2011, the European Medicines Agency, via Dr. Abadie said, “The presence of recombinant DNA fragments does not represent a case of contamination and is not considered to be a risk to vaccine recipients. All medicinal products manufactured using recombinant technology may contain small fragments of residual DNA.”
23 September 2011, the Food and Drug Administration (FDA) said, “We have determined that Gardasil is not contaminated with HPV DNA and remains safe and effective….Gardasil does contain recombinant HPV L1 specific DNA fragments. This is expected, since DNA encoding the HPV L1 gene is used in the vaccine manufacturing process to produce the virus-like particles. The presence of these expected DNA fragments, which are inevitable in vaccine production, is not a risk to vaccine recipients, is not harmful, and this DNA is not a contaminant.”
28 September 2011, MedSafe in New Zealand, via email to a local vaccine safety advocate said, “Gardasil is manufactured using recombinant DNA technology so any finding of residual DNA fragments in the vaccine is expected and does not represent contamination.”
7 October 2011, the Queensland Immunisation Program in Australia, via email to an Australian advocate, said, “Gardasil is manufactured using recombinant DNA technology so any finding of residual DNA fragments in the vaccine is expected and does not represent contamination.”

The above statements are all in direct contradiction to the following documentation used on a world-wide basis to either approve, and/or market Gardasil™:
From the United Kingdom: 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.
From the FDA: “GARDASIL® is not a live virus vaccine; it contains no viral DNA, and is therefore incapable of causing infection.”
From Australia: “GARDASIL contains HPV 6, 11, 16 and 18 L1 VLPs. Each VLP is composed of a unique recombinant L1 major capsid protein for the respective HPV type. Because the virus-like particles contain no viral DNA, they cannot infect cells or reproduce.”
From the Gardasil Access Program: “GARDASIL® is not a live virus vaccine; it contains no viral DNA, and is therefore incapable of causing infection.”

To date, all health agencies responding to the SANE Vax announcement of Gardasil™ contamination have completely ignored the fact that the residual HPV DNA is firmly attached to the aluminum adjuvant. Furthermore, no regulatory authority, anywhere, has asked to see the detailed genetic sequences contained in the laboratory results, in order to ask their own laboratories to confirm the Genbank DNA sequences found.

It is important to note that every single time the SANE Vax team communicates with any health ‘authority’ our claims are backed up and referenced with peer-reviewed published scientific studies, data from the manufacturer, or data from government sponsored health agencies. When a response is received, there is no evidence to back up the health agency’s position.

Where does this leave medical consumers? Medical consumers around the world are no longer satisfied with a simple ‘pat on the head’ and ‘assurances’ that vaccines are safe and effective. They demand and deserve scientific proof.

If parents of the Gardasil™ victims had been fully informed of all the risks and limited benefits of Gardasil™, including the presence of recombinant DNA in the vaccine which may cause autoimmune-based disorders, immediate death, or permanent disabilities, they might have been able to make an informed decision. They could have made an informed choice as to whether it was better for their children to risk immediate negative outcomes with a vaccine, or to teach their children about an already proven safe and effective method of controlling cervical cancer, namely regular screening and good gynecological care.

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WHAT MERCK DOES NOT KNOW ABOUT GARDASIL

Although people's interest in investigating about vaccines is generally increasing, it may often be difficult to gain access to sufficient information in order to be able to make an informed choice.

Many parents feel that they do not receive satisfactory answers to their questions. Some are disappointed to learn that the doctor has not even studied the information in the package inserts.

Vaccine manufacturers and other promoters including health authorities and doctors often seem to have little knowledge about the products which they advise and it may be insufficient for them to be able to weigh safety factors against the risks.

Gardasil's manufacturer Merck certainly does not have sufficient knowledge regarding their product.

WHAT MERCK THE MANUFACTURER DOES NOT KNOW:

- Whether Gardasil prevents cancer.
- How long and if the vaccine is effective in preventing infection.
- Relevance of possible booster doses.
- Whether the vaccine targets the relevant virus strains in different countries/regions/races.
- Whether these strains will change in time.
- What the long term serious side effects will be.
- What are the adverse events due to concomitant administration with other vaccines.
- The true number of serious adverse events, as reports in for example VAERS are known to represent only a fraction of the real numbers.
- What the results of clinical trials would be if they had not used their exclusion criteria, but instead a cross section average of groups most likely to be vaccinated.
- Whether there is an increased risk of blood clots when combined with hormonal contraceptive pills.
- Whether there is an increased risk of brain damage due to the presence of polysorbate which facilitates passage of toxic aluminium and other substances through the blood-brain barrier into the brain.
- The consequences regarding hormonal changes in connection with eg puberty and menstrual cycles.
- Health consequences due to the presence of l-histidine and toxic sodium borate.
- The consequences if and when the vaccine is not agitated thoroughly prior to administration.
- Whether there is increased risk of cancer as the vaccine has not been tested for carcinogenicity.
- Whether there is increased risk of cancer due to replacement of some virus strains with new strains which may be more carcinogenic.
- Whether there is increased risk of cancer due to the unexpected discovery of gene manipulated HPV DNA.
- The extent of increased risk of autoimmune diseases due to the vaccine ingredients and especially the recombinant/gene manipulated HPV DNA.
- Consequences due to the HPV DNA being aluminium bound.
- Whether the vaccine will increase the risk of sterility due for example to polysorbate.
- Whether the vaccine will increase the risk of babies being born with anomalies.
- Whether Gardasil is excreted in human milk.
- What is the potential to cause genotoxicity.

Nor does Merck or other vaccine promoters know the complete list of ingredients:
Unexpected discoveries are made, not necessarily by the manufacturer as there is no incentive for them to search for substances which might be detrimental to health. Discoveries have been made long after vaccines have been marketed. Examples are the SV40 (suspected of causing cancer) in polio vaccines, pig DNA in retrovirus vaccine and the recent discovery of aluminium bound recombinant HPV DNA Gardasil, the consequences of which are unknown and may be horrific.

If Merck had known that aluminium bound recombinant DNA was present in the vaccine, this should have been specified in the list of ingredients in the package insert. It was not listed, this being yet one more illustration that they do not know which substances the vaccine actually contains.

The list is of what Gardasil promoters do not know about the vaccine is long and is certainly not complete.

The conclusion is that they know very little.

 
SANEVAX LETTER TO COMMITTEE OF MEDICAL PRODUCTS

For Immediate Release
Contact: Freda Birrell, Secretary
This e-mail address is being protected from spambots. You need JavaScript enabled to view it

October

3, 2011

Dear Mr Chairman and Vice-Chairman of the EMA Committee for Medicinal Products for Human Use

I am sending the undernoted to all the members of your Committee

The two press releases, "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

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