Sheep vaccine study – aluminum adjuvants alter their behavior

sheep vaccine study

Over the past 20 years or so, I’ve read a lot of vaccine research studies. Most, published in top journals by real scientists, are worthy of respect. And they provide powerful evidence that vaccines are safe and effective. Of course, there are a handful of studies that are pseudoscientific garbage. Or retracted. But today, I think I’ve seen it all – a Spanish animal research team published a sheep vaccine study that they claim shows that the aluminum adjuvants in the vaccine altered their behavior. And you just know that the anti-vaccine religion will jump all over it as “proof” that vaccines are dangerous. Yawn.

In case you missed it, yes, this is a sheep vaccine study.

To be fair, I have no idea whether these researchers are part of the anti-vaccine religion – it’s possible that they think they’ve found something, but they do rely upon some discredited anti-vaccine tropes and falsehoods as the premise of their studies. Moreover, this article furthers the false narrative about aluminum in vaccines. And we’ll keep seeing it repeated on anti-vaccine Twitter and Facebook posts because the anti-vaccine zealots have nothing else.

The sheep vaccine study by Javier Asìn et al., published in Pharmacological Research, investigated cognitive and behavioral changes in lambs that had received repeated vaccination with aluminum-containing vaccines.

Let’s take a critical look.

Sheep vaccine study results

I’m not going to spend much time with the results, because I find it very troubling that the author’s conclusions are based on a total study of 21 animals, seven in each group. I laugh at clinical trials in humans that don’t contain 1,000 or more patients or epidemiological studies that don’t include a sample population over 100,000. An animal study that includes 21 lambs ranks near at the bottom half of the hierarchy of biomedical research.

The researchers put those 21 sheep into three equal groups:

A. Control group

B. Adjuvant only group

C. Vaccine with adjuvant group

I will get to a criticism below, but based on the small experiment, the authors concluded that:

Animals in groups B and C exhibited behavioral changes: affiliative interactions were significantly reduced and aggressive interactions and stereotypies increased significantly. They also exhibited a significant increase in excitatory behavior and compulsive eating. In general, changes were more pronounced in the Vaccine group than they were in the Adjuvant-only group. Some changes were already significant in summer, after seven inoculations only. This study is the first to describe behavioral changes in sheep after having received repetitive injections of Al-containing products, explaining some of the clinical signs observed in ovine ASIA syndrome.

Aluminum in vaccines

For those of you who are unfamiliar with aluminum in vaccines, aluminum adjuvants are added to vaccines to stimulate the immune response to the vaccine’s antigen – however, they do not induce any immunity to anything by themselves.

Aluminum adjuvants have been used for over 70 years in vaccines without any evidence that they cause harm. Unfortunately, these adjuvants have only become an issue for the anti-vaccine world because they keep running out of real science to support their beliefs about the safety of vaccines.

There are a few key points to be made about aluminum adjuvants:

  1. The amount of aluminum in vaccines (and remember, only a few vaccines have aluminum) is measured in micrograms. The maximum allowable amount of aluminum in a vaccine is 125 µg.  Based on the recommended schedule of vaccines, the maximum amount of aluminum an infant could be exposed to over the first year of life would be 4225 µg (or 4.225 mg). Let’s put this into context – a newborn baby averages body burden of about 384 µg of aluminum. In addition, typical concentrations of aluminum in breast milk (10-49 µg/L), soy-based infant formula (460-930 µg/L), and milk-based infant formula (58-150 µg/L) mean that the dose of aluminum from these sources far exceed the dose of vaccines in just a few weeks. A baby also inhales several thousand micrograms of aluminum per day, unless they live in some bubble with ultra-pure air.
  2. As I constantly mention, the dose makes the poison. And these doses of environmental and vaccine aluminum are far below the minimum risk level for the body burden of aluminum.
  3. Only if you assume that the body cannot clear aluminum (usually only in the case of kidney failure), the cumulative dose of the metal doesn’t actually matter.
  4. There is a trope, pushed by the anti-vaccine world, that somehow injecting aluminum is much different than consuming or inhaling it. This is simply not based on any science known to the biomedical world. The kidneys filter out most of the aluminum salts way before it accumulates. Furthermore, inhaled and ingested aluminum occurs every single day unless your baby doesn’t eat or breathe, whereas the tiny dose of injected aluminum occurs infrequently.

