By Helen Petousis Harris 20/02/2017

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.

Links added to the BLA 8/7/19

0 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 🙂

  • The link above to Current Opinion in Obstetrics and Gynecology is paywalled, but I found a free version here

    • 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?

  • Hi Professor, my comments aren’t coming through? I have so many more questions to ask lol

  • 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.

    • Vaccine Papers many thanks for your clarity and accuracy. I think it will fall on deaf ears here unfortunately and note, that a response to your question and posting is not forthcoming from the author of this blog.

      • Non conformist (assuming this is a pseudonym?). I have not bothered to reply to Vaccine Papers because this person and their website are anonymous and their claims are standard anti-vaccine propaganda and recycled myths, most of which I have already addressed until blue in the face. In other words, the material on Vaccine Papers is not scientific and there are no credentials about the authors provided. For all I know the blogger may be a dog.

        • Helen Harris:

          Your reply is a cop out. I make specific arguments and I invited you to rebut them. My arguments are not in any way based on anything about me, so it is not reasonable for you to cite my anonymity as a reason not to respond. I believe you are simply not able to respond, because you do not have scientific evidence to support the things you say.

          If you have already written about the specific arguments I made, then please cite/link where you have done so. You have written about Al adjuvants but not addressed my specific claims or evidence.

          You state: “the material on Vaccine Papers is not scientific”

          This is blatantly false. is heavily cited. In many places the specific data relied upon for specific claims is shown. Your statement is hypocritical, because you do not cite scientific sources for your claims. For example, the claim “Aluminium salts have an established safety record therefore they provide a good comparator” has no citation. YUou do cite Petrovsky 2015, but this paper also has no data or citations related to long term or neurological safety.

          Another statement you make misuses the citations. Specifically: “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.]”

          The citations do not support what you wrote. Keith calculates much slower dissolution than the figures you provided. You misuse the Priest paper, which is a study of INGESTED WATER SOLUBLE Al salts. The priest paper is a not a study of Al adjuvant.

          These are basic and embarrassing errors. You should be ashamed.

          You have not addressed the following:
          1) That Al exposure from vaccines is much higher than from ingestion (in infants), in view of the low absorption of ingested Al (0.3%).

          2) The lack of studies in humans (or animals) demonstrating long term or neurological safety of Al adjuvant, especially for the full vaccine schedule. 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.

          3) Why “long history of use” can be relied upon as evidence for safety.

          4) 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. Mitkus has numerous fatal flaws, including:
          1) Assuming Al adjuvant has zero toxicity while in particulate form
          2) Assuming Al adjuvant toxicity can be determined from studies with ingested, water-soluble aluminum lactate. This is wrong because its a different form delivered by a different route.
          3) Use of a wrong NOAEL (26mg/kg/day in animals), which is too high by a factor of 7.6, at least. More recent studies show brain damage/inflammation and other adverse effects from 3.4mg/kg/day aluminum.

          • Hi VP.

            Please cite the peer reviewed studies (the plural is important) that find a statistically significant detrimental health outcome from aluminium used in vaccines.


  • Helen Harris wrote:
    “First, the bottom line on aluminium salts as adjuvants is that they have a strong safety record.”

    “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.”

    CITATIONS ARE NEEDED. I have searched the scientific literature extensively for the alleged safety evidence. It does not exist, as far as I can tell.

    Please link to the specific studies supporting these claims about Al adjuvant safety.

  • Some of the points raised by ‘Vaccine Paper’ are deeply concerning ..

    • Very interested in seeing the reply to the questions vacccine papers has posted. If this is, in fact, propaganda it should be no problem addressing these concerns.

      I have to say I was not particularly moved about any of this until I saw you refuse to answer VP because it’s a pseudonym? That is just a shocking decision.

      As someone who is on the fence with all of this, these are the types of questions I need to see reasonably addressed.

      • Jack, as I have said, I have already addressed the issues raised by VP – over and over again. In terms of the pseudonym, there are many credible bloggers that use a pseudonym. However, they also usually provide some credentials. Credibility can be also gauged by the quality of the science presented. If we are not going to all apply the scientific method to weigh up the validity of the evidence, in other words if we are going to have a debate where one side uses subjective truth and the other uses objective truth (as determined by science) then we are wasting our time. I am happy to address any concern about vaccines. However, I will use science based evidence to do so. If people counter argue using relativistic views, cherry picked material, or anecdote then neither of us will reach a satisfying conclusion because we are not playing by the same rules. VP claim they objectively present the science – then don’t. I have addressed many of the claims they make in these pages over the past few years. If you have a specific question about how safe a vaccine is then I am happy to provide evidence and comment on it.

        • I am personally not interested in credentials, just the discussion. Whoever the anonymous person brought up some very interesting points of discussion, which you did not address. I would love to hear your response to this portion about small dosage of aluminum. If not all of the aluminum is excreted after a vaccination, then it makes sense that after x amount of vaccines an issue could arise, even if an individual does is not significant enough to cause damage. Have studies been done on this? It seems likely that in the future more vaccines will be added to the schedule, and these numbers will grow: in order to do this safely shouldn’t we determine the precise cumulative amount that is safe? Below is the portion of VP’s post that I would like to be addressed. Thank you for your reply.

          “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.”

          • Why does it make sense that after receiving a series of vaccine a problem may arise? There is no epidemiological evidence for this even after many decades of use in all the world’s populations. I get the sense that your question “do vaccines with aluminium adjuvants increase the risk certain health conditions?’ or are you trying to prove that they do by arguing the relative dose and bioavailability of vaccine adjuvants? You see the problem here is you cannot answer questions about relative vaccine safety by calculating possible dose scenarios of one of the ingredients. If there were evidence that vaccines caused the harm you seem to be concerned about then we could look to toxicokinetic studies to help understand why. But this is not the case. Before we go down a rabbit hole where we argue the relative aluminium dose scenarios and sources of aluminium exposure during infancy perhaps we could first agree that babies who receive vaccines are at higher risk for some kind of poor outcome. Then we could explore the mechanism.

            Just to keep aluminium in perspective, we have evolved on a planet abundant in aluminium, along with many other non-essential elements. Exposure occurs prior to birth and throughout our life. It is the dose that makes the poison. Aluminium in vaccines is not in a form that is easily absorbed. Most is excreted. It is also injected into muscle, not intravenously. There is a big difference. First year vaccines provides about 4mg as you say. Breast milk about 7mg over first six months. Infant formula is apparently about 38,000mg. Then you need to get into the bioavailable, etc. I am not qualified to go there.

            My expertise is in vaccine safety and vaccine effectiveness. I have 20 years research experience in these fields and know quite a lot about vaccine safety. I can tell you how safe a vaccine is and what the risks and the benefits are if that is what you want to know. However, I am not a biochemist or toxicologist and would not profess expertise in these areas. Rather I would turn to respected representatives in those fields for scientific advice about aluminium adjuvant biology. Credentials are most definitely important, I am not likely to ask an epidemiologist about the bioavailability of aluminium. Like I don’t consult my lawyer about a rash, although she is bound to have an opinion.

