Preterm birth, vaccination and neurodevelopmental disorders

Image result for vaccine homeschool studyThis is a vitally important research paper to book mark!  It is very rare to be able to find a scientific/medical study that compares vaccinated children to unvaccinated children, which, of course, is because the very last thing the medical establishment wants is uncontroversial Proof that vaccines cause not just neurodevelopmental disorders, such as autism, but also a whole host of life long health problems like Asthma, autoimmune disorders, and numerous other physical and mental issues.

This study looked at over 600 homeschooled children, and their vaccine records, their medical history and the information about their births, with a specific focus on pre-term births.  While the pool of data was smaller than what we really want for a hard core study on this, the information derived from this research was definitely astounding.  The question is:  Will anyone step up to do a much larger study from a wider base to prove this outcome, without a shadow of a doubt?

I am posting just the highlights of this study, for informational purposes, but I highly recommend reading the entire paper as there are several very interesting factors that come to light.

 

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Preterm birth, vaccination and neurodevelopmental disorders: a cross-sectional study of 6- to 12-year-old vaccinated and unvaccinated children

Anthony R Mawson Professor, Department of Epidemiology and Biostatistics, School of Public Health, Jackson State University, 350 West Woodrow Wilson Avenue, Jackson, Mississippi 39213, USA

Azad Bhuiyan Associate Professor, School of Public Health, Jackson State University, Jackson, MS 39213, USA

Binu Jacob Former graduate student, School of Public Health, Jackson State University, 350 West Woodrow Wilson Avenue, Jackson, Mississippi 39213, USA

Brian D Ray

 

Introduction

Preterm birth (defined as birth occurring before 37 completed weeks of gestation) is known as a major risk factor for neurodevelopmental deficits, including cerebral palsy, intellectual disability, cognitive and speech delays, motor deficits, and visual impairment associated with retinopathy of prematurity. In particular, preterm birth is the leading cause of neurodevelopmental disorders (NDD) and disability, including the development of autism spectrum disorder (ASD) [1-3], but the underlying mechanisms are not well understood. Preterm infants receive the same doses of the recommended vaccines on the same schedule as term infants in order to protect them from several infections [4-7]. However, the possible role of vaccination in the development of NDD in premature infants has not been assessed, partly because pre-licensure clinical trials of pediatric vaccines have routinely excluded ex-preterm infants, and because of the assumed overall safety of vaccinations [8-15].

This paper presents additional results of a survey designed to compare the health outcomes of vaccinated and unvaccinated children educated at home, based on mothers’ anonymous reports on the birth histories and physician-diagnosed illnesses in their children. The analysis explores the possible role of vaccination in NDD among children born preterm.

Preterm birth and vaccination

In 2012, 450,000 babies (11%) were born preterm in the United States, resulting in 35% of all infant deaths in that year, more than any other single cause. Worldwide, an estimated 15 million infants were born preterm in 2010, of which about 13 million survived beyond the first month. In addition to the acute complications of prematurity, which include respiratory distress, intracranial hemorrhage, necrotizing enterocolitis and retinopathy, 345,000 (2.7%) preterm infants were estimated to have moderate to severe neurodevelopmental impairment; a further 567,000 (4.4%) had mild neurodevelopmental impairment, and many more had specific learning or behavioral disorders [4]. Advances in medical care have led to increased rates of preterm birth and decreased preterm mortality rates. However, neurodevelopmental disabilities have increased, especially in infants born at ≤25 weeks’ gestation, with nearly half of surviving extremely preterm infants having significant disabilities [16]. Total annual costs of preterm birth in the United States exceed $26 billion per year, with an overall average cost of approximately $51,600 per preterm infant [17].

In a follow-up study of 11-year-old children born extremely preterm, the rate of ASD was 8% compared to zero percent among their classmates born at term [18] – a rate at least 5 times higher than recent population estimates for ASD (14.7 per 1,000, or 1 in 68 children aged 8 years) [19]. In another study involving 84 children born at <27 weeks of gestation who were screened for ASD at 6.5 years, 23 (27.4%) tested positive for ASD. The ASD-positive group had a significantly higher frequency of neonatal complications than the ASD-negative group [20].

