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Influenza Vaccine

INTRODUCTION

Influenza viruses are 80–120 nm enveloped viruses of the family Orthomyxoviridae (Treanor, 2010). Divided into three types—A, B, and C—these viruses can infect a range of hosts from humans only (influenza B) to humans and swine (influenza C) to multiple host organisms including humans, swine, equine, avian, and marine mammals (influenza A) (Treanor, 2010). Influenza viruses are highly changeable viruses. Small antigenic changes, known as “antigenic drift,” occur regularly, usually as point mutations in the virus genome or through exchange of small gene segments with another strain of influenza virus (Han and Marasco, 2011; Treanor, 2010). Occasionally, influenza viruses undergo an abrupt and dramatic change in genome. This change, known as “antigenic shift,” results in a new virus that is so different from previous viruses that no immunity exists in the population and can lead to pandemic influenza (Treanor, 2010). Antigenic shift is usually caused by genetic recombination between two strains of influenza virus; one from a strain that can infect humans and one that, prior to the genetic exchange, could not (Han and Marasco, 2011). The impact of these changes depends on the extent of the change, but because viral epitopes from the variant strains that result from antigenic shifts and drifts may not be recognized by the immune system, vaccines must be altered regularly to combat the infection.

Influenza viruses are named based on the type of influenza, the location of initial isolation, strain designation number, and the year of isolation (e.g., A/Brisbane/59/2007). Influenza A viruses are further divided into subtypes



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6 Influenza Vaccine INTRODUCTION Influenza viruses are 80–120 nm enveloped viruses of the family Ortho- myxoviridae (Treanor, 2010). Divided into three types—A, B, and C—these viruses can infect a range of hosts from humans only (influenza B) to hu- mans and swine (influenza C) to multiple host organisms including humans, swine, equine, avian, and marine mammals (influenza A) (Treanor, 2010). Influenza viruses are highly changeable viruses. Small antigenic changes, known as “antigenic drift,” occur regularly, usually as point mutations in the virus genome or through exchange of small gene segments with another strain of influenza virus (Han and Marasco, 2011; Treanor, 2010). Occasionally, influenza viruses undergo an abrupt and dramatic change in genome. This change, known as “antigenic shift,” results in a new virus that is so different from previous viruses that no immunity exists in the popula- tion and can lead to pandemic influenza (Treanor, 2010). Antigenic shift is usually caused by genetic recombination between two strains of influenza virus; one from a strain that can infect humans and one that, prior to the genetic exchange, could not (Han and Marasco, 2011). The impact of these changes depends on the extent of the change, but because viral epitopes from the variant strains that result from antigenic shifts and drifts may not be recognized by the immune system, vaccines must be altered regularly to combat the infection. Influenza viruses are named based on the type of influenza, the location of initial isolation, strain designation number, and the year of isolation (e.g., A/Brisbane/59/2007). Influenza A viruses are further divided into subtypes 293

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294 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY based on the characteristics of the hemagglutinin (H or HA) and neuramini- dase (N or NA) surface proteins (Treanor, 2010). This subtyping is the basis of the H#N# designations of the influenza A viruses. At least 16 distinct HA and 9 distinct NA surface proteins have been identified (Treanor, 2010). Influenza B viruses are subdivided as Yamagada or Victoria based on genetic lineage (Xu et al., 2004). Of the three distinct types of influenza viruses, influenza A viruses are the only viruses proven to cause pandemic disease and are capable of interspecies transmission, as demonstrated with the 1997 outbreak of avian (H5N1) influenza from poultry to humans (de Jong et al., 1997; Subbarao et al., 1998; Yuen et al., 1998). Influenza viruses have caused epidemics every 1 to 3 years during the past four centuries, and four major pandemics have occurred including the great pandemic of 1918 (Treanor, 2010). These pandemics were caused by influenza A viruses H1N1 (1918 and 2009), H2N2 (1957), and H3N2 (1968) (Treanor, 2010). In any given year, two influenza A strains consid- ered to be most likely to contribute to widespread (epidemic or pandemic) illness are included in the trivalent vaccine. Because of its ability to produce epidemic disease, an influenza B virus strain is also included in all current vaccines. In the United States, a nearly annual influenza epidemic usually begins in late fall and peaks in mid to late winter. Influenza viruses are transmit- ted by contact with aerosol secretions containing the virus, and this occurs generally through coughing and sneezing (Belshe et al., 2008; Treanor, 2010). Following an average incubation period of 2 days but ranging from 1 to 4 days, adults and children remain infectious for approximately 5 days after the onset of the illness (CDC, 2002). Children, who generally have the highest attack rate and serve as the major source of transmission within communities (Glezen and Couch, 1978; Monto and Kioumehr, 1975), can be infectious for longer periods both before and after the onset of illness (Belshe et al., 2008). Uncomplicated influenza often begins abruptly with systemic symptoms of fever, chills, headaches, myalgia, malaise, anorexia, and fatigue. These symptoms persist for the duration of the fever—typically for 3 days (Treanor, 2010). Respiratory symptoms such as dry cough, sore throat, and nonproductive cough may also occur and usually persist for 2 weeks or more (Belshe et al., 2008; Treanor, 2010). Fevers tend to be higher in children and can lead to febrile seizures, while elderly individuals may experience afebrile disease with lassitude or confusion (Babcock et al., 2006; Bridges et al., 2008; Neuzil et al., 2003). The risk of complications from influenza is higher in children and the elderly and those with certain underlying conditions (Barker, 1986; Bridges et al., 2008; Simonsen et al., 2000; Thompson et al., 2004). The most common complications include primary influenza viral pneumonia, secondary bacterial pneumonia, and the