        • In regards to cherry picking, if one is unsure about the safety of vaccines, it seems to make sense to cherry pick all of the potential downsides and have them addressed. If I had a jar of 10,000 jelly beans and cherry picked the one poisonous one out of the lot, that one jelly bean would carry significant weight, no? I think it would be unreasonable to accuse the person unwilling to to eat from that jar for cherry picking even though 9,999 of the jelly beans are totally harmless. Likewise, one study that suggests that something in a vaccine could be dangerous is not to be ignored as an outlier, it ought to be disproved, no?

          • Hi Jack – to your second point (I’m not qualified for the first):

            If one is unsure about the safety of vaccines as a consumer ie what risk is presented by using a vaccine, one should refer to the literature and compare the risk of serious complication from the vaccine vs the risk of contracting whatever it is the vaccine protects against.

            Your analogy doesn’t meet this – it presents a null for the 9,999 jelly beans. The 9,999 for a vaccine is an immune state which has a benefit.

  • My analogy was in regards to studies. Even if there are lots that prove safety, any one that suggests problems still carries weight and must be disproved.

    • I am frankly fairly surprised by your response. You yourself have stated that the amount of aluminum is very small and, therefore, not dangerous. If this accumulates, then we must study how much is too much.

      The idea that we “must first agre” that there are adverse reactions and then investigate is insane. Maybe we start by investigating. What if vaccinating as it is done now is completely safe, but with the addition of, say, 10 more, the aluminum levels become quite dangerous? It sounds like you are saying that if they were unsafe we would look into their safety, but since they are, we won’t?Am I misunderstanding your argument here?

      How can you possibly with a straight face say that conversing about the amount of aluminum in vaccines vs. what would be normal natural exposure is not a worthwhile “rabbit hole” to go down?

      As far as credentials are concerned, something is objectively true or false whether it comes from the mouth of a janitor or a rocket-scientist. Just because you are an expert does not give you or anyone else the right to declare what is a rabbit-hole that should not be explored or should be. Because you are an expert, I, and others, are interested in your opinion on this matter, which you refuse to address.

      I am not against vaccines. I am a reasonable person. When I see a reasonable question be avoided I grow concerned. I find this concerning.

  • I believe that there is scientific evidence that vaccines can save lives. I am not convinced that there is scientific evidence that alum adjuvants are perfectly safe,

    I did research the aluminum adjuvant science and discovered the following: (Please correct me if I am wrong.)

    1. Gardasil had two placebo groups one with aluminum and one with the saline solution.

    In the aluminum group serious side effects were monitored and in the saline group mild side effects.
    That means serious side effects did not have a proper placebo control group. One of the main reasons why vaccine can cause adverse effects is immune stimulation via adjuvants.

    That means they took the problematic substance out of the vaccine and compared it with the effects of the vaccine including the problemtic substance. That would be comparing the effects of Vodka with ice cubes vs. Vodka alone

    Obviously the two Vodka groups would not differ much in terms of side effects.

    There is no reason to use alum as a placebo. Doing it for reasons of blinding is not valid since substances like histamine could be valid placebos for this purpose.

    2. Aluminum in vaccines is not just naturally occurring aluminum. It is a proprietary formulation of alum particles designed to cause a immune response. I was not able to find a single study that compared the effects of alum adjuvant particles vs. a inert placebo. According to this one must conclude it has not been studied scientifically much or not at all or at least the studies were never published.

    It does not matter how many years alum adjuvants have been used if they have never been compared to a placebo. According to this reasoning homeopathy must be effective because it has been used for so many years and many people think it is highly effective. This is an unscientific claim of course.

    It appears that at least in the past 30 years almost no vaccine study used an inert placebo. They either used an other vaccine with an adjuvant or an adjuvant as a placebo. One must conclude that all these safety studies were unscientific since they did not use valid placebos. Makes you wonder why?

    3. As for epidemiological studies, there are very little studies that attempted to compare health of alum vaccinated populations vs. alum particle untreated populations. One can not say this is a well researched subject. It is also difficult to research since almost anyone got exposed to alum adjuvants. That does not mean that vaccine populations can not be healthier. This is not a black and white issue. Vaccines can increase the health of populations and cause adverse reactions in some individuals. Showing that vaccinated populations live longer does not mean that alum adjuvants are safe.

    Does anyone disagree with this? Please let me know why.

    Thanks for reading.

    • Hi Skeptic
      I have never claimed vaccines (including adjuvants) are perfectly safe. In fact I have highlighted cases where vaccines have been associated with harms, led research that concluded this and have advocated strongly for a family with a vaccine injured child.

      In response to your statements, (1) yes Gardasil had two placebo groups. The rational for the choice is summarised in this blog and responds to the rest of your comments.

      (2) Not all data on things like adjuvants is published. Often it is in dossiers provided to the regulatory authorities and they are far more rigorous in their assessments than the peer reviewed literature. Again, refer to the blog for the rational for placebo choice. Vaccine development is highly scientific, your conclusion otherwise is based on false premises such as the nature of placebos, clinical trials, and the broader body of evidence (see my last statement below as to why).

      (3) Re epidemiological evidence. I am interested to understand why you, and many others, are not actually interested in the safety of vaccines. For example, when I present studies that compare outcomes such as neurological conditions or autoimmunity in vaccinated (people who had a vaccine) and unvaccinated (people who had no vaccine) and there are no differences, why do you refuse to acknowledge them? Why do you keep challenging us to prove a negative? When you make an extraordinary claim the onus is on you to provide convincing proof.

      If you are going to be scientific about this you must pose a question, develop a hypothesis, then put it to the test? Because if you refuse to take this course of action then you are being unscientific.

  • Thanks for commenting. regarding 3) : I am interested in the safety of vaccines that is why I had left a comment here.

    to sum my previous comment up:

    There are no clinically-approved aluminium adjuvants only clinically approved vaccines which use aluminium adjuvants.

    Vaccines are tested for safety, aluminum adjuvants have never been tested according to the peer reviewed medical literature.

    The mechanism of action is poorly understood and the metabolism even less. Look at this study published in Nature.

  • I think this document did not contain any reference to safety studies.

    Section 11 – Toxicological Information
    11.1 Information on toxicological effects
    Acute toxicity:
    Oral LD50: No data available
    Inhalation LC50: No data available
    Dermal LD50: No data available
    Other information on acute toxicity: No data available
    Skin corrosion/irritation: No data available
    Serious eye damage/irritation: No data available
    Respiratory or skin sensitization: No data available
    Germ cell mutagenicity: No data available
    Carcinogenicity: No data available
    Reproductive toxicity: No data available
    Additional information: No data available

    Section 11 – Toxicological Information
    11.1 Information on toxicological effects
    Acute toxicity:
    Oral LD50: No data available
    Inhalation LC50: No data available
    Dermal LD50: No data available

  • Sceptic

    MSDS information is for large quantities, for; for example, firemen and truck drivers dealing with large amounts of material. Not relevant for the tiny amounts in vaccines.

    Helen has already answered your question. Her answer; all components of vaccines are thoroughly checked by competent and appropriate professionals. And, please remember, outcomes for the vaccinated are much better than for vaccinated.

    • @Maurice,

      I do not doubt that the vaccinated have better health outcomes but that does not eliminate the possibility of adverse reactions.

      Who are the professionals checking them and where are the studies? There must be some published research if the studies have been done. So far I did not find anything.

  • Sorry, that is. ” And, please remember, outcomes for the vaccinated are much better than for those not vaccinated”.

  • More trial flaws are being uncovered..