There simply is no robust, peer-reviewed evidence that the amount of aluminum salts in vaccines are in any way harmful. But that never stops the anti-vaccine religion from making unfounded claims.

ASIA, not the continent

Asin et al. start out their paper by stating that autoimmune syndrome induced by adjuvants (ASIA) is an adverse reaction of vaccines. ASIA is a belief, pushed by Israeli immunologist Yehuda Shoenfeld, that certain autoimmune conditions are caused by aluminum adjuvants in vaccines.

However, ASIA has been thoroughly dismissed by most scientists and regulatory agencies. Numerous large case-control and cohort studies, both near the top of the hierarchy of biomedical research, have found no evidence of a relationship between vaccines, especially the HPV vaccine, and ASIA. For example, researchers looked at nearly 300,000 vaccinated and unvaccinated women (reviewed here) and found no link to ASIA. There are many more studies that show a similar lack of causal links.

Thus, before we even start critiquing this paper, the authors start with a bogus hypothesis that is unsupported by real scientific investigations. Unless, of course, you subscribe to anti-vaccine lies, memes, and tropes. Then you probably are a true believer.

Sheep vaccine study critique

Despite the fact that the paper has a couple of discredited claims, about aluminum and ASIA, there are other significant issues with the paper. Let’s review:

  1. The researchers only looked at a total of 21 sheep in 3 groups. Important clinical and epidemiological studies have thousands or even millions of data points. It is difficult, if not impossible, to determine a causal link with such a tiny sample size.
  2. The animals in the two experimental groups, one vaccinated with the typical vaccines given to sheep and the other with just aluminum adjuvant. The animals received 16 vaccine doses within 12 months for a total of 70.861 mg of aluminum. These are the number of doses that a sheep receive over 6-7 years! Furthermore, if you’re prone to comparing sheep to humans, that’s 20X more aluminum adjuvant than a human receives over a year – of course, human infants are smaller. Nevertheless, even though I dismiss any link between injected aluminum and neurological issues, giving 6-7 years of vaccines over 12 months biases the results. In addition, I’m skeptical of the behavioral observations, but it is possible that the serum aluminum levels are so high that it exceeds the safe limit for aluminum.
  3. The study was not randomized or blinded (or they failed to mention it in the methods section). You might think that randomization on matters with humans, but the researchers could have biased the results by the way they treated the sheep.
  4. This study relied upon subjective observations of the sheep’s “behavior” post-vaccination. These are the type of issues that hinder many behavioral and neurological studies – a subjective analysis of change in behavior is almost impossible to quantify. And when there are just 21 animals, it’s almost impossible.
  5. Sheep are social animals and the process of vaccination itself, especially so many over a short period of time, may induce behavioral changes irrespective of any contents of the vaccine, although the control group did receive a placebo injection.
  6. This sheep vaccine study is a primary research article – that means it lacks any supporting data anywhere else. It’s like the old vaccines cause autism canard – one retracted study supported it. On the other hand, literally hundreds of clinical and epidemiological studies along with meta-reviews have debunked that claimed link. That’s why most real biomedical researchers ignore primary animal studies – they pique interest, but rarely form the foundations of science-based medicine. Since we have dozens of studies that show no behavioral changes post vaccination, how much does a very small, very poorly designed sheep study tell us? Next to nothing.
  7. In a 2013 study by the same research group, they observed that around 0.5-1.0 % of animals of a flock exhibit the type of behavioral symptoms, irrespective of vaccination, described in the newer paper – yet they conveniently ignore it. Given the tiny sample size, the lack of randomization or blinding, and other issues, it’s impossible to tell if this is background noise.

I’m done here

The anti-vaccine religion has pounced on this study, which doesn’t surprise me or any other pro-science person out there. Dr. Bob Sears (the California pediatrician on probation for some issues about vaccine exemptions) and the crackpot science denier Robert F Kennedy Jr have tried to abuse this pathetic study to further their pro-disease for children beliefs.

This sheep vaccine study barely rises to the level of bad evidence – it provides us with nothing useful about the discussion regarding aluminum in vaccines. Moreover, there is overwhelming evidence, as shown in so many powerful peer-reviewed studies, that there simply is no link between aluminum adjuvants and anything.

