By Helen Petousis Harris 20/02/2017 64

Gardasil was assessed in Double Blind Randomised Placebo Controlled Trials that used the fully formulated vaccine and compared it with two different placebos, the aluminium adjuvant and a saline solution.

What is a placebo?

A placebo is a substance as similar as possible to the active drug except it has no therapeutic effect. It does not need to be ‘inert’. The best placebo is one that mimics the active therapy as much as possible. This is because the ‘placebo effect’ is a powerful phenomenon and to truly measure the effect of an active product it important that all recipients are equally as likely to think they received the “real deal’.

What is an adjuvant?

“Adjuvant” is derived from the Latin “adjuvare” which means to help.

Adjuvants are added to vaccines in order to help the immune response, specifically:

  • Improve the immune response so that a greater amount of antibody is produced or guide a more desirable selection of immune effectors
  • Reduce the amount of active ingredient required as that can be challenging and expensive to produce
  • Reduce the number of doses required

The most commonly used adjuvants in vaccines are aluminium salts which have been licenced and used in humans for well over 70 years. They cause inflammation at the injection site which is an important process in generating an immune response to the vaccine. In vaccine formulations the active ingredient (antigen) is adsorbed (adhered) to at least some degree to the aluminium adjuvant. This makes a tasty combination for the immune system to respond to.

Adjuvants are an important and very active area of research.

What is an aluminium adjuvant?

Aluminium is the most common metallic element on earth and is in the food we eat and water we drink. Babies are born with aluminium in their body and receive more through breast milks and formula.

Aluminium adjuvants are a range of aluminium-based salts that vary in their affinity (attraction) to the active ingredients. The choice of adjuvant will depend on the chemical properties of the antigen (e.g. positively or negatively charged). Many vaccines contain a tiny bit of aluminium to enhance the immune response. The quantity is miniscule compared to the regular exposure we have over our life time.

Aluminium adjuvants have been used in vaccines for over 70 years and their safety in this context is well established.

What adverse events are associated with aluminium adjuvants?

There are a range of adverse events known to be associated with aluminium adjuvants. These include:

  • (Very rare) Sterile abscesses, subcutaneous nodules, granulomatous inflammation, contact hypersensitivity
  • (Relatively common) Erythema (redness)

While there are gaps in the literature, no associations have been found with serious or long-lasting events.

Aluminium adjuvants cause injection site reactions (mild to moderate injection site reactions are a good thing). Systemic events are rare and consist of post-immunisation headache, arthralgia and myalgia (joint and muscle aches).

What happens to aluminium adjuvants in the body?

Below is a general stepwise process.

  1. Once injected the vaccine antigen and the aluminium adjuvant tend to dissociate in the fluid around the cells in the muscle.
  2. Other proteins in the fluid gather around the aluminium adjuvant.
  3. The aluminium forms an aggregate which traps the vaccine antigen
  4. The aluminium adjuvants attract and activate important immune cells that are required for an effective immune response.
  5. These cells take up a combination of the antigen and the antigen along with the adjuvant.
  6. The cells take their ‘cargo’ to the local lymph node where the adaptive immune response that will result in protection against disease occurs
  7. Most aluminium is then excreted in the urine and faeces over a period of several days

Some adjuvant can remain at the injection site for a long period of time and occasionally cause a lesion (see above for adverse events).

Ultimately, the tiny amount of aluminium in vaccines is absorbed into the blood then eliminated in urine.

Observations using humans show 50% is eliminated in 24 hours, 85% after 13 days, and 96% after 1178 days. Bone is the primary long term reservoir for aluminium that we acquire through our life time. [Here and here.]

So if aluminium causes an inflammatory response why was it used as a placebo?

There are several reasons why aluminium is used as a placebo in vaccine trials.

  • It is desirable to mimic the formulated product as closely as possible without a therapeutic effect.
  • It is important that people think they may have got the real drug. Some placebos are more effective than others. The more noticeable the placebo it the more effective it is.
  • Aluminium salts have an established safety record therefore they provide a good comparator
  • The question being asked in the studies was around the effectiveness and safety of the new product – in other words Gardasil, if you take the vaccine antigen (the HPV virus like particles) away then you are left with an empty formulation. It makes a perfect placebo.

What placebos’ were used in the Gardasil trials?

Most people who received a placebo in the Gardasil trials got aluminium adjuvant. However there was one protocol (Protocol 18) conducted in 9-15 year old girls and boys where the placebo used was a saline solution. In this study 1184 were randomised to receive the vaccine and 596 randomised to receive the saline solution placebo. The proportion of participants completing the study was similar in each group. The proportion of systemic events was comparable in each group. Keep in mind that we expect some people to have a transient generalised response such as fever after a vaccine. These were generally mild to moderate in intensity. As would be expected, there were more injection-site reactions in the Gardasil group compared with the placebo group.

Event Gardasil (n=1165) Saline* placebo (n=594)
Any systemic event 541 (46.4%) 260 (44.5%)
Headache 221 (19.0%) 110 (18.8%)
Fever 100 (8.6%) 45 (7.7%)
Sore throat 52 (4.5%) 24 (4.1%)
Diarrhoea 43 (3.7%) 21 (3.6%)
Nausea 38 (3.3%) 22 (3.8%)
Abdominal pain 38 (3.3%) 17 (2.9%)
Nasopharyngitis (a cold) 34 (2.9%) 22 (3.8%)
Myalgia (muscle pain) 30 (2.6%) 10 (1.7%)
Vomiting 26 (2.2%) 18 (3.1%)
Dizziness 25 (2.1%) 9 (1.5%)
Arthralgia (joint pain) 21 (1.8%) 9 (1.5%)
Pain in extremity 19 (1.6%) 14 (2.4%)

Food and  Drug Administration, Clinical Review of Biologics License Application for Human Papillomavirus 6, 11, 16, 18 L1 Virus Like Particle Vaccine (S. cerevisiae) (STN 125126 GARDASIL), manufactured by Merck, Inc, Vaccines Clinical Trial Branch, Office of Vaccines Research and Review, Centre for Biologics Evaluation and Research, Editor. 2006, Food and Drug Administration.

*The ‘saline’ solution consists of water, 9.56mg sodium chloride, 0.78mg L-histidine and 50micrograms polysorbate-80

Local Reaction GARDASIL® n=11778 (%) Aluminium-containing placebo (%) Carrier placebo (saline *)






































Did vaccine recipients develop new medical conditions?