    “Lyng’s experience was not unique. Interviews with five study participants and more than 2,300 pages of documents obtained through freedom-of-information requests from hospitals and health authorities suggest inadequacies built into Merck’s major clinical tests of Gardasil. To track the safety of its product, the drugmaker used a convoluted method that made objective evaluation and reporting of potential side effects impossible during all but a few weeks of its yearslong trials. At all other times, individual trial investigators used their personal judgment to decide whether or not to report any medical problem as an adverse event—essentially, as a potential side effect worth evaluating further. Other health issues went on a worksheet for “new medical history,” reserved for conditions that bore no relation to the vaccine. This study design put the cart before the horse, asking investigators to decide which symptoms might be side effects, rather than tracking everything in the same way. While the company now says otherwise, there is no indication in the confidential study protocol that it submitted to regulators for approval that it would use new medical history as a safety metric. And it hardly would have qualified as such: The worksheet allotted just one line per entry, with no measurement of symptom severity, duration, outcome, or overall seriousness. Even if the company then used the data in subsequent safety assessments, the lack of detail would have hampered meaningful analysis.”

    Why is it so hard to accept that industry cheats and lies to put a product on the market? This is objective science…NOT.

    • Skeptic
      You have cited a magazine article written by a journalist with no credentials in this topic area. Yet you demand scientific proof from (I presume) high quality peer reviewed journals. If you are referring to the EMA letters and reviews I have summarised here. This is all an argument from ignorance and Slate even tried to justify but failed to acknowledge that the author provided no scientific proof for the claims.

      Also, have you ever seen the clinical reports from an FDA approved clinical trial? Have you ever been involved in a clinical trials of this nature? They are pretty damn objective, but the story never stops there and nor should it. Again, ignoring the postlicensure plethora of safety data is a pretty big omission.

      If you were truly sceptical you would take an objective approach.

  • Skeptic.

    To put your comment in perspective. You cited one relatively small study. Well I am accepting Helan’s comment: above, “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.” The vaccine was thoroughly and carefully tested.

    And your comments about Merch; part of the scientific method is checking methods, cross-checking, reviewing. It goes on and on. And the regulators demand careful checking and journalists are part of that checking too. All of that makes vaccines safer. That ethic of honestly and integrity is central to the success of the scientific method. (And I know there are some problems). If there are problems, they will be sorted.

    Every time my children received a vaccine I worried but the risks of not vaccinating are just so much higher. Every parent finds that tough. Remember; vaccinated children have better outcomes.

  • Maurice, yes problems will be sorted. The question is how long it takes. Tobacco science dominated medicine and public policy for decades. The CDC refused to accept the smoking/cancer link for a long time. The CDC is now telling us Gardasil is very safe!

    Helen, letting an investigator decide if a side effect is due to a vaccine is not objective at all. If you have a placebo group you do not need to do this. A real placebo group will take care of that. This is not objective science.

    Some of the postlicensure studies I have seen were designed by Merck, had people from Merck doing them and the other researchers had received consulting fees from Merck. I am sure there was no conflict of interest or bias involved at all.

    They were as objective as the safety trials and the “placebo” groups, I guess. In addition, epidemiological studies can not replace double blind placebo studies and vice-versa. You need both if you want to make sure you have a safe product. Both have flaws both can miss potential problems. A functioning system where adverse reactions are monitored and reported is also needed.

    Long-term population studies often focus on specifc problems, GBS for example and leaving out many other problems. You can only find something if you are looking for it.

    We can not allow drugs on the market that are based on fraudulent safety studies and rely on epidemiological studies to assure the product is safe. Even if the product were safe it would still be unethical.

    Everyone can look at the Gardasil trial and see how autoimmune disease in Gardasil patients is compared with the alum adjuvant group but there is no way of knowing what the rate in the saline group is. The design hides that. What is the point of using a placebo if you cherry-pick the data you publish or collect and only show what you want to show?

  • We can compare Vioxx with Gardasil and see the deceptive strategies used are more less the same. Business as usual.

    VIOXX: “The cardiovascular data reported in that article were incomplete, in part because of incomplete ascertainment: the design and execution of the trial had not anticipated that untoward cardiovascular events might occur.”

    Trial deisgn looking only for adverse effects that are NOT associated with the drug. (Gardasil trial on monitoring adverse effects as decided by the manufacturer)

    VIOXX: “Merck issued a relentless series of publications, beginning with a press release on May 22, 2001, entitled “Merck Reconfirms Favorable Cardiovascular Safety of Vioxx” and complemented by numerous papers in peer-reviewed medical literature by Merck employees and their consultants. ”

    Postlicensure studies done by either Merck employees or their consultants. (Many Gardasil postlicensure studies by either Merck employees or their consultants.)

    VIOXX: “Each time a study was presented or published, there was a predictable and repetitive response from Merck, which claimed that the study was flawed and that only randomized, controlled trials were suitable for determining whether there was any risk. But if Merck would not initiate an appropriate trial and the FDA did not ask them to do so, how would the truth ever be known?”

    If trials show no evidence of adverse effects insist that only controlled trials are scientific evidence and if epidemiological studies show no problem insist that epidemiological studies are evidence of safety. (Gardasil controlled trial results do not matter since epidemiological studies show it to be safe)

    VIOXX: “The only significant action taken by the FDA occurred on April 11, 2002, when the agency instructed Merck to include certain precautions about cardiovascular risks in its package insert.”

    Regulators says Gardasil is perfectly safe.

    VIOXX: “The first fun thing to emerge in the Australian case is email documentation showing staff at Merck made a “hit list” of doctors who were critical of the company, or of the drug. This list contained words such as “neutralise”, “neutralised” and “discredit” next to the names of various doctors.”We may need to seek them out and destroy them where they live,” said one email, from a Merck employee. Staff are also alleged to have used other tactics, such as trying to interfere with academic appointments, and dropping hints about how funding to institutions might dry up. Institutions might think about whether they wish to receive money from a company like that in future. Worse still, is the revelation that Merck paid the publisher Elsevier to produce a publication.”

    Threaten any researcher who dares to question the safety of your product. Harm or destroy the reputation and career of anyone who asks the right questions. Reward anyone who supports you. Not many want to publish about the un-safety of Gardasil if this could mean the end of your academic career. Then insist that “Science” has shown that Gardasil is safe and the scientific “consensus” is that Gardasil is not associated with adverse reactions.

  • Ah, the beauty of a Gish Gallop in action.

    Yet vaccinated people have much better outcomes than those not vaccinated. That is all that we need to know. Remember that.

  • Maurice, this is a bit ad hominem and what people say when they have nothing else to offer. I am not offended, it helps me understand other points of view.

    That is not all we need to know since it assumes side-effects are required for efficacy. This is not true. Vaccines can be safe and effective. They do not need to be unsafe to make them work. Safety and efficacy are two different things.

    I just looked at two Gardasil follow-up studies. Ignoring the conflicts of interest(so far I have not seen a study without conflicts of interest) they had major design flaws. I think one of them was the large study you were talking about.

    Perhaps I will post more details later.

  • Skeptic brings up very valid points. I’ve been researching general aluminum adjuvants and guardacil’s uniq aluminum adjuvant in particular over the past couple weeks because I’m interested in taking the vaccine myself.

    We get it; vaccination in general is a blessing to humanity even with the standard older aluminum adjuvants.