Since special efforts are made to vaccinate preterm infants, the effects of prematurity are difficult to separate from those of vaccination. Given the benefits of vaccination, it has not been thought necessary to do so. On the other hand, vaccine safety assessment in preterm infants is particularly important due to the frequency of adverse events associated with prematurity itself [21]. Adverse cardiorespiratory events including apnea, bradycardia and desaturations (oxygen saturation <90%) are well documented following vaccination in many preterm infants, yet vaccination is strongly recommended regardless of such events, since the prevention of infection is considered paramount. Pertussis-containing pediatric vaccines in particular can increase apnea and bradycardia in ex-preterm infants, typically after the 2-month dose [22,23]. In a study evaluating the safety of hexavalent vaccines (DTaP‐IPV‐Hib) involving 78 preterm infants, vaccination triggered transient cardiorespiratory events in 47% (15% apnea, 21% bradycardia, 42% desaturations), and those with pre‐existing cardiorespiratory symptoms had a five- to eight-fold increased risk of cardiorespiratory events post-vaccination [24].

Age at vaccination of preterm infants is inversely associated with adverse effects. In one study of 27 preterm infants vaccinated at ≤70 days of age, 9 (33.3%) developed apnea, bradycardia or desaturations compared to none among those vaccinated at >70 days of age [25]. A study of nearly 14,000 extremely low­­-birth-weight (ELBW) infants reported a 3.7-fold increase in Rule-Out Sepsis evaluations in the immediate post-vaccination period as well as high rates of apnea, bradycardia and intubations [26]. Pre-licensure clinical trials of pediatric combination vaccines have, however, often specifically excluded ex-preterm infants, even though these vaccines are routinely administered to all infants regardless of gestational age at 2, 4 and 6 months of age [27].

At present, over 95% of all U.S. children receive the CDC-recommended vaccines [28,29] in accordance with the policy that universal vaccination is essential for maintaining herd immunity [30]. Vaccination is estimated to have prevented millions of illnesses and hospitalizations and 732,000 premature deaths among U.S. children born during 1995-2013, at an overall cost savings of $1.38 trillion [31]. Much less is known about the extent and cost of vaccine-associated injury, which can include severe morbidity and death [32]. Since 1988 over 16,038 claims have been filed with the Vaccine Injury Compensation Program, which was created in 1986 to compensate individuals and their families for injuries caused by vaccines. Total compensation paid since the program began is approximately $3.2 billion [33]. Since only about one percent of serious vaccine injuries are officially reported [34], the true extent and cost of vaccine-associated damage on a population basis is likely to be much higher.

A complicating factor in evaluating the vaccination program is that individual vaccines against infectious diseases have nonspecific effects on morbidity and mortality that extend beyond prevention of the targeted disease. In some instances these effects are beneficial; in others they increase morbidity and mortality [35]. For instance, the measles and Bacille Calmette- Guérin (BCG) vaccines reportedly reduce overall morbidity and mortality [36], whereas the diphtheria-tetanus-pertussis [37] and the hepatitis B vaccines [38] are associated with increased morbidity and mortality risks. These nonspecific effects are consistently reported in studies carried out in low-income countries but require replication in higher-income populations.

Exploring the association between preterm birth, vaccination and neurodevelopmental disorders

While the safety of vaccines is officially assured, observational studies have involved only a limited number of vaccines and vaccine ingredients, and none has reported on the long-term outcomes of the present vaccination schedule [39], which has been expanded and accelerated in recent decades [40]. The current childhood vaccination program now includes 48 doses of vaccines for 14 diseases from birth to age 6 years compared to 3 vaccinations for 7 diseases in the 1970s [41]. Given the many unknowns related to the long-term effects of vaccines and their ingredients, the U.S. Institute of Medicine has recommended that studies be carried out to compare health outcomes in vaccinated and unvaccinated groups of children and to determine the cumulative effects of vaccines [12].

A difficulty in comparing vaccinated and unvaccinated children has been the apparent absence of a readily available pool of unvaccinated children. The growing population of homeschool children (i.e., children educated at home) is a suitable source for such studies, as vaccination rates are lower in homeschool children [42]. Homeschool families and children are approximately representative of US families and children in general, with an approximately equal median income to that of married-couple families nationwide, somewhat more years of formal education than parents in the general population, and a higher average family size of just over three children compared to the national average of just over two children [43-45]. Geographically, homeschooling families are slightly overrepresented in the south; children from all racial/ethnic backgrounds are involved in homeschooling; about 23% are nonwhite; and the age distribution of homeschool children in grades K-12 (ages 6 to 18) is similar to that of children nationwide [46]. About 3.4% (1.8 million) of the school-age population was homeschooled in the 2011-2012 school year [47].

