Health and Science News for Parents

The “One Study,” or why the anti-vaccine movement doesn’t really understand science

written by Guest Author

This guest post was written by Allison Hagood, who originally published a version of it on the Facebook page for Your Baby’s Best Shot, a science-based book on childhood immunizations she co-authored with Stacy Minzter Herlihy.

This post is the first in a Red Wine & Apple Sauce series called “Epidemiology 101.” While it does not explain a specific epidemiological concept, it makes clear how a mythical study often demanded by anti-vaccine propagandists would not be possible when abiding by the standards of quality epidemiological research.

Multiple studies in multiple countries using multiple research models and multiple research groups, with multiple funding sources, have found no link between vaccines and autism. They have also found no links between vaccines and a long list of other conditions, such as ADHD, asthma, diabetes and auto-immune disorders, that anti-vaccine propagandists attempt to link to vaccinations. 

What would it take to conduct "the One True Study" of all vaccines? An alternate universe. Photo by Sanja Gjenero.

What would it take to conduct “the One True Study” of all vaccines? An alternate universe. Photo by Sanja Gjenero.

These studies have been dismissed by those anti-vaccine propagandists as having the wrong funding source, the wrong research design, the wrong focus, not separating out antigens from other vaccine ingredients, separating antigens from other vaccine ingredients inappropriately, not testing this or that, or some other reason that likely lacks validity.

Meanwhile, those in the anti-vaccine movement want ONE study. The One Study To Rule Them All. The One Study that tests every possible aspect of every vaccine and finds them all, together and separately, through this One Study, to be completely effective and completely safe for all children and not linked to any conditions. 

Basically, anti-vaccine propagandists are asking for the following (they may not realize that this is what they’re demanding, but the expectations of valid research design would require these conditions):

1. Eliminate the use of all vaccines immediately in every country on the planet. Immediately — regardless of any public health concerns that exist. 

2. Randomly sample an acceptable number of children with similar characteristics for an experimental group and a control group for each of the group configurations discussed below (in #4).

The numbers in each group would need to be in the hundreds or thousands to satisfy statistical requirements for validity and significance, and would have to include children from every country, every ethnicity, every socioeconomic status, with every possible genetic combination from parents, and of every possible health history based on parental family health. (It is a common tactic of anti-vaccine propagandists to claim that such-and-such vaccine can be a problem for children with this or that genetic make-up or some other characteristic – they frequently move the goalposts in making this argument – so the One Study would need to account for all those potential variations.)

Anti-vaccine propagandists have rejected studies with 3,000 or more participants, so each group below would likely need to contain huge numbers in order to satisfy them. (But then again, many of them accept 12 subjects – the number in Andrew Wakefield’s fraudulent and retracted case study – as valid, so who knows?)

Anti-vaccine propagandists are fond of saying “There are plenty of unvaccinated kids already, so just use them!” However, researchers cannot use pre-existing groups who selectively vaccinate or do not vaccinate at all because research has shown that families that don’t vaccinate differ from families that do vaccinate, and those pre-existing differences would be a confounding variable in the study. That is, it would be impossible to tell whether any conditions or differences in effects in the children occurred because of receiving/not receiving vaccines or because of the other inherent differences between families who do and families who don’t vaccinate.

To do a credible study of the kind that the anti-vaccine propagandists are demanding, then, researchers MUST randomly sample children and then MUST randomly assign them to the groups below. Parents would therefore have no choice about whether their children were assigned to a group receiving vaccines or a group not receiving vaccines.

3. Obtain permission from parents of children in each group to administer an injection into their child. The parents and children will not know what injection the child is receiving. The parents would not be allowed to have their children receive any injection from any other source, to avoid contamination of the data. Some children in the study would be completely unprotected from any disease outbreak, and their parents would be unaware of whether or not the children were unprotected.

