We are told by the media and many doctors that vaccines are safe and effective. We are told that vaccines are responsible for saving thousands to millions of lives from infectious diseases that we are taught to fear. We are told that vaccines provide life-long immunity to these diseases (with booster shots?). However is this accurate?
I want to start by saying that I am not completely against vaccines and I believe it is every person’s right to decide for themselves whether or not to be vaccinated. I also strongly believe that people should have adequate information to be able to make an informed decision. This is the biggest problem that I have with vaccination: that often vaccines are either forced on people or that individuals are only given limited, one-sided information—if any at all—to make a decision about vaccinating. This post only very briefly presents some of the ‘other side’ of the debate. In researching for this post, I continued to come across more and more information about vaccines and can only present very little here. There are several links to other articles and websites at the end for more information. I think there are many important questions that should be asked before deciding to vaccinate and I hope this will stimulate some thought when it comes to vaccines.
Vaccine Safety
First off, what are the requirements to claim that a vaccine is safe? Are there even any specific requirements? The Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule (long enough name?) had this to say about vaccine safety:
Vaccine safety is critically important, but a determination of safety is ultimately a value judgment. For example, some might believe that a serious adverse event that occurs once in 1 million doses is “safe enough” relative to the benefit of preventing a serious disease, whereas others may consider that risk unacceptably high.(1)
So as far as I can tell from my research there is no specific set standard as what is considered safe enough. I hope that there is some common sense used in making that determination, but likely it would be different for each and every vaccine. So what does a vaccine go through before being approved to be sold in the US?
Like other pharmaceutical products, vaccines, undergo extensive safety and efficacy evaluations in the laboratory, in animals and in sequentially phased human clinical trials prior to licensure. Phase I trials usually number in the tens and can only detect the grossest toxicity. Phase II trials generally enroll hundreds of people and, when carefully coordinated, can provide important conclusions. These conclusions might address the relationship between the concentration of antigens, number of vaccine components, formulation technique, effect of successive dose and profile of common reactions, all of which impact on the choice of the vaccines chosen for Phase III trial. The sample size for Phase III vaccine trials are based primarily on efficacy considerations, usually ranging between 100 and 10,000 participants. The maximum duration of observation is also generally limited to a couple of years. The availability of unvaccinated control group, however, allows clear identification of true common local and systemic reactions (e.g., injection site swelling, fever, fussiness). To identify potential safety problems, vaccines go through pre-release lot testing for safety and potency. This evaluation usually occurs parallel to the clinical trials prior to vaccine licensure.(2)
It is interesting to note that these trials are carried out by the pharmaceutical companies producing the vaccine. This really is a conflict of interest and brings into question the validity of those studies. Specifically with the flu vaccine the Cochrane Review Vaccines for preventing influenza in healthy adults contains this warning:
This review includes 15 out of 36 trials funded by industry (four had no funding declaration). An earlier systematic review of 274 influenza vaccine studies published up to 2007 found industry funded studies were published in more prestigious journals and cited more than other studies independently from methodological quality and size. Studies funded from public sources were significantly less likely to report conclusions favorable to the vaccines. The review showed that reliable evidence on influenza vaccines is thin but there is evidence of widespread manipulation of conclusions and spurious notoriety of the studies. The content and conclusions of this review should be interpreted in light of this finding.(3)
Also in the process of approval for a vaccine, the unvaccinated control group really only refers to an individual being unvaccinated with the specific vaccine that is being tested. There have been few if any studies and no randomized control trials that compare health outcomes of completely unvaccinated individuals and fully vaccinated individuals. And you are unlikely ever to see a randomized controlled trial (the gold standard) comparing vaccinated with completely unvaccinated because it is considered unethical to withhold vaccines to perform the trial (that seems awfully convenient for the vaccine companies).
So before approval of a vaccine, it is basically left up to the pharmaceutical company to show that it is safe. Aside from that, the longest trials are only limited to a couple of years, so long-term effects cannot be determined from them. So how do we determine if there are long-term negative effects to vaccination? The only way to definitively answer the question would be several long-term randomized control trials, but that isn’t going to happen as stated before. That leaves looking back and trying to figure how vaccination plays into the declining health in the US, which really doesn’t give a clear answer.
Passive reporting systems have also been created, such as the Vaccine Adverse Event Reporting System (VAERS), to help track vaccine safety after marketing. So basically the pharmaceutical companies ‘show’ a vaccine is safe in the short-term, it is licensed, and then we monitor reported health problems after vaccination to see if trends develop. This essentially means the entire population is in a vaccine safety study. While having a passive reporting system is better than nothing, it is not foolproof. One major problem with passive reporting systems like VAERS is that adverse events are known to be underreported. The rates vary for different types of adverse events, but it is universally acknowledged that underreporting is a problem. Just how much of a problem is difficult to ascertain.
Vaccine safety has been a concern for a number of years. In 1986 adverse reactions to childhood vaccines were reviewed.
