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Who is at Highest Risk for Complications from Pertussis Vaccine?


vaccine complications

There is a gap in medical knowledge in terms of doctors being able to predict who will have an adverse reaction to pertussis vaccination, and who will not.

Since 1982, the co-founders of NVIC have been concerned about the lack of scientific studies investigating the biological mechanisms and high risk factors for pertussis vaccine, which has long been associated with reports of injury and death in more than 70 years of medical literature. Acknowledgement of biodiversity and genetic variation between individuals argues for a national scientific research agenda, which responsibly examines the biological factors that predispose some individuals to responding adversely to vaccination, including pertussis vaccination, and suffering brain and immune system damage or death.

In 1946, Werne and Garrow reported the deaths of identical twins within 24 hours of their second diphtheria-pertussis shot. The same outcome in identical twins following receipt of a pertussis vaccine-containing vaccine suggested genetic predisposition. The possibility of genetic predisposition to adverse responses to vaccination has been cited in the scientific literature. Additionally, there have been reports of two, three and four children in the same family, who have experienced serious reactions to pertussis-containing vaccines and suffered permanent brain damage.1

Following is a list of potential high risk factors for pertussis vaccine reactions, which are not acknowledged by public health officials, vaccine manufacturers or medical organizations, but which deserve serious scientific investigation.

Family History of Convulsions or Neurological Disease For most of the time that pertussis vaccine has been used, a personal history of convulsions or neurological disease has been listed as an absolute contraindication or serious precaution. In the past, some European countries have exercised caution and contraindicated pertussis vaccination if a member of the child’s immediate family (brother, sister, mother or father) has a history of convulsions or neurological disease. In 1985, CDC officials reported that children who experienced a neurological problem after DPT vaccination had a 7 times greater risk if they had a personal history of convulsions and a 4.5 times greater risk if they had a family history of convulsions. 2

The product information circular accompanying DPT vaccine manufactured by Lederle Laboratories in 1985 stated, "Routine immunization with this product should not be attempted if the child has a personal or family history of central nervous system disease or convulsions."

The product information circular accompanying DPT vaccine manufactured by Connaught Laboratories in 1989 stated, "Use of this product is also contraindicated if the child has a personal or family history of a seizure disorder.”

In 1975, a World Health Organization-sponsored international meeting of pertussis vaccine experts recommended that "children from families with a history of neurological disorders should not be vaccinated." 3

In 1977, the Department of Health and Social Security in England stated that children should not be given pertussis vaccine if they have a "family history of epilepsy or other diseases of the central nervous system.” 4

In a 1987 recommendation published in the Morbidity and Mortality Weekly Report, the CDC stated "recent studies suggest that infants and children with a history of convulsions in the first degree family members (i.e. siblings and parents have a 3.2 fold increase risk for neurologic events compared with those without such histories (CDC, unpublished data)."5 The CDC went on to recommend, however, that these children should still receive pertussis vaccine.6

Premature Birth or Low Birth Weight – Babies who are born prematurely may have neurological, respiratory, and immunological systems that are not as fully developed as those who are full-term. Premature and low weight babies are at high risk for dying from pertussis whooping cough disease but may also be at higher risk for adverse responses to pertussis vaccination.

A 2006 study of preterm infants (defined as newborns born before or at 32 weeks gestation) found an increase in adverse cardiorespiratory events such as desaturations, bradycardia, and apnea in the first 72 hours following the first dose of a combination Diphtheria, tetanus, pertussis, inactivated polio and HIB vaccine. The risk was determined to be similar for acellular pertussis vaccine versus whole cell pertussis vaccine.  Lower current weight was found to be a risk for adverse events and the study suggested that vaccination should occur at least 72 hours prior to discharge from the hospital. 7