4. The injection received may contain any of the following configurations:

a. Just saline. This comparison (or “control,” in scientific terms) group would be necessary for every single group involved in the study. No one in this group would receive any ingredient of any vaccine ever, just injections of saline.

b. Just the antigen, in saline. (An antigen is the inactivated pathogen – the virus or bacterium – or portions of it, or a weakened version of the live pathogen, which the body recognizes as an intruder and causes the immune system to build up the white blood cells that could fight the real deal later on.)

c. Just one ingredient of the vaccine (e.g., formaldehyde), in saline.

d. Two or more of the ingredients, in various combinations (e.g., formaldehyde and the antigen, formaldehyde and the aluminum salts, the antigen and the aluminum salts, etc.). For example, according to the CDC pink book, the MMR-II (measles, mumps, rubella) vaccine contains these ingredients:

i. Vitamins

ii. amino acids

iii. fetal bovine serum

iv. sucrose

v. sodium phosphate

vi. glutamate

vii. recombinant human albumin

viii. neomycin

ix. sorbitol

x. hydrolyzed gelatin

xi. chick embryo cell culture*

xii. WI-38 human diploid lung fibroblasts*

*These two items are not actual ingredients present in the final formulation of the vaccine, but they are used in the production of it, and, presumably, those calling for this sort of study would want to see “evidence” that using these ingredients during the course of vaccine production is not “unsafe.”

So, starting with the first ingredient on the list, researchers would have to have a group that received every single vitamin injected, every single vitamin in combination with every single other vitamin, in combination with multiple of the other vitamins, etc. Let’s say there are four different vitamins (A, B, C, D). There would have to be an A only group, a B only group, a C only group a D only group, an A/B group, an A/C group, an A/D group, a B/C group, a B/D group, a C/D group, an ABC group, an ABD group, an ACD group, a BDC group, and an ABCD.

That’s 15 comparison groups for four ingredients – and that is only for the vitamins, one of the 12 ingredients in the MMR vaccine (not including any part of the actual measles, mumps or rubella viruses). Then, researchers would have to include a group for each vitamin in combination with each other ingredient – vitamin A combined with sucrose, B with sucrose, D with sucrose, etc. Then each ingredient would have to be tested in various combinations with other ingredients. This would add up to thousands of groups, each having hundreds or thousands of children to cover all combinations mentioned above.

The above breakdown of possible combinations would have to be repeated for every vaccine, for every booster and for every possible combination of boosters.

5. Researchers would be expected to follow every single child in every single group throughout the course of their entire lifetime (which, with current life expectancy, can be 70-80 years in developed countries), monitoring every medical/health condition that develops, and comparing the rates for those conditions between each and every group above. If one of the thousands of study groups lost a single participant (through moving, withdrawal, death, etc.), then anti-vaccine propagandists would declare the study null and void, even though such attrition is to be expected, and is controlled for in the study design.

6. For each and every group mentioned above, a control group would have to exist, in which the children received no injection at all, of anything. No saline, no antigen, nothing.

7. Remember that the anti-vaccine movement wants each vaccine tested individually, THEN see the vaccines tested in combinations. So, one generation of children would have to receive the above breakdown of ONE vaccine over an entire lifetime, then another generation of children receiving the above breakdown of ANOTHER vaccine over an entire lifetime, etc., until all vaccines have been tested individually. (It’s unlikely that enough children in one generation would exist to meet the requirements of all those groups for each individual vaccine, so the complete study would require multiple generations.)

Then, and only then, do researchers start testing vaccine boosters. Then after that, they test vaccines in combinations, but only two at a time. Then three at a time. This requirement would mean that the study that would fit the criteria demanded – the One True Study – would last until approximately the heat death of the sun.

We haven’t yet discussed the ethics of the various groups (spoiler: It wouldn’t pass muster with any ethical board), the sampling difficulties or the enormous amounts of money that would be required (money that could not come from any government, any governmental agency, any institution of higher education or any scientist who’s ever done vaccination research in their career).

At this point, it should be apparently that such a study is not possible. 

It’s also not necessary.