Why do the anti-vaccine use this terrible sheep vaccine study to support their claims? Because they’ve got nothing else. Nada. Squat. Zilch.

Citations

Debunking myths about vaccine testing and safety

vaccine testing

The goal of this article is to respond to a number of recurring myths raised by anti-vaccine activists regarding vaccine testing and safety – a common trope used against vaccines.

The bottom line is that vaccines are extensively and carefully tested for safety, and that vaccine safety is shown by many, many studies from a variety of sources, reinforcing each other and all pointing to the same result – serious problems from vaccines are possible, but extremely rare. And those small, rare risks are far outweighed by the benefits vaccines provide by protecting us against much larger risks.

Continue reading “Debunking myths about vaccine testing and safety”

Autoimmune diseases unrelated to HPV vaccine – new Canadian study

autoimmune diseases

There are so many outlandish and unsupported claims about the HPV vaccine, it’s difficult to keep up with them all. One of the most outrageous lies about the HPV vaccine is that it causes autoimmune diseases, despite the robust epidemiological or clinical evidence that firmly establishes the safety of the HPV vaccine, especially with respect to autoimmune diseases.

Autoimmune diseases are conditions where the immune system has an abnormal response to normal cells in the body. Celiac disease, type 1 diabetes mellitus, multiple sclerosis, and many other conditions are as a result of an autoimmune disorder. We don’t know what causes the autoimmunity, but there is almost no biological plausibility that any vaccine could induce the disease.

Despite the lack of a reasonable biological mechanism leading from the HPV vaccine to any of the multitudes of autoimmune diseases, the anti-vaccine forces continue to try to establish a link. For example, Yehuda Shoenfeld has pushed a ridiculed hypothesis that the vaccine causes something he calls autoimmune syndrome induced by adjuvants (ASIA). Not a single respected scientist buys into ASIA, and Shoenfeld has presented no vigorous clinical or epidemiological evidence supporting its existence.

Not to pile onto the anti-vaccine tropes about the vaccine, but a large, and new, Canadian study has once again shown us that there are no links between the HPV vaccine and autoimmune diseases. This adds to the body of evidence that, for real science, reinforces the conclusion that the HPV vaccine is an incredibly safe vaccine. Continue reading “Autoimmune diseases unrelated to HPV vaccine – new Canadian study”

Autoimmune syndromes induced by adjuvants – another anti-vaccine myth

autoimmune syndromes induced by adjuvants

One of the enduring myths (there are so many) about the HPV vaccine is that it is linked to one or more autoimmune syndromes, an abnormal immune response to a healthy body part. These claims, pushed by an Israeli physician, Yehuda Shoenfeld, are called “autoimmune syndrome induced by adjuvants (ASIA)” and, sometimes, Shoenfeld’s Syndrome.

Of course, ASIA is not accepted by the scientific and medical community (and see this published article), was rejected by the United States vaccine court as a claim for vaccine injury, and should not be accepted by parents deciding whether they should vaccinate their children. Furthermore, the European Medicines Agency, which is the primary regulatory body in the EU for pharmaceuticals, has rejected any link between the HPV vaccine and various autoimmune disorders. The science stands in direct opposition to autoimmune syndromes being caused by any vaccine.

Despite the lack of evidence supporting the existence of autoimmune syndrome induced by adjuvants, and even more powerful evidence that it doesn’t exist, the anti-vaccine religion still cherry-picks articles to support their preconceived conclusions that the HPV cancer-preventing vaccine is dangerous. Continue reading “Autoimmune syndromes induced by adjuvants – another anti-vaccine myth”

HPV vaccine causes infertility and primary ovarian insufficiency – myth

HPV vaccine causes infertility

The HPV vaccine causes infertility through primary ovarian insufficiency (POI) – a belief unsupported by evidence. And the claim appears to be based on anti-vaccine ideology instead of real science.