    This does not rule out that the newer Guardacil adjuvant in particular does not have long term mild or acute neurological effects. I’m mainly concerned about the possibility of Alzheimer’s or mild Alzheimer’s down the road. Maybe mild depression? Etc etc…

    ///Exhibit A: What the public needs to see to put all these poorly funded or sloppy scientific studies to rest///
    A proper study. As an example (and I’m no scientist):
    1) Guard+Alum Adj / vs /
    2) Alum Adj / vs /
    3) Saline Placibo
    At least 5,000 particicipants in each of the three categories over at least a 10 year period (especially if we want to scratch the surface on diseases such as Alshiemer’s).

    Do we have a study like that?

    ///Exhibit B: Efficacy. What I need to know///
    The sloppy scientist Tomljenovic whose paper was retracted still has some interesting points on the efficacy of Guardacil.

    She claims that gov studies show:

    -8 in 100,00 women will develop cervical cancer with current screening methods
    -16 in 100,000 women who take the Guardacil vaccine will develop cervical cancer (not sure who the latter study is by)

    Can you please let us know if these efficasy figures are correct. If not, what are more reliable figures?

    I’m debating the pros and cons of a vaccine that has an excellent chance of protecting me against a virus I might already have, agreed. Protecting me against a virus that has a 10 in 100,000 chance of giving me head or throat cancer vs (and the following statement is totally not scientific) my own theoretical figure of a 10 in 100,000 chance of Guardacil’s Alum Adjuvant giving me Alzheimer’s or some other neurological dysfunction like mild depression (As in, am I depressed? I’m not sure ? 1000 in 100,000 theoretical chance of mild depression).

    1- Can you please give me transparent scientific studies with proper controls to answer my questions from Exhibit A, specifically in regards to Guardacil’s adjuvants.

    2- Can you please give me a counter argument to Exhibit B. Perhaps Tomljenovic speaks out of context. Like age or demographic? If so can you please be specify.

    Until an alternative is found, I 100% agree that people should still get vaccinated with older alum adjuvants used in a Hep or Tetanus shot for example. Guardacil on the other hand, unless my questions are not addressed thoroughly and scientifically seems questionable to me. Don’t get me wrong, if HPV was as dangerous as small pox or polio of course I’d definitely take the shot.

    Thank you very much for your time

  • Maurice, I think this is the study you mentioned:

    This is the largest to date with 1 million girls from Sweden and Denmark. At least 2 of the authors have previously received funding from a HPV manufacturer so there is a potential conflict of interest here.

    What they did was to compare the rates of more than 50 autoimmune diseases from HPV vaccinated vs. non-vaccinated girls for up tp 180 days.

    What is the problem with this study?

    The follow-up period is only 180 days after the last vaccine dose. So that means if someone would receive a diagnosis of autoimmune disease 300 days after the last vaccine they would be ignored. In the real world autoimmune disease is difficult to diagnose, on average it can take years to receive a proper diagnosis and patients have to see at least several doctors.

    “People on average see six doctors over a period of 4 years before they get a diagnosis.”

    Basically, measuring for a period of only 180 days means that you would miss most cases. This is not a design that is suitable for finding out if a vaccine causes autoimmune disease. They do not try too hard to find problems.

    These follow-up studies look great if you ignore essential details. The others that I have seen so far are questionable. as well.

    • Skeptic,
      With respect to your criticism of the Danish study. Lets follow some logic. There were no clustering of events in this study. If the vaccine caused an autoimmune disease then the onset should occur in a particular time frame in order to be biologically plausible. Also, if something triggers an autoimmune response it happens quickly. Are you suggesting that no clusters of cases could occur earlier than this? Because if you are you are discounting a very large proportion of the cases reported where attempts have been made to link them to the vaccine. Most case reports state onset from hours to days to weeks after. In cases where vaccines have triggered autoimmune reactions that have occurred in close proximity to the vaccine event.

      You say that this is not a design suitable for finding out if a vaccine causes autoimmune disease. I am just wondering what your expertise in epidemiology is, because the authors have quite a lot of experience with these sorts of studies, are highly respected among epidemiologists, and the study has been published in a highly respected Journal. It will have been rigorously reviewed. It has also been reviewed by the WHO. I think it is fair to say that it is a pretty good study.

      Also, This is one study, all the other studies with different methods and different populations have produced the same results.

  • Helen,

    First, they are not measuring biological onset, what they are measuring is the time of diagnosis. When you get diagnosed has to do with a lot of other factors that are not related to biology. It will vary a lot between patients.

    No one knows when the biological onset of the disease happened. In the real world autoimmune disease is not diagnosed when the biological onset happens. There will be a delay of weeks, months, years, up to 10 years.

    Of course case reports are selected in a way that they are as close to the vaccine as possible. The clusters of cases were analysed only in 3 diseases. Also clusters show time of diagnosis not onset. Not everyone gets diagnosed at the same time.

    The fact that something is peer-reviewed is great for PR and marketing but means little in the real world.

    That does not mean the study is bad it just very selective in what is being looked at. It is not a study that tells us about long term health outcomes. The other study you mentioned does more less the same. They have an even shorter follow-up period. It was entirely funded by Merck and even a Merck doctor handling the data or establishing the diagnosis. I am sure that will result in unbiased data. We have already seen that in the real world, patients in the trial get extremely ill and their documentation mentions zero of it.

    The only long term study that I have seen was entirely funded by Merck, had no placebo groups, no control groups at all.
    It is over a period of 10 years.

    The original placebo group got adjuvants and a few months later the HPV vaccination. Merck doctors collect the data and determine health outcomes. There is very little published about health effects. It is noted that no adverse effects on health were noted, but no real data is presented. We have to believe what they say.

    It was done in Colombia. It is well known that studies done in developing countries are often highly biased.

    So we have no real independent studies monitoring health over a longer period of time, we have no double blind placebo trials, we have a company with a criminal record and in almost all studies there is a conflict of interest but we have to believe the product is very safe?

  • Helen:

    I find this whole discussion strange. Your original post was making a case that the vaccine was carefully tested and against appropriate placebos. I’m inclined to follow your expertise and that of your colleges around the world, and your conclusions are that the vaccine is safe.

    This is particularly so when I see headlines like this, “A decade on, vaccine has halved cervical cancer rate”. ( We have a decade of experience with this vaccine and no scary problems have emerged. I’m happy for my daughter and son’s partner who have had the vaccine.

  • I think the point is that no one had ever shown with carefully controlled studies that aluminum adjuvants are safe. It is a claim that is not backed up with real data. The only data that is mentioned refers to aluminum in food but nanoparticles and ionic aluminum are much different. So far no one has been able to present a credible well-designed study, placebo controlled study (animals or humans) that shows it to be safe.

    A placebo is per definition an inert, biologically inactive substance, Adjuvants are per definition not placebos.

    Various animals studies show that they are far from inactive and can have serious side effects and induce chronic illness.

    “We describe a form of the autoimmune/autoinflammatory syndrome induced by adjuvants in commercial sheep, linked to the repetitive inoculation of aluminum-containing adjuvants through vaccination”

  • The following is about one side effect Merck refused to study, but applies to all adverse effects.

    This article “Adolescent Premature Ovarian Insufficiency Following Human Papillomavirus Vaccination’” is on the National Centre for Biotechnology Information (NCBI) USA government website.