Various studies have addressed various aspects of each of the embedded questions in the above scenarios, and in combination, those answers address the concern of the anti-vaccine movement. For example, aluminum salts (not elemental aluminum, as is claimed) are one ingredient used in vaccines. These are used as an adjuvant, a substance that induces a stronger immune response so that less antigenic material is required. The safety of this particular adjuvant has been well established. That’s just one meta-analysis of the studies of the safety of one ingredient. It’s not part of The One Study that anti-vaccine propagandists want, though, so they reject it.

Meanwhile, there are other meta-analyses about aluminum salts, and about other adjuvants and about all the various other ingredients in vaccines, not including the clinical trials that the vaccines went through before licensure and the many post-licensure studies about individual vaccines and about combinations of vaccines.

Think of all these studies – thousands and thousands of them – as a jigsaw puzzle. The puzzle isn’t one piece. It is composed of many pieces that fit together, creating a complete picture. The big picture on vaccinations is that they are safe and save lives. For individuals with conditions counter-indicating one or more vaccines, studies have already identified those conditions and the risks to guide clinicians. More studies are being done all the time to keep an eye out for developing risks.

Science is a process. Science is not about The One Study. It’s about ALL the studies.

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30 Responses to “The “One Study,” or why the anti-vaccine movement doesn’t really understand science”

  1. Dorit Reiss

    An extremely important post – thank you.

  2. Cat L.

    Thank you for this post!

  3. Thank you. In my experience talking to friends who are anti-vaccine, they absolutely do not understand how science or research based evidence actually works. You are addressing so many objections I’ve heard over the years and I’m glad to finally have a resource to point them to! I could never explain this as well as you just did. Bravo!

  4. Jessica

    This is interesting, and as someone who is not anti-vaccine but has many unanswered questions, I appreciate a blog that actually teaches something rather than shaking fingers and proclaiming that everyone who questions vaccines is a moron whose unwarranted fears are grounded in fraudulent research. I’m not a doctor or a scientist, but I’m also not an idiot. I’ve conducted as much research as I can with the resources that I have, and as much as I want to believe that vaccines are safe, I still have questions that no one will answer. I understand the outcome of Wakefield’s research, and like many other concerned parents, that research is not what concerns me. There is a body of research authored by credible scientists that shows evidence of some association between autism and/or chronic illnesses that remain a mystery. Why is it being ignored? I’m certainly not saying that this research is conclusive or that it should trump any research that suggests otherwise. I’m just not sure why Wakefield’s fraudulent research is waved in the air as a reason not to buy into the anti-vaccine literature while credible research goes unmentioned. I’m not here to debate. I genuinely want answers that will help me make the most educated decisions. I’m also not sure I understand why children who are previously unvaccinated cannot be used as a control group in research. What kind of “inherent differences” disqualify them? Once again, I’m not anti-vaccine, and I’m not looking for a debate. I just hoped you or someone who reads this could help shine some light on something that causes me to lose a lot of sleep.

    • Tara Haelle

      Jessica, thanks for leaving your comment. I agree it can be challenging to find reliable information that explains things without insulting the intelligence of the reader but without talking over their head — and without being insulting or snarky. I try to accomplish that as much as possible on this blog, and I am always open to suggestions on topics you’d like to see more on, especially those unanswered questions you refer to.

      I cannot speak to the “body of research authored by credible scientists that shows evidence of some association between autism and/or chronic illnesses that remain a mystery” that you mentioned because I’m not aware of a body of evidence by credible scientists that shows this with autism, and I don’t know what the other chronic illnesses are that this refers to. I am, however, open to looking at studies that you have questions about. There are peer-reviewed, published studies that come to concerning conclusions. Sometimes these are by credible scientists and sometimes not. (The ones regarding one flu vaccine in Europe and narcolepsy, which I discuss on my flu vaccine post, ARE credible.) There are about a half dozen to a dozen researchers who have had work published in peer-reviewed journals but are not actually credible or reliable researchers. Their methods are flawed, or they come to conclusions that are inappropriate for what their results show. (That gives me an idea for a blog post I may do actually!) But I can’t say that those are definitely the researchers you’re referring to without seeing the studies or links to the studies you’re describing. I can say that looking for a link between vaccines and autism has been the single most studied aspect of vaccine research of the past decade, and the body of that research has conclusively shown no link, but that’s harder to accept if you have not seen those studies or find it difficult (which it often is) to distinguish between those studies and others that may claim to show otherwise.