The subjects were followed up for new medical conditions. This means they were contacted in the twelfth month of the study and assessed for new conditions that may have developed since they were vaccinated. A slightly lower proportion of vaccine recipients reported a new medical condition compared with the saline placebo recipients. 29% of vaccine recipients and 31% of  placebo recipients reported a new medical conditions (such as allergy, infection, neurological, musculoskeletal etc.)

Key points

  • A placebo is a substance that is non-therapeutic and ideally mimics the drug being tested as closely as possible. The placebo effect is very powerful and must be carefully controlled for in studies
  • An adjuvant is a substance that enhances the immune response. Aluminium salts are the most widely used
  • Aluminium adjuvants cause reactions at the injection site but systemic reactions are uncommon
  • Most aluminium is absorbed into the blood then excreted from the body
  • The Gardasil trials used two placebos, one was the aluminium adjuvant, the other a saline solution placebo.
  • There was no difference in overall systemic events or the development of new medical conditions between those receiving the vaccine and those receiving the saline solution placebo.


Updated 21/2/17 to reflect that the saline had two other components (L-histadine and polysorbate-80). To the best of my knowledge the 0.35 micrograms of sodium borate present in the full vaccine formulation is a residual from the adjuvant related manufacturing process and  therefore have excluded, keen to hear if someone can verify.

64 Responses to “Was the Gardasil vaccine ever compared with a placebo?”

    • Fiona these are cases I have considered in the previous post. My reasons, and those of the rest of the scientific community for excluding them as any kind of proof of causality are listed. The claims are far fetched, scratching at the door of fantasy. If Little and colleagues truly wanted to do the community a favour they would undertake work that first defines the condition and provides a time frame following vaccination in which the event must occur in order to be caused by it. Then they could conduct an epidemiological study like real scientists do in order to investigate their hypothesis. A well considered opinion on this can be found here by David Hawkes and Jim Buttery can be found in the Current Opinion in Obstetrics and Gynecology.

      • The TGA has admitted that the placebos used in Protocol 018, tables 11 and 12, do not represent the contents stated in the trial data and will amend this. This was stated in 2015.The saline placebo, was not saline. Both the ‘saline placebo’ and the ‘non alum’ placebo contents will be corrected, to state what was used. You can verify this with the TGA.

        • Fiona you are correct. The non-aluminium placebo was indeed the isotonic carrier and while primarily a saline solution, not saline by the definition of sodium chloride and water. I will amend my blog to reflect this. Of course this does not change any of my arguments.

          I would also point out that of the components in the carrier 9.56mg is Sodium Chloride, the three other components make up less than 0.87mg of the formulation.

          • The TGA will disclose ensure the full disclsoure of all the contents, in the placebo, which was not a saline placebo and the non alum solution.

  • Fiona: “The TGA will disclose ensure the full disclsoure of all the contents, in the placebo, which was not a saline placebo and the non alum solution.” What is your problem? As far as I understand Helen’s post; standard, well tested and understood protocols were used in the trials. So the results are valid and comforting to those of us with daughters! The risks of remaining unvaccinated are orders of magnitude larger than the risks of accepting the vaccine. Helen has already answered your question clearly and patently. I don’t understand your problem.

    • That’s pretty much what I though when I read her comments. She’s nit picking at something that doesn’t effect the overall safety profile of Gardasil.

      And, Gardasil is recommended for boys too now, so even those with sons should be comforted 🙂

    • I think if you check the authors of the article you have posted in the link, you will find they have conflicts of interest…not listed at foot of article, but do a thorough search and a different story is emerges.

  • You have stated the incorrect amount of Sodium borate. It is not 0.35 micrograms, it is 35micrograms or .035milligrams

  • On the placebo issue, if you were aiming to mask possible side-effects caused by the adjuvant, is this not how you would design an experiment to do so?

    On adjuvants…
    “The biggest remaining challenge in the adjuvant field is to decipher the potential relationship between adjuvants and rare vaccine adverse reactions, such as narcolepsy, macrophagic myofasciitis or Alzheimer’s disease. While existing adjuvants based on aluminium salts have a strong safety record, there are ongoing needs for new adjuvants and more intensive research into adjuvants and their effects.”

    “Despite a lack of good-quality evidence we do not recommend that any further research on this topic is undertaken.”

    I would like to be convinced but those links just raise more questions. Could you please give your professional opinion on this article?

    • Paul I think Maurice has summed it up.

      The evidence for vaccines of any kind not causing autism is beyond extensive. From what I see on your link there are a range of studies, some are certainly interesting in their own right. The problem is that a study showing maternal immune activation in the lab and potential neurological outcomes is not a study that shows vaccines cause cause autism. The cherry picked studies on this site are coupled with flights of fancy, the drawing of very long bows. I come back to the point I labour constantly. Vaccinated children are more healthy/have less adverse outcomes that unvaccinated children. That is not an alternative fact, it is a real fact. If vaccines caused autism wouldn’t you expect more autism in vaccinated children???

      If you are interested in the role of infection and fever, like influenza, during pregnancy and neurological outcomes in the baby then there is an area that is exciting. There is evidence to show infection in pregnancy can have quite far reaching affects on the baby. I can also tell you that flu vaccination in pregnancy is associated with better infant outcomes. I think this would be a good topic for a blog. Will try to get to it.

  • How to assess a website:

    First question:
    What does the URL tell us? In this case it is unusual: not a university, UN, govt site or any authoritative site. A quick Google search on Healthcare-us yields nothing useful. Not a strong start.

    Second question: What about the author?
    Another quick search on J.B. Handley brings up nothing useful. That is strange; anyone with any credibility generally comes up straight away. What about Generation Rescue? An answer. That is clearly an anti-vax source; The author is likely strongly biased against vaccines.

    Third question: Content.
    The Wikipedia piece on Generation Rescue concludes with this comment, “Much of Generation Rescue’s case is based on publications that do not go through a proper peer review process”. ( Certainly some of the papers presented have reputable scientific publishers, but I am inclined to agree with the Wikipedia author(s). The piece looks like a cherry picked Gish gallop to me. Which is typical for anti-vax material.

    Fourth question: What are other authors saying (Triangulation)? That is Helen’s area but the scientific and medical community have looked for problems with adjutants and found nothing. I suggest you follow Helen’s chain of evidence as a starting point.