    It is authored by Dr’s Deirdre Therese Little, MBBS, DRANZCOG, FACRRM (Obstetrician for 27 years) and Harvey Rodrick Grenville Ward, Bsc(Med), MBChB, DMCOG, FCOG(SA), MMed (O&G), FRANZCOG2. Dr Ward is a member of Genea and Medical Advisory Committee of Baringa Private Hospital. He is a Fellow of The Royal Australian and New Zealand College of Obstetricians and Gynecologists as well as a NSW Board Certified Specialist. He is registered as a RANZCOG examiner and is a RAMUS mentor.

    In ‘Vaccine Components Used as Safety Study Controls’ they say:
    “The ‘placebo’ that formed the control selected for phase III safety studies of Gardasil (older girls) was the aluminium adjuvant present in the vaccine solution, amorphous aluminium hydroxyphosphate sulfate. The selection of aluminium as a control in vaccine studies is AT VARIANCE WITH THE SCIENTIFIC PRINCIPLES OF A CONTROL. The ‘placebo’ in the only controlled study of very young girls was the remainder of the vaccine carrier solution: The ‘placebo’ used in this study contained identical components to those in the vaccine, with the exception of HPV L1 VLPs and aluminium adjuvant. It contained 50 µg polysorbate 80 (polyoxyethylene sorbitan mono-oleate also known as Tween 80), 35 µg borax, 9.56 mg sodium chloride, and 0.78 mg l-histidine”.

    “Safety studies identified at licensing (there have been no post market trials done) did not compare HPV4 with NORMAL SALINE CONTROLS. The second ‘placebo’ contained several substances together with saline”.

    What the authors are saying here is that in trials by MSD one ‘placebo’ of aluminium adjuvant one of the most dangerous ingredients in vaccines, was used on older girls; and the less dangerous ‘placebo’ was applied to younger girls.

    MSD did not conduct the research on the younger girls themselves, but rather poached the safety results of another researcher whose ‘placebo’ contained all the other ingredients including another of the dangerous ingredients, but not the viral active parts and aluminium.

    There was NO double blind placebo. Not even a single blind placebo applied!
    Dr’s Little and Ward explain the significance of this:

    “Published safety studies only compared HPV4 vaccine with its own components. This may be significant since injected substances in both ‘placebo’ control arms have either a suggested association with autoimmune ovarian damage or known direct ovarian toxicity. Completed vaccine and ‘placebo’ courses each administered 675 μg of aluminum to older girl safety study participants; or components including 150 μg polysorbate 80 to all 9- to 15-year-old safety study Participants””.

  • “Perhaps you could explain how saline would be used when testing a medicine that came in tablet form”.

    OMG Helen Seriously!!!!!!!!!!!!!!!!!! How do you have your job position?

    Ummmmmmmmmmmmm really hard trick question that one. Sugar!

    I think you have anger and defensive issues. You get so hot under the collar with being cornered with truth that you dig yourself in deeper and deeper.

    The testing of vaccines involves its side effects and efficacy to be researched prior to approval.

    Gardasil 9 would not have been approved if a correct placebo was used. They had to commit fraud to fast-track and get approval and pull the wool over the FDA’s eyes. What better way to make it appear the vaccine was not dangerous then to use the most dangerous component, the aluminum and another vaccine with all the risky ingredients, as “placebos” This could then make a benchmark that was on a par with the extensive side effects of Gardasil 9 so the sides effects could be brushed off as statistically insignificant.

    It is absolute BS that the vaccine has to be compared to another vaccine to assess the dangers. Merck performed a practice which if they follow and were not pulled up with in their fraud case, would escalate the dangers of vaccines as time went by. Merck crossed the line with their complacency of corruption and their smoke-screen of appalling scientific trials and how much propagandists would support the vaccine come hell or high water and how condoning people such as those from Immunisation Advisory centre, MOH, Medsafe etc. are happy to throw all professional conduct out the window to say the opposite of the transparency they had to use to the FDA

    I can see Merck will try and put it over people even more by having Gardasil 9 vaccine as the placebo for their next HPV vaccine, because of what the condoners turn a blind eye to and let them get away with. So they will base a fraudulent research upon fraudulent research upon fraudulent research….. The side effects will snowball without any recognition or acknowledgement at all of the vaccines being the cause if Merck and the condoners have their way.

    Hence the purpose of having a standard of NO VACCINATION as the benchmark, a saline placebo. One totally neutral universal standard of placebo for all.

    Here’s hoping their fruad case and the FDA keep them in check, or at least carry on publishing the information that shows how wrong the propagandist ‘scientists’ are.

    If one looks at the stories of why the condoners condone other placebos, pathetic!

    Recipients need to think they are getting the real thing. LOL In other words you want the recipients to expect adverse effects and will know they haven’t got the real thing if they don’t. Great idea to give them a dangerous ‘placebo’ then.

    It doesn’t take a doctorate for anyone to see what BS they are being told, if they just think about it rather then trust the condoning so called ‘scientists’ and health professionals.

    Hello Helen

    True to yourself, personally attack then get someone else to step in when the going gets too hard for you.

    Grant Jacobs you obviously think your doctorate makes you so much higher and mightier than everyone else. I realise you and Helen call yourselves scientists, but your manipulation of ‘evidence’ to only back up your agenda, is not science. It is not reputable or professional in the least. It is unproven propaganda. Note how I said “how do you call yourself a scientist”

    I do not need to look up the word “placebo”. I was taught what that is at university. A more reputable one than yours that permits staff members to put up blogs such as this. It is you who needs to learn the correct definition and terminology of a placebo.

    There was a fraud court case against Merck in part for advertising in their inserts that they used a ‘placebo’ when it fact they used what Helen says is a placebo. Merck ended up having to admit they did not use a placebo. How do you explain that away?

    I realise the vaccine industry is re-defining what science is and scientific validity to suit their own personal agenda of $$$$$$ and to downplay and eradicate side-effects and low efficacy; but that does not make it science. That is what is the actual “magicians ploy” that makes it hocus pocus.

    By pointing at placebos that are NOT placebos it highlights to people how BS the trials were, so it is about the trials. They do not use ‘placebos’ containing only the most dangerous component or another vaccine, without hiding a lot of side effects. With side effects you want to know if the vaccine has more adverse effects than to not have the vaccine. NOT how dangerous it is compared to another danger.

    Your sort of “scientists” have the gift of the gab. The gift to talk your way around all the BS with smokescreens, but that does not make it science. It makes it dogmatic propaganda manipulated to suit your own agenda. People like you make up your own stories to support your agenda and twist around reputable science to a pretzel. You are a thorn in the side or true scientists.

    “A lie will go round the world while truth is pulling its boots on.”

    And this is so true when propagandists and the government with all their power sabotage, oppress and gag the truth and throw the boots over a cliff.

    And exactly my point. You block people from this blog whom you can not give answers to because you are so full of it.