      Regarding your other question on using unvaccinated children: they can be used in observational, epidemiological studies, and they often are. In fact, a number of pertussis and measles studies of the past decade have included groups of children whose parents chose not to vaccinate them as comparison groups to vaccinated children. The problem is not that they cannot be included in studies at all. Rather, those studies that include them have limitations about what we can say about the results because the groups involved were not randomized. If you want to conduct a study without bias (“bias” in the scientific sense, which is a natural part of resarch and is not related to the common definition of the term in everyday language), then you have to start with a large group of participants with characteristics representative of the population. Then you have to randomly assign the participants to one of two groups. Then, one group receives the intervention (ie, a vaccine) and the other receives a placebo (fake treatment, such as an injection with saline). The groups should have approximately similar characteristics to be able to effectively compare them. This is the kind of study that usually cannot be done ethically with vaccines.

      In the case of comparing a group who were voluntarily unvaccinated with another group that is vaccinated, the conclusions you draw from those results will contain bias related to “confounding factors.” Confounders are characteristics that are different between two groups not because of the intervention/lack thereof (getting vaccines or not) but because of other things that vaccinators may share in common that non-vaccinators don’t, or vice versa. It’s easier to provide examples unrelated to vaccines. Here are two: For years, it looked as though drinking alcohol was linked to lung cancer. That wasn’t the case though. Rather, smoking was linked to lung cancer, and it just so happened that smokers were more likely to drink more alcoholic drinks than nonsmokers. Once that link was understood, researchers could make adjustments to their calculations to account for that difference, but sometimes the differences aren’t always clear or understood.

      Another example: A lot of (mostly European) studies have shown that women who drink one drink a day during pregnancy have children with higher IQs (or other positive attributes) than women who don’t drink at all during pregnancy. On the surface, it looks like having a drink a day is not only unharmful but could even be helpful. The problem is that, generally, women who drink a drink a day tend to be from higher income and better educated social groups. Their children are already likely to have a higher IQ. Does exposure to one alcoholic drink a day help or hurt or not affect those children? We don’t know. There is no way to be sure how much a child’s IQ was attributed to socioeconomic status and parental education versus the alcohol exposure. (Heck, it could be that the kids would have EVEN HIGHER IQ if their moms didn’t drink at all — but we can’t know that from the study.)

      So, if you take families that intentionally vaccinate and compare them to families that don’t intentionally vaccinate, you have a harder time knowing what confounders exist. Non-vaccinating families are less likely to see doctors regularly than vaccinating families. They are also more likely to eat organic food and to breastfeed for longer. They are also more likely to associate socially with other families of unvaccinated children (which would increase their risk of exposure to vaccine-preventable diseases). All of those factors — and many others that may not be known about yet — could affect their health in ways that would make it difficult or impossible to know if being vaccinated or not being vaccinated made a difference.

      Does all that make sense?