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295 INFLUENZA VACCINE exacerbation of chronic pulmonary and cardiopulmonary diseases such as asthma and congestive heart failure (Bridges et al., 2008). The influenza viruses were first isolated in the early 1900s by Smith and his associates (influenza A, 1933), Francis (influenza B, 1939), and Taylor (influenza C, 1950) (Francis, 1940; Smith et al., 1933; Taylor, 1951). In 1936, Burnet discovered that the virus could be grown in embryonated hen eggs, and in the 1950s animal cell culture systems were developed (Burnet, 1936; Mogabgab et al., 1954; Treanor, 2010). In 1943, the first commercial influenza vaccines were approved for use in the United States, and consisted of inactivated virus grown in chicken eggs (Treanor, 2010). With a few adaptations, propagation of influenza viruses in chicken eggs remains the primary means for growing virus for vaccine production and biomedical research (Treanor, 2010). Currently, two types of vaccines are available in the United States—the trivalent, inactivated influenza virus (TIV) vaccine, and the live, attenuated, cold-adapted influenza virus (LAIV) vaccine (also trivalent). TIV vaccines, which were first licensed for use in the United States in 1943, are inac- tivated (killed) virus vaccines that provide immunity against the viruses without causing any signs or symptoms of the infection (Treanor, 2010). The LAIV vaccine is a live but attenuated virus vaccine that is capable of causing mild signs and symptoms of vaccine virus infection (Treanor, 2010). Approved in 2003, LAIV is a live virus vaccine that is cold-adapted (attenuated) so that it does not replicate in the warmer body temperature of the lower airways (CDC, 2003; Treanor, 2010). It is capable of causing mild signs and symptoms of wild-type influenza infection (Treanor, 2010). TIV is administered through an intramuscular injection, while LAIV is administered intranasally via an aerosol sprayer. Both vaccines contain two influenza A and one influenza B subtypes which are recommended by the World Health Organization (WHO) Global Influenza Programme—for example A/California/7/2009 (H1N1)-like,1 A/Perth/16/2009 (H3N2)-like, and B/Brisbane/60-2008-like for the 2010–2011 season (WHO, 2010). The Advisory Committee on Immunization Practices (ACIP) recom- mends that all persons 6 months or older receive an annual influenza virus vaccine (CDC, 2010b). For healthy, nonpregnant persons aged 2 to 49 years either TIV or LAIV vaccine is recommended without preference (CDC, 2010b). LAIV is not recommended for children under 2 years of 1 A/California/7/2009 (H1N1)-like is derived from the 2009 pandemic influenza A (H1N1) virus. This strain was included in the trivalent vaccine in 2010. The monovalent vaccine developed for the pandemic is not covered under the National Vaccine Injury Compensation Program (VICP); it is covered under the Countermeasures Injury Compensation Program and is therefore beyond the scope of this report.

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296 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY age, pregnant women, adults over 50 years of age, and persons with a history of hypersensitivity to eggs or LAIV vaccine components (CDC, 2010b). It is also not recommended for persons with asthma and children between 2 and 4 years of age with a history of asthma or wheezing episodes in the 12 months prior to vaccination (CDC, 2010b). For these individu- als and individuals with chronic conditions such as hematologic, hepatic, metabolic, neurologic or neuromuscular, pulmonary, or renal disorders; the immunosuppressed; and those between the ages of 6 months and 18 years receiving aspirin or other salicylates; ACIP recommends use of the age-appropriate TIV vaccine (Table 6-1) (CDC, 2010b). In the 2008–2009 season, influenza vaccination was received by 29.1 percent of all persons aged 6 months to 18 years (CDC, 2010a). Thirty- three percent of individuals aged 19 to 49 years, who were considered high-risk for this age group, were vaccinated in comparison to 19.7 per- cent of individuals who were not considered high-risk for influenza (CDC, 2010a). The vaccine was administered to 51.5 percent of high-risk adults aged 50 to 64 years and 34.2 percent of non-high-risk adults in this age group (CDC, 2010a). ENCEPHALITIS AND ENCEPHALOPATHY Epidemiologic Evidence The committee reviewed four studies to evaluate the risk of encepha- litis or encephalopathy after the administration of influenza vaccine. One study (Nakayama and Onoda, 2007) was not considered in the weight of epidemiologic evidence because it provided data from a passive surveil- lance system and lacked an unvaccinated comparison population. Three controlled studies (France et al., 2004; Goodman et al., 2006; Hambidge et al., 2006) had very serious methodological limitations that precluded their inclusion in this assessment. The studies by France et al. (2004), Goodman et al. (2006), and Hambidge et al. (2006) were unable to find any cases of encephalopathy or encephalitis following influenza vaccination using a case-crossover or case-control design, so no conclusions could be drawn from these analyses. Weight of Epidemiologic Evidence The epidemiologic evidence is insufficient or absent to assess an association between influenza vaccine and encephalitis or encephalopathy.