A 2012 Dutch study found that nearly 25 percent of preterm infants born before 33 weeks gestation experiences bradycardia or a slight decrease in oxygen saturation following vaccination at 2 months. 7 percent, however, experienced a moderate cardiorespiratory event requiring stimulation. The study found that younger and lower birth weight infants experienced higher adverse events following vaccination.8

Several pertussis containing vaccines on the market today, list apnea as a reported adverse event and also advise caution when vaccinating premature babies with some pertussis containing vaccines.9

Cerebral Irritation in the Neonatal Period – Newborn babies can exhibit cerebral irritation following birth, including high pitched screaming (encephalitic cry) with arching of the back, depressed consciousness and other neurological signs. A difficult labor and birth can cause cerebral irritation as can inflammation of the brain from meningitis or other infection. An infant with symptoms of cerebral irritation after birth may be manifesting evidence of a weakened or damaged neurological system that may be especially vulnerable to the inflammatory effects of the pertussis vaccine.10

In years past, the British department of Health and Social Security stated that pertussis vaccination "should not be carried out in children who have … a history of cerebral irritation or damage in the neonatal period."

A Personal or Family History of Severe Allergies and Autoimmune Disorders – A healthy, mature immune system requires an equal balance of cellular (Th1 - innate) and humoral (Th2 - learned) immune system responses to prevent inflammatory responses from remaining unresolved and causing chronic illness. A disruption in immune function can lead to chronic inflammation and development of allergy or autoimmune disorders.11

Vaccination does not exactly mimic the natural infection process and often bypasses cellular immunity in favor of humoral immunity (measured by antibodies in the blood). There have been persistent reports that some individuals may be at risk for developing autoimmune disorders after vaccination.12

In more than 70 years of scientific literature reporting complications of pertussis vaccine, there have been reports by some researchers that a history of severe allergies or autoimmune disorders in a child or his family (eczema, asthma, hay fever, milk allergy) may predispose a child to reacting to the pertussis vaccine. In England in past decades, a personal or family history of allergies was considered a contraindication.

Dow Chemical Company’s DPT product insert in the 1960s stated "fractional doses are recommended in infants with cerebral injury, asthma, a strong family history of allergy …"

In 1961, Hopper found that in a group of babies who reacted strongly to the pertussis vaccine, there was twice as much eczema, asthma, hay fever, and allergic skin rashes in the child, his brothers and sisters, parents, and grandparents as there was in a control group of the same size. 13

In 1969, Hannik found a positive family history of allergies in a significant proportion of infants who reacted with high-pitched screaming, shock and convulsions.14

In 2000, a study comparing the health of vaccinated and unvaccinated children between 1988 and 1994 found that a child who received DPT or tetanus vaccination was 50 percent more likely to experience severe allergic reactions, more than 80 percent more likely to experience sinusitis, and twice as likely to experience asthma as those who were not vaccinated. The conclusion of the authors was that “asthma and other allergic hypersensitivity reactions and related symptoms may be causes, in part, by the delayed effects of DTP or tetanus vaccination.” 15

A healthy, mature immune system requires an equal balance of cellular (innate) and humoral (learned) immune system responses so that inflammatory responses do not remain unresolved and cause chronic illness. A disruption in immune function can lead to development of allergy and autoimmune disorders. Vaccination does not exactly mimic the natural infection process and often bypasses cellular immunity in favor of humoral immunity. There have been persistent reports of development of autoimmune disorders and allergy after vaccination, including pertussis vaccination. 16

Milk Allergy (Casein Intolerance) – Studies have identified genetic susceptibility to pertussis vaccine induces encephalopathy involving genes of the major histocompatibility complex correlating to genetic regulation of antibody responses to bovine serum albumin (a cow’s milk protein). 17

A personal or family history of allergies, particularly milk (casein) allergy, may be one high risk factor for reacting to pertussis vaccine. There were many cases of pertussis vaccine injury documented in the 1985 book DPT: A Shot in the Dark 18 of children, who had milk allergy before or developed milk allergy after suffering a serious DPT vaccine reaction. Casein is a protein in milk and symptoms of milk allergy include frequent spitting up of milk after bottle or breast feeding; projectile vomiting of milk; frequent diarrhea; constipation; gas and abdominal pain; persistent crying after feedings (colic); eczema or recurrent skin rashes.19

Is Tdap vaccine safe during pregnancy?

For many years, pregnancy was also a contraindication to pertussis vaccine but, today, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control (CDC) recommends pertussis vaccine for all pregnant women. Currently, the ACIP recommends that pregnant women receive a dose of Tdap vaccine between 27 and 36 weeks gestation, during each pregnancy, regardless of a previous history of Tdap vaccine.20 However both Tdap vaccines are FDA approved to be administered as a single dose, and the CDC’s recommendation that every pregnant woman receive a Tdap vaccination during every pregnancy - regardless of whether a woman has already received a dose of Tdap- is an off-label use of the vaccine.21

Drug companies did not test the safety and effectiveness of giving Tdap vaccine to pregnant women before the vaccines were licensed in the U.S.22 23 and there is almost no data on inflammatory or other biological responses to these vaccines that could affect pregnancy and birth outcomes.24 In fact, product inserts for both Adacel and Boostrix, the two available Tdap vaccines for children and adults, including pregnant women, both state that safety and effectiveness have not been established in pregnant women.25 26

Adacel vaccine is considered a Pregnancy Category C biological. According to the U.S. Department of Health and Human Services, Category C biologicals are products where ” Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.” 27 No animal reproduction studies have been completed on Adacel and it is unknown if this vaccine can cause fetal harm or impair reproduction.28 Sanofi Pasteur, the manufacturer of Adacel, warns that this vaccine should “be given to a pregnant woman only if clearly needed.”29

Boostrix vaccine is considered a Pregnancy Category B biological. According to the U.S. Department of Health and Human Services, Category B biologicals are products where “Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.”30 Toxicity studies performed on female rats found no evidence of fetal harm, however, no well-controlled and adequate studies have been completed on pregnant women.31 GlaxoSmithKline, the manufacturer of Boostrix, also warns that this vaccine should “be given to a pregnant woman only if clearly needed.”32

There are ingredients in the pertussis containing Tdap vaccines that have not been fully evaluated for potential genotoxic33 or other adverse effects on the human fetus developing in the womb that may negatively affect health after birth, including aluminum adjuvants and many more bioactive and potentially toxic ingredients.34 35 36 37 38 39 40 41 42 As well, there are no published biological mechanism studies that assess pre-vaccination health status and measure changes in brain and immune function and chromosomal integrity after vaccination of pregnant women or their babies developing in the womb.43

Since licensure of Tdap vaccines in the U.S., there have been no well-designed prospective case controlled studies comparing the health outcomes of large groups of women who get pertussis containing Tdap vaccines during pregnancy either separately or simultaneously with influenza vaccine, compared to those who do not get the vaccines, and no similar health outcome comparisons of their newborns at birth or in the first year of life have been conducted. Safety and effectiveness evaluations that have been conducted are either small,44 or have been performed by drug company or government health officials using unpublished data.45

A 2017 review of 15 published articles, including 2 randomized controlled trials and 13 observational studies determined that while vaccination boosted maternal antibodies, evidence was lacking on whether or not this had any impact on reducing the incidence of pertussis, serious complications from pertussis, or death in infants.46

Vaccine manufacturers, doctors, and other vaccine providers are shielded from vaccine injury lawsuits47, however, it is unclear whether injuries sustained by an unborn child in the womb will qualify for federal vaccine injury compensation.48 The Health Resources & Services Administration (HRSA) is seeking public comment until October 1st pertaining to “Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table.”49

IMPORTANT NOTE: NVIC encourages you to become fully informed about Pertussis and the Pertussis vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

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References

1 Werne J, Garrow I. Fatal anaphylactic shock occurrence in identical twins following second injection of diptheria toxoid and pertussis antigen. JAMA 1946 131(9): 730-35.

2  Stetler HC, Orenstein WA et al. History of convulsions and use of pertussis vaccine. J Pediatr 1985; 107(2): 175-179.

3 Coulter HL, Fisher BL. DPT: A Shot in the Dark. Harcourt Brace Jovanovich, 1985; Warner, 1986; Avery 1991; Penguin Books

4 IBID

5 CDC Recommendation of the Immunization Practices Advisory Committee Pertussis Immunization; Family History of Convulsions and Use of Antipyretics -- Supplementary ACIP Statement. MMWR. May 15, 1987 36(18);281-2

6 Ibid

7 Lee J, Robinson JL, Spady DW Frequency of apnea, bradycardia and desaturations following first diphtheria-tetanus-pertussis-inactivated polio-Haemophilus influenza type B immunization in hospitalized preterm infants. BMC Pediatr. 2006 Jun 19;6:20.

8 Buijs SC, Boersma B. Cardiorespiratory events after first immunization in premature infants: a prospective cohort study. Ned Tijdschr Geneeskd. 2012;156(3):A3797.

9 FDA Vaccines Licensed for Use in the United States. Mar. 29. 2018

10 Coulter HL, Fisher BL. DPT: A Shot in the Dark. Harcourt Brace Jovanovich, 1985; Warner, 1986; Avery 1991; Penguin Books

11 Romagnani S. Human TH1 and TH2 subsets: regulation of differentiation and role in protection and immunopathology. Int Arch Allergy Immunol. 1992;98(4):279-85.

12 Rook GA, Zumla A. Gulf War syndrome: is it due to a systemic shift in cytokine balance towards a Th2 profile? Lancet. 1997 Jun 21;349(9068):1831-3.

13 Hopper, J.M. Illness after whooping cough vaccination. Medical Officer 1961. (October 20), 241-44

14 Hanik, C.A. Major reactions after DPT-polio vaccination in the Netherlands. International Symposium of Pertussis, Bilthoven. Symposium Series on Immunobiological Standardization. 1969.  13 161-70: Basel, Mughen, New York: Karger.

15 Hurwitz EL, Morgenstern H Effects of diphtheria-tetanus-pertussis or tetanus vaccination on allergies and allergy-related respiratory symptoms among children and adolescents in the United States. J Manipulative Physiol Ther. 2000 Feb;23(2):81-90.

16 Fisher BL. In the Wake of Vaccines. A Special Report for Mothering Magazine. Issue 126, September/October 2004

17 L Steinman, A Weiss, N Adelman et al. Pertussis toxin is required for pertussis vaccine encephalopathy. Proc Natl Acad Sci U S A. 1985 Dec; 82(24): 8733–8736.

18 Coulter HL, Fisher BL. DPT: A Shot in the Dark. Harcourt Brace Jovanovich, 1985; Warner, 1986; Avery 1991; Penguin Books

19 WebMD Casein Allergy Overview. Jun. 17, 2018

20 CDC Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Apr. 27, 2018 / 67(2);1–44

21 Infectious Diseases in Children. ACIP recommends Tdap vaccine during each pregnancyHealio.com November 2012. 

22 Gruber MF. Maternal Immunization: US FDA Regulatory Considerations (Abstract). Vaccine 2003; 21(24): 3487-3491.

23 CDC. Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) in Pregnant Women and Persons Who Have or Anticipate Having Close Contact with an Infant Aged Under 12 Months – ACIP, 2011. Safety of Tdap Vaccine In Pregnant Women. MMWR Oct. 21, 2011; 60(41): 1424-1426.

24 Christian LM, Iams JD, et al. Inflammatory Responses to Trivalent Influenza Virus Vaccine Among Pregnant Women. Vaccine 2011; 29(48): 8982-8987.

25 FDA Adacel Vaccine Product Insert. Sep. 29, 2017

26 FDA Boostrix Vaccine Product Insert. Apr. 26, 2016

27 U.S. Dept. of Health & Human Services. FDA Pregnancy Categories. Sept. 29, 2017

28 FDA Adacel Vaccine Product Insert. Sep. 29, 2017

29 Ibid

30 U.S. Dept. of Health & Human Services. FDA Pregnancy Categories. Sept. 29, 2017

31 FDA Boostrix Vaccine Product Insert. Apr. 26, 2016

32 Ibid

33 Schmidt CW.Uncertain Inheritance: Transgenerational Effects of Environmental Exposures. Environmental Health Perspectives October 2013;12(10).

34 CDC. Vaccine Excipients & Media Summary (Vaccine Ingredients).Appendix B.The Pink Book, 13th Edition, June 2018

35 Tomlejenovic L, Shaw CA. Aluminum Vaccine Adjuvants: Are They Safe? Curr Med Chem. 2011; 19(17): 2630-2637.

36 Krewski D, Yokel RA, Nieboer E et al. Human Health Risk Assessment for Aluminum, Aluminum Oxide, Aluminum HydroxideJ Toxicol Environ Health B Crit Rev 2007; 10(Suppl 1); 1-269.

37 Elce D, Celik A. Genotoxicity of thimerosal in cultured human lymphocytes with and without metabolic activation sister chromatid exchange analysis proliferation index and mitotic index. Toxicology in Vitro June 2008; 22(4): 927-934.

38 Speit G, Neuss S, Schutz P et al. The genotoxic potential of gluteraldehyde in mammalian cells in vitro in comparison with formaldehyde. Mutation Research 2008; 649: 146-154.

39 Toxicology Data Network. 2-PhenoxyethanolNational Library of Medicine. Webpage last reviewed Jan. 19, 2012.

40 ScienceLab.com. Material Safety Data Sheet: Polysorbate 80(Tween 80). ScienceLab.com. Webpage last updated May 21, 2013. 

41 Gajdova M, Jakubousky J, Valky J. Delayed effects of neonatal exposure to Tween 80 on female reproductive organs in rats. Abstract. Food Chem Toxicol 1993; 31(3): 183-190.

42 FDA. Summary: Potential for contamination of biological products with the agent of bovine spongiform encephalopathy (BSE). Transmissable Spongiform Encephalopathies Advisory Committee (TSEAC) and Vaccines & Related Biological Products Advisory Committee (VRBPAC). July 27, 2000.

43 Food and Drug Administration (FDA). Guidance for Industry: Consideration for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications (Non-Binding Recommendations). Design of Developmental Toxicity Studies: General Considerations and Recommendations. Centers for Biologics Evaluation Research (CBER) February 2006.

44 Zeteyeva YA, Moro PL, Tepper HK et al. Adverse event reports after tetanus toxoid, reduced diphtheria toxoid and acelullar pertussis vaccines in pregnant women. Am J Obstet Gynecol 2012 207(1)

45 CDC. Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) in Pregnant Women and Persons Who Have or Anticipate Having Close Contact with an Infant Aged Under 12 Months – ACIP, 2011.Safety of Tdap in Pregnant Women. MMWR Oct. 21, 2011; 60(41): 1424-1426.  

46 Furuta M, Sin J, et al. Efficacy and safety of pertussis vaccination for pregnant women – a systematic review of randomised controlled trials and observational studies. BMC Pregnancy Childbirth. 2017; 17: 390.

47 Businesswire NVIC Cites “Betrayal” of Consumers by U.S. Supreme Court Giving Total Liability Shield to Big Pharma. NVIC Press Release Feb. 23, 2011.

48 Feemster KA. Advisory Commission on Childhood Vaccines Maternal Immunization Working Group Draft RecommendationsACCV June 7, 2013.

49 Federal Register. Proposed Rules. Vol. 83, No. 65. Apr. 4, 2018


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