In the United States, The National Childhood Vaccine Injury Act of 1986 established a Committee from the Institute of Medicine (IOM) to review the adverse consequences of childhood vaccines. This group found severe limits in the knowledge and research capability on vaccine safety. Of the 76 vaccine adverse events they reviewed for causal relation, 50 (66%) had no or inadequate research. Specifically, the IOM Committees identified the following limitation’s: 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 epidemiologic studies; 4) Limitations of existing surveillance systems to provide persuasive evidence of causation and 5) Few experimental studies published relative to the total number of epidemiologic studies published.(2)
So how has the research improved since then? Well when it comes to the safety of the whole vaccination schedule, The Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule (remember them?) had this to say:
In summary, few studies have comprehensively assessed the association between the entire immunization schedule or variations in the overall schedule and categories of health outcomes, and no study has directly examined health outcomes and stakeholder concerns in precisely the way that the committee was charged to address in its statement of task. No studies have compared the differences in health outcomes that some stakeholders questioned between entirely unimmunized populations of children and fully immunized children. Experts who addressed the committee pointed not to a body of evidence that had been overlooked but rather to the fact that existing research has not been designed to test the entire immunization schedule.(1)
And…
In summary, to consider whether and how to study the safety and health outcomes of the entire childhood immunization schedule, the field needs valid and accepted metrics of the entire schedule (the “exposure”) and clearer definitions of health outcomes linked to stakeholder concerns (the “outcomes”) in rigorous research that will ensure validity and generalizability.(1)
So after basically saying there was little evidence about the safety of the vaccination schedule and a need for “valid and accepted metrics” to even adequately study the matter, what was the committee’s final conclusion? “The committee found no significant evidence to imply that the recommended immunization schedule is not safe.”(1) Claiming that there is no significant evidence (where there is little to no evidence to begin with) that something is not safe does not equate to it being proven safe, though I think few people realize this.
In my mind the question about safety is far from adequately answered!
Vaccine Effectiveness
There are many studies to show that vaccines do affect the body and that the body will make antibodies to the antigens in the vaccines. This in turn will affect how the body will respond to an infection. However, there are many questions that remain. One big question is whether or not vaccines are responsible for the decline in deaths from infections disease as we are taught. Another important question is do vaccines provide long-term protection against disease and that in turn has a huge impact on the idea of herd immunity.
To begin with let’s discuss the question of if vaccines are responsible for the decrease in deaths from infectious diseases. Now it is interesting that to have good evidence of a causal relationship you need a randomized control trial. So if you want to say that vaccines caused a reduction in deaths you would need to set up a randomized control trial to test that. That is not the case. So did deaths decrease from infectious diseases after vaccines were introduced? Yes, but that does not mean that vaccines were responsible for the decrease.
I will not go into too much detail here because there is a good article specifically on the subject in the links below. But there is evidence that deaths from infectious diseases were already on the decline before vaccines were introduced. So was it the vaccines that were responsible or something else like improved living conditions and nutrition? I personally am inclined to believe that better nutrition, living conditions and even medical treatment had a greater impact than vaccines themselves. Something else to consider with this question is what about ‘diseases’ that do not have a vaccine, did death or incidence decline as well without a vaccine? For example, scarlet fever (which is caused by group A streptococcus, the same type of bacteria responsible for strep throat), is practically unheard of today. There is no vaccine for scarlet fever or group A streptococcus, but this deadly disease has practically disappeared without a vaccine.
As far as long-term protection goes, it is assumed that finding a certain level of antibodies in the blood should give protection. It was thought that vaccines would provide lifelong protection against disease. But more recently we are finding that vaccines do not offer lifelong protection and this is the idea behind giving booster shots to maintain antibody levels. However at least in the case of pertussis “antibody levels do not correlate well with protection against pertussis.”(4) So there is a question of whether or not antibody levels offer protection, but this is what is assumed to ‘show’ protection. So if a certain level of antibodies is not protective, the assumption that we have been protected would be incorrect. What does offer protection, or have we been unprotected without having huge outbreaks? I do not have the answers to these questions but it does cast doubt in my mind about the effectiveness of vaccines and the concept of herd immunity.
I hope this has given you some questions to think about. Again I am not completely against vaccines, but strongly believe that what we often hear in the media is not the whole story. Everyone should have the right to make an informed decision about vaccination, and I currently believe that most people don’t have adequate information to make an informed decision. I hope you will do your own research and look at some of the links below to get some more of the ‘other side’ of the story.
Additional Information
National Vaccine Information Center – lots of good information about vaccines and the importance of informed consent http://www.nvic.org
About herd immunity http://www.vaccinationcouncil.org/2012/07/05/herd-immunity-the-flawed-science-and-failures-of-mass-vaccination-suzanne-humphries-md-3/
Decline in infectious disease before vaccines http://www.vaccinationcouncil.org/2013/11/12/vaccines-a-peek-beneath-the-hood-by-roman-bystrianyk-and-suzanne-humphries-md/
Vaccines are some of the most recalled drugs http://articles.mercola.com/sites/articles/archive/2012/04/24/most-recalled-type-of-drug-will-surprise-you.aspx
Contamination of vaccine with pig virus, but not recalled by the FDA only suspended for a time http://articles.mercola.com/sites/articles/archive/2010/04/17/major-vaccine-suspended-due-to-contamination-with-pig-virus.aspx
Vaccines changing the way the immune system responds to disease http://pathwaystofamilywellness.org/component/option,com_crossjoomlaarticlemanager/Itemid,375/aid,1369/view,crossjoomlaarticlemanager/
Dr. Blaylock, MD – more on herd immunity and risks of vaccine and forced vaccination http://www.thenhf.com/article.php?id=1975
References
(1) National Research Council. The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. Washington, DC: The National Academies Press, 2013. Available online at: The National Academies Press
(2) Chen RT, Hibbs B. Vaccine Safety: Current and Future Challenges. Pediatric Annals July 1998; 27 (7): 445-455. Can be accessed here: http://www.utoronto.ca/virology/mby480/VaccineSafe/VaccineSafe.htm
(3) Jefferson T, Di Pietrantonj C, Rivetti A, Bawazeer GA, Al-Ansary LA, Ferroni E. Vaccines for preventing influenza in healthy adults. Cochrane Database of Systematic Reviews 2010, Issue 7.
(4) Dajani NA, Scheifele D. How long can we expect pertussis protection to last after the adolescent booster dose of tetanus-diphtheria-pertussis (Tdap) vaccines? Paediatrics & Child Health Vol 12 No 10 December 2007.
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