Maternal Gestational Tdap Vaccination and Autism: A Critique of Becerra-Culqui et al. (2018)

Authors

  • James Lyons-Weiler The Institute for Pure and Applied Knowledge (Michigan Office), St. Clair Shores, MI 48080
  • Alison Fujito The Institute for Pure and Applied Knowledge (Michigan Office), St. Clair Shores, MI 48080
  • Bernadette Pajer Informed Choice Washington, DC

DOI:

https://doi.org/10.56098/ijvtpr.v2i1.39

Keywords:

acellular pertussis vaccine, Advisory Committee on Immunization Practices (ACIP), California Department of Developmental Services (CDDS), diphtheria vaccine, maternal immune activation (MIA), Tdap vaccine, tetanus vaccine, vaccine efficacy (E), vaccine injury (VI), vaccine negative efficacy (NE), vaccine utility (U)

Abstract

We report flaws and inconsistencies in a critically important study of autism risk following maternal Tdap vaccination. The authors of the 2018 study, Prenatal Tetanus, Diphtheria, Acellular Pertussis Vaccination and Autism Spectrum Disorder (BC18), concluded that Tdap gestational vaccination is not associated with increased autism risk and claimed to provide “evidence supporting the ACIP’s recommendation to vaccinate pregnant women”. Our observations, based on information from the study itself, challenge these conclusions. We find evidence of a peculiar study design and approach to data analysis forcing outcomes by arbitrary data adjustments, overlooked variables of importance such as Bordetella pertussis infection prevalence and vaccine injury rates, insufficient consideration of likely interactions between multiple historical medical challenges by vaccines and other interventions on their participants, exclusion from the study individuals likely at risk of vaccine intolerance due to genetics, and indications that the study samples were not representative of the general population. Their first-year data show a concerning spike in ASD rates, and their findings and conclusions did not hold up to real-world data, which currently reports 3.8% ASD rate in California. Our observations, based on information from the study itself, challenge the conclusions of Becerra-Culqui et al, 2018.

References

Aveyard, P., Bellgrove, M., Bertamini, M., Bestmann, S., Bishop, D., Brembs, B., & Wolfe, J. (2013). Trust in science would be improved by study pre-registration. Strona Internetowa: http://www. Theguardian. Com/Science/Blog/2013/Jun/05/Trust-in-Science-Study-Pre-Registration.

Baxter, R., Bartlett, J., Fireman, B., Lewis, E., & Klein, N. P. (2017). Effectiveness of vaccination during pregnancy to prevent infant pertussis. Pediatrics, 139(5). https://www.publications.aap.org/pediatrics/article-split/139/5/e20164091/38778/Effectiveness-of-Vaccination-During-Pregnancy-to

Becerra, T. A., Massolo, M. L., Yau, V. M., Owen-Smith, A. A., Lynch, F. L., Crawford, P. M., Pearson, K. A., Pomichowski, M. E., Quinn, V. P., Yoshida, C. K., & Croen, L. A. (2017). A Survey of Parents with Children on the Autism Spectrum: Experience with Services and Treatments. The Permanente Journal, 21, 16–009. https://doi.org/10.7812/TPP/16-009

Becerra, T. A., Wilhelm, M., Olsen, J., Cockburn, M., & Ritz, B. (2013). Ambient Air Pollution and Autism in Los Angeles County, California. Environmental Health Perspectives, 121(3), 380–386. https://doi.org/10.1289/ehp.1205827

Becerra-Culqui, T. A., Getahun, D., Chiu, V., Sy, L. S., & Tseng, H. F. (2018). Prenatal tetanus, diphtheria, acellular pertussis vaccination and autism spectrum disorder. Pediatrics, 142(3). https://www.publications.aap.org/pediatrics/article-split/142/3/e20180120/81652/Prenatal-Tetanus-Diphtheria-Acellular-Pertussis

Becerra-Culqui, T. A., Getahun, D., Chiu, V., Sy, L. S., & Tseng, H. F. (2020). Prenatal tetanus, diphtheria, acellular pertussis vaccination and attention deficit hyperactivity disorder. American Journal of Epidemiology. https://academic.oup.com/aje/article-pdf/doi/10.1093/aje/kwaa074/34304895/kwaa074.pdf

Braunschweig, D., Krakowiak, P., Duncanson, P., Boyce, R., Hansen, R. L., Ashwood, P., Hertz-Picciotto, I., Pessah, I. N., & Van de Water, J. (2013). Autism-specific maternal autoantibodies recognize critical proteins in developing brain. Translational Psychiatry, 3(7), e277–e277. https://www.nature.com/articles/tp201350