Yes, I know, this story seems to repeat itself, but stay tuned, this is a good one. So let’s examine this myth from a scientific aspect and show how the HPV vaccine is actually unrelated to POI. Continue reading “HPV vaccine causes infertility and primary ovarian insufficiency – myth”

Vaccine injury compensation and autoimmune syndromes

Vaccine injury compensation and autoimmune syndromes

This post examines the treatment by the National Vaccine Injury Compensation Program (NVICP) of the second of two claims (see first one here) heard from those claiming vaccines cause more injuries than acknowledged in recent days. This article will focus on vaccine injury compensation and autoimmune syndromes.

The Special Master’s decisions – as many decisions in NVICP are – are long, complex, and examine the evidence closely and in detail. They address factual debates, expert disagreements specific to the case and expert disagreements on the science.

This post won’t cover them – that’s not my goal. All I will address are the Special Master’s conclusion about two hypotheses raised by those who believe vaccines injured their child (and also promoted by anti-vaccine organizations).

The NVICP (commonly called the Vaccine Court) is a no-fault program created by Congress to serve two goals: to protect the vaccine supply by offering limited liability protections to vaccine manufacturers and providers and to help those injured by vaccines – or even those who may have been so injured – be compensated more easily than in the regular courts.

As I addressed in the past, NVICP provides petitioners – as claimants are called – with substantial breaks compared to the regular courts. Petitioners do not have to prove a product defect or any kind of fault; the requirements for proving causation are relaxed; evidentiary rules are relaxed, allowing the introduction of evidence and experts that would not be allowed in a regular court.

NVICP is not, however, a benefits program. Its goal is not providing any parent with a child with a problem support. The United States certainly needs to offer more support to families of children with disabilities, but NVICP’s aim is different: it focuses on compensating injuries that may, at least, have been caused by vaccines.

To be compensated by an NVICP decision a petitioner does need to meet minimal standards suggesting a possible connection between a vaccine and an injury (a settlement does not require similar proof; parties settle for all kinds of reasons, including a view that the case isn’t worth litigating). At the very least a petitioner needs to show an injury, and provide expert testimony (expert testimony is generally needed when someone claims medical causation in the courts as well – that a medical act, device, drug etc. caused harm – with very narrow exceptions).

Continue reading “Vaccine injury compensation and autoimmune syndromes”

HPV vaccine and lupus – bad expert testimony in a lawsuit

HPV vaccine and lupus

In a lawsuit filed with a court in Israel a young girl and her mother are suing, apparently (since I do not have the lawsuit, I’m reporting based on a news report that included an interview with the girl’s mother) claiming that the girl was negligently administered an HPV vaccine because the family was not warned that it can trigger an autoimmune disease, lupus. Because the evidence does not support the claim that there is a link between the HPV vaccine and lupus, the claim is unfounded, and should be rejected. The Ministry of Health is not required – and should not – warn parents about risks vaccines do not have: that would be misleading those parents.

Continue reading “HPV vaccine and lupus – bad expert testimony in a lawsuit”

Aluminum adjuvant in vaccines – let’s go cherry picking

Aluminum adjuvant

With the success of California’s vaccination law, SB277, there appears to be a trend to increase vaccination uptake among school-aged children. And it’s a great thing that we protect our children from vaccine preventable diseases. Yet, the anti-vaccine crowd is still looking for lame excuses to not vaccinate – today, it’s the aluminum adjuvant in vaccines.

The anti-vaccine crowd has a tendency to ignore the vast and powerful scientific consensus on vaccines. Instead, they prefer to cherry pick research, often from biased “scientists” who publish in the lowest quality journals. That cherry picking is a form of confirmation bias – the individual seeks evidence that supports their a priori conclusions rather than letting the robust body of evidence point them to a conclusion.

Generally, these myths, based on cherry picking, are debunked. But the anti-vaccine cult is nothing if not creative. They just move on to a new boogeyman. This time, it’s aluminum adjuvants in vaccines. To be honest, anti-vaccine tropes are zombies, so we think we destroy those tropes, but they rise again, fed by new cherry picking. And debunking the danger of aluminum in vaccines has been an age-old discussion amongst the pro-science crowd.

Today, we’re going to look at one of those articles which was recently published. If one accepted this research, while ignoring critical analysis and the body of other science, then it would be a great one to confirm one’s own pre-conceived beliefs. But that’s not how we do science, so let’s take a look. Continue reading “Aluminum adjuvant in vaccines – let’s go cherry picking”