“Higher OR*s were observed within the vaccinated versus unvaccinated group for developmental delays, asthma and ear infections. No association was found for gastrointestinal disorders in the primary analysis, but a significant relationship was detected in the third and fourth quartiles (where more vaccine doses were administered), at the 6-month cut-off in the temporal analysis, and when time permitted for a diagnosis was extended from children ⩾ 3 years of age to children ⩾ 5 years of age. Similar results have been observed in earlier studies by Mawson et al. and Delong.”.
This are the results of a study published by Sage Journals only two days ago.
- OR = oddis ratio = a ratio showing the strength of an association. Hiher OS = stronger association / higher prevalence / higher incidence
Using data from three medical practices in the United States with children born between November 2005 and June 2015, vaccinated children were compared to unvaccinated children during the first year of life for later incidence of developmental delays, asthma, ear infections and gastrointestinal disorders.
The study, published May 27, 2020 by Sage Journals, is titled “Analysis of health outcomes in vaccinated and unvaccinated children: Developmental delays, asthma, ear infections and gastrointestinal disorders“ and was conducted last year by Brian S Hooker, Department of Sciences and Mathematics, Simpson University, and Neil Z Miller, Institute of Medical and Scientific Inquiry, Santa Fe,
Dr Hooker is a paid scientific advisor and serves on the advisory board for Focus for Health (formerly Focus Autism). He also serves on the Board of Trustees for Children’s Health Defense (formerly World Mercury Project) and is a paid independent contractor of Children’s Health Defense as well. Dr Hooker is the father of a 22-year old male who has been diagnosed with autism and developmental delays.
Mr Miller is the director of Thinktwice Global Vaccine Institute and was a paid consultant to Physicians for Informed Consent.
This study employed a cohort study design with strata for medical practice, year of birth and gender. Cases were evaluated against non-cases for an association between vaccination status and the different health conditions considered.
In general, with a sample size of approximately 2000 subjects, the study was designed to have a power of 80% to detect odds ratios of 1.8 (α = 0.05 and a confidence level of 0.95), but because of some more rare diagnoses, 80% power in select instances was only sufficient to detect odds ratios of 2.4 and above.
The study couldn’t analyse illnesses with low incidences because the sample was too low. That means insufficient data.
The strongest relationships observed for vaccination status were for asthma, developmental delays and ear infections (Table 4). Although the association between vaccinations and asthma in males was elevated (Table 5), it should be noted that there were only three asthma cases in the unvaccinated group. No association between vaccinations and asthma in females was found ; this may also be due to just four asthma cases in the unvaccinated group. Although some studies were unable to find correlations between vaccines and asthma, a relationship between vaccination and allergy/atopy incidence (including asthma) has been reported. In a study involving Korean children who were all vaccinated against hepatitis B, a significantly higher asthma incidence was seen among children who had actually seroconverted to produce anti-HepB.In addition, Hurwitz and Morgenstern reported an association between diphtheria–tetanus–pertussis (DTP) and tetanus toxoid vaccination and allergy symptoms and could not rule out a relationship with asthma. In an animal study, mice vaccinated according to the Chinese infant vaccine schedule showed airway hyperresponsiveness at a significantly higher rate than unvaccinated mice.
The IOM Immunization Safety Review Committee conducted an evaluation regarding thimerosal-containing vaccines and concluded that “the hypothesis that exposure to thimerosal-containing vaccines could be associated with neurodevelopment disorders” was biologically plausible. Mawson et al. found a relationship between vaccination status and learning disability and neurodevelopmental disorders. Delong also reported a significant relationship to neurodevelopmental disorders (autism and speech and language delay) when looking at the proportions of vaccine uptake in US children. Other research, focused more on the uptake of specific vaccines, has elucidated such relationships. Gallagher and Goodman saw a greater number of boys receiving special education services if they had received the entire hepatitis B vaccine series in infancy. Geier et al. also documented a link between neurodevelopmental disorders and thimerosal-containing vaccines. (Although thimerosal has been phased out of most vaccines administered in the United States, it still remains in some formulations of the influenza vaccine given to pregnant women and infants.)