  • Any time when vaxxed vs unvaxxed populations are studied the vaxxed children end up with severely more health problems than the unvaxxed populations. There are countless such peer reviewed studies posted here: There is no shortage of these kind of studies but the filtered pro-pharma media environment in the USA makes certain that as few people as possible have access to these results. We can’t even use google properly due to the dishonest filtering. 159 sources cited within this article

    • Claudette
      You have posted a link to a publication in a journal that does not specialise in public health written by individuals vehemently opposed to vaccination who have a track record of misrepresenting data. Perhaps you could pull one of the studies they present here that purports to show what you claim and explain how it is a quality study and why it is at odds with the body of scientific evidence. I am asking you this because you have made outrageous conspirational claims. And as Ashton mentions, how about you demonstrate how Google is dishonest. To the best of my knowledge it will simply give you what you want because it knows what you like. Your Google search will return largely anti vaccination rhetoric and mine will return scientific articles. Neither are ideal and therefore a more systematic unbiased approach is required when searching for evidence. Along with an ability to determine what is true and what is not.

    • Claudette
      Have you got any evidence to go with your claims? That Mawson paper you link to was retracted, it is such a load of rubbish it could not even make the predatory press.

      With respect to the FB link, can you put your hand over your heart and tell me that you have read those articles and understood them along with the context in which they fit into the scientific body of evidence? Because I am familiar with a few despite their vintage. Perhaps you could present one of those studies and we could discuss what it means in the context of the safety of our vaccines. I am interested in hearing your perspective.

      Your last comment is insulting. Please show respect if you wish to engage here.

  • Hi Claudette,

    Any time when vaxxed vs unvaxxed populations are studied the vaxxed children end up with severely more health problems than the unvaxxed populations.

    That claim only works if you ignore the number of people who vaccinate v the number who don’t. If ten times more people vaccinate than don’t, then, all other things being equal, we’d expect ten times more illness in vaccinated people simply because there are ten times more of them.

    If you compare per every 1,000 people who vaccinate or not, those who vaccinate are (much) better off.

  • Hi Claudette. That’s two powerful and interesting claims.

    Can you provide any direct examples of the studies that support your claim of more illness in vaccinated populations? The link you provide goes to an article apparently unrelated to your claim.

    Can you provide any direct evidence of your claim that google searches are “dishonestly” filtered?

  • I have one question. I am not a doctor or a scientist, but I do remember 6th grade science. The safety/effectiveness of this particular vaccine simply cannot be argued by either side because there was never a valid study to scientifically prove that it is or is not safe/effective.
    In regards to the scientific method, when testing your hypothesis you must conduct a fair and unbiased experiment with the use of a placebo that is specifically designed to have no effect. Without a placebo, pertinent measures and comparisons can not be made. Two groups were made, yes, but no placebo. A comparison between two substances was made, but it does not test the efficacy or safety of this particular vaccine.
    So many professionals were involved in the making and approval of this vaccine and they undoubtedly know how to conduct an experiment. My question is simple. Why are we injecting hundreds of thousands of children with a chemical based on information that is scientifically unsound? I am not arguing the importance of vaccinations. I am alarmed by this particular vaccination. My reasoning may seem simplistic, but that is the beauty of the scientific method. It is simple.
    Concerned Mother

    • Hi there
      You are correct that when testing your hypothesis a fair an unbiased experiment it required. However, you are wrong in the assumption that this has not occurred and what constitutes an appropriate experiment in this case. Much of our knowledge about the safety of this vaccine comes from many experiments that compare children who have had the vaccine with children who have not. These studies do not have to be randomised placebo controlled trials, we have cohort studies some with over one-million individuals where hypotheses about even rare safety outcomes can be tested robustly and repeated over time and in different settings. With respect to a placebo study, how about a randomised placebo controlled cross over trial in twins of MMR as an example? here is a link.

      The science on the safety of this vaccine is not unsound and it is extensive.

  • Sadly, there appears to be a gulf between ‘the science’, the person with a (genuinely) enquiring mind, and the apparent link between ‘post clinical follow-up’. Perhaps, that is a (the) big challenge ..

  • “Sadly, there appears to be a gulf between ‘the science’, the person with a (genuinely) enquiring mind, and the apparent link between ‘post clinical follow-up’. Perhaps, that is a (the) big challenge ..”

    I’m not following you – “the apparent link between…” doesn’t make sense with only one object.

    Aside from that, where is the gulf, and what would you consider marks a genuine enquiring mind from a disingenuous one?

  • Hi everyone.
    First of all thank you all for sharing your opinions.
    In fact, after reading this blog i got more confused. As a former pharma employee (in a role of clinical research specialist and medical advisor) and well educated medical doctor I just want to know the truth. I am not antivaccine at all, but i am very selective at the same time. Have read a lot pros and cons with regard to Gardasil and yet can’t make my opinion. I apply common sense to all issues i come across, and now all i can see is that Gardasil story (both positive and negative sides of it) can’t be farther from over.
    Anyhow i enjoyed the conversation (have ignored non-productive harsh and impolite remarks). Will continue my own research.

  • Without proper trials conducted with animals the safety of aluminium is a myth. The initial article here states that aluminium is excreted. This only applies to ingested aluminium. According to animal studies inoculated aluminium hydroxide and nanoparticles are NOT excreted but are transported to lymps nodes, organs and brain. Aluminium is highly neurotoxic. If scientifically plausible research would deem aluminium unsafe, then vaccination programs would be altered and the profits of multinational pharmaseutical endangered. As a result research on aluminium by pharmaseuticals is virtually nonexistant, yet, at the same time, they claim it is safe . Gardasil and Cervarix use new type of aluminium adjuvant creating more potent (dangerous?) immune reaction.

    • Hello Paavo
      You appear to have come armed with your own facts about aluminium but have not provided any evidence to support your assertions. Given you appear to be declaring the body of knowledge, evidence, and scientific experience on aluminium toxicology to be false you are required to provide a plausible explanation for said claims.

  • Helen have you watched the 2018 depostion from dr Stanley Plotkin the making vaccines since the 60s? Seems in a court of law you wouldn’t be able to say vaccines don’t cause autism. And on the Japan issue, the two HPV vaccines were on the market for 6 weeks. One vaccine had six complaints in that time the other had 52. Interesting that in a court of law almost all of the pro vaccine generalizations fall apart. And just to further that. Can you tell me how long the monitoring periods for side effects were for all the vaccine trials they’ve conducted?

  • Normal definitions of placebo include that the substance should be inert. This is not only standard scientific practice, but common sense if you are trying to determine if a vaccine is safe. If active compounds are included in the controls (as they are here) then this is not a true placebo (unless you choose to re-define the term). As a result you really don’t know if those added compounds are causing the serious adverse events recorded in the control group.

    You say “… 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’.” Are you seriously suggesting that a child being injected with pure saline would somehow know that he or she was not being injected with the real vaccine? This seems unlikely and an insignificant issue compared to adding controversial constituents to the control such as aluminium adjuvants, L-histidine and polysorbate-80. which could well be contributing to the adverse events. This is a flawed experiment that doesn’t lead to the conclusion that the vaccines are safe. Why not provide trials with pure saline placebo? This is universally recognised as safe and would be a good baseline to compare against the vaccine.

    • Jack, the reasons for this have been explained.
      ..and no of course a child, or an adult for that matter, will not know. However a person who has an injection site reaction might assume they got the real deal, or the parent of the child for that matter.
      The other ingredients are most certainly not controversial. There is no scientific dispute on this, only the pseudoscientific garbage promulgated on social media.

  • Hello Maurice,
    You mention a BBC article that is entitled “A decade on, vaccine has halved cervical cancer rate”.
    This popular article that has no references, nor does it explain how this conclusion was reached. I have tried searching for any related paper using the author’s name and related phrases but cannot find any study that suggests a halving of cervical cancer rate related to vaccination. Perhaps you or someone else can point me in the right direction?