Brown, A. S., Sourander, A., Hinkka-Yli-Salomäki, S., McKeague, I. W., Sundvall, J., & Surcel, H.-M. (2014). Elevated maternal C-reactive protein and autism in a national birth cohort. Molecular Psychiatry, 19(2), 259–264. https://www.nature.com/articles/mp2012197

Busnelli, A., Paffoni, A., Fedele, L., & Somigliana, E. (2016). The impact of thyroid autoimmunity on IVF/ICSI outcome: A systematic review and meta-analysis. Human Reproduction Update, 22(6), 775–790. https://academic.oup.com/humupd/article-abstract/22/6/775/2420584

CDC. (2022, March 2). Data and Statistics on Autism Spectrum Disorder | CDC. Centers for Disease Control and Prevention. https://www.cdc.gov/ncbddd/autism/data.html

CDC, 2021 Autism Prevalence Higher in CDC’s ADDM Network https://www.cdc.gov/media/releases/2021/p1202-autism.html

Chambers, C., & Munafo, M. (2013). Trust in science would be improved by study pre-registration. The Guardian, 5.

Cherry, J. D. (2015). Epidemic pertussis and acellular pertussis vaccine failure in the 21st century. Pediatrics, 135(6), 1130–1132. https://www.publications.aap.org/pediatrics/article-split/135/6/1130/75787/Epidemic-Pertussis-and-Acellular-Pertussis-Vaccine

Christian, L. M., Iams, J. D., Porter, K., & Glaser, R. (2011). Inflammatory responses to trivalent influenza virus vaccine among pregnant women. Vaccine, 29(48), 8982–8987. https://www.sciencedirect.com/science/article/pii/S0264410X11014459

Dal-Ré, R., Caplan, A. L., & Marusic, A. (2019). Editors’ and authors’ individual conflicts of interest disclosure and journal transparency. A cross-sectional study of high-impact medical specialty journals. BMJ Open, 9(7), e029796. https://doi.org/10.1136/bmjopen-2019-029796

Delong, G. (2021a). Receipt of HPV vaccine associated with increased prevalence of high-risk HPV infections. International Journal of Vaccine Theory, Practice, and Research, 2(1), 81–92. https://ijvtpr.com/index.php/IJVTPR/article/view/28

Delong, G. (2021b). Lowered female fertility associated with human papilloma virus vaccines. International Journal of Vaccine Theory, Practice, and Research, 2(1), 125–148. https://ijvtpr.com/index.php/IJVTPR/article/view/31

DeStefano F., Price C.S., Weintraub E.S. (2013) Increasing exposure to antibody-stimulating proteins and polysaccharides in vaccines is not associated with risk of autism. J Pediatr. 163(2):561-7.

Eaton, A., Lewis, N., Fireman, B., Hansen, J., Baxter, R., Gee, J., & Klein, N. P. (2018). Birth outcomes following immunization of pregnant women with pandemic H1N1 influenza vaccine 2009–2010. Vaccine, 36(19), 2733–2739. https://doi.org/10.1016/j.vaccine.2017.08.080

Edlich, R. F., Olson, D. M., Olson, B. M., Greene, J. A., Gubler, K. D., Winters, K. L., Kelley, A. R., Britt, L. D., & Long, W. B. (2007). Update on the National Vaccine Injury Compensation Program. Journal of Emergency Medicine, 33(2), 199–211. https://doi.org/10.1016/j.jemermed.2007.01.001

Estes, M. L., & McAllister, A. K. (2016). Maternal immune activation: Implications for neuropsychiatric disorders. Science, 353(6301), 772–777. https://www.science.org/doi/abs/10.1126/science.aag3194

Fine, P. E. (1997). Adult pertussis: A salesman’s dream—and an epidemiologist’s nightmare. Biologicals, 25(2), 195–198. https://www.sciencedirect.com/science/article/pii/S104510569790083X

Fox, E., Amaral, D., & Van de Water, J. (2012). Maternal and fetal antibrain antibodies in development and disease. Developmental Neurobiology, 72(10), 1327–1334. https://onlinelibrary.wiley.com/doi/abs/10.1002/dneu.22052

Gallagher, C. M., & Goodman, M. S. (2010). Hepatitis B Vaccination of Male Neonates and Autism Diagnosis, NHIS 1997–2002. Journal of Toxicology and Environmental Health, Part A, 73(24), 1665–1677. https://doi.org/10.1080/15287394.2010.519317

Glanz, J. M., Newcomer, S. R., Jackson, M. L., Omer, S. B., Bednarczyk, R. A., Shoup, J. A., DeStefano, F., Daley, M. F., Goddard, K., & Panneton, M. (2016). White Paper on studying the safety of the childhood immunization schedule in the Vaccine Safety Datalink. Vaccine, 34, A1–A29. https://www.sciencedirect.com/science/article/pii/S0264410X1501525X