      • Jessica

        Thank you. Yes, this does make sense. I understand bias in the scientific sense, and your illustrations were helpful. You may have seen the list of studies that show “evidence of links” (and I use quotations because I realize this is very controversial), but I’m including the link just in case. I haven’t read them all, and I admittedly don’t fully understand how some of them relate to this particular issue. I would like to see this list addressed by someone outside of the anti-vaccine movement, however. It appears to have been largely ignored, possibly in part because it appears on the blog of someone who is vehemently anti-vaccine, but that doesn’t change the original sources. After all, I wouldn’t expect a steadfast vaccine proponent to take the time to compile such a list. Many of them are links to just abstracts, and unfortunately, I can’t access the original journal publications without paying for each individual issue. For me, this topic is incredibly sensitive. I have read and heard so many stories about vaccine injuries, and though I realize these are anecdotal and carry no scientific significance, it’s difficult to ignore them. I also understand the likelihood of this happening is extremely low, but for those who lived it or are living with it, statistics mean nothing – and they are often the people who pour so much energy into the anti-vaccine movement. I can’t say I blame them. If I were in their shoes, I can’t say I would do anything differently. I do have a child with autism, but I don’t think vaccines caused it. I’m inclined to believe she was born autistic. However, I do have concerns about her individual makeup and how she might react differently to those “environmental factors.” She is fully vaccinated according to CDC recommendations, but I’d be lying if I said I don’t wonder sometimes if the vaccines contributed. It’s hard not to think this way, as you mentioned, when I can’t see this conclusive research you refer to. I’m following the thread and look forward to any future posts on the subject. Thanks for taking the time discuss this.

        • Allison Hagood

          Jessica – the list to which you linked is an early version of an ongoing and regularly-updated (and rearranged) list of studies that supposedly link vaccines to autism. However, the list (in your version, it is 61 studies – newer versions have as many as 87 studies) actually contains nothing of the sort. Many people have addressed and debunked this list in detail. Liz Ditz of the blog “I Speak Of Dreams” has an excellent discussion, in four parts, of the studies in your link. I hope you find this helpful!

        • Dorit Reiss

          Two points:
          a. That list had been addressed – several people took the time to go through the studies and explain why they do not show what Ms.Taylor, who compiled it, says, some because they’re off topic, some because they’re fatally flawed, and some before they do not support what she says they do:
          b. stories: to remind you, we vaccinate, in the U.S., four million babies a year. Vaccines don’t prevent SIDS, autism, seizure disorder diabetes etc’; so a vaccinated child can get those. With that many babies vaccinated, it really is inevitable that some will see harm shortly after – and believe it’s the vaccine. Today there is also so much on the internet that googling can get a parent to make a connection they would not otherwise – or to hear it from others:

          I know several mothers who lost children to SIDS that keep getting told by anti-vaccine people that it must have been the vaccine (i’ve met at least three who find this very upsetting). That’s why yes, I”n a bit skeptical of vaccine injury stories without support – medical and scientific – that vaccines can cause this condition and some support outside the parent’s belief that it was the vaccine. Even parents can be wrong. Here is a blog post on that:

        • Tara Haelle

          Jessica, I hope the link Dorit provided above helps in addressing the link you posted. It’s the same link I would have provided. I agree that statistics mean little when it’s *your* child who experiences a vaccine injury. I always go to pains to make it clear that yes, a vaccine injury *is* possible. It’s why we have the vaccine courts set up. As discussed before, it comes down to the benefit-risk scenario. I am taking the risk that my baby (I’m currently pregnant) will end up having an allergic reaction to his first round of childhood vaccines, which I plan to get him at 2 months, on schedule. That risk is incredibly tiny – less than one in a million – but it exists. And then, so does the risk of his catching chickenpox or measles or pertussis, any one of which could kill him or leave him with permanent brain damage. He’s more likely to catch one of those three (especially pertussis) than to have an allergic reaction. He’s less likely to die of chickenpox than of the other two. He’s probably less likely to catch polio than any other reaction, including perhaps an allergic reaction, but it doesn’t take much for an outbreak to be brought back (such as has happened in Syria) and it’s a nasty enough disease that I’m willing to take the risk of the allergic reaction to vaccinate him against polio. And so on. I know this is all stuff you know, and I imagine you’ve consciously or subconsciously made similar calls. (Every time I get in a car with my son is a heck of a risk, statistically!) But yea, the stories do stick with us and can be emotionally convincing. I completely understand the nagging voices that make us question, “What if?” I’m glad you’re seeking answers with an open mind, and I hope my blog can be of help :)