An opportunity to address the question of the possible role of vaccination in NDD associated with preterm birth arose from the availability of data from a cross-sectional pilot study of the birth histories and health outcomes of vaccinated and unvaccinated homeschool children ages 6 to 12, carried out by the authors [48]. The first aim of the study was to compare vaccinated and unvaccinated children on a broad range of health outcomes, based on mothers’ reports in an anonymous online survey. The collected data included physician-diagnosed acute and chronic illnesses, medications and the use of health services, as well as pregnancy experiences and birth histories. The second aim of the study was to determine whether an association found between vaccination and NDD, if any, remained significant after controlling for other measured factors.

This report presents additional findings on the independent association and/or interaction between preterm birth, vaccination and NDD…..

 

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Study design

The study was cross-sectional in design, aimed at determining the association between vaccination and health outcomes, and was based on a survey of homeschooling mothers on the overall health of their vaccinated and unvaccinated biological children. Contact information on homeschool families was unavailable. Hence, there was no defined population or sampling frame from which a randomized study could be carried out and response rates could be determined. However, the goal of the pilot study was rather to obtain a convenience sample of unvaccinated children of sufficient size to test for significant differences in outcomes between the groups.

We proceeded by selecting 4 states (Florida, Louisiana, Mississippi, and Oregon) for the survey (Stage 1). NHERI compiled a list of statewide and local homeschool organizations, totaling 84 in Florida, 18 in Louisiana, 12 in Mississippi and 17 in Oregon. Initial contacts were made in June 2012. NHERI sent emails to the leaders of each statewide organization requesting their support for the study; this was followed by a second email, explaining the study purpose and background, which the leaders were asked to forward to their members (Stage 2). Prospective respondents were provided with a link to the questionnaire. With funding limited to a one-year study period, we sought to obtain as many responses as possible, contacting families only indirectly through homeschool organizations. This is considered a pilot study for a future national study of homeschool children.

Biological mothers of homeschool children ages 6-12 years were asked to serve as respondents in order to standardize data collection. They were asked to confirm their consent to participate, to indicate their home state and zip code of residence, and to confirm that they had biological children ages 6 to 12. This age-range was selected because children have completed most of their vaccinations by then, and would have been diagnosed with the common diseases of childhood if they were to develop them. The communications company Qualtrics (http://qualtrics.com) hosted the survey website. Mothers were asked to use their children’s vaccination records to complete the online survey and to check off items from a list that pertained to them and their child or children, including pregnancy-related conditions and medications used, birth histories (including preterm birth—yes or no), vaccinations, physician-diagnosed illnesses, medications used by the child, and the use of health services. Vaccination was defined as receipt of one or more of the recommended vaccines. NDD, a derived outcome measure, was defined as a diagnosis of one or more of the following: Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), and a learning disability. Only closed-ended questions were used. The data were analyzed using SAS (Version 9.3) to determine the strength of associations between vaccination and health outcomes in terms of odds ratios (OR) and 95% Confidence Intervals (CI). Odds ratios describe the strength of the association between two categorical variables measured simultaneously and are appropriate measures of that relationship in a cross-sectional study [49]…..

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Conclusions

This study compared the birth histories and health outcomes of vaccinated and unvaccinated children and sought to determine the association, if any, between vaccination, preterm birth and neurodevelopmental disorders (NDD). Vaccination (i.e., receipt of one of more of the recommended vaccines) was significantly associated with NDD, while preterm birth without vaccination was not. Preterm birth coupled with vaccination, however, was associated with a synergistic increase in the odds of NDD, suggesting the possibility that vaccination could precipitate adverse neurodevelopmental outcomes in preterm infants. These results provide clues to the epidemiology and causation of NDD but question the safety of current vaccination programs for preterm infants. Further research is needed to validate and investigate these findings in order to optimize the impact of vaccines on children’s health.

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