“You may choose to look the other way, but you can never say again that you did not know.”

— William Wilberforce

Front Page » Law » Federal Agencies » The Vaccine Science is Unsettled
Federal Agencies
Text size:

The Vaccine Science is Unsettled

lots of questions about vaccine scienceStory Highlights
  • With eroding FDA regulations governing the licensing of drugs and “biological products,” such as vaccines, it is important to understand the different types of study designs used to prove safety and effectiveness and what they mean.
  • Most vaccine research depends on epidemiological studies, which compare two groups of participants that are similar except for one single variable.
  • There is a pressing need for well designed, unbiased clinical studies to evaluate potential overall health outcome differences between vaccinated and unvaccinated children.

The foundation of scientific research on human health is the clinical study, and the strength and reliability of conclusions reached is a direct reflection of the study methods used in that research. If the trial design is sound and the research methods followed with integrity, the results will be robust. If not, the results are going to remain open to question and interpretation.

One of the most widely repeated phrases bandied about by those who maintain that vaccines very rarely, if ever, cause injury and death is, “the science on vaccines is settled.”1 Aside from how absurd it is to insist that any science is ever completely settled, such a statement presupposes that vaccine safety and efficacy studies have been rigorous and exhaustive and that their conclusions, therefore, are reliable and authoritative. It would be great if that were the case.

Relaxed Guidelines Weaken Vaccine Safety Data

Many consumer safety groups opposed the 21st Century Cares Act, which was pushed through Congress in December 2016. The law allows far laxer licensing standards than had previously been required for approval of a new drug, medical device or biological product, including vaccines.2 The bill was originally proposed to allow seriously ill patients to voluntarily accept treatment with new and minimally tested drugs and medical devices by accepting the risks in exchange for hope of a cure.

Under the law’s new guidelines, producers of experimental drugs, medical devices, and ‘biological products,’ such as vaccines, are no longer required to provide evidence from large clinical trials to demonstrate safety and effectiveness but can base their conclusions on statistical analyses and observational clinical experience.3

With fewer rules in place to justify approval of new vaccines, it is important to understand the strengths and weaknesses of the different types of scientific studies used in medical research in order to be better equipped to evaluate the evidence.

Research Study Types

Medical research can be broadly delineated as either primary research (original studies) or secondary research (reviews and analyses of existing studies), with innumerable sub-categories.4 Within that overarching definition, there are three basic categories of research: experimental, clinical, and epidemiologic. They can be further sub-classified into observational or interventional studies, and, from there, the sub-types are many and can be truly daunting to categorize.

For example, observational or epidemiologic studies may include any of the following:

  • Case reports (individual patients)
  • Case control studies (retrospective analyses comparing groups of patients who do or do not have a given condition)
  • Cohort studies (analysis of groups of patients with a given condition, followed over time and compared to similar groups without that condition)
  • Systematic reviews (comparison of data from previous well-controlled clinical trials)
  • Meta-analyses (similar to systematic reviews, but with the data from previous clinical trials combined and analyzed as if they all came from one trial).

Different types of observational studies are variously reliable in terms of the information gleaned from them, and those mentioned here are listed essentially in order of credibility,5 but all are more prone to bias than controlled clinical trials.

Primary Research: Clinical Trials

While preclinical studies are often done in the laboratory, first at the cellular level and, then, in animal studies, clinical trials involve human beings and are generally designed to answer a specific question about a disease or a medical intervention (such as use of a drug or vaccine).

Clinical trials are broken down into stages:

  • Phase I trials enlist very few patients and are meant to evaluate safety,  including side effects and dosage if an experimental pharmaceutical product is being tested.
  • Phase II trials include a larger study population and evaluate safety and effectiveness.
  • Phase III trials are larger-scale studies that typically involve large patient populations and compare an experimental new treatment or therapy approach to either the current standard of care or non-treatment. These trials are also used to monitor the occurrence of any side effects or other safety data in large numbers of participants.
  • Phase IV trials are also known as “post-marketing surveillance studies” and involve the ongoing study of new products and medical therapies once they are FDA approved and used in the general population.6

Randomized clinical trials, which have been used in most Phase III and some Phase II trials, are generally considered the “gold standard” of clinical research because they minimize the chance for bias. In a randomized clinical trial, the study population is broken down into two groups, with one group receiving the experimental treatment or product and the other getting either the current standard of treatment or a “placebo” (which is supposed to be a non-bioactive or inert substance).

In some kinds of randomized trials, either the patient or the doctor/researcher knows which treatment or product is being given, which is called a “masked” or “single-blind” trial. This design ensures some degree of objectivity for investigators analyzing the results, though with one side “un-masked” trials, there is the possibility that interpretation of results could be biased.

The purest clinical trial design is the “double-blind, placebo-controlled trial,” where neither the patient or physician or researcher knows in advance which treatment the subject receives, so conclusions are based purely on observational results.7

One of the main reasons for using epidemiologic, or observational, studies is when there are ethical questions about subjecting people to an experimental therapy. If, for example, study results appear lopsided, investigators may “un-blind” a study. If it turns out that one treatment or the other offers a clear advantage or disadvantage, the study may be halted and the more advantageous treatment substituted.

Pressing Need for Unbiased Evaluation of Vaccines

In the case of vaccines, the core assumption among mainstream medical and academic research circles is that vaccines are always better than no vaccines. This belief has confined vaccine research, for the most part, to non-interventional, observational study.8 A prospective, randomized, double-blind study examining health outcomes of fully vaccinated versus unvaccinated children is deemed impossible to conduct because (1) withholding vaccines is considered unethical and (2)  parents would not allow their child to take part in a study that would randomly assign their child to be vaccinated or unvaccinated without parental knowledge or consent.