    In conclusion: It looks like baloney to me. (

  • Just reading the link you provided regarding safety, the “Comparative Safety of Vaccine Adjuvants: A Summary of Current Evidence and Future Needs” and felt it didn’t really provide any reassurance of aluminium adjuvant safety.
    On the contrary it said that it wasn’t fully understood how aluminium adjuvants work and also in a roundabout way, that there was a need to develop new, safer, non-inflammatory adjuvants.
    Some of the more serious adverse events/associations listed in the paper were:
    -a propensity to induce Th2 immune bias which increases risk of allergy and anaphylaxis
    -Macrophagic Myofasciitis described as a “combination of musculoskeletal pain, chronic fatigue, and cognitive disturbance (which) generates chronic disability with possible social exclusion.”

    Petrovsky said assessing the whether these conditions were caused by vaccination was difficult as there was a lack of data, and also there could be a long time between receiving a shot and when symptoms arose.
    Personally, I find that if someone says they don’t fully understand a subject and there’s lack of data, I don’t associate that with a long record of safety, it just shows we have kept doing the same thing for years without really knowing why.

    • Toni, I think you make good points but have also been selective in what you have taken from the article (And this article is the opinion of a single individual). First, the bottom line on aluminium salts as adjuvants is that they have a strong safety record. I think you have also pulled out the discussion on extreme cases such as the RSV vaccine that failed miserably in early clinical studies. With respect to serious events, these are not events that are associated with the vaccines that we use. For example there is no increased risk for allergic disease in vaccinated children. The Th2 bias is toward the antigen in question, this does not mean the whole immune system gets twisted. I think the authors have explored the potential hypothesis that have been raised over the years. It is important to visit these regularly. The overwhelming evidence supports the on going safety of aluminium adjuvants. Also, remember that we know the safety of adjuvants primarily through the safety profiles of the vaccines and a vast number of studies comparing safety outcomes in vaccinated and unvaccinated. Pointing out what is not known about something does not negate what is known. Petrovsky is highlighting out areas for research. The long (80 year) record of safety is indeed a long record of safety which is why we continue to use aluminium salts as adjuvants which in turn get studied and reviewed by many experts in many countries including the WHO.

      • Hi Helen, thanks for the response. Just so I understand, you’re saying the safety record of aluminium adjuvants is not assessed separately? So we rely on the safety record of each vaccine as a measure of the safety of the adjuvant?
        Given that the body of research over the last 30 years has established aluminium as a mammalian neurotoxin; shouldn’t we demand that the safety of this substance – previously taken for granted – now be evaluated in a scientific manner? Surely if it is as safe as claimed, then there would be no problem with such an assessment.

        • Toni, no, that is not what I am saying. What I am saying is that there is vast amount contributing to the totality of evidence, including the safety profiles of the vaccines themselves. The safety data on aluminium adjuvants ranges from laboratory in vitro and in vivo experiments, clinical studies in humans receiving only the adjuvant as well as studies on full vaccine formulation safety. The totality of evidence is considerable. Re being a neurotoxin, aluminium does not cause Alzheimer’s as some people claim, it is a neurotoxin in situations of high doses combined with renal failure. Vaccines do not even figure in terms of the dosage and renal failure is not relevant. Everything is poison however, it is the dose that makes the poison. Aluminium adjuvants have been scientifically assessed using many angles of investigation which is why regulators (who are very fussy about these things) have so much confidence in them and allow them for wide spread use in humans.

  • PS * Just wanted to point out that the description of the symptoms of Macrophagic Myofasciitis were mine, not Petrovsky’s.

  • Would you be able to suggest a suitable review or meta analysis on aluminium adjuvant safety that I could read? (Preferably one that is not behind a paywall!!) Thanks.

    • Firstly perhaps you could explain why you think a clinical trail study looking purely at aluminium would be more useful than a trial of an adjuvanted vaccine with a saline comparator? Is it vaccine safety you are concerned about? I am not sure what a clinical trail of aluminium adjuvant would contribute to the argument about vaccine safety and it is not a trail that would happen for pragmatic and ethical reasons.

      • Re- a clinical trial, how can any adverse events due to aluminium adjuvants be separated from that caused by the active ingredients if the two are not tested separately?

        Yes, vaccine safety is a major concern. The research on aluminium toxicity extends beyond that related to renal failure; aluminium has been shown experimentally in vitro and in vivo, variously using rats/rat cells and human cells, to induce motor neuron death, inflammation, learning and memory deficits and is thought to cause oxidative stress and mitochondrial impairment.

        In humans it is suspected to be linked with various neurodegenerative diseases, but because the precise way in which aluminium causes these conditions is unknown, the issue is controversial. Still, it is widely accepted by researchers that aluminium is a neurotoxin and has an adverse effect on the CNS. (see Kawahara’s 2011 review – Link between Aluminum and the Pathogenesis of Alzheimer’s Disease: The Integration of the Aluminum and Amyloid Cascade Hypotheses)

        It seems that excipients like aluminium, which are already in use, are currently not subject to regulatory status independent of the product in which they are included.
        For proposed new excipients, the FDA recommends a safety database including safety profiles and risk-benefit assessments so they can establish permissible and safe limits of the product. If new excipients have to be evaluated for safety, why would older substances, like aluminium, not be subject to the same process and resulting safety standards, especially as it is a substance well established as a mammalian neurotoxin?

  • Of course that comments posts lol.

    If I understand your argument, your saying it would be unethical to conduct a trial of aluminium adjuvant in humans, presumably because of guidelines which says there should be some possible benefit to the patient for the trial? But if its unethical to trial aluminium adjuvant safety than surely it is unethical to use it as a placebo? Does that follow?

    Professor Chris Exley also has concerns: “There are no clinically-approved aluminium adjuvants only clinically approved vaccines which use aluminium adjuvants. This makes it imperative that all vaccine trials which use aluminium salts as adjuvants must not use the aluminium adjuvant as the control or placebo. This has been common practice for many years and has resulted in many vaccine-related adverse events due in part or in entirety to aluminium adjuvants being unaccounted for in vaccine safety trials.”