      • Michael

        I think the “body of research that shows a link between illness” an autism are studies of epigenetic effects of teratogenic exposure during prenatal development. There is a body of literature, and some of the best in my opinion, on mothers who took valproic acid and thalidomide during pregnancy and had a significantly larger incidence of autistic children than the rest of the population. This data was used to create the VPA rat model of autism. A study from last year reported that an inflammatory reaction during pregnancy could lead to autism. I’m autism myself and my mother had a severe flu during her pregnancy, but that’s purely anecdotal. What’s interesting about the VPA model is that it results in a hyper-connected brain and sees autism as a primarily sensory disease because hyper-sensitivity leads to hyper-reactivity. Too much bottom up processing overloads the attentional gate (ACC) and prefrontal areas can’t function well (poor executive functioning). It’s quite a beautiful theory called the Intense World Theory. The theory has helped me overcome so many of the difficulties of being autistic. You can read it here:

  5. Henry

    You have written a very good analysis of how to undertake a complete study of the effects of vaccines. The title of the article is miss leading as you have not actually pointed out how the anti vaccine movement does not understand science.

    The closing comment “Science is a process. Science is not about The One Study. It’s about ALL the studies” is absolutely correct it is a process of knowledge building. This very statement is what the anti vaccine movement has been doing. They have been compiling studies on both pros and cons of vaccines. There are also numerous doctors and scientists within this group.

    When undertaking research one must take an un-bias view point so not to miss any possible date/outcome and must be open to change.

    Remember when the sun revolved around us and the world was flat…

    • Tara Haelle

      In looking at “ALL the studies,” it’s also important to recognize that one study does not equal another. They have different limitations and strengths, and some are far superior in their methodologies than others. This must be taken into account when assessing the WHOLE of the literature. Most arguments and literature I have seen among those in the anti-vaccine movement cherry-pick studies and/or dismiss the studies that contradict what their conclusions are. They also do not seem to take into account the *quality* of the study, including its methodology, sample size, etc. Those who advocate for vaccines also look at the WHOLE of medical research evidence. When one does this, it becomes very clear very quickly that the benefits of vaccines outweigh the risks by a tremendous margin.

  6. Wendy

    Bravo! A wonderful post. Thank you for taking the time.

  7. Joseph Bonnar

    Thank you for the post. You made a logical, honest, and easily understandable argument about the risks of buying into the psuedo-scienctific arguments put out by many in the vaccine denier community. I appreciate it.

  8. Vickie

    Have any one of you actually seen a vaccine-related injury firsthand? As a parent, or grandparent who has seen this happen, don’t insult my intelligence by name-calling. All we want is truthful answers, medical help for the children, and knowing the medical community wants the same. If there was no fear of knowing that vaccines DO cause injuries, then in our democratic society, don’t you think I should be able to sue in a REGULAR court of law, instead of being heard & herded into the special ‘vaccine court’,,, now that’s where the ‘deniers’ live. Read “Deadly Immunity” by Robert F. Kennedy, Jr.

    • Tara Haelle

      There are risks associated with vaccines, and vaccines can cause injuries. The rate of serious injuries from vaccines is incredibly tiny — usually less than 1 in a million or even much rarer. One example is the last case of polio in the US, which was caused by the live polio vaccine. Truthful answers and medical help is available and always has been. Those seeking it, however, must be willing to accept what the evidence base tells us. Unfortunately, many people believe a condition is a vaccine injury when that is not the case. Hence the over-reporting that occurs with VAERS.

      No, those who experience a serious adverse effect from a vaccine should not be able to sue in a regular court of law because the onslaught of lawsuits that were NOT associated with vaccines nearly stopped the manufacturing of vaccines in the 80s and seriously endangered the national immunization program. That is why vaccine courts were set up and why they are overly generous with their awards. (It only takes a “preponderance of evidence” to settle a claim — it is not even necessary to *prove* the vaccine caused the injury, which is why there are cases in which families receive damages awards even if there is good scientific reason to believe the injury was not even caused by the vaccine).

      RFK, Jr. is not a reliable source. He spreads misinformation and refuses to accept the evidence related to vaccine research. He is a textbook example of a vaccine denier.

