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What is the History of Pertussis Vaccine use in America?


pertussis

In 1906, Octave Gengou and Jules Bordet of the Pasteur Institute of Brussels, were successful in growing pertussis bacterium using an artificial media.1 As a result of the breakthrough, the pertussis bacterium was renamed Bordetella pertussis in honor of Jules Bordet. Following publication of research on the Bordet-Gengou technique, several scientists began development of a pertussis vaccine using whole cell killed pertussis. The first crude whole cell pertussis vaccine was licensed in 19142 but was not routinely used until after 1949, when it was combined with diphtheria and tetanus vaccines to become the DPT vaccine.3 Prior to 1949, the crude whole cell pertussis vaccine was in limited use and reports of serious side effects, including deaths, following vaccination appeared in published medical research.4 5 6

A 1974 published study7 reporting serious side effects following DPT vaccination received widespread publicity in Great Britain and DPT vaccination rates drop from 80 to 30 percent.8 In 1975, Japan suspended the use of pertussis vaccine for several months in response to concerns over vaccine safety. The vaccine was reinstated for use but recommended for children ages 2 years and older only.9 It was Japan that introduced the first acellular pertussis vaccine, the less reactive DTaP vaccine, in 1981, replacing the highly reactive whole cell pertussis vaccine.10

In 1982, the damaging effects of the highly reactive DPT vaccine was profiled in an award-winning television documentary DPT: Vaccine Roulette. This documentary led to the founding the organization known today as the National Vaccine Information Center and the publishing of the book DPT: A Shot in the Dark in 1985.11 During the 1980’s, parents of DPT vaccine injured children worked tirelessly for over a decade to get the less reactive DTaP vaccine licensed in the United States. Since 1981, Japan had used the DTaP vaccine with far fewer serious reactions and no reported whooping cough outbreaks. 12

It was the highly reactive whole cell DPT vaccine that caused many children to suffer permanent brain damage or death, which prompted vaccine makers in the United States to push Congress into giving pharmaceutical companies a partial product liability shield in 1986.13 Parents of children who were severely injured or who died as a result of the whole cell DPT vaccine were suing vaccine manufacturers for damages, and as a result of the growing number of lawsuits, vaccine manufacturers were threatening to stop the sale of vaccines in the United States.14 15 As a result, the National Childhood Vaccine Injury Act was passed by the 99th Congress in 1986.16 The goal of the National Childhood Vaccine Injury Act was to restrict vaccine lawsuits against vaccine manufacturers and negligent doctors when vaccines such as the highly reactive DPT vaccine injure or kill to Americans. NVIC’s co-founders worked with Congress on the historic law and as a result, Congress acknowledged the reality of vaccine injuries and deaths, that safety reforms are needed, and that those who are harmed by vaccines should be financially compensated.17 The National Vaccine Injury Compensation Program, set up in response to the passage of the National Childhood Vaccine Injury Act, was promised by Congress to be “a non-adversarial, expedited, less traumatic and less expensive administrative alternative to a lawsuit - not an exclusive legal remedy that prohibited all product liability lawsuits against vaccine manufacturers.”18

Between 1988 and 1995, following the passage of the National Childhood Vaccine Injury Act of 1986, DPT vaccine injured children were receiving awards through an administrative procedure.19 However, in 1995, Health and Human Services Secretary Donna Shalala, officials at the CDC, and attorneys in the U.S. Department of Justice actively worked to substantially weaken the compensation and safety provisions of the National Childhood Vaccine Injury Act of 1986. Beginning in March of 1995, only anaphylaxis occurring within four hours and encephalopathy/encephalitis occurring within 72 hours of a DPT vaccination (or resulting in hospitalization) would be presumed to be associated with DPT vaccination. This rule change meant that any child who suffered classic pertussis vaccine reaction symptom such as collapse or shock, high pitched screaming, bulging fontanelle, or seizures within 72 hours of a DPT vaccination, and suffered permanent neurological damage (including residual seizure disorder), would no longer be presumed to have suffered a vaccine injury and be eligible for “no fault” compensation in the federal program. As a result of this change, attorneys representing children suffering these classic DPT vaccine reaction symptoms followed by permanent injury or death would have to prove causation in the U.S. Court of Claims whenever the Secretary of Health and the Justice Department refused to award compensation.20 Since this change in 1995, it has become extremely rare for any vaccine injured child to qualify for uncontested compensation, and currently, most vaccine injury claims take many years to adjudicate because the Departments of Health and Justice fight against awarding compensation for the majority of children and adults who apply.21

In February 2011, the U.S. Supreme Court chose to inaccurately interpret the National Childhood Vaccine Injury Act of 1986, and removed the right of vaccine injured Americans to sue a vaccine maker, even when evidence existed that injuries could have been prevented if a pharmaceutical company had chosen to make a safer vaccine.22 When the National Childhood Vaccine Injury Act passed in 1986, the Act protected a citizen’s right to sue drug companies when federal compensation was denied, or in the case that evidence existed that the company had the technological ability to make a vaccine safer but refused to do so. The February 2011 Supreme Court decision to remove this provision completely shielded pharmaceutical companies from all liability for harm caused by any vaccine.23

The Supreme Court decision was a result of a lawsuit filed by the attorneys and parents of Hannah Bruesewitz, a young woman who suffered from seizures within hours of her six month whole cell DPT vaccination that resulted in lifelong developmental delays. In 1995, one month prior to the hearing of her case in the federal compensation program, the injuries that Hannah suffered were removed from the vaccine injury table and Hannah was denied compensation by an administrative judge.24 As a result of this denial, her parents filed a lawsuit against Wyeth, the company that had acquired the vaccine’s manufacturer, Lederle Laboratories, and provided evidence that Wyeth-Lederle had the technology to produce a less reactive, purified pertussis vaccine but declined to do so.25 The case went all the way to the Supreme Court and in a 6-2 split decision, the Court ruled in favor of the pharmaceutical companies, protecting them against any lawsuits as a result of injuries and deaths resulting from the vaccines they design, manufacture and market. Only Justices Sotomayor and Ginsburg stood up for the American public by dissenting.26

Although the FDA approved the first acellular DTaP vaccines for use in the United States in 1991,27 it took until 1996 for this less reactive vaccine to be granted approval for use in infants and children for all five of the recommended doses of pertussis, diphtheria, and tetanus vaccination.28 Between 1991 and 1996, the DTaP vaccine was approved only for use in children ages 15 months to 6 years of age, following administration of three doses of the whole cell DPT vaccine.29 In 1997, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended the DTaP vaccine for use instead of the highly reactive whole cell DPT vaccine.30

In 2005, the FDA approved two additional pertussis-containing vaccines, Tdap, targeting adolescents and adults. Boostrix, initially approved for persons ages 10 through 18 years of age, and Adacel, approved for persons ages 11 through 64 years of age. Following FDA approval, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended all adolescents receive a dose of Tdap vaccine between the age of 11 and 12. This recommendation was made in response to high rates of pertussis outbreaks in adolescents as a result of waning vaccine-induced pertussis immunity.31

In 2006, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended Tdap vaccination for all persons between the ages of 19 and 65 years, especially encouraging individuals to be vaccinated if they anticipate close contact with infants under one year of age. This recommendation was made without any scientific evidence to support the theory that vaccinating adults with Tdap would reduce the risk of pertussis in infants.32 In fact, a 2013 published study found that baboons that were recently vaccinated carried the pertussis infection in their throats and spread the illness to others despite being asymptomatic themselves.33 34 Recommendations also included women of childbearing age, recommending vaccine with Tdap vaccine prior to pregnancy or immediately postpartum if Tdap was not administered prior to pregnancy. Breastfeeding women who did not receive the Tdap prior to pregnancy were also included in this recommendation35 despite a lack of information on whether Tdap is excreted in human milk and what implications this may have on the nursing infant.36 The ACIP also recommended that health care personnel working in ambulatory care and hospital settings receive a Tdap vaccine as soon as possible, especially if their practice places them in direct contact with infants under the age of one year.37

In October 2011, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended that health-care personnel implement a Tdap vaccine program for pregnant women after 20 weeks gestation, who had not been previously vaccinated with Tdap. The ACIP also continued to recommend vaccination all adolescents and adults, especially those who may come into close contact with infants.38  One year later, in October of 2012, the CDC’s Advisory Committee on Immunization Practices (ACIP) updated its Tdap vaccination recommendations for pregnant women, recommending the vaccine be administered between 27 and 36 weeks gestation during each pregnancy.39 This recommendation was made despite the fact that both available 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.40 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.41 42 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.43 44 and almost no data exists on inflammatory or other biological responses to these vaccines that may have an effect on pregnancy and birth outcomes.45  Further, a 2017 review of 15 published articles, including 2 randomized controlled trials and 13 observational studies determined that while Tdap 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

Currently, the CDC recommends infants and children receive 5 doses of DTaP vaccination followed by a booster dose of Tdap vaccination in adolescence (age 11-12). Adults who have not received a Tdap vaccine are also recommended to receive a single dose. Pregnant women are recommended to receive Tdap vaccination with each pregnancy regardless of a previous history of Tdap vaccine.47

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 Institute of Medicine. Pertussis and Rubella Vaccines: A Brief Chronology (Appendix B, pp. 320) In: Adverse Effects of Pertussis and Rubella Vaccines. The National Academies Press 1991.

2 Ibid

3 NIH. Historical Record of Vaccine Product Licensing Holders in the United States. (Table H-1). In: The Children’s Vaccine Initiative: Achieving the Vision. The National Academy of Sciences 1993.

4 Madsen, T. Vaccination against whooping cough. JAMA. 1933 101(3):187-88.

5 Byers RK, Moll FC Encephalopathies following prophylactic pertussis vaccine. Pediatrics.1948 Apr;1(4):437-57.

6 Brody M, Sorley RG, Neurologic complications following the administration of pertussis vaccine. N Y State J Med. 1947 May 1;47(9):1016.

7 Kulenkampff M, Schwartzman JS, Wilson J Neurological complications of pertussis inoculation. Arch. Dis. Child. 1974, 49, 46

8 Institute of Medicine. Pertussis and Rubella Vaccines: A Brief Chronology (Appendix B, pp. 320) In: Adverse Effects of Pertussis and Rubella Vaccines. The National Academies Press 1991.

9 Ibid

10 Kuno-Sakai H, Kimura M. Safety and efficacy of acellular pertussis vaccine in Japan, evaluated by 23 years of its use for routine immunization. Pediatr Int. 2004 Dec;46(6):650-5.

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

12  Sato Y, Kimura M, Fukumi H. Development of Pertussis Component Vaccine in Japan. Lancet 1984; 323(8369): 122-126.

13 National Vaccine Information Center. NVIC Position Statement on the National Childhood Vaccine Injury Act of 1986. May 2018.

14 Hinman AR. DTP vaccine litigation. Am J Dis Child 1986; 140(6): 528-530.

15 NVIC No Pharma Liability? No Vaccine Mandates. Mar. 2, 2011

16 NVIC The National Childhood Vaccine Injury Act of 1986

17 NVIC NVIC's History

18 NVIC Vaccine Injury Compensation: Government’s Broken Social Contract with Parents. Nov. 2, 2015

19 Ibid

20 NVIC Back to the Future: Shalala Takes Away Compensation for DPT Injured Children. Aug. 14, 2017

21 NVIC Vaccine Injury Compensation: Government’s Broken Social Contract with Parents. Nov. 2, 2015

22 NVIC No Pharma Liability? No Vaccine Mandates. Mar. 2, 2011

23 BusinessWire National Vaccine Information Center Cites “Betrayal” of Consumers by U.S. Supreme Court Giving Total Liability Shield to Big Pharma. Feb. 23, 2011

24 Meier B Supreme Court to Consider Vaccine Case. The New York Times. Oct. 11, 2010

25 NVIC No Pharma Liability? No Vaccine Mandates. Mar. 2, 2011

26 Ibid

27 CDC Pertussis Vaccination: Acellular Pertussis Vaccine for Reinforcing and Booster Use -- Supplementary ACIP Statement Recommendations of the Immunization Practices Advisory Committee MMWR Feb. 07, 1992; 41(RR-1);1-10

28 CDC. Pertussis vaccination: use of acellular pertussis vaccines among infants and young children. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Mar. 28, 1997;46(RR-7):1–25

29 Ibid

30 CDC  Notice to Readers Recommended Childhood Immunization Schedule -- United States, 1997. MMWR. Jan. 17, 1997; 46(02);35-39

31 CDC Preventing Tetanus, Diphtheria, and Pertussis Among Adolescents: Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccines - Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Mar. 24, 2006; 55(RR03);1-34

32 CDC Preventing Tetanus, Diphtheria, and Pertussis Among Adults: Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine - Recommendations of the Advisory Committee on Immunization Practices (ACIP) and Recommendation of ACIP, supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC), for Use of Tdap Among Health-Care Personnel MMWR. Dec. 15, 2006. 55(RR17);1-33

33 Tavernise S. Whooping Cough Study May Offer Clue on Surge. The New York Times. Nov. 25, 2013

34 Warfel JM, Zimmerman LI, Merkel TJ. Acellular pertussis vaccines protect against disease but fail to prevent infection and transmission in a nonhuman primate model. Proc Natl Acad Sci U S A. 2014 Jan 14;111(2):787-92.

35 CDC Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (Tdap) in Pregnant Women and Persons Who Have or Anticipate Having Close Contact with an Infant Aged <12 Months --- Advisory Committee on Immunization Practices (ACIP), 2011 MMWR. Oct. 21, 2011

36 FDA Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed. Mar. 1, 2018

37 CDC Preventing Tetanus, Diphtheria, and Pertussis Among Adolescents: Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccines - Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR. Mar. 24, 2006. 55(RR03);1-34

38 CDC Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (Tdap) in Pregnant Women and Persons Who Have or Anticipate Having Close Contact with an Infant Aged <12 Months --- Advisory Committee on Immunization Practices (ACIP), 2011 MMWR. Oct. 21, 2011 60(41);1424-1426

39 CDC Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine (Tdap) in Pregnant Women — Advisory Committee on Immunization Practices (ACIP), 2012 MMWR. Feb. 22, 2013  62(07);131-135

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

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

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

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

44 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.

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

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 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


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