  • Jack: yes it is frustrating when popular articles don’t contain sufficient information to find sources.

    I often set a source-find and cross-check exercise for my students to encourage them to develop their skills in finding sources and checking that they are supported by the literature. I suggest you reread Helen’s original post – after all, she is an expert – and track down her sources, and that you look for useful reviews on the WHO website.

  • An interesting exchange. I am not anti vax, but like Larisa I try and understand the science behind each vaccine as obviously they are not all the same. One thing I have noted is that Merck say that the aluminum adjuvant used in Gardasil is a proprietary ingredient called aluminum hydroxyphosphate sulfate but they never say how much is in the vaccine. Does anyone know how much of the adjvant is present?

    • The quantity of the ingredients in each dose of the vaccine including the adjuvant are on the data sheet, in many of the published studies, and noted in numerous other places such as regulatory submissions. The quantity in Gardasil4 is 225micrograms and 500micrograms in Gardasil9.

  • So one “placebo” contained aluminum. The other “placebo,” which you continually state contained saline only, actually contains L-histadine and polysorbate-80. That means there was no real placebo given in the Gardasil trial, and it should have never gone to market. What is your deal?

  • If a researcher wanted to elicit the impact of the vaccine antigens, then a placebo that consisted of saline only wouldn’t be appropriate.

  • “That means there was no real placebo given in the Gardasil trial, and it should have never gone to market. ”

    If aluminium was a scientifically identified and acknowledged problem in vaccines (relatively easy given the vast number of vaccines administered containing Al) OR if the quantity of Al in the vaccine was significantly different to that in other vaccines with similar composition, OR if this was the first ever vaccine using an Al adjuvant , then you might have a point.

    It isn’t, it isn’t, it wasn’t, you don’t.

    There is a significant body of evidence that Al adjuvants are safe in use, and a significant body of review that point out the shortcomings in the findings of people claiming otherwise. ScepticalRaptor rounds it up here. Worth a read.

  • Hi, not sure if this is ‘on topic’ but i just discovered Dr Yao’s mice study

    Is this the first ever animal/vaccine study?? Is there some reason i should dismiss these conclusions?

    My daughter is due for her first set of vaccinations and this makes me want to start questioning all the other vaccines..

    • Hi, There are quite a number of studies like this. Many have earned retractions due to poor methods, even falsified data. While we could debate the merits/shortcomings of using mice in this manner (personally I think it is unethical, not to mention the validity of the model, the study looks dodgy) I think it is more useful to consider whether there are any good data that investigate the safety of this, and other, vaccines in humans. There is vast data on the safety of the infant vaccine schedule and most of this data compares the health of infants who received the vaccines with those that did not in various ways. Millions of individuals have been assessed across such studies. The only reason that I can think of that justifies using a mouse in this way is if there is concern that the vaccine causes neurological damage and you wish to use an animal model to help understand why. Given there is no evidence for a safety problem with the hepB vaccine there is little justification for these experiments.

      You can choose to believe the conclusions from an unvalidated Chinese study using 24 mice, rather dubious methods, and erroneous assumptions, then extrapolate it to humans, or to look to the global safety data on childhood vaccines.

      Sadly there are a growing number of these types of studies appearing. If you want specific comment on this article we could look into it.

  • Maurice said, ” I suggest you reread Helen’s original post – after all, she is an expert ”

    Maurice, have you read her PhD? She presented as an expert to the Japanese authorities saying that her research proved that there was no cytokine response of note post Gardasil.

    The Powerpoint slides Helen Petousis-Harris presented at the public hearing claimed Dr Lee’s case report regarding case reports of his had no controls to prove that unvaccinated New Zealand teenage girls do not have HPV DNA in non-B conformations in their blood, therefore the findings are not scientifically valid. She said, “There are no controls used (unvaccinated). This is a vital part of the scientific process.”

    Her research contained no controls and her study made no such findings. Her statement was fraudulent. It was fake.

    You can download her PhD thesis here.

    If that is what her expertise is based on all I can say is what a house of cards.

    • Rob,
      You must have read my thesis! Perhaps you did not notice that my research was not about adverse events after HPV vaccination and I was not comparing vaccinated with unvaccinated in the study that looked at cytokines after vaccination. My study found no difference in cytokine levels on day two after vaccination between those who had local injection site reactions and those that did not (no correlation). Please do not misrepresent what I said in the Japanese presentation, nor my thesis. I would also add that my expertise comes from over 20-years of research experience and empirical enquiry, it has little to do with with a PhD.

  • I am perfectly confident with Helen’s experience and expertise. And what she is telling us, is what the other experts are saying too. That is an important check.

    However, you do raise an interesting question. Your view is that the metaphor for science is a “House of cards”,;I would see something like a “self-correcting web of models and evidence”.

  • Hi Robyn,

    You appear to be running off Dr Lee’s claims, rather than what Helen has written or done.

    Remember that thing that “assumptions make an ass of you and me”?

    You are are assuming that Lee’s claims are sound.

    I briefly read the abstract one of Lee’s papers on this “other DNA conformation” stuff. Not meaning to be offensive but I literally bust out laughing. I haven’t seen a claim so ridiculous in years.

    His abstract is—literally—several assumptions piled on top of each other, which he then launches his work from. Now that’s a house of cards.

    It’s a pile of speculations.

    Silly thing is it’s easy avoid the confusion he’s creating. He claims to be offering a ‘how’ adverse effects happen. There have to be actual adverse effects for his speculative ‘how’ to explain or it’d be meaningless, right?

    Researchers who’ve investigated the safety of the HPV vaccine say there aren’t any concerns to address.

    For example this paper from CDC scientists concludes “Safety findings for 4vHPV have been reassuring with no confirmed safety signals identified.”

    More here, “This review of VAERS non-manufacturer reports following vaccination with HPV4 in pregnancy did not find any unexpected patterns in maternal or fetal outcomes.”

    And so on. A point here is that it’s easy to ‘scare up’ something if you ignore that there are no actual safety concerns and go off speculating. (I’ve seen this done for GMOs too. It’s probably common to other things like water fluoridation and so on.)

  • Helen, is this your thesis here? all 333 pages?

    followed by a randomised trial of three
    injection techniques used to deliver the quadrivalent human papillomavirus vaccine in
    females aged 14-45 years and males aged 14-26 years. Data collected included stress
    variables and blood samples for evaluation of cytokines.

    No cytokine functional groups nor individual cytokines were associated with
    reactogenicity outcomes.

    5.2.2 Hypotheses
    The hypotheses of this study were that:

    4. Inflammatory cytokines are associated with the presence of local vaccine reactions.

    you had no controls.
    took blood sometime on day two

    finding: no cytokine functional groups could be shown to be associated with
    reactogenicity outcomes and there was little more correlation between
    individual cytokines and reactogenicity than could be expected by chance.

    Low recruitment rate [you got a fraction of intended respondents… less than 1/4…]

    Timing and lack of baseline cytokine measures
    Only a single blood sample was taken. The absence of a baseline measure precludes
    any within-individual changes. It cannot be determined if there were any changes in
    cytokine levels as a result of the administration of the vaccine or if these were base-line
    levels. In addition, blood samples were taken on day two, the day following vaccine
    administration, as it was thought local reactions would peak on this day. Injection site
    reactogenicity is not reported in a way that clarifies the peak time of reactions therefore
    this was an educated guess. Reactions actually peaked on the day of vaccination. It is
    possible that any elevations in cytokine levels may have waned by day two.

