Vaccine Safety Studies: Where Are The Unvaccinated?
The gold standard in safety studies is the randomized, double-blind, placebo-controlled study (RDBPCS). This is the kind of study they do in clinical trials. To make sure drugs are safe. Before you take them.
This is the most effective way to assess the risk of ‘something’: by comparing the ‘exposed’ group to the ‘unexposed’ group, and examining their health outcomes. A good scientist would also be looking at unintended consequences. If a drug that prevents heart attacks causes liver failure, it would probably be a good thing to know, right?
The only problem is, clinical trials for vaccines don’t use this gold standard. And what’s amazing to me is that injections are more invasive than taking a pill. We really should know that these “injections” are safe.
I have searched far and wide. It’s really hard to find an ‘unexposed’ group in vaccine research. Many clinical trials use older vaccines as placebos, or different vaccines. And even if the particular trial has a placebo for one vaccine, the children are still getting all the other recommended vaccines at the same time. There’s no truly “unexposed” group.
Even the retrospective studies I could find don’t have an ‘unexposed’ reference group. It would not be unethical to include completely unvaccinated children in retrospective studies, because the argument that you are “withholding life saving medication” is null for someone who chose to not take that injection.
Maybe I’m wrong. Surely, there’s got to be a completely ‘unexposed’ group somewhere, or else how can we be reassured that vaccines are as safe as they say they are?
Well, let’s take a walk down ‘Vaccine Safety Study Lane’, shall we?
1. Association Between Estimated Cumulative Vaccine Antigen Exposure Through the First 23 Months of Life and Non–Vaccine Targeted Infections From 24 Through 47 Months of Age, Glanz J, et al. JAMA. 2018; 319(9):906-913.
Notes: Comparing health outcomes for different ranges of antigen exposure. The lowest antigen exposure reference group is 0-198 antigens. So, no unvaccinated group.
Notes: 5 case-control and 5 cohort studies. Studies were included that looked at either MMR vaccination, cumulative mercury (Hg) or cumulative thimerosal dosage from vaccinations. No individual study had an unvaccinated control reference group.
3. Patterns of childhood immunization and all-cause mortality. Natalie L. McCarthy, et al. 2017
Full study here —–> McCarthy, et al
Notes: Study compares mortality rates between children following the ACIP recommended vaccine schedule against children considered “undervaccinated” which are children missing at least one dose. Curiously, 3.3% of the “undervaccinated” group received no vaccines but they are not examined distinctly from the “undervaccinated” group. So, no unvaccinated reference group.
4. Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism. ,
Notes: This study wanted to examine the relationships between prenatal and infant ethylmercury exposure from thimerosal-containing vaccines and or immunoglobulin preparations and ASD, but it forgot to include unvaccinated kids. No unvaccinated reference group.
5. Increasing Exposure to Antibody-Stimulating Proteins and Polysaccharides in Vaccines Is Not Associated with Risk of Autism. DeStefano, et al. 2013.
Notes: They tried to evaluate the association between autism and the level of immunologic stimulation received from vaccines administered during the first 2 years of life, but forgot to keep the ZERO exposure group all by itself in its own cute little section. The reference groups are: 0-25 antigens, 0-125 antigens, and 0-311 antigens. And then for an even more sensitive analysis, their reference group for a single day exposure was 0-25 antigens, 0-25 antigens, and 0-100 antigens (compared to kids with 3000-6258 antigens). Sadly, this was another missed opportunity. No unvaccinated reference group.
6. Number of antigens in early childhood vaccines and neuropsychological outcomes at age 7-10 years. Iqbal S, et al. 2013
Full Study —-> Iqbal, et al
Notes: They used a publicly available dataset to evaluate the association between antibody-stimulating proteins and polysaccharides from early childhood vaccines and neuropsychological outcomes at age 7-10 years. Lowest exposure reference group is <100. So, no unvaccinated group.
7. On-time Vaccine Receipt in the First Year Does Not Adversely Affect Neuropsychological Outcomes. Michael J. Smith 2010
Full Study —–> Smith, et al
Notes: Comparing timely (within 30 days of recommended schedule) to untimely (children who did not meet that criteria). There is no unvaccinated group.
8. Analysis of health outcomes in vaccinated and unvaccinated children: Developmental delays, asthma, ear infections and gastrointestinal disorders. Brian S. Hooker, et al. 2020
Notes: This does have an unvaccinated group. This is their findings:
Vaccination before 1 year of age was associated with increased odds of developmental delays (OR = 2.18, 95% CI 1.47–3.24), asthma (OR = 4.49, 95% CI 2.04–9.88) and ear infections (OR = 2.13, 95% CI 1.63–2.78). In a quartile analysis, subjects were grouped by number of vaccine doses received in the first year of life. Higher odds ratios were observed in Quartiles 3 and 4 (where more vaccine doses were received) for all four health conditions considered, as compared to Quartile 1. In a temporal analysis, developmental delays showed a linear increase as the age cut-offs increased from 6 to 12 to 18 to 24 months of age (ORs = 1.95, 2.18, 2.92 and 3.51, respectively). Slightly higher ORs were also observed for all four health conditions when time permitted for a diagnosis was extended from ⩾ 3 years of age to ⩾ 5 years of age.
Conclusion: In this study, which only allowed for the calculation of unadjusted observational associations, higher ORs were observed within the vaccinated versus unvaccinated group for developmental delays, asthma and ear infections. Further study is necessary to understand the full spectrum of health effects associated with childhood vaccination.
