10

Diphtheria Toxoid–, Tetanus
Toxoid–, and Acellular Pertussis–
Containing Vaccines

INTRODUCTION

Diphtheria Toxoid

Diphtheria is an acute upper respiratory illness caused by Corynebacterium diphtheriae. C. diphtheriae is a minimally invasive gram-positive bacillus that is resistant to environmental change and whose virulence is mostly confined to the secretion of an exotoxin that inhibits protein synthesis in mammalian cells (MacGregor, 2010). C. diphtheriae is spread through direct contact with infected respiratory secretions and cutaneous lesions (MacGregor, 2010).

Following an incubation period of 1 to 5 days, diphtheria presents most commonly as local invasion of the respiratory tract including the back of the mouth and upper pharynx (Vitek and Wharton, 2008). Early symptoms may include low-grade fever (less than 101.3°F), malaise, and sore throat (Vitek and Wharton, 2008). Approximately 24 hours after disease onset, small patches of exudate are visible, and within 2 to 3 days a glossy, white membrane covers one or both tonsils and other oral structures including the tonsillar pillars, uvula, soft palate, oropharynx, and nasopharynx (Vitek and Wharton, 2008). The magnitude of the membrane is an indication of disease severity. Localized disease is often mild; however, the involvement of posterior structures like the soft palate and periglottal areas generally suggests the development of more substantial disease (Vitek and Wharton, 2008). In such cases, local lymph node enlargement also occurs due to



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10 Diphtheria Toxoid–, Tetanus Toxoid–, and Acellular Pertussis– Containing Vaccines INTRODUCTION Diphtheria Toxoid Diphtheria is an acute upper respiratory illness caused by Corynebac- terium diphtheriae. C. diphtheriae is a minimally invasive gram-positive bacillus that is resistant to environmental change and whose virulence is mostly confined to the secretion of an exotoxin that inhibits protein synthesis in mammalian cells (MacGregor, 2010). C. diphtheriae is spread through direct contact with infected respiratory secretions and cutaneous lesions (MacGregor, 2010). Following an incubation period of 1 to 5 days, diphtheria presents most commonly as local invasion of the respiratory tract including the back of the mouth and upper pharynx (Vitek and Wharton, 2008). Early symptoms may include low-grade fever (less than 101.3°F), malaise, and sore throat (Vitek and Wharton, 2008). Approximately 24 hours after disease onset, small patches of exudate are visible, and within 2 to 3 days a glossy, white membrane covers one or both tonsils and other oral structures including the tonsillar pillars, uvula, soft palate, oropharynx, and nasopharynx (Vitek and Wharton, 2008). The magnitude of the membrane is an indication of disease severity. Localized disease is often mild; however, the involvement of posterior structures like the soft palate and periglottal areas generally suggests the development of more substantial disease (Vitek and Wharton, 2008). In such cases, local lymph node enlargement also occurs due to 525

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526 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY swelling and inflammation, and the individual may present with a “bulk neck” appearance (Vitek and Wharton, 2008). While diphtheria in the respiratory tract is the most common manifesta- tion, aural, conjunctival, cutaneous, and vaginal diphtheria can also occur and taken together account for approximately 2 percent of diphtheria cases (Vitek and Wharton, 2008). The obvious consequences of diphtheria are manifested in the com- plications that arise from the presence and subsequent shedding of the membrane. In severe cases, the membrane may extend into the tracheo- bronchial tree causing pneumonia and expiratory respiratory obstruction and membrane aspiration (Vitek and Wharton, 2008). Other complica- tions are caused by the effect of the absorbed diphtheria toxin on organs and organ systems proportional to the severity of the disease (Vitek and Wharton, 2008). Evidence of myocarditis has been found in up to 66 percent of patients with 10 to 25 percent developing clinically significant cardiac dysfunction (MacGregor, 2010). Neuropathy occurs rarely in mild disease but occurs in up to 75 percent of patients with severe diphtheria (MacGregor, 2010). Hypotension, pneumonia, and renal failure are also common in severe cases, while encephalitis and cerebral infarction has been described in rare cases (MacGregor, 2010). Death occurs most frequently within 3 to 4 days from disease onset and is most often caused by asphyxia or myocarditis (MacGregor, 2010). Immunization with diphtheria toxoid has dramatically altered the epi- demiology of diphtheria in the United States and data obtained from the 1988–1994 National Health and Nutrition Examination Survey (NHANES) III serosurvey indicated that 80 percent of persons age 12 to 19 years were immune to diphtheria (McQuillan et al., 2002). The first vaccine against diphtheria was developed in the early 1800s and was widely used in the United States as early as 1914 (Vitek and Wharton, 2008). The vaccine consisted of a toxin-antitoxin formulation and was found to be 85 percent effective in preventing diphtheria (Vitek and Wharton, 2008). In the 1920s, Ramon found that by treating the toxin with formalin and creating the toxoid, the toxicity of the prepara- tion could be reduced while maintaining the immunogenic properties (Vitek and Wharton, 2008). In 1926, Glenny and his associates discovered that alum-precipitated toxoid was even more effective, and by the mid-1940s diphtheria toxoid was being combined with tetanus toxoid and whole-cell pertussis vaccine to create the diphtheria-tetanus-pertussis (DTP) vaccine (Vitek and Wharton, 2008). Soon after, the DTP combination vaccine was adsorbed onto an aluminum salt and researchers noted the enhanced immu- nogenicity of the diphtheria and tetanus toxoid in the presence of pertussis vaccine and the aluminum salt (Vitek and Wharton, 2008).

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527 DT–, TT–, AND aP–CONTAINING VACCINES Tetanus Toxoid Unique among the vaccine-preventable diseases, tetanus is not transmis- sible from person to person (Wassilak et al., 2008). The disease is caused by the gram-positive spore forming bacillus Clostridium tetani, which is widespread throughout the environment, particularly in the soil (Wassilak et al., 2008). C. tetani spores are introduced into the body through direct contact with compromised tissues, where they germinate and produce a plasmid-encoded exotoxin that binds to gangliosides at the myoneural junction of skeletal muscle and on neuronal membranes in the spinal cord, blocking inhibitory impulses to motor neurons (AAP, 2009; Wassilak et al., 2008). “The action of tetanus toxin on the brain and sympathetic nervous system is less well documented” (AAP, 2009). The incubation period for tetanus can range from 1 day to several months but generally lasts 3 to 21 days (Weinstein, 1973). Shorter incu- bation periods are associated with more severe disease, while incubation periods of 10 or more days generally result in milder disease (Adams, 1968; Bruce, 1920; Garcia-Palmieri and Ramirez, 1957; LaForce et al., 1969). There are three clinical descriptions of C. tetani infection: generalized, localized, and cephalic. Generalized tetanus occurs in more than 80 percent of all tetanus cases (Wassilak et al., 2008). Trismus (lockjaw) caused by spasm of the facial muscles is the most common manifestation of general- ized tetanus (Newton-John, 1984; Pratt, 1945; Weinstein, 1973). Trismus may be followed by muscle spasms in other parts of the body including the neck, back, and abdomen (Wassilak et al., 2008). Tetanospasm, also known as generalized tonic tetanic seizure-like activity, is a sudden contraction of all the muscle groups and can occur in the presence of mild external stimuli such as sudden noise (Wassilak et al., 2008). In addition to these spasms, those with severe tetanus are at risk of developing severe autonomic nervous system abnormalities including diaphoresis, high or low blood pressure, flushing, and cardiac complications (Hollow and Clarke, 1975; Kanarek et al., 1973; Kerr et al., 1968). Tetanus neonatorum is the most com- mon manifestation of generalized tetanus and occurs when the bacterium infects the umbilical stump (Wassilak et al., 2008). Typically manifesting 3 to 14 days after birth, tetanus neonatorum begins with excessive crying and decreased sucking capability, and is followed by trismus, difficulty swallowing, and tetanic spasm (Wassilak et al., 2008). Infants who survive this disease may experience neurologic damage and may also develop in- tellectual and behavioral abnormalities (Anlar et al., 1989; Barlow et al., 2001; Okan et al., 1997; Teknetzi et al., 1983). Localized tetanus is rare in humans and involves muscle spasms confined to areas. These spasms may last several months before subsiding or developing to generalized tetanus (Millard, 1954). Cephalic tetanus is associated with lesions on the head or

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528 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY face in line with the facial nerve and orbits (Weinstein, 1973). Considered a form of localized tetanus, incubation is complete in 1 to 2 days after the initial insult, which is most often a head wound (Weinstein, 1973). Following the widespread use of tetanus toxoid–containing vaccines, tetanus infections have become an uncommon occurrence in the United States. In 1947, the incidence of reported cases was 0.39 per 100,000 in the United States (Wassilak et al., 2008). This number dropped dramatically, and from 1998 to 2000, the average incidence was approximately 0.16 cases per 1,000,000 representing a 96 percent decrease in the incidence rate (CDC, 2003). Tetanus infections peak in midsummer and are more common in warm, damp climates. This is likely due to soil conditions and increased expo- sure to spores as well as increased injuries that occur during the summer months (Axnick and Alexander, 1957; Bytchenko, 1966; Heath et al., 1964; LaForce et al., 1969). Although described by the ancient Egyptians and Greeks, the origin of tetanus disease was not described until 1884 when Carle and Rattone showed that tetanus symptoms could be induced in rabbits when inoculated with pustular fluid from a fatal case of human tetanus (Wassilak et al., 2008). In the late 1800s, C. tetani spores were shown to survive heating and germinate in anaerobic environments, and the repeated inoculation with small quantities of toxin led to antibody production that was able to neutralize the effects of tetanus toxin (Wassilak et al., 2008). In 1924, the tetanus toxoid created by chemically inactivating the tetanus toxin was shown to induce active immunity to tetanus disease prior to exposure to the pathogen (Wassilak et al., 2008). Currently, commercial tetanus toxoid is produced by culturing C. tet- ani in liquid medium and transforming the purified toxin with 40 percent formaldehyde at 37°C (Wassilak et al., 2008). In the United States, tetanus toxoid vaccines are available as a single tetanus toxoid vaccine (TT) (Sanofi Pasteur) and in combination with diphtheria toxoid as DT/Td, acellular pertussis as DTaP/Tdap, and as DTaP with other antigens such as Hae- mophilus influenzae B (HiB) conjugate (Wassilak et al., 2008). Pertussis Antigen Pertussis (whooping cough) is an upper respiratory infection caused by Bordetella pertussis, a gram-negative, pleomorphic bacillus that attaches to cells lining the respiratory tract (Edwards and Decker, 2008). B. pertussis is not a particularly invasive bacterium and typically does not penetrate sub- mucosal cells or the bloodstream, although toxins secreted by the bacteria may produce systemic effects (Edwards and Decker, 2008).

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529 DT–, TT–, AND aP–CONTAINING VACCINES The incubation period lasts 7 to 10 days, and pertussis disease is trans- mitted by large respiratory droplets (Waters and Halperin, 2010). B. per- tussis infections range from asymptomatic to severe. Symptomatic disease is characterized by three phases: catarrhal, paroxysmal, and convalescent (Gordon and Hood, 1951). The catarrhal phase lasts 1–2 weeks; symp- toms of this phase may include nasal discharge, eye redness, and frequent coughing and sneezing (Gordon and Hood, 1951; Waters and Halperin, 2010). The paroxysmal phase is characterized by periods of intense cough- ing (paroxysms) that may lead to choking, vomiting, and an inspiratory whoop (Gordon and Hood, 1951; Waters and Halperin, 2010). This phase may last 2–6 weeks, as does the convalescent phase during which the symp- toms decline. Fever is rare in pertussis infection and usually results from a secondary infection or co-infection (Gordon and Hood, 1951; Waters and Halperin, 2010). According to Cortese and her colleagues (2008), apnea and respira- tory arrest was the most common complication of pertussis followed by pneumonia and gastroesophageal reflux. Pneumonia is the most common complication in hospitalized patients (Cortese et al., 2008). Encephalopathy is a rare complication and occurs most often in younger patients (Waters and Halperin, 2010). B. pertussis antibodies have been found in the ce- rebrospinal fluid (CSF) of patients with pertussis encephalopathy (Grant et al., 1998). Other complications include seizures, ataxia, aphasia, blind- ness, deafness, subconjunctival hemorrhages, syncope, and rib fractures (Waters and Halperin, 2010). Pertussis is most serious in infants less than 12 months of age, and the risk of death is highest among infants less than 6 months old (Cortese et al., 2008; Tanaka et al., 2003; Vincent et al., 1991; Vitek et al., 2003). B. pertussis was first isolated and grown in culture by Jules Bordet and Octave Genou in 1906, and the first whole-cell pertussis vaccines were licensed in the United States in 1914 (Edwards and Decker, 2008). These vaccines were suspensions of killed bacteria and were improved upon by Kendrick and her colleagues before being combined with diphtheria and tetanus toxoids to produce DTP vaccine (Edwards and Decker, 2008). Ow- ing to the reactogenicity of whole-cell vaccines, alternative vaccines were sought, and the first acellular vaccine was developed in Japan (Edwards and Decker, 2008). These vaccines were composed of purified filamentous hemagglutin (FHA) and leukocytosis-promoting factor hemagglutin (Sato et al., 1984) and were widely used in Japan starting in 1981. In 1996, acel- lular pertussis vaccines were licensed in the United States. Currently, the acellular pertussis vaccine is only available in combination with diphtheria and tetanus in the United States.

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530 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY Diphtheria Toxoid–, Tetanus Toxoid–, and Pertussis Antigen–Containing Vaccines Vaccines to prevent diphtheria, tetanus, and pertussis are available in various formulations and are given in 0.5 mL doses (see Table 10-1). The four most common combination vaccines are DTaP, Tdap, DT, and Td. Of these vaccines, two (DTaP and DT) are given to children younger than 7 years of age, and two (Tdap and Td) are given to individuals 7 years or older.1 The Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians recommend that children routinely receive a five-dose series of vaccine against diphtheria, tetanus, and pertussis before age 7 years. ACIP recommends that the first four doses be administered at ages 2, 4, 6, and 15–18 months and the fifth dose at age 4–6 years (CDC, 1997). Because the immunity provided by childhood diphtheria, tetanus, and pertussis-containing vaccines is not lifelong, booster vaccinations are needed to maintain disease immunity. These booster vaccinations of either Td or Tdap, which in 2006 was recommended by the ACIP as a single-dose booster for those who previously had not been vaccinated with Tdap, are given every 10 years or after a tetanus exposure under certain circumstances (CDC, 2008). According to the National Immunization Survey from 2005 through 2009 more than 95 percent of children age 19 to 35 months had received at least three doses of the DTP, DT, or DTaP vaccine and approximately 85 percent had received four doses (CDC, 2010b). In 2009, the National Immunization Survey estimated that 76.2 percent of adolescents between 13 and 17 years of age had received at least one dose of the Td or Tdap vaccines (CDC, 2010a). One of the challenges the committee faced in assessing the safety of diphtheria toxoid–, tetanus toxoid–, and acellular pertussis–containing vaccines is that these particular antigens are often combined with other antigens in a number of different formulations (see Table 10-1). This variety at times made comparisons difficult. The committee was not charged with reviewing the evidence regarding whole cell pertussis vaccine. When the committee uses the phrase “diphtheria toxoid–, tetanus toxoid–, or acel- lular pertussis–containing vaccine,” it is limiting the assessment to these antigens. 1 Upper-case letters denote full-strength doses of diphtheria (D) and tetanus (T) toxoids and pertussis (P) vaccines. Lower-case (d) and (p) denote reduced doses of diphtheria and pertussis used in the adolescent/adult formulations. The (a) in DTaP and Tdap stands for “acellular,” meaning that the pertussis component contains only a part of the pertussis organism (CDC, 1997).

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TABLE 10-1 Diphtheria Toxoid–, Tetanus Toxoid–, and Acellular Pertussis–Containing Vaccines Licensed and Available in the United States Trade Dose Age Vaccine Name Manufacturer (Presentation) Antigen Concentration Preservative Group Doses Route DT No Trade Sanofi Pasteur, Inc 0.5 mL (single- 6.7 LF diphtheria toxoid; 6 weeks– 3 or 4* Intramuscular ≤ 0.3 µg Name dose vials) 5 LF tetanus toxoid Hg/0.5 mL 6 years dose DT No Trade Sanofi Pasteur, Inc 0.5 mL (single- 25 LF diphtheria toxoid; 0 6 weeks– 5 Intramuscular Name dose vials) 5 LF tetanus toxoid 6 years DTaP Tripedia Sanofi Pasteur, Inc 0.5 mL (single- 6.7 LF diphtheria toxoid; 6 weeks– 5 Intramuscular ≤ 0.3 µg dose vials) 5 LF tetanus toxoid; Hg/ 6 years 23.4 µg PT; 0.5 mL 23.4 µg FHA dose DTaP Infanrix GlaxoSmithKline 0.5 mL (single- 25 LF diphtheria toxoid; 0 6 weeks– 5 Intramuscular Biologicals dose vials and 10 LF tetanus toxoid; 6 years syringes) 25 mg pertussis toxin; 25 mg FHA; 8.0 mg pertactin DTaP DAPTACEL Sanofi Pasteur, Ltd 0.5 mL (single- 15 LF diphtheria toxoid; 0 6 weeks– 5 Intramuscular dose vials) 5 LF tetanus toxoid; 6 years 10 mg pertussis toxin; 5 mg FHA; 3 mg PRN; 5 mg FIM 531 continued

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TABLE 10-1 Continued 532 Trade Dose Age Vaccine Name Manufacturer (Presentation) Antigen Concentration Preservative Group Doses Route DTaP- Pediarix GlaxoSmithKline 0.5 mL (single- 25 LF diphtheria toxoid 0 6 weeks– 3 Intramuscular IPV-Hep Biologicals dose vials and 10 LF tetanus toxoid; 6 years B syringes) 25 µg pertussis toxin; 25 µg FHA; 8 µg pertactin; 10 µg HBsAg; 40 DU type 1 poliovirus; 8 DU type 2 poliovirus; 32 DU type 3 poliovirus DTaP-IPV KINRIX GlaxoSmithKline 0.5 mL (single- 25 LF diphtheria toxoid 0 4–6 years Booster Intramuscular Biologicals dose vials and 10 LF tetanus toxoid; syringes) 25 µg pertussis toxin; 25 µg FHA; 8 µg pertactin; 40 DU type 1 poliovirus; 8 DU type 2 poliovirus; 32 DU type 3 poliovirus DTaP- Pentacel Sanofi Pasteur 0.5 mL 15 LF diphtheria toxoid; 0 6 weeks– 4 Intramuscular IPV-Hib Limited (two vials: 5 LF tetanus toxoid; 4 years combination 20 µg PT; of DTaP- 20 µg FHA; IPV vaccine 3 µg PRN; and ActHIB 5 µg FIM; vaccine) 40 DU type 1 poliovirus; 8 DU type 2 poliovirus; 32 DU type 3 poliovirus; 10 mg PRP of HiB bound to 24 mg tetanus toxoid

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Td No Trade MassBiologics 0.5 mL (single- 2 LF tetanus toxoid; 3 and/ Intramuscular ≤ 0.3 µg ≥ 7 years Name dose vials) 2 LF diphtheria toxoid Hg/0.5 mL or dose booster Td DECAVAC Sanofi Pasteur, Inc 0.5 mL (single- 5 LF tetanus toxoid; 3 and/ Intramuscular ≤ 0.3 µg ≥ 7 years dose vials and 2 LF diphtheria toxoid Hg/0.5 mL or syringes) dose booster TT No Trade Sanofi Pasteur, Inc 0.5 mL (7.5 4 LF tetanus toxoid 25 µg Booster Intramuscular ≥ 7 years Name mL 15 dose Hg/0.5 mL or Subcutaneous vials) dose Tdap Adacel Sanofi Pasteur, Ltd 0.5 mL (single- 5 LF tetanus toxoid; 0 11–64 Booster Intramuscular dose syringes) 2 LF diphtheria toxoid; years 2.5 µg PT; 5 µg FHA; 5 µg FIM; 3 µg PRN Tdap Boostrix GlaxoSmithKline 0.5 mL (single- 5 LF tetanus toxoid; 0 Booster Intramuscular ≥ 10 Biologicals dose vials and 2.5 LF diphtheria toxoid; years syringes) 8 µg PT; 8 µg FHA; 2.5 µg PRN *This vaccine is given in a five-dose series to infants between the ages of 6 weeks and 12 months, and a three-dose series in children 1 to 6 years of age. SOURCE: GlaxoSmithKline, 2010a,b,c, 2011; MassBiologics, 2009; Sanofi Pasteur, Inc., 2005a,b,c, 2008, 2009, 2010a,b, 2011. 533

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534 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY ENCEPHALITIS AND ENCEPHALOPATHY Epidemiologic Evidence The committee reviewed nine studies to evaluate the risk of encephalitis or encephalopathy after the administration of vaccines containing diphthe- ria toxoid, tetanus toxoid, and acellular pertussis antigens alone or in com- bination. Seven studies (Geier and Geier, 2004; Gold et al., 1999; Isomura, 1991; Kuno-Sakai and Kimura, 2004; Rosenthal et al., 1996; Stetler et al., 1985; Zielinski and Rosinska, 2008) were not considered in the weight of epidemiologic evidence because they provided data from passive surveil- lance systems and lacked unvaccinated comparison populations. The two remaining controlled studies (Greco, 1985; Yih et al., 2009) contributed to the weight of epidemiologic evidence and are described below. Greco (1985) conducted a case-control study in children (3 to 48 months of age) admitted to the Santobono Hospital in Campania, Italy, from January 1980 through February 1983. The cases were identified from the hospital intensive care unit register. Patients were included as an encephalopathy case if they were admitted to the intensive care unit for the following diagnoses, which were obtained from medical records: Reye’s syndrome, coma due to unknown causes, convulsions due to unknown causes, death due to unknown causes, or stupor due to unknown causes. Two hospital controls were matched to each case on age (within 6 months), sex, and date of admission (within 30 days), and had confirmed diagnoses different from the cases. Two residence controls from the national birth register were matched to each case on age (within 1 month), sex, and place of residence (by zone or by town), and were alive during the time cases were hospitalized. A total of 45 cases, 90 matched hospital controls, and 90 matched residence controls were included in the analysis. Vaccination histories for the cases and controls were obtained from an extensive search of the national immunization register. During the 1 month preceding the hospital admission, 64 percent, 10 percent, and 13 percent of the cases, hospital controls, and residence controls received a diphtheria and tetanus toxoids vaccine, respectively. Oral polio vaccine was given at the same time as the diphtheria and tetanus toxoids vaccine in 51 percent of the cases and 28 percent of the controls; however, the authors did not explicitly state that other vaccinations were not also given. The odds ratio for encephalopathy within 1 month of the administration of diphtheria and tetanus toxoids vac- cine compared to the hospital controls was 291.9 (95% CI, 53.3–1,596.9) and compared to the residence controls was 22.5 (95% CI, 8.2–62.1). The authors observed an increased risk but concluded that the study design

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535 DT–, TT–, AND aP–CONTAINING VACCINES was insufficient to infer a causal relationship between the administration of diphtheria and tetanus toxoids vaccine and encephalopathy. Yih et al. (2009) conducted a cohort study in patients (10 to 64 years of age) enrolled in seven managed care organizations (MCOs) participat- ing in the Vaccine Safety Datalink (VSD) from August 2005 through May 2008. The study investigated the occurrence of adverse events (reported from outpatient, inpatient, and emergency department visits) following Tdap vaccination. The exposed group included approximately 660,000 patients that received a Tdap vaccination. Diagnoses of encephalopathy, encephalitis, and meningitis were obtained from the medical records and included in the analysis if they occurred within 42 days of vaccination. The disease incidence following Tdap vaccination was compared to the disease incidence 1 to 42 days after Td vaccination in a historical VSD comparison population; this could have introduced bias if coding practices or back- ground disease incidences differed in the two cohorts. The comparison group included approximately 890,000 patients that received a Td vac- cine from 2000 through 2004. The observed number of encephalopathy– encephalitis–meningitis events in the Tdap cohort (34 events) was less than the historical Td cohort (40.33 events), which resulted in a relative risk of 0.84 (confidence interval not provided). The authors concluded that the risk of encephalopathy–encephalitis–meningitis following Tdap vaccination is not significantly higher than the risk following Td vaccination, which only provides information on the safety of the acellular pertussis antigen component. Weight of Epidemiologic Evidence Greco et al. (1985) investigated the association of diphtheria and teta- nus toxoids vaccine with encephalopathy; however, 50 percent of the cases considered had oral polio given with the diphtheria and tetanus toxoids vac - cine, and it is not clear if any other vaccines were administered at the same time. Additionally, the case definition included a wide range of diagnoses. The paper by Yih et al. (2009) found no increased risk of encephalopathy– encephalitis–meningitis after Tdap vaccination compared to historical data on this adverse event after Td vaccination, which only provided information on the safety of the acellular pertussis antigen component. The committee has limited confidence in the epidemiologic evi- dence, based on two studies that lacked validity and precision, to assess an association between diphtheria toxoid–, tetanus toxoid–, or acellular pertussis–containing vaccine and encephalitis or encephalopathy.

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TABLE 10-6 Continued 588 Studies Contributing Cases Contributing Epidemiologic to the Epidemiologic Mechanistic to the Mechanistic Causality Vaccine Adverse Event Assessment Assessment Assessment Assessment Conclusion DT, TT, or Arthropathy Limited 2 Lacking None Inadequate aP containing (diphtheria toxoid or tetanus toxoid) Insufficient None (acellular pertussis) DT, TT, or Type 1 Diabetes High 5 Lacking None Favors aP containing (null) Rejection DT, TT, or Myocarditis Insufficient None Weak None Inadequate aP containing (diphtheria toxoid) Lacking None (tetanus toxoid or acellular pertussis) DT, TT, or Fibromyalgia Insufficient None Lacking None Inadequate aP containing DT, TT, or Sudden Infant Death Insufficient None Lacking None Inadequate aP containing Syndrome DT, TT, or Immune Thrombocytopenic Insufficient None Lacking None Inadequate aP containing Purpura *Although not originally charged to the committee by the sponsor, the committee considered this adverse event in its review of the literature.

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