      • Ellen

        The front page of the VAERS database states very clearly that ALL passive data collection systems suffer from *under-reporting*, both of positive & negative outcomes. So one can’t just toss around phrases like ‘the over-reporting that happens with VAERS’.

        • Dorit Reiss

          Both under reporting and over reporting are inherent to VAERS. See: “Underreporting is an inherent problem of passive surveillance systems, including VAERS. The degree of underreporting varies according to the adverse event. For example, one study estimated that 68% of cases of vaccine-associated polio are reported to VAERS, but only 4% of MMR-associated thrombocytopenia are reported9. This variability in undereporting can make it hazardous to assume that the relative frequencies of adverse events in VAERS reflects their relative rates of occurrence. In addition, for new products on the market, increased reporting of adverse events may occur; this has been termed the “Weber effect””

          Refs: Rosenthal S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health 1995;85:1706-9.

          Weber JCP. Epidemiology of adverse reactions to non-steroidal antiinflammatory drugs. Advances in Inflammation Research 1984;6:1-7.

          But also this: “Overreporting. Adverse events may be included in the VAERS database that are not accurate descriptions of the event that occurred, and erroneous diagnoses may be reported. For example, a case of simple fainting after vaccination may be incorrectly reported as anaphylaxis, a potentially life-threatening condition.

          Overreporting may also result from reports that describe adverse events for which a definitive diagnosis has not yet been reached. For example, if the reporter writes on the reporting form a diagnosis of “rule out meningitis”, that VAERS report will be computer coded as meningitis. Unless specific follow-up is received indicating that meningitis was ruled out, the meningitis coding term will remain associated with the computerized VAERS report.

          Adverse Event Incidence And Trends. As a result of the overreporting and underreporting issues described above, drawing conclusions from VAERS data about how many adverse events occurred in the United States must be done extremely carefully. Similarly, because the factors affecting overreporting and underreporting may vary over time, drawing conclusion from observations of changes, or lack of changes, in the frequency of adverse events in VAERS over time (trends) may be hazardous. In addition, numbers of adverse events reported to VAERS will at least partially reflect the number of doses of vaccine administered. For example, VAERS reports reflect the current trend of a decline in usage of whole-cell pertussis-containing vaccines and a simultaneous increase in the use of acellular pertussis vaccines; however, it would be incorrect to draw conclusions about the relative safety of these vaccines from such trend data. Finally, the number of doses of vaccine administered according to age is not part of the VAERS database, and therefore actual rates of adverse events are not strictly calculable.”

    • Chris

      “Have any one of you actually seen a vaccine-related injury firsthand?”

      No. But I have seen the effects of a real disease before its vaccine was available. Well, actually more than one. The one that made the most impression was the one that caused my toddler son to have seizures and the subsequent trip to the hospital.

      He is also permanently disabled, and could not speak when he was three. Which the neurologist would only say “may or may not” be from the seizures. After ten years of speech therapy he does speak, but he still has many social/cognitive issues at age 25 (too functioning to qualify for the state’s department of developmental disability, but not functioning enough to work or live alone).

      I am very aware that vaccines cause injuries, but they are rare. The issue is relative risk. As it stands the risk from the diseases are much greater than the diseases. If you have actual data to the contrary, please present the PubMed indexed study by a reputable qualified researcher showing a vaccine on the present American pediatric schedule causes more injuries than the disease. For instance, measles causes encephalitis at a rate of about one in a thousand cases.

      As a lawyer, Mr. Kennedy is not a qualified researcher in medical matters.

      • Lindy

        I know this was posted a long time ago,however, I just came across it today, so hopefully others will as well.