Mawson et al. reported a significant relationship between vaccination status and ear infections. Wilson et al. found that for both males and females, top reasons for emergency room visits and/or hospital admissions after their 12-month vaccinations included ear infections and non-infective gastroenteritis or colitis. Prior to the RotaTeq rotavirus vaccine achieving FDA approval, 71,725 infants were evaluated in three placebo-controlled clinical trials. Otitis media (middle ear infection) occurred at a statistically higher incidence (p < 0.05) within 6 weeks of any dose among the recipients of RotaTeq as compared with the recipients of placebo.
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.Analysis of health outcomes in vaccinated and unvaccinated children: Developmental delays, asthma, ear infections and gastrointestinal disorders
Also important from the conclusion note of the study: “The findings in this study must be weighed against the strengths and limitations of the available data and study design, which only allowed for the calculation of unadjusted observational associations. Additional research utilizing a larger sample from a variety of pediatric medical practices will yield greater certainty in results and allow for the investigation of health conditions with lower prevalence, such as autism. A thorough evaluation of vaccinated versus unvaccinated populations is essential to understanding the full spectrum of health effects associated with specific vaccines and the childhood vaccine schedule in totality.”
One of the main strengths of this study is that the data are based directly on patient chart records and diagnosis codes. Practitioners making these diagnoses were also directly available for consultation on how specific diagnosis codes were applied. In addition, vaccination records were based on patient chart data, although coding practices for vaccination varied among the three different pediatric practices. To account for any differences in diagnosing among the three different practices, cases and non-cases were stratified based on medical practice. Thus, no “cross comparisons” were made among two or more medical practices. To account for differences in likelihood of particular diagnoses based on the age and gender of the patient, cases and non-cases were stratified based on the year of birth and gender.
It is possible that diagnoses may have been missed or information regarding vaccines administered could have been incorrectly recorded leading to exposure misclassification, which might explain the high rates of unvaccinated children in the cohort. However, all children considered in the study were enrolled in their medical practice from birth and followed up continuously to minimum age cut-offs of 3 years and 5 years. This minimized the risk of missing vaccination doses or diagnoses associated with tracking patients with multiple practitioners. This also eliminated recall bias associated with studies focused on parental surveys. The high proportion of unvaccinated children is most likely indicative of pediatric practices which accepted unvaccinated and partially vaccinated children into their case load.
The main weakness of this study is the use of a convenience sample of three different pediatric practices. In addition, the size of the sample, although sufficient for some diagnoses, such as the five main conditions studied, was too small for analysis of conditions with lower prevalence, such as autism. Also, this sample may not accurately represent a cross-section of US children given the low incidence of autism (0.5%) and ADD/ADHD (0.7%) compared to incidences observed nationwide (at 1.7% and between 5% and 9%, respectively). In addition, vaccine uptake, which is approximately 95% nationwide, is rather low in these practices and may reflect demographic differences between the study sample and the general population. Also, due to different coding practices among the three caseloads studied, we were unable to differentiate between the types of vaccinations given. This limited the analysis to counting the number of vaccinations received by 1 year of age.
The low level of vaccine uptake overall in these practices (mean = 8.9 vaccines by 1 year of age) obviates our ability to do a comparison between fully vaccinated and unvaccinated children within this cohort. Also, the median age at first vaccine dose in the cohort was 81 days (just under 3 months) as compared to the hepatitis B vaccine that is recommended within 24 h of birth. Medical chart records did not include specific demographic factors that may be associated with health outcomes, including socioeconomic status, maternal education, gestational age at birth, Appearance, Pulse, Grimace, Activity and Respiration (APGAR) score, type of birth and duration of breastfeeding, among others.