    And you told the Japanese that your research confirmed there was no cytokine involvement post Gardasil.

    And you berated Dr Lee for being unscientific by not having controls for case studies?


    I suggest anyone wanting to make further comment should read Helen’s thesis so they cn make informed comment.

    • Rob/Robyn,
      You really should not pick excerpts from a study and make your own interpretation, or misrepresent someone’s comments, or introduce unrelated topics – these are strawman and red herring arguments. As you cannot keep to topic (this post is about a study that assessed MMR vaccine and Autism), and have made ad hominem attacks on a contributor who has patiently addressed your issues, your comments are no longer welcome on this blog. As I have made clear, trolling will not be tolerated so further such comments will be deleted/trashed. You have had your say.

  • Safety of Aluminium Hydroxide has NEVER been done. It’s historical record relates to efficacy only. In the era when leaded paint and asbestos still was accepted. Not 1 trial exists for the safety profile of injected aluminium hydroxide being easily excreted. Using it as a placebo for measuring safety, and adverse events, proves it has not been tested for safety. You cannot have a reactive placebo to what you are testing in adverse events. To say otherwise is ignorant. Tobacco science 101.

    • Hello Cameron,
      The claims you make are demonstrably untrue and you provide no evidence for them, nor rationale.
      1. Every vaccine trial includes safety outcomes. Some studies have a different vaccine as a control, some studies have a saline placebo as a control. Observational studies compare vaccinated people with unvaccinated people. The objective is to determine the safety of the vaccine. In addition to thousands of vaccine studies there are also studies that look at other medicines that include aluminium hydroxide as an ingredient and comparisons with placebo.
      2. There are studies that look at the kinetics of injected aluminium.
      3. We are interested in the safety of vaccines. Aluminium is not a medicine and is not given on its own. This is why we compare vaccinated with unvaccinated people. Why on earth would one want a study comparing aluminium with a placebo? We are never going to use it like that. I can also tell you that it would be unethical to do such as study in a paediatric population. Do you propose injecting children with aluminium or a placebo in order to measure safety outcomes for a substance that will never be used in that way? It would be useless.

      You are calling virtually the entire medical and scientific community ‘ignorant’. That is pretty rude, it is also unlikely to be true.

      If you wish to participate in this forum please be respectful and also provide scientific evidence for your claims.

  • Hi Helen,

    Can you please tell me how much AAHS is in Gardasil 4 and 9?

    Thanks ?

  • The MMR twins study did not use an inert placebo. It was an active placebo which included the vaccine excipients. Both twins ultimately received the MMR.

    • Krista,
      Not sure what your point is. The placebo in the Peltola study had traces of antibiotic and pH indicator. It will also had sodium chloride or some other salts which you have not mentioned, no doubt in greater quantities. What is you issue? Please provide evidence that the substances in the placebo had some invivo activity in a human to make your point or I will assume you are trolling.

  • Thank you for your reply, Helen.
    Unfortunately none of those references you gave say how much AAHS is present in the vaccines. Do you know?

  • Bindy,

    I’ve only checked the first document (I’m sure you can check the rest), but if you search using the full name, the amounts are there alright. (AAHS = aluminium hydroxyphosphate sulphate.)

  • Thanks Grant. I realise I’m not an expert like yourself, but when I open the first document Helen gave it says, “adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (0.225 milligrams Al).” The second says “Adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (0.5 milligrams Al). And the IMAC one says, “Aluminium as amorphous aluminium hydroxyphosphate sulphate 225 μg .”

    None of them say how much AAHS is present, just the amount of Aluminium.

    Helen, I understand you are now chair of the WHO expert committee dealing with vaccines like Gardasil so I was hoping you would know how much AAHS is present in each dose of Gardasil. Are you able to tell me? Thanks ?

    • Bindy,
      The adjuvant concentration is calculated based on the aluminium content, it is not reported as total weight of the adjuvant. If you are inclined I am sure you can calculate it. The total molecular weight of AAHS is 235.03 g/mol and the molecular formula is AlHO(9)PS(-3), away you go. Personally I am not inclined to do so because 1) there is no earthy reason I can think of to bother, seriously those kind of calculations drive me nuts, 2) I am not a chemist, 3) it has no bearing on vaccine safety.

      I am involved in assessing vaccine safety, I can see by your comments that you have no interest in this topic and appear to be trolling. As per my brief for this blog, dissent is welcome, trolling is not. If you have something to contribute please do – perhaps once you have calculated the total weight of adjuvant in the vaccine you could report back. I trust you realise that this fun fact has no bearing on the safety of the vaccine, which has been extensively assessed.

  • Hi Helen, thanks for your response – much appreciated. My calculations put it at 1,958ug AAHS in Gardasil4 and 4,352ug AAHS in Gardasil 9.

  • My daughter is due to get an HPV vaccine in a year’s time. She won’t be getting it. As a lawyer, I think that the experiences of parents whose children suffered harm after taking vaccines is relevant. I’ve looked at the public health information published by the NHS and the Singapore government. Not satisfactory at all. My kids have had all their vaccinations, but I think that the risk of the HPV vaccine outweighs the benefits. I doubt if anyone on this forum doubts that the petroleum industry has a strong vested interest in keeping petrol-engine cars on the roads. I am sure the same is true of the medical / pharmaceutical industry and their defence of the HPV vaccine. Many years ago (whenever Gardasil was first introduced in the UK), I recall reading about a girl who was among the first to take the vaccine. She suffered a massive reaction and ended up – in non-medical terms – a vegetable. I don’t know much about science, but that represents enough for causation in law.

    • Hi Peter
      I think your last sentence is important and well supported by the preceding ones.

      The facts support the safety of HPV vaccine. Had you done any investigation you might have noticed that it is not the pharmaceutical industry defending the reputation of HPV vaccine.

  • Peter,

    Representing biological and legal causation to be the same thing is flawed reasoning. If you do “not know much about the science” then it would be prudent refrain from making statements about biological causation, particularly in this arena where these kinds of claims can have far reaching negative effects.


  • Also, I have had two HPV doses and am not a “vegetable” but I am protected against certain cancer types.

  • Hi Peter. Have you considered the possiblity that the legal fraternity have a conflict of interest in thier involvement?

    Not blaming, just saying.

  • Helen

    I have read many of the comments on this forum. You take great exception to anyone who writes anything you perceive to be critical of you personally – including from those who are at their wits’ end having had a family member suffer what they believe is ‘vaccine injury’. In that context, I find your opening sentence surprising to say the least.

    I always tell my children that any idea, however complex, can be explained to 7-year-olds. If the audience doesn’t understand, I tell them, it’s the fault of my children, not the audience. For the avoidance of doubt, it is not my duty to go out and research vaccine safety before I proceed with a proposed vaccine for my daughter, just as it is not my duty to go to Wuhan and do research on COVID-19 to find out what steps I should take to keep safe from that virus.

    The science community has not cornered the market on logical thinking. Primodos and mad cow disease tell us that much.

    You can have the last word. I won’t bother to respond next time.