However, it does not follow that vaccine questioners are “loons”9 for demanding unbiased clinical studies of vaccine safety and effectiveness and investigation of health outcome differences between highly vaccinated and unvaccinated children. To the contrary, there is a compelling need for a true single-blind, placebo-controlled trial to objectively compare the overall health outcomes (not the incidence of “vaccine-preventable diseases”) of vaccinated and unvaccinated populations.


References:

1 All Things Considered. Science Of Vaccines Is Settled—But Politics Are More Complicated. National Public Radio Feb. 3, 2015.
2 U.S. House of Representatives. 21st Century Cures Act (July 2, 2015).
3 Fisher BL. Here Comes the 21st Century Cures Act: Say Goodbye to Vaccine Safety Science. National Vaccine Information Center July 21, 2015.
4 Rohrig B et al. Types of Study in Medical Research. Deutsch Arzteblatt Intl Apr. 10, 2009 (translated).
5 Introduction to Evidence Based Practice: Type of Study. Duke University Dec. 20, 2016.
6 What are the different types of research studies? Breast Cancer Deadline C 2013.
7 Rohrig B et al. Types of Study in Medical Research. Deutsch Arzteblatt Intl Apr. 10, 2009 (translated).
8 Weinberg GA, Szilagyi P. Vaccine Epidemiology: Efficacy, Effectiveness, and the Translational Research Roadmap. Journal of Infectious Diseases 2010.
9 Orac. For the anti-vaccinationists out there: The results of a real “vaxed versus unvaxed” study. Science Blogs Mar. 11, 2011.

7 Responses to The Vaccine Science is Unsettled

  1. Leo Raabe Reply

    December 2, 2017 at 12:55 pm

    I would like to get clarification on one point here. In the final paragraph of this article, author Kate Raines says “there is a compelling need for a true single-blind, placebo-controlled trial to objectively compare the overall health outcomes … of vaccinated and unvaccinated populations.” This quote implies an important assumption. In “single blind” research, information that may bias the results is concealed from either the subject or the tester. Which of these two parties would be blind in the research that Raines is calling for here? Ethically, it seems that a given subject (or that subject’s parents) should be the people choosing whether that subject receives the vaccine. In that case, it would be the tester who is “blind” in the single blind research that Raines calls for. In other words, this is a case where ethics prevents researchers from randomly assigning treatments. However, now I am the one making assumptions. Can anybody clarify this point for me? Who would be blind in the research Raines calls for here?

  2. Joe Reply

    January 29, 2017 at 8:08 pm

    There never will be published a conclusive and properly performed vaccine study. I’m pretty sure the research has already been done. It’s just that vaccines are pretty much used for sinister purposes. The people at the top know this.

    To do an extensive and exhaustive study would just reveal this. And you can bet any results of prior studies are under lock and key, kept out of sight under interests of “national security.”

    The purpose behind mainstream vaccines is eugenics and population control. That’s the bottom line and it’s what we need to come to terms with. It’s biological and chemical warfare being performed against the population. Until we come to terms with that fact, we’ll never be able to properly fight this battle.

    GMO, fluoridation and chemtrails are just different arms of the same beast. Know your enemy and know how to fight him.

  3. SDSerf Reply

    January 27, 2017 at 5:48 pm

    I just read a post on The Daily Sheeple regarding vaccinations. It is not new information. It contains comments by Robert F Kennedy Jr. about corruption in the CDC. I recommend that all check it out. As per the above article; it does not matter how many test and trials “they” conduct if they are all fraudulent. SDSerf

  4. Hannah Reply

    January 27, 2017 at 11:19 am

    I agree that safety studies are urgently needed, but I don’t see how single-blind studies would eliminate the ethical issues that the government agencies are concerned about. Any trial would necessitate having some vaccinated and some unvaccinated, leaving the unvaccinated “unprotected”. The only way to get around this is to do epidemiological studies, which bypass the ethical considerations, and more comprehensive animal studies, including animal studies that follow animals through to their natural deaths so we can get an idea of long term effects as well.

    • David Weiner Reply

      January 29, 2017 at 12:31 pm

      “Any trial would necessitate having some vaccinated and some unvaccinated, leaving the unvaccinated “unprotected”.”

      This is question-begging. You can’t determine whether it is appropriate to characterize the unvaccinated population as “unprotected” without doing a valid experiment.

      You are assuming that the hypothesis of the experiment is valid before it has even been conducted.

    • Leah Reply

      July 5, 2017 at 11:35 am

      I think there are many parents of unvaccinated children who would consent to a study of their child’s health compared to those fully vaxxed children. Funny that I mentioned consent since it’s not required for children to be vaxxed.

  5. David Weiner Reply

    January 26, 2017 at 12:43 pm

    The other issue with respect to determining whether or not the vaccine program should be considered a success or a failure is as follows:

    Even if one could make a good case that the program was a success at some point in time (say the 1960’s or 1970’s), does not mean that it necessarily WILL be a success at any future point in time.

    Note that I am not setting forth the claim that the program WAS a success at any point in the past, nor do I believe that to be the case.

    The point is, that its success or failure at any point in time can only be assessed based on the state of the program at that point in time and the impact that it is having in relation to if we didn’t have such a program.

Leave a Reply

Your email address will not be published. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>