In brief: insufficient data for laser-precision. Which doesn’t deny the main observation
Vaccination is considered to be one of the most important advances in modern public health.1 Currently, children between birth and 6 years of age receive up to 36 vaccine doses to protect against 14 different diseases, according to the Centers for Disease Control and Prevention’s (CDC) recommended schedule. By ages 1 and 2 years, the CDC recommends approximately 21 and 28 such vaccination doses, respectively. The number of vaccine doses received by infants and children has increased most notably since the early 1990s, when the hepatitis B and Haemophilus influenzae type B vaccines were introduced. Currently, children in the United States are vaccinated for hepatitis A and B, Haemophilus influenzae type B, diphtheria, pertussis, tetanus, polio, measles, mumps, rubella, rotavirus, pneumococcal pneumonia, influenza and varicella.
Although short-term clinical testing is completed on individual vaccines (with limited longer-term follow-up for specific vaccine adverse events) prior to approval by the US Food and Drug Administration (FDA), the health outcomes related to these vaccines and the vaccination schedule as a whole are largely unknown. For instance, Kuter et al. detailed 23 different post-licensing trials conducted on the measles, mumps and rubella (MMR)-II vaccine and in no instance were the patients followed for more than 42 days post-vaccination. In 2011, the Institute of Medicine (IOM) published the report “Adverse Effects of Vaccines: Evidence and Causality” where the relationships between specific vaccines and different adverse health effects were considered. Based on the current scientific literature, the IOM committee found inadequate evidence to accept or reject a causal relationship between 135 of 158 relationships between vaccines and adverse events. Among the remaining 23 adverse events, 18 were found to be associated with vaccination and 5 were not.
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The medical community does in general acknowledge that vaccination is not without health risks, including death. However, it is widely purported that these side effects or “adverse events” are extremely rare and justified compared to the overall benefit of vaccination.7 There have been very few studies reported where health effects of the US infant and childhood vaccination schedule have been assessed. This is in part based on ethical concerns of withholding vaccination from an unvaccinated control group within such a study. Indeed, this precludes the use of double-blinded placebo studies on vaccine health effects, and even in clinical trials an earlier version of the same vaccine is often used as the placebo control for the newly tested vaccine.
One study, published by Mawson et al., was based on a convenience sample of homeschooled children where a significant portion of the sample (39%) was unvaccinated. In this small sample, vaccinated children showed higher odds of being diagnosed with pneumonia, otitis media, allergies and neurodevelopmental disorders. In addition, preterm birth coupled with vaccination significantly increased the odds of a neurodevelopmental disorder diagnosis. This study was unique in the inclusion of entirely unvaccinated populations to provide a comparison to partially vaccinated and fully vaccinated children. However, the risk of bias is high when comparing vaccinated versus unvaccinated children. Also, health outcomes were based on parental survey, not confirmed by medical chart review, and may be subject to recall bias, and the small size of the sample (666 patients) made it difficult to analyze for rare disorders.
Between 2001 and 2004, the IOM Immunization Safety Review Committee rejected a relationship between multiple vaccinations and sudden infant death syndrome (SIDS) but could not rule out a relationship with other types of “sudden unexpected infant death.” This included the neonatal hepatitis B vaccine as well as the diphtheria and tetanus toxoids and whole-cell pertussis (DTwP) vaccine, which was strongly associated with anaphylaxis but is no longer given in the United States. A relationship between multiple vaccines and type 1 diabetes was ruled out, but evidence was inadequate to accept or reject a relationship with asthma. In addition, the committee rejected a relationship between multiple vaccines and increased “heterologous” infections, such as bacterial infections unrelated to vaccine-preventable diseases, although recent studies have provided evidence of both beneficial and detrimental non-specific effects associated with several vaccines. The remainder of the IOM Immunization Safety Review Committee focused on single types of vaccines and specific adverse events as recommended by the CDC who commissioned these studies.
! Articles can always be subject of later editing as a way of perfecting them