Haley, B. E. (2005). Mercury toxicity: Genetic susceptibility and synergistic effects. Medical Veritas, 2, 535–542. https://doi.org/10.1588/medver.2005.02.0006

Institute of Medicine & Committee to Review Adverse Effects of Vaccines. (2011). Adverse Effects of Vaccines: Evidence and Causality (K. Stratton, A. Ford, E. Rusch, & E. W. Clayton, Eds.). National Academies Press (US). http://www.ncbi.nlm.nih.gov/books/NBK190024/

Ioannidis, J. P. A. (2005). Why most published research findings are false. PLoS Med, 2(8), e124. https://doi.org/10.1371/journal.pmed.0020124

Ioannidis, J. P. A. (2007). Molecular evidence-based medicine.: Evolution and integration of information in the genomic era. European Journal of Clinical Investigation, 37(5), 340–349. https://doi.org/10.1111/j.1365-2362.2007.01794.x

Ioannidis, J. P. A. (2016). The mass production of redundant, misleading, and conflicted systematic reviews and meta-analyses. Milbank Quarterly, 94(3), 485–514. https://doi.org/10.1111/1468-0009.12210

Kataoka, M., Ochiai, M., Yamamoto, A., & Horiuchi, Y. (2012). A need for careful evaluation of endotoxin contents in acellular pertussis-based combination vaccines. Biologicals, 40(1), 49–54. https://www.sciencedirect.com/science/article/pii/S1045105611001977

Kay, A. W., Fukuyama, J., Aziz, N., Dekker, C. L., Mackey, S., Swan, G. E., Davis, M. M., Holmes, S., & Blish, C. A. (2014). Enhanced natural killer-cell and T-cell responses to influenza A virus during pregnancy. Proceedings of the National Academy of Sciences, 111(40), 14506–14511. https://www.pnas.org/content/111/40/14506.short

Kennedy, D., Seneff, S., Davidson, R. M., Oller, J. W., Haley, B. E., & Masters, R. D. (2016). Environmental toxicants and infant mortality in America. Peertechz Journal of Biological Research and Development, 1(1), 36–61. https://www.peertechzpublications.com/articles/OJBS-1-105.php

Lingam, R., Simmons, A., Andrews, N., Miller, E., Stowe, J., & Taylor, B. (2003). Prevalence of autism and parentally reported triggers in a northeast London population. Archives of Disease in Childhood, 88(8), 666–670. https://adc.bmj.com/content/88/8/666.abstract

Liu, J. J., Bell, C. M., Matelski, J. J., Detsky, A. S., & Cram, P. (2017). Payments by US pharmaceutical and medical device manufacturers to US medical journal editors: Retrospective observational study. BMJ, 359, j4619. https://doi.org/10.1136/bmj.j4619

Lombardo, M. V., Moon, H. M., Su, J., Palmer, T. D., Courchesne, E., & Pramparo, T. (2018). Maternal immune activation dysregulation of the fetal brain transcriptome and relevance to the pathophysiology of autism spectrum disorder. Molecular Psychiatry, 23(4), 1001–1013. https://www.nature.com/articles/mp201715

Lyons-Weiler, J 2018. Autism is an Acquired Cellular Detoxification Syndrome with Genetic Heterogeneity. Autism Open Access 8(1):1-15. https://www.longdom.org/abstract/autism-is-an-acquired-cellular-detoxification-deficiency-syndrome-with-heterogeneous-genetic-predisposition-36965.html

Mawson, A. R., Bhuiyan, A. R., Jacob, B., & Ray, B. D. (2017). Preterm birth, vaccination and neurodevelopmental disorders: A cross-sectional study of 6- to 12-year-old vaccinated and unvaccinated children. Journal of Translational Science, 3(3). https://doi.org/10.15761/JTS.1000187

Mawson, A. R., Ray, B. D., Bhuiyan, A. R., & Jacob, B. (2017). Pilot comparative study on the health of vaccinated and unvaccinated 6- to 12-year-old U.S. children. Journal of Translational Science, 3(3). https://doi.org/10.15761/JTS.1000186

Miller, N. Z., & Goldman, G. S. (2011). Infant mortality rates regressed against number of vaccine doses routinely given: Is there a biochemical or synergistic toxicity. Human & Experimental Toxicology, 30(9), 1420–1428. https://doi.org/10.1177/0960327111407644

Mumper, E. (2013). Can awareness of medical pathophysiology in autism lead to primary care autism prevention strategies? North American Journal of Medicine and Science, 6(3). http://www.najms.com/index.php/najms/article/view/191

Munafò, M. R., Nosek, B. A., Bishop, D. V., Button, K. S., Chambers, C. D., Percie du Sert, N., Simonsohn, U., Wagenmakers, E.-J., Ware, J. J., & Ioannidis, J. (2017). A manifesto for reproducible science. Nature Human Behaviour, 1(1), 1–9.

Nevison, C., Blaxill, M., & Zahorodny, W. (2018). California autism prevalence trends from 1931 to 2014 and comparison to national ASD data from IDEA and ADDM. Journal of Autism and Developmental Disorders, 48(12), 4103–4117. https://link.springer.com/article/10.1007/s10803-018-3670-2

Niforatos, J. D., Narang, J., & Trueger, N. S. (2020). Financial Conflicts of Interest Among Emergency Medicine Journals’ Editorial Boards. Annals of Emergency Medicine, 75(3), 418–422. https://doi.org/10.1016/j.annemergmed.2019.02.020

Oller, J. W. (2020). Human Anatomy and Physiology: An Introduction for Undergraduate Students of Speech-Language Pathology and Audiology (2nd ed.). Sentia Publishing. https://www.sentiapublishing.com/health-sciences/human-anatomy-and-physiology-for-speech-language-pathologists-and-audiologists-3rd-edition-oller-online-textbook/

Ozonoff, S., Young, G. S., Landa, R. J., Brian, J., Bryson, S., Charman, T., Chawarska, K., Macari, S. L., Messinger, D., & Stone, W. L. (2015). Diagnostic stability in young children at risk for autism spectrum disorder: A baby siblings research consortium study. Journal of Child Psychology and Psychiatry, 56(9), 988–998. https://acamh.onlinelibrary.wiley.com/doi/abs/10.1111/jcpp.12421

Piras, I. S., Haapanen, L., Napolioni, V., Sacco, R., Van de Water, J., & Persico, A. M. (2014). Anti-brain antibodies are associated with more severe cognitive and behavioral profiles in Italian children with Autism Spectrum Disorder. Brain, Behavior, and Immunity, 38, 91–99. https://www.sciencedirect.com/science/article/pii/S0889159113006053

Seneff, S., Swanson, N., & Li, C. (2015). Aluminum and glyphosate can synergistically induce pineal gland pathology: Connection to gut dysbiosis and neurological disease. Agricultural Sciences, 06(01), 42–70. https://doi.org/10.4236/as.2015.61005

Shakib, J. H., Korgenski, K., Presson, A. P., Sheng, X., Varner, M. W., Pavia, A. T., & Byington, C. L. (2016). Influenza in infants born to women vaccinated during pregnancy. Pediatrics, 137(6). https://www.publications.aap.org/pediatrics/article-split/137/6/e20152360/52373/Influenza-in-Infants-Born-to-Women-Vaccinated

Shaw, C. A. (2020). Weaponizing the Peer Review System. International Journal of Vaccine Theory, Practice, and Research, 1(1), 11–26. https://ijvtpr.com/index.php/IJVTPR/article/view/1

Shrank, W. H., Patrick, A. R., & Alan Brookhart, M. (2011). Healthy user and related biases in observational studies of preventive interventions: A primer for physicians. Journal of General Internal Medicine, 26(5), 546–550. https://link.springer.com/article/10.1007/s11606-010-1609-1

Tomljenovic, L., & Shaw, C. A. (2011). Do aluminum vaccine adjuvants contribute to the rising prevalence of autism? Journal of Inorganic Biochemistry, 105(11), 1489–1499. https://doi.org/10.1016/j.jinorgbio.2011.08.008

Warfel, J. M., Zimmerman, L. I., & Merkel, T. J. (2014). Acellular pertussis vaccines protect against disease but fail to prevent infection and transmission in a nonhuman primate model. Proceedings of the National Academy of Sciences, 111(2), 787–792. https://www.pnas.org/content/111/2/787.short

Wong, V. S. S., Avalos, L. N., & Callaham, M. L. (2017). Industry payments to physician journal editors (e3359v1). PeerJ Inc. https://doi.org/10.7287/peerj.preprints.3359v1

Zimmerman, A. W., Connors, S. L., Matteson, K. J., Lee, L.-C., Singer, H. S., Castaneda, J. A., & Pearce, D. A. (2007). Maternal antibrain antibodies in autism. Brain, Behavior, and Immunity, 21(3), 351–357. https://www.sciencedirect.com/science/article/pii/S0889159106002947

Downloads

Published

2022-04-27

How to Cite

Maternal Gestational Tdap Vaccination and Autism: A Critique of Becerra-Culqui et al. (2018). (2022). International Journal of Vaccine Theory, Practice, and Research , 2(1), 287-300. https://doi.org/10.56098/ijvtpr.v2i1.39

Similar Articles

11-20 of 59

You may also start an advanced similarity search for this article.