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TABLE 6-1 Influenza Vaccines Licensed and Available in the United States Mercury Content Number (mcg Hg/ of Vaccine Trade Name Manufacturer Presentation 0.5 mL dose) Age Group Doses Route TIVa Fluzone Sanofi Pasteur, Inc. 0.25 mL prefilled syringe 0.0 6–35 months 1 or 2b Intramuscularc 0.5 mL prefilled syringe 0.0 36 months– 1 or 2b Intramuscularc 8 years 0.5 mL single-dose vial 0.0 1 or 2b Intramuscularc ≥ 36 months 5.0 mL multidose vial 25.0 1 or 2b Intramuscularc ≥ 6 months TIV Fluzone Sanofi Pasteur, Inc. 0.1 mL prefilled 0.0 18–64 years 1 Intradermal Intradermal microinjection system TIV Fluzone High-Dosed Sanofi Pasteur, Inc. 0.5 mL prefilled syringe 0.0 1 Intramuscularc ≥ 65 years TIV Fluvirin Novartis Vaccines and 5.0 mL multidose vial 25.0 1 or 2b Intramuscularc ≥ 4 years Diagnostics Limited 0.5 mL prefilled syringe 0.0 1 or 2b Intramuscularc ≥ 4 years TIV Fluarix GlaxoSmithKline 0.5 mL prefilled syringe 0.0 1 or 2b Intramuscularc ≥ 3 years TIV FluLaval ID Biomedical 5.0 mL multidose vial 25.0 1 Intramuscularc ≥ 18 years Corporation of Quebec TIV Afluria CSL Limited 0.5 mL prefilled syringe 0.0 1 or 2b Intramuscularc ≥ 5 years 5.0 mL multidose vial 24.5 1 or 2b Intramuscularc ≥ 5 years 297 continued

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TABLE 6-1 Continued 298 Mercury Content Number (mcg Hg/ of Vaccine Trade Name Manufacturer Presentation 0.5 mL dose) Age Group Doses Route TIV Agriflu Novartis Vaccines and 0.5 mL prefilled syringe 0.0 1 Intramuscularc ≥ 18 years Diagnostics, Inc. LAIVe FluMistf MedImmune, LLC 0.2 mL sprayer, divided dose 0.0 2–49 years 1 or 2b Intranasal a Trivalent inactivated vaccine. b Children less than 9 years of age not previously vaccinated with an influenza vaccine or vaccinated for the first time in the last season with only one dose should receive two doses, spaced more than 4 weeks apart. Children less than 9 years of age given two doses in the previous season and individuals greater than 9 years of age should receive only one dose of the vaccine. c For adults and older children, the recommended site of vaccination is the deltoid muscle. If applicable, the preferred site for infants and young children is the anterolateral aspect of the thigh. d Trivalent inactivated vaccine high dose. A 0.5-mL dose contains 60 mcg each of A/California/7/2009 (H1N1)-like, A/Perth/16/2009 (H3N2)-like, and B/Brisbane/60/2008-like antigens. e Live attenuated influenza vaccine. f FluMist is shipped refrigerated and should be stored in the refrigerator between 36°F and 46°F (2°C to 8°C) after arrival in the vaccination clinic. The dose is 0.2 mL divided equally between each nostril. SOURCES: CSL Limited, 2011; GlaxoSmithKline, 2011a,b; MedImmune, LLC, 2011; Novartis Vaccines and Diagnostics, Inc., 2010, 2011; Sanofi Pasteur, 2011.

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299 INFLUENZA VACCINE Mechanistic Evidence Regarding Encephalitis The committee identified 11 publications reporting meningoencephali- tis or encephalitis after administration of an influenza vaccine. Ten publi- cations did not provide evidence beyond temporality (Blanco et al., 1999; Buchner et al., 1988; Chhor et al., 2008; Drouet et al., 2002; Ehrengut and Allerdist, 1977; Gross et al., 1978; Rosenberg, 1970; Saito and Yanagisawa, 1989; Turkoglu and Tuzun, 2009; Utumi et al., 2010). One publication at- tributed the development of encephalitis after vaccination to a concomