Is the US Vaccination Program Safe?

This article is Part 3 of a 5-Part series on Vaccines. See the full list of (and links to) the rest in this series below.

I used to think that concerns about the safety of vaccines were either overblown, misconstrued, or flat-out made up. My wife and I weren't aware of the competing risks of the decision. We vaccinated our children. We had concerns about those who didn't vaccinate potentially causing harm to our children. We had close friends who didn't vaccinate and they were more "crunchy" then we were. I remember feeling annoyed at them. Our kids played together. How terrible would it be if their child got sick with a "vaccine-preventable illness" and hurt one of our children. But we loved them and wanted to understand their decision. So it required a deeper look.

Initially, my research into the topic consisted of really only looking at one side of the facts. Basically similar to what Joe Carter laid out in his article.

However, now having examined the data, it turns out there really are significant competing risks to be considered, and what once seemed obvious now became cloudy. Upon further inspection, what once seemed obvious became highly dubious.

Is it reasonable for parents to be skeptical regarding the safety of vaccines as balanced over and against what benefit they may provide to the point where they decide to delay or decline vaccinations?

Skyrocketing Childhood Cognitive Illness & the Correlation Game

In my review of these issues, something I have noticed is that the pro-vaccine lobby frequently points to what they see as a lack of correlation between vaccination and harmful health outcomes. They point to what they see as a correlation between vaccination rates and positive health outcomes. These alleged correlations don't hold up under scrutiny because of the underlying faulty assumptions, but the point is: they are all about correlation when convenient (not when it comes to correlations that do not comport with their predetermined ideas.) When correlations arise which combat their narrative, we are reminded that "correlation does not equal causation." Yes, we know. Please be consistent. It works both ways. Correlation suggests a causal relationship, but doesn't prove it. It does not mean that because the correlation is not proven to have a causal relationship that concern should go away. We cannot then declare vaccines proven "safe."

In the United States, the most heavily vaccinated population in the world, we have seen an unprecedented rise in childhood illness, especially in the area of autoimmune diseases where the body has an overactive immune response and begins attacking itself. While there may be a whole host of factors involved including pesticides, agricultural practices, dietary habits. and other environmental changes, we cannot ignore the correlation between the rise in these illnesses and the ever increasing prevalence of mass vaccination. Afterall, vaccines are specifically engineered to trigger the body's immune response.

With the rise in these illnesses and the correlative rise in mass vaccination in the United States on a scale never before seen, why wouldn't it be reasonable to look into the possible causal link that vaccines may present?

"Vaccines Do Not Cause Autism"

Autism is but one of many afflictions that comprise the rise in early childhood disorders. 

But if we want to look at autism, we must first establish the difference between a positive claim that vaccines do not cause autism, and the claim that links between vaccination and higher rates of autism have not (yet) been found. Even if the second claim were true, the first claim doesn't follow. It would mean the first claim is still uncertain.

Beyond this, the notion that there are no scientific studies that show a link between vaccines and autism is simply false. The degree to which this falsity keeps getting stated over and over compared with the amount of studies that show the exact opposite makes the continuing disclaimers using this claim seem Orwellian.

Joe Carter makes it seem like all the cause for concern about the relationship between vaccines and autism is due to some isolated discredited Doctor. It seems that Carter is simply repeating the pro-vaccine lobby rhetoric which seeks to marginalize vaccine skeptics as a group of easily swindled, unhinged kooks who ignore evidence.

To the contrary, there are a plethora of peer reviewed medical and scientific journals which show there is indeed cause for concern with regard to the relationship between vaccines, autism, and a host of other neurological illnesses. Just to sprinkle in a few:

Here. Here. Here. Here. Here. Here. Here. Here. Here.

These studies truly are just the tip of the iceberg. I'll include links to more at the end of the article but there truly are a trove of peer-reviewed scientific journal articles in the same vein.

"Odds of a Serious Vaccine Injury are One-in-a-Million"

This line is typically the most that you'll get from the pro-vaccine lobby with regard to acknowledging the seriousness of vaccine injury risk. It's also the grounds by which the CDC justifies the alleged safety of it's entire vaccine program. When presented with the notion of competing risks being present in a parents decision whether to vaccinate, they are commonly whisked away by claims that such injuries are less likely then being struck by lightning. "It's a 1-in-a-million chance" they tell us. One-in-a-million? Doesn't sound very scientific. It kind of sounds, well, made up. So is there legitimate reason to be skeptical about this "1-in-a-million" claim?

Turns out, while not quite "made up", the claim rests on an extremely sloppy foundation.

To quote the Department of Health & Human Services which manages the vaccine injury compensation program:

"According to the CDC, from 2006 to 2017 over 3.4 billion doses of covered vaccines were distributed in the U.S. For petitions filed in this time period, 6,314 petitions were adjudicated by the Court, and of those 4,328 were compensated. This means for every 1 million doses of vaccine that were distributed, approximately 1 individual was compensated."

So when HHS computes the "1-in-a-million" number, they compute it by dividing 3.4 billion "doses" administered by the number of approved petitions in the vaccine court. What's the problem with this? The CDC schedule recommends 74 doses per child across 16 vaccines (some injections combine vaccinations for multiple diseases). Most parents want to know what the risk of harming their child is if they vaccinate them according to schedule as a whole. How helpful is it for parents to be properly informed of the risk if they say that each of the 74 doses they given their children has a "1-in-a-million" chance of a serious reaction? If HHS wanted to provide numbers that better approximated the information parents are actually after they would provide the risk per child of an adverse reaction receiving all 74 doses and the entire schedule of vaccines. But then the "1-in-a-million" claim would plummet by orders of magnitude. In any case, these vaccine court petition numbers are the wrong numbers to use because they represent only a fraction of the people actually experiencing adverse reactions and cannot be relied upon.

Let's be clear: The basis for the "1-in-a-million" claim is not based on the amount of reported deaths and serious injuries reported in HHS's own reporting system (Vaccine Adverse Event Reporting System or VAERS) which is supposed to collect reports of vaccine reactions to CDC recommended vaccines. The "1-in-a-million" claim is calculated by the amount of people who have petitioned the government for compensation.

An analysis of the VAERS data gives us a very different picture.

A Harvard Medical Study commissioned by HHS estimated that less than 1% of the amount of vaccine injuries and deaths which occur are actually reported on VAERS.

Even with this, the figures reported by VAERS paint a very different picture than the "1-in-a-million" line. In 2016 alone, VAERS received 59,117 vaccine adverse reaction reports including 432 deaths, 1,091 permanent disabilities, 4,132 hospitalizations & 10,274 emergency room visits. If we make use of the HHS/Harvard extrapolations, we have 5,911,700 adverse reactions, 43,200 deaths, 109,100 permanent disabilities, 413,200 hospitalizations & 1,028,400 emergency room visits. This amounts to 1.59 million serious vaccine reactions every year. This blows the "1-in-a-million" figure out of the water (it was on shaky ground to begin with.) If we go by the VAERS numbers, the potential risk for danger from a vaccine reaction is significantly greater than the risk of contracting the actual disease which the vaccine is supposed to prevent. Of course these numbers are only estimated and shouldn't be relied upon either, but the point is that the numbers being touted to allege that chances of a serious reaction are "1-in-a-million" are unreliable. Ultimately, the "1-in-a-million" line is nothing more than a marketing slogan. It get's much worse the more we dig. 

As we shall see, VAERS data isn't the only cause for skepticism regarding the "1-in-a-million" line. In 2006 HHS funded Harvard Medical with a grant to attempt to make the VAERS reporting system automated and active (versus passive) with better reporting capability. To accomplish this, the Harvard team used the electronic medical records from Harvard Pilgrim Healthcare to track 376,452 patients who were administered 1.4 million doses of 45 different vaccines over 3 years. The study carefully tracked vaccination and the results for 30 days following and found 35,570 adverse reactions. The CDC reports an average of 30,000 adverse reactions every year across the entire nation! Yet here we have 35,570 reactions reported from 377,452 patients! 

Quoting directly from the report:

"Adverse events from drugs and vaccines are common, but under-reported. […] Likewise, fewer than 1% of vaccine adverse events are reported. Low reporting rates preclude or slow the identification of ‘problem’ drugs and vaccines that endanger public health. New surveillance methods for drug and vaccine adverse effects are needed."

So again, the CDC is basing the safety claims of its entire vaccine program on their being only extremely rare cases of injury, and yet the study it commissioned determined that current reporting is not sufficient to identify the problems. Harvard identified the issues, created a system to solve this problem, and what was the response from the CDC?

“Unfortunately, there was never an opportunity to perform system performance assessments because the necessary CDC contacts were no longer available and the CDC consultants responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation.”

Translation: The CDC went radio silent. They declined to follow the Harvard recommendations and delve further into these numbers.

To add to this, a similar Canadian study was performed where patients were actually followed up with returned similary concerning results which put the number at 1 in 168 (not 1-in-a-million) with "statistically significant elevations in emergency room visits following all vaccinations."

Now stay with me because this part is important. The CDC, the FDA, and their congressional overseers are tasked with ensuring the safety of the vaccination program. According to congressional findings, former FDA head David Kessler is noted in the 2000 congressional report affirming the VAERS problems:

"Former FDA commissioner David A. Kessler has estimated that VAERS reports currently represent only a fraction of the serious adverse events."

Further in this report, the Institutes of Medicine (IOM, now renamed National Academy of Medicine) warned that:

"if research capacity and accomplishments are not improved, future reviews of vaccine safety will be similarly handicapped."

What were the problems according to the IOM?

“1) Inadequate understanding of biologic mechanisms underlying adverse events; 2) Insufficient or inconsistent information from case reports and case series; 3) Inadequate size or length of follow-up of many population-based epidemiological studies; 4) Limitations of existing surveillance systems to provide persuasive evidence of causation; and 5) Few published epidemiological studies.”

This wasn't new. In 1994 the IOM was sounding the alarm about the lack of data:

"The lack of adequate data regarding many of the adverse events under study was of major concern to the committee. Presentations at public meetings indicated that many parents and physicians share this concern."

For 23 years the IOM has been screaming to the CDC that they lack adequate information to inform them on any causal relationship between vaccines and adverse events that are reported.

They conducted another study in 2011 with the same result. This is the result that Joe Carter cited to buttress the notion that vaccines are allegedly safe. This is the report that found a whole slew of causal relationships between vaccines and adverse reactions.

If you read the report in it's entirety, it's basically saying "not enough information to make a judgement either way" for the lions share of vaccines or it's actually affirming that "there is a causal relationship." There are comparatively very few instances where it denies a causal relationship between the various vaccines and adverse reactions.

Regarding a causal connection between vaccines (broadly speaking) and autism, they concluded again (as they have been for decades) that they needed an adequate data reporting system (the one that Harvard was trying to give the CDC when the CDC went radio silent).

So again, the report says they can't come to a conclusion about a causal connection between vaccines and autism or other adverse events. For instance with the Dtap vaccine:

Conclusion 10.6: The evidence is inadequate to accept or reject a causal relationship between diphtheria toxoid–, tetanus toxoid–, or acellular pertussis–containing vaccine and autism.

They aren't saying either way. They need better data! Now how is this interpreted and repackaged to the public by the CDC?

They are actually citing this report as a reason to state as the headline "Vaccines Do Not Cause Autism."  This is what they are basing the safety of the program on.

Even though in the report the IOM specifically states:

"The vast majority of causality conclusions in the report are that the evidence was inadequate to accept or reject a causal relationship. Some might interpret that to mean either of the following statements:

  • Because the committee did not find convincing evidence that the vaccine does cause the adverse event, the vaccine is safe.
  • Because the committee did not find convincing evidence that the vaccine does not cause the adverse event, the vaccine is unsafe.

Neither of these interpretations is correct. “Inadequate to accept or reject” means just that—inadequate."

These are the kinds of games the CDC is playing. We have MANDATORY VACCINATION MANDATES coming down the pipe and this is what the CDC is doing. They offer misguided summations of reports they favor.

In fact, one of the only significant finding that supports the possibility of a lack of causality between vaccines and autism was with the specific MMR vaccine and autism. In the case of MMR and encephalitis (swelling and inflammation in the brain which is a hallmark of children with autism) the causality connection was strongly affirmed:

Causality Conclusion

Conclusion 4.1: The evidence convincingly supports a causal relationship between MMR1vaccine and measles inclusion body encephalitis in individuals with demonstrated immunodeficiencies.

The report also affirmed the causality of the connection between MMR and febrile seizures:

Causality Conclusion

Conclusion 4.4: The evidence convincingly supports a causal relationship between MMR vaccine and febrile seizures.

Regarding autism and the MMR vaccine specifically, they concluded that the evidence of this one specific vaccine favors a rejection of a causal relationship beween MMR and autism. It DOESN'T say anything about "vaccines do not cause autism" or "vaccines are safe." Yet this is how they deceptively report it on their website.

Causality Conclusion

Conclusion 4.8: The evidence favors rejection of a causal relationship between MMR vaccine and autism.

So regarding this rejection of causality they looked at 22 studies. They dismissed 17 of them. The 5 remaining were all foreign studies done in the UK, Poland, and Denmark. None of the studies compare the health of completely unvaccinated children and children receiving the full CDC schedule. Another problem as represented with the Danish study, they didn't compare unvaccinated children to those that received only the MMR vaccine. They compared those that received the entire Danish schedule of vaccines against those that also received the entire schedule but had MMR removed. As some point out, that's like having one group of people drink shots of 8 different brands of liquor and the other group only 7  brands with the tequila shot removed and then when the results show that instances of tripping over your feet is the same for both groups conclude that there is no causal relationship between tequila and balance. The IOM begins implicitly with the premise that the mix of 30 vaccines administered and the correlated dosage on the American CDC schedule included alongside MMR do not effect instances of autism. There is good rational reason to hold out skepticism for these findings.

Especially when the CDC translates these IOM findings on their website as "Vaccines do not cause autism." Ludicrous. 

In Closing

We could go on for much longer on why there is cause for skepticism regarding claims of the alleged safety of the US vaccination program, but that would require this article turn into a book.

To briefly address a few more things:

Vaccine Guide offers information for parents to stay informed (package inserts, peer reviewed journal articles, studies, VAERS data, etc.)

"The experts agree that vaccines are safe!"

Well Cited White Papers on:

Thought provoking discussion with a vaccine skeptic here

Subtle DNA changes and the overuse of vaccines in autism
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3364648/

Vaccine and Autism- a New Scientific Review
http://www.cbsnews.com/news/vaccines-and-autism-a-new-scientific-review/

Summary of previous Journal of Immunology
http://danmurphydc.com/wordpress/wp-content/uploads/2011/01/AR-10-12-rata-AUTISM-VACCINE.pdf

Autism and Resulting Medical Conditions:
http://www.tacanow.org/wp-content/uploads/2011/09/autism-studies-april-2008.pdf

Elevated levels of measles in children with Autism
http://www.ncbi.nlm.nih.gov/pubmed/12849883

Abnormal MMR antibodies in children with autism
http://www.ncbi.nlm.nih.gov/pubmed/12145534

Tylenol, MMR and Autism - A parent survey study
http://www.ncbi.nlm.nih.gov/pubmed/18445737

A Positive Association found between Autism Prevalence and Childhood Vaccination
http://www.ingentaconnect.com/content/tandf/uteh/2011/00000074/00000014/art00002?token=004c170388ee06a6e5865462431636f5720415d23763c247b5e4e26634a492f2530332976261

Stories

Anecdotes are just that, anecdotal. That said, it is frequently the case that it takes a heartbreaking tragedy to prompt someone to research the popular narrative regarding vaccines thoroughly and critically. Here are some that have been compiled.

5 Counter Articles on Vaccines

Part 1: Vaccines & Aborted Babies: Should Christians be Concerned?

Part 2: Are Vaccines What Saved Us from Epidemics of Infectious Disease?

Part 3: Is the US Vaccination Program Safe?

Part 4: What About Herd Immunity?

Part 5: Are Vaccine Skeptics Conspiracy Theorists?

Author

Jordan Wilson

Jordan Wilson is pursuing the Great Commission with his wife and children and is a regular contributor at New City Times.