        I have been giving vaccines for about 40 years. I have given the old whole-cell DTP, oral polio vaccine, and even a few doses of smallpox vaccine to travelers in the 1970s. I estimate that conservatively, the agencies that I have worked for during my time of employment at them have given about 1,000,000 doses of vaccine. I have seen: simple fainting, usually by teens who haven’t eaten in hours; high temps of around 103 degrees, especially from the old wDTP; other fevers, a few rashes from MMR/chickenpox vaccine (usually given together so that it can’t be determined which vaccine caused it) and ONE (1) Uno, case of uncontrollable sneezing after a second dose of chickenpox vaccine (given separately) in a five year old. The doctor gave the child some Benadryl, the sneezing stopped, and the doc thought the child was allergic to a vaccine component. That’s IT!

        I have two friends whose children got Hib meningitis before the vaccine became available. Both lived,and both have permanent neurological sequelae, fortunately not severe.

  9. Jim Easter

    This post is a great explanation of the many reasons a prospective study comparing the vaccinated with the unvaccinated is not practical or ethical. Retrospective studies, however, have been done when circumstances permit. One such study was done in Poland, where different vaccines were introduced at different times. As a result, there were populations in Poland that had received the monovalent measles vaccine, the MMR vaccine, and no vaccine at all. The researchers compared 96 children with autism and 192 controls, each group containing children vaccinated with the monovalent vaccine, with the MMR vaccine, and not vaccinated against measles at all. No correlation was found between vaccination and autism. There was a slight correlation between not being vaccinated and autism, but this is not likely to be significant — if only because the small number of unvaccinated children in the study, 8 with autism and 1 without, limits its statistical power. This at least shows that a study of unvaccinated vs. vaccinated is possible, but difficult to do, because it is rare that historical accident gives us the opportunity.,d.cGU

  10. Gav

    That is an impressive and cogent account that I hope helps any truly “open-minded” but undecided/confused/misled person to understand that proper presentation of evidence is not the same as censorship. The latter tends to be the resort of the anti-vaccination propagandists while wailing that they are being shut down by evil scientists who want to keep the world sick to make themselves rich (they mustn’t have met a real researcher living from grant to grant).

  11. […] not only died but has decayed to the point its skeleton has bleached in the sun. There will never be a study that is satisfactory to anti-vaxxers because science will never say what anti-vaxxers want to hear […]

  12. […] in Choosing Not to Vaccinate ‘Toxins’ in vaccines: a potentially deadly misunderstanding The One Study AntiVaxxers want Dear parents: You are being lied to Biggest Lies Spread By Anti-Vaxxers Vaccine Shedding: Why this […]

  13. Lindy

    I agree; if even a part of this study were done, and found no problem with vaccines, the anti-vaxers would just cook up some different study they want done.

  14. Stevens

    I think you have a typo in your excellent article.

    “The numbers in each group would need to be in the hundreds or thousands to satisfy statistical requirements for validity and significance”

    You mean hundreds OF thousands, of course.

  15. Sandy

    What they are asking is impossible to satisfy, and of course, no one is preventing anti-vaxx groups to carry out such studies themselves, rather than asking for someone else to do it. But, coming to the main topic, it is possible to have an imperfect study on this, using existing unvaccinated and vaccinated children for shorter period time, say 10 to 18 years old. Socioeconomic and family backgrounds can be filtered out statistically. For example, there are cases of autistic siblings were one was vaccinated and one was not. Such patters may become evident is such an imperfect meta analysis. It is not that difficult to do such a study as the pro-vaccine groups suggest, although such a study may not (most probably will not) satisfy the anti-vaxx groups, since they are not after the results, they are after finding a procedure to object what they already believe.

    • Tara Haelle

      Yes, you’re right that smaller versions of this can be done, and they have done. The frustrating thing is that those who oppose vaccines do not accept the conclusions of those studies (or any others). They continue to find flaws (ALL studies have limitations and risk of bias) and insist on impossible study designs.

  16. Sandy

    instead of “since they are not after the results, they are after finding a procedure to object what they already believe.” I should have said, “they are after finding a procedural hurdle that will help them to continue to believe what they want to believe.”

  17. Sandy

    I should have said, “they are after finding a procedural hurdle that will help them to continue to believe what they want to believe.”

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