    • Paul, have you read the Australian TGA letter, in which they state, that they will be instructing MSD to amend the words ‘saline placebo’ to state ‘placebo,’ in the HPV vaccine Gardasil clinical trials data information? This was in protocol 018, which if I am not mistaken, is supposed to be the only time a saline placebo was used in the trials. They were instructed to disclose the contents of the non alum placebo. Placebos in the trials were composed of the excipients, including the neurotoxic adjuvant AAHS and were the same excipients in the Gardasil vaccine in the trials. Given the serious adverse events reported in both placebo and vaccine participants, it is staggering that the conclusions were that there were no problems regarding the safety profile. Post marketing adverse events reflected the same adverse events and continue to be reported globally, wherever Gardasil is administered to this day.

      • Fiona, If the small amount of AAHS in the vaccine was neurotoxic obviously it would not be in the vaccine.
        I wonder, how do you explain the fact that there is no difference in the rates of serious adverse events between vaccinated and unvaccinated persons? I am referring to the post marketing studies. Why are there no differences? Please explain if AAHS is neurotoxic how come we don’t see a difference?

        • Because the post marketing studies don’t compare unvaccinated with vaccinated populations. They compare populations who are unvaccinated for that particular vaccine with populations who have received the vaccine. So the population is not completely unvaccinated, but have probably been vaccinated many times already with adjuvanted vaccines. I can’t think where you would find a completely unvaccinated group large enough to compare against the vaccinated group, given that our vaccination rates are roughly 70 – 90%?

          • Toni,
            Hang on…What are you claiming? Are you claiming MMR vaccine causes autism? are you claiming the infant primary series of vaccines causes autism? This seems like you are begging the question – in which you have concluded that vaccines cause autism.

        • Sorry Fiona, I haven’t, but I do find it concerning and wish there was some more transparency about how such a mistake could take place… if there is a good article explaining it, please let me know.

          Professor, I think two of the links you have provided don’t use adjuvants in their study but AL26; one is oral administration. Exley actually makes the point that the Gardasil adjuvant isn’t available to study. Is this true?

          “The toxicity of an aluminium adjuvant depends upon the aluminium salt with aluminium hydroxyphosphate (known commercially as AdjuPhos™) being more toxic at the injection site than aluminium oxyhydroxide (known commercially as AlHydrogel™). The aluminium adjuvant used in the Gardasil HPV vaccine is a sulphated version of aluminium hydroxyphosphate and is likely, based upon what we know about aluminium chemistry, to be even more toxic.
          Unfortunately, Merck, the manufacturers of this adjuvant have not made it available for any independent analyses, never mind safety testing.”

          I only ask because I saw some doctor on the television the other week blaming the flu vaccine injuries of 2010 on a “new adjuvant that is no longer being used”. Which left me thoroughly confused.

          • Hi Paul
            I think we are going down a rabbit hole here. First of all the premise that aluminium adjuvants and vaccines are unsafe is false. There is no scientific evidence for this. In the case of the HPV vaccine there are now a significant number of large postlicensure studies which show no difference between vaccinated and unvaccinated persons. This review is open access, see table two for example.

            I cant imagine that companies would give their proprietary adjuvants to an anti vaccination person such as Chris Exley. The safety of their adjuvant is reviewed by the regulatory agencies. See by blog on how vaccines are licenced and by whom.

            The premise that aluminium adjuvants are toxic is false.

            In terms of the flu vaccine adverse events of 2010. There were two flu vaccines in 2010 with the pandemic strain that caused problems. One was the CSL trivalent vaccine. It never contained an adjuvant. It had an increased risk for febrile convulsion in children aged under 5 years and therefore withdrawn for use in that age group here is a summary. Studies revealed that it was aspects of the manufacturing process combined with the exceptional nature of the pandemic H1N1 virus that caused the problems. The vaccine has since been reformualated and is undergoing testing.

            The other flu vaccine problem was an adjuvanted vaccine called Pandemrix from GSK. It was found to trigger narcolepsy in genetically predisposed people, mainly in the Nordic countries. You can read the most recent WHO position here

  • Helen
    Please explain why your studies did not predict the exceptional level of adverse effects reported in the case of the HPV vaccine. Did you ever consider a genetic link? You failed to answer to the above questions regarding adequate testing of the effect of the Aluminium adjuvant used, simply brushing it off as irrelevant. I have two daughters who have been seriously affected by the vaccine. No one knows how to help these children because of the lack of understanding as to how these vaccines work – they seem to over stimulate the immune system in some people – creating some kind of auto-immune disease. There appears to be a genetic link – as siblings seem to be higher risk. Of course since no one admits to the risk, and parents are given zero information, there is no informed consent. My elder daughter had so much talent she was being advised to apply to Oxford or Cambridge after her Intermediate 2 exams. Her English paper was deemed perfect. She had already received this poison. The symptoms developed over time – they gradually built up – from pain in the lower extremities to the heart breaking point when this young woman, who had read King Lear for holiday reading, Nietche, Machiavelle, Russian Literature – all by age 13 – said ” I cannot spell. I was never not able to spell any thing before. I cannot write papers because I cannot find words.” Through your ignorance, incompetence and complete arrogance, you have personally played a significant part in destroying her life. Now, 7 years later, she is housebound with hair loss, pain, deathly thin and pale, racing heart, chronic fatigue, sleep reversal, loss in concentration… you have destroyed our family, my children. You are complicit in a crime against a generation of such girls. Shame on you. And how dare you. Admit your failings and work to support these girls. They are treated dreadfully by medics who do not understand why they are ill. Who do not know how to treat them. Perhaps you might write a letter I can bring to the GP which might explain how the toxic elements in the vaccine do cause the common serious of adverse effects that many girls are now living with – if you call this living. Shame on you. The thing is, it gets worse over time. My younger daughter, beautiful, athletic, now suffers increasingly severe chronic back, neck and head pain. She was NEVER sick, had NEVER missed a day of school. Her period has stopped. I am a real mother with real children – young adults now. You should feel guilt and shame. It is not a rare occurrence – my children had ALL the other vaccines. This one is different. This is marketing and trade deals over the lives of the young. You have taken away my daughters entire teenage years, and god knows what else. See if you are even capable of taking positive action. There is nothing more I can say. I am sure you will delete this and go back and ignore the tens of thousands young boys and girls whose lives have been wracked with pain and fear and misery. All unnecessary. You have been part of the cruelest of actions. You have made your name, got your Phd. But at what cost? Look at your own country. Would you give your children this vaccine knowing what you must know? You have the power to help by using your name and role to publicize the risks. Admit that the testing fell short. It did not run long enough to enable this damage to be seen. Young teens do not talk about feeling a bit unwell. It is not until they realise that something is very very wrong and they are frightened that they talk about it. By then you lose the clear causal relationship in time. This horrible thing sets off a catastrophic series of events that take over and progress. Nerve damage, heart damage. I am frightened for what will happen to my own daughters. I am very frightened of what you, GSK, Merk, CDC, etc have done. Shame on you.

    • As a mother as well, I can appreciate that your family’s health concerns must be terrifying. I do sincerely hope that there will a positive outcome for you all. That said, the tone and content of your communication is personally vicious and inappropriate. Given this personally aggressive tone, I do not believe specific responses to your points are either warranted or helpful.

      As a scientist and in the absence of extensive information about your daughters I cannot in anyway comment on the medical issues you have raised. All I can do is provide the large body of data that fails to find a relationship between the HPV vaccines and autoimmune conditions. Here is a link to a review of the safety which has a table summarising the evidence. The volume and quality of the safety data behind this vaccines is remarkable, and includes comparisons of millions of vaccinated and unvaccinated people. While no one can ever say never there is just so signal to suggest that this vaccine causes any harm, only that HPV disease is declining.

      The safety of HPV vaccine has been reviewed by The Institute of Medicine and the WHO. The WHO’s Global Advisory Committee on Vaccine Safety frequently review the safety of HPV vaccine based on the latest data (Seven times so far). It was last reviewed in December 2015 and will be again reviewed next month.

      I will finish by saying that I have vaccinated all my sons against HPV, and as was the case prior to 2017, had to pay a lot for that benefit. I remain highly confident in the safety of Gardasil and our on going ability to monitor the positive outcomes in our communities, as well as the known risks of the vaccine.

      • The poster has injured children and you should at least cut her some slack as to her “inappropriate tone” because for all of this discourse on science, in her case, and in the case of many who are giving their heartfelt testimonies on the internet, science has failed them.

        The studies always seem to exonerate vaccines. How do I know that studies that do not exonerate vaccines are not being suppressed? What about this interview, what is your response to the alarming things that Dr. Marcia Angell is saying about many of the so-called ” studies ” published in the New England Journal Of Medicine where she worked for 20 years?

        Kids today are sicker than ever

        1 in 6 children have learning disabilities.
        1 in 9 has asthma
        1 in 10 has ADHD
        1 in 12 has food allergies
        1 in 20 has seizures
        1 in 45 boys have autism
        1 in 68 children have autism

        Whatever vaccines are doing, one thing they are not doing is doing more good that harm, kids are not getting more healthy, they are becoming less healthy. Is there a link between the above stats and vaccines? If you are looking for A causes B causality, probably not. But what if the reality is more like A causes Z, and the many interim dots between the two are not being connected, or perhaps they can never be connected, given the many variables, length of time, if there were a study on this, the study would have to encompass.

        I’m not a scientist, I’m a layperson, but I can link to many outbreaks in highly vaccinated populations published on government websites. Whatever rationalization you can give, whatever excuse you can give, science has clearly failed children of today. What I’m seeing is, declining diseases ostensibly the result of vaccinations, in one column,and in the other, a whole slew of other illnesses growing exponentially. Could it be true that vaccines are merely replacing one set of illnesses for another? Nature doesn’t give freebies, and whenever you attempt to take a shortcut on health, she always exacts a price. Just on the stand point of mere logic, it’s logical that one flows from the other. I often hear people exclaim, “it’s not vaccines, it’s preservatives, etc, other toxins in the environment”, but they are just guessing, and what is the logical reason they are excluding vaccines from this equation? Vaccine studies are not telling the tale of the tree, but not the forest, it seems — they measure safety results of a particular vaccine or multi-dosage vaccine, and more often comparing one vaccine to a prior version of the same vaccine, but not the cumulative effects of all the vaccines given to a child by the time that child reaches, say, the age of 6 ( and that number is way more than it was when I was a child ). When I observe the state of children’s health today, I’m sorry, I just do not trust scientists and doctors and medical professionals who seem to have the attitude that vaccines are sacred, as they are always quick to exclaim, “vaccines are one of the greatest advances in medical science” and pat themselves on the back as the numbers of sick kids grow exponentially.

        • Dear Patricio
          There is little more devastating than a child who has serious health problems. However, you are wrong to suggest that vaccines are not one of the greatest advances in medical science because the fact is that they are. This fact is supported by over 200 years of scientific enquiry and you can dislike this fact as much as you like but you can never change it.

      • Vicious, inappropriate, aggressive? Her emotion and her distress is understandable. Her experience is not unique or rare. Show some respect please. You cannot possibly understand what she is going through and as for wishing for a positive outcome… perhaps if this vaccine had not been fast tracked onto the market, without meeting the fast tracking criteria, one would have a better idea about that! As we do not know what became of those in the trials who survived with serious adverse outcomes, just as we do not know what happened to the 41 serious adverse event cases in NZ, there is no answer to that. She did not mention Dr Sing Hang Lee’s allegations which were made to the WHO, Director General, related to Gardasil and those named in the allegations… but let’s not dwell on that….Don’t even bother to try and discredit Dr Lee, as anyone who is informed about this subject, knows he has the best of intentions and is a competent and thorough pathologist. The majority of those commenting here, do not solely rely on NZ mainstream media, IMAC or the NZ MOH for their information on this vaccine. They will be well aware of the flawed science around it and the undone science, the omissions in the clinical trials and the word massaging that went on. They will understand what bridging studies mean and surrogate endpoints and the implications for these,, in regard to the clinical trials and the outcomes reported. I also know many girls in NZ and abroad, who are suffering because of this vaccine and one of these girls is currently in ICU in a NZ Hospital. You may be able to convince those who accept the ‘leaflets’ that are given out to them, as proof of safety and efficacy, but many parents in NZ and around the World, are waking up and will not tolerate this any longer. The require detailed information and full disclosure of risks, known and those as yet to be evaluated. There is no scientific consensus about this vaccine and the science is not settled, never was and never will be. For the record, ‘injected’ aluminium does not leave the body… Saying it does over and over, does not make it anymore convincing. Please do not bother responding to this comment by requesting citations, links or correcting me, on how to lay out my comment on this site… If you are offended by what is being said, perhaps you need to reflect on how these people are coping, with the lack of a duty of care or due diligence to this matter, by the NZ MOH and how it has impacted on their lives and consider what Informed Consent really ought to mean… full disclosure of risks.. This takes time and means more than a sore arm and a fever. Finally, it is pointless to keep repeating the mantra that this vaccine has been robustly researched, tested and is ‘safe.’ The Emperor’s Clothes are not working, for those who can see. One day I hope you will see Helen, how these girls and in some cases boys, lives have been affected. Like your children, they hope to realise self determination, achieve their dreams and be free from chronic health problems, that they did not have, prior to receiving this vaccine. We all want the best for our children. On that we can surely agree. The perceived success of a vaccine, must not require that those who have had a serious adverse event, be cast aside, in order to maintain the success and ongoing uptake, of that vaccine. First Do No Harm.

        • Dear person hiding behind a pseudonym.

          Firstly, I have not trashed your tirade because I think it illustrates the ad hominem well. I can imagine how brave you can be when you use a sock puppet to deliver your baseless attack rather than your own name and profile.
          Secondly, in response to to your “Please do not bother responding to this comment by requesting citations, links or correcting me, on how to lay out my comment on this site.”
          I think I rest my case!

          • Please do trash what you refer to as a ‘tirade’ …be my guest…you have failed to be convincing with your other attempts to the other people posting here, with deflections, when someone speaks of the unpalatable truths. Deny the use of bridging studies, surrogate end points, the existence of Dr Lee’s work and questions, deny the CARM statistics regarding this vaccine and deny the scientific evidence, that aluminium does not get excreted when injected and finally, deny there is a young girl in a hospital right now, in NZ, because of chronic conditions related to this vaccine. It is your blog, just your opinion right, just as we have our opinions, based on real life. I hope your 200 years of Scientific Inquiry comforts you..inquiry being the operative word. Fortunately there are those that disagree that the science is not settled and there is nothing more powerful than Mother love, for finding the truth….

  • Helen – Regarding your reply to my comment about post marketing studies, I’m not sure what your question about MMR and autism has to do with the discussion on Gardasil and aluminium adjuvants, given that MMR contains no adjuvant. Maybe you have replied to the wrong person?

  • In regards to the comment regarding aluminum being a neurotoxin. I believe that Helen explained why this is not the case with aluminum salts used as adjuvants in vaccines.

    Also, why this is incorrectly assumed may also be explained by basic chemistry. Sodium is a very volatile metal (Google videos on dropping Sodium into water). Sodium hydroxide is a very potent base that is not safe for human consumption. However, sodium chloride is very safe for human consumption.

    Regarding the claim that there is a casual relationship between aluminum adjuvants and macrophagic myofasciitis. “As of today, available evidence indicates that although vaccine aluminium may persist at the site of injection for years (“vaccine tattoo”), this does not reflect the existence of a diffuse inflammatory muscular disease and is not associated with a specific clinical disease. The existence of sampling bias inherent to the complexity of the clinical and pathological diagnoses remains the most likely hypothesis.”

  • Aluminum adjuvants cause brain injury and immune disorders. They are not safe and there is no evidence they are safe for these health outcomes.

    There are no empirical studies of Al adjuvants demonstrating safety.

    Studies of Al adjuvanted vaccines are not designed to demonstrate safety with respect to neurological and immune disorder outcomes. The follow up periods are too short, and appropriate placebos are not used. Notice that Helen Harris did not provide any citations supporting her safety claims.

    The most-cited paper by vaccine promoters concerning aluminum adjuvant safety is Mitkus 2011. It is debunked here:

    This new paper provides further evidence demonstrating the great danger of aluminum adjuvants:

    It is very clear there is a serious problem with aluminum adjuvants. The dissembling, bad logic and lies need to stop.

  • Helen Petousis Harris, regarding “To the best of my knowledge the 0.35 micrograms of sodium borate present in the full vaccine formulation is a residual from the adjuvant related manufacturing process and  therefore have excluded, keen to hear if someone can verify”:
    Sodium borate is intentionally included to function as a buffer (to stabilise pH changes).

  • I am at a loss as to why we are even discussing this mess. According to Diane Harper, lead researcher in the development of Gardasil 1 in 10,000 will experience a serious adverse event. Now 1 in 10,000 may sound like a low number to a public health official but you can bet your bottom dollar that it is very important to the families who deal with these, especially as doctors don’t see inclined to recognise the events for what they are. As the rate of cervical cancer, as stated by Diane Harper is 7 in 100,000 women having pap smears (a singificantly lower rate than that of the injuries) it hardly seems worth the effort and the angst for those injured. On top of that she emphasises the need to have regular pap smears even if you have had the vaccine. Given how treatable pre cancerous lesions are in the early stages why are we spending all this money on a vaccine which does so little we still need to have annual smear tests. The only ones who have smiles on their faces are the manufacturers and those in their pockets. How many young people have been fully or partially vaccinated in New Zealand. How many will be recognised for what they are? Not nearly as many as should be.

    • Karen, lets gets some facts straight. First, Diane Harper WAS NOT the lead researcher in the development of Gardasil. This is a myth that you can find roaming around on the internet. Second, the serious events are not caused by the vaccine. For Diane Harper’s views on the vaccine you can read her latest publication – a review on the last ten years of Gardasil.

      If you wish to cite Diane Harper please do so from a more somewhat reliable source.

      • Mea culpa, My description of Diane Harper’s role minimised the value and extent of her intimate knowledge with the positives and negatives of the launch of the vaccine. As principle investigator, she was responsible for assembling a research team to recruit participants, deliver the health care during the study, collect biological specimens at the correct time, and retain subjects over the entire time frame of the study. After the data collection was complete, she had a professional/medical/clinical obligation to review the data for interpretation, comment and publication. She further describes herself thus: I am an international expert in HPV science, its vaccines, its clinical disease and treatment. I have personally seen tens of thousands of women with abnormal Pap smears and have a referral clinic/office that includes women coming from all continents of the world to consult for my opinion on their personal care.

        Gardasil offers sexually active women, who do not currently have HPV 6, 11, 16, or 18 infections, protection from genital warts and CIN 2+ disease for five years. If the vaccinated person is not sexually active during the five years of its efficacy, then the vaccine has not protected her from disease (as we do not have evidence that Gardasil offers efficacy any longer than five years). Its faults include tiny antibody titers for all HPV types other than HPV 16; limited protection; limited duration of efficacy; and safety concerns (as outlined in my opening statement).”

        I do love her stance on informed consent, which is woefully lacking in the New Zealand context wrt vaccines. The little sheets handed out listing a handful of very minor side effects, no mention of Pap smears still being absolutely vital, no disclosure of the ingredients and their potential for harm. She says ”
        “The most important point that I have always said from day one, is that the use of this vaccine must be done with informed consent and complete disclosure of the benefits and harms of Pap screening and HPV vaccines. The decision to be vaccinated must be the woman’s (or parent’s if it is for a young child), and not the physician’s or any board of health, as the vaccination contains personal risk that only the person can value”
        Among her findings
        Gardasil only maintains antibody titers for HPV 16 (not 18, not 11, not 6) at five years, making the true long lasting (five years) coverage of Gardasil only for one type of cancer causing HPV.
        Gardasil protects against onlythree cancer-causing types of HPV, which lead to CIN 2+ (precancers and cancers).
        Duration of efficacy is key to the entire question. If duration is at least fifteen years, then vaccinating 11-year-old girls will protect them until they are 26 and will prevent some precancers, but postpone most cancers. If duration of efficacy is less than fifteen years, then no cancers are prevented, only postponed.
        There is at least one verified case of auto-immune initiated motor neuron disease declared triggered by Gardasil [presented by neurologists at the 2009 American Neurological Association meeting in Baltimore, Maryland). There are serious adverse events, including death, associated with Gardasil use.
        Incidence rate of cervical cancer in the United States based on screening is 7/100,000 women per year.
        Incidence rate of cervical cancer if women are only vaccinated with Gardasil (i.e. Do not also have regular pap screenin) is 14/100,000 per year (twice the rate of cervical cancer if young women vaccinated with Gardasil do not seek Pap testing at 21 years and the rest of their life).
        Incidence of cervical cancer without screening and without vaccination is nearly 90/100,000 per year. The combination of HPV vaccine and screening in the U.S. will not decrease the incidence of cervical cancer to any measurable degree at the population level. Those women who do not participate in Pap screening, and who are vaccinated, will have some personal benefit for five years for Gardasil and 7.4 years for Cervarix (maybe longer), but they will not affect the population rates.

        • Hi Karen,

          You should take care not to present other’s words as your own, and to quote and give sources for other’s words when you lift them from another source.

          However you meant your reply to be, as it is written large parts of it plagiarise from a HuffPo interview. (here)

          You probably will also want to be aware that most people read extensive so-called “copy-pasta” efforts to mean that the person offering them is unfamiliar with the subject (and that in some cases they will just be trolling).

          You’d be much more convincing and relevant if you asked questions about whatever it is that you want to know. It’s understandable to have concerns—even if they’ve come from reading unsound material elsewhere—but you’re not going to sort out for yourself what the story actually is by copy-pasting other’s words (never mind presenting them as your own!)


        • I should also add that the interview that you lift material from uses an email written in 2009 as it’s source. If you want to present her views, you’d do better to use her current views – Helen pointed you to her recent review paper in her comment that you reply to.

  • Possibly the following website will throw some light on what Diane Harper said –
    I do not believe the cost benefit analysis of this vaccine merits the spending of close to $18 million per year, especially since the efficacy will have worn off long before there’s any incidence of cervical or any other type of cancer. Pap smears are safe, cheap and mostly effective – why risk the health and well being of our future generations, especially since (according to Merck’s package insert) “the vaccine has not been evaluated for the potential to cause carcinogenicity, genotoxicity or impairment of male fertility.”

    • Pointing to a blog about what Diane Harper said (eight years ago if the 2009 content is referred to) is not scientific evidence. If your argument is about the effectiveness of the HPV vaccine I suggest you source published manuscripts documenting the effectiveness. It is absolute bollocks to suggest protection from Gardasil does not last more than five years. Blatant utter nonsense. Perhaps I sound harsh here but this has been pointed out over and over again, please see Grant’s replies below because he addresses this. There are not yet signs of waning protection and antibody titres are not necessarily relevant or correlated with protection.

      On the matter of safety, the safety data for this vaccine is so vast you could paper mâché Jupiter with it. Other than fainting (common) and anaphylaxis (3 per million) there are no serious adverse events causally associated with this vaccine. This statement is based on studies now totalling millions of participants. Do you think, perhaps, if the vaccine caused infertility, for example, that it would have been detected by now? Particularly given huge studies have looked specifically for it, simply because chicken little kept screaming ‘infertility!’?

      The facts are that the HPV vaccine is extremely safe and extremely effective. But you can believe whatever you wish. Some people believe that there are fairies at the bottom of their garden. No one has managed to catch one yet.

  • Karen:

    Yet the evidence is that vaccinated people have better health outcomes (Like not dying), clearly documented over many studies. Helen keeps providing real studies that show this. A couple of cherry picked videos don’t change that.

      • No Karen, Science is a method and tool for looking at the the world, your links to vaccine denier websites are not it, even if they have science-sounding studies. I clicked on a few and they do not constitute either science or evidence.
        Try this concept: Ask a question, pose a hypothesis, design an experiment, look at the results, decide if they support your hypothesis, choose to accept or reject your hypothesis. Here is an example.
        Observation – a girl developed ovarian dysfunction after her HPV vaccine.
        Hypothesis – The HPV vaccine caused ovarian dysfunction
        Experiment – Compare ovarian dysfunction in a (well designed) study that compares vaccine exposure in people with ovarian dysfunction (vaccinated vs. unvaccinated)
        Results – Do the results support your hypothesis?
        Whether they do or not you still do not have a fact. The findings need to be repeated. Oh wait, they have! Several large studies refute this hypothesis.

        Please try to present some thoughtful science here and stop posting multiple links to pseudoscientific websites. This behaviour is deliberately attempting to instigate discord by posting off topic and inflammatory comments and links. It does not contribute to a healthy discussion or debate.

        • To dismiss “Little and colleagues” in the way you have above, is disrespectful at best and arrogant at worst. Many researchers have found (and are finding) worrying features about adjuvants and the possibility that they can cause serious problems in people that are genetically susceptible, or have compromised immune systems. The HPV vaccines have had more reports of adverse reactions and even deaths (291 reports), considering the relatively short time they have been around, than any other vaccine. It’s not possible to say YET whether these vaccines will prevent cervical cancer. Wait another ten years and maybe then we will know. Furthermore, HPV is NOT a serious infectious disease requiring universal vaccination, so why are we spending $18 million a year in the hope that it MIGHT prevent cancer 25 years down the track?

        • The agenda driven scientistm that you expound is a trend world wide. The denial of studies that contradict your blinkered view is lacking in a concern It doesn’t constitute science. Science is never settled, and even less where those who profit from it are the very ones supplying those studies. Your peer review process, while laudable in intent is also now a bought process. There are reports to this very effect by multiple editors of esteemed medical journals. There seems little point in supplying you with studies, as I have noted that, when you don’t like the content of a study that contradicts your narrow view the post is removed. Whatever happened to open honest discussion? What you and your ilk forget is that, when you have finished fighting and being insulting to good scientists work, there is still a discussion to be had. You may never reach consensus, but silencing of opposing views is not the way to reach the truth about the genuine risks and benefits for individuals (and let us be very clear that there are subsets of individuals who are at risk of serious harm from vaccines) and best health outcomes for all. It still astounds me that anyone believes that the path to authentic health is through injecting ever increasing doses of toxic substances into a body. It is quite simply irrational.

  • Censorship is the last refuge of those who have lost the argument and who cannot disprove the truth Helen. Your emotional bankruptcy is astounding. No doubt you will not post this, because it would alert others who have commented here, that you are perhaps fragile after all and therefore capable of feeling something, if only for yourself. I cannot say that I have ever read s Y thing you have posted that demonstrates any genuine concern for anyone who has reached out to you. Your comment regarding ‘fairies at the bottom of the garden,’ demonstrates how removed that you are from reality. You insult those with vaccine injured family members and that is unacceptable. You are a disgrace to your profession. How the MOH permits someone they take advice from, to refer to members of the public with such disdain and hatred, is beyond comprehension, unless they think that a blog is just not that important and does not reflect on them…..

    • At this point I will block Fiona, Virginia and Karen from further comments. They refuse to engage in a respectful manner, make personal attacks, and refuse to remain on topic. The technical term for this is trolling. The claims they make have been addressed ad nausea in the blogs and in the comments section.

      • Fair enough! Great work on responding to the comments, but you shouldn’t have to spend your days getting yelled at on the internet.

  • Hi can you clarify what is going on in the “What placebos’ were used in the Gardasil trials?” section? I see number of vaccine, number of saline placebo, but are there numbers for Al adjuvant containing placebo? How many got that one and how do they compare to the other groups’ results? Thanks

    • Hi Bree
      In the pivotal trials there were 11,778 who received the Gardasil vaccine and 9686 who received placebo (either the vaccine formulation without the key ingredient or saline). The only differences between all three groups are in the local injection site reactions where the vaccine had higher rates of reactions (as you would expect) and the saline had the lowest rates. Other than injection site reactions there was really no difference between the groups. Fever was slightly more likely in the vaccine group, again as you would expect. If you want to know the difference in adverse events between vaccinated and unvaccinated then you will need to look at the studies published since 2007. There are now well over 20 very large studies, some including over one million participants and they compare vaccinated people with unvaccinated people.

  • Hi Helen:

    can you reply to my comment above?Also, here are some more arguments for you to rebut.

    You write several times that there is lots of supporting evidence for aluminum adjuvant safety. I have searched the scientific literature for this evidence, and it does not seem to exist. Evidence for aluminum adjuvant safety is especially lacking for:

    1) exposures in infants
    2) exposures at dosages received from todays vaccine schedule (about 3675mcg in the first 6 months)
    3) long term neurological outcomes (e.g. at least 6 months, and preferably longer), such as autism, ADHD, depression, anxiety etc.

    Mitkus 2011 is the paper cited the most often by vaccine promoters in support of Al adjuvant safety. But the Mitkus paper is merely a theoretical modeling study of aluminum adjuvant dissolution and kinetics. Mitkus reports no toxicity data, and, outrageously, does not cite any aluminum adjuvant safety data. it has numerous fatal flaws, including:
    1) Al adjuvant has zero toxicity while in particulate form
    2) Al adjuvant toxicity can be based on studies of ingested, water-soluble aluminum lactate. This is wrong because its a different form delivered by a different route.
    3) use of a wrong NOAEL, with is too high by a factor of 7.6, at least.

    Another paper commonly cited is Jefferson 2004 (title: Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence). This review includes 8 studies, which the paper acknowledges are low quality. NONE of the included 8 studies looked for long term neurological or immune outcomes. They only looked at short term, acute reactions. Follow-up periods was at most a few weeks. Further, outcome data was from parental questionnaires. Medical examinations looking for adverse effects were not performed in any of the studies. Some of the studies were of children and adults, not infants. One of the studies compared two different kinds of Al adjuvant, which clearly cannot be used as evidence of safety. And finally, none of the studies looked at total vaccine schedule exposure. Exposure comparisons were for one or a couple vaccine doses, at most.

    Jefferson 2004 clearly cannot be used to claim aluminum adjuvant safety in infants at vaccine schedule dosages, particularly for neurological outcomes.

    So, do you have any other papers supporting your claim that aluminum adjuvants are safe, especially with respect to autism and neurological disorders? I don’t think this evidence exists.

    Safety claims cannot be based on a long history of use. Thats not scientific. Establishment of safety requires real science: studies with proper design, statistical power and data collection etc. Your “long history of use” argument is totally invalid. I should not have to explain why in detail.

    You also claim that aluminum dosage from vaccines is small. This is not so. Here are the numbers, for the US CDC vaccine schedule:

    Birth (Hep B): 74 mcg/kg (250 mcg for 3.4 kg infant)
    2 month: 245 mcg/kg (1225 mcg for 5 kg infant)
    4 month: 150 mcg/kg (975 mcg for 6.5 kg infant)
    6 month: 153 mcg/kg (1225 mcg for 8 kg infant)

    Total: 3675 mcg

    Oral absorption of aluminum is 0.3%.

    Over the first 6 months, a baby will absorb (these number are from CHOP):
    From milk: 7mg x 0.3% = 21 micrograms (0.021 mg)
    From formula: 38mg x 0.3% = 114 micrograms (0.114 mg)
    From soy formula: 117mg x 0.3% = 351 micrograms (0.351mg)

    Therefore, vaccines give 3675/21 = 175 times more aluminum than human milk in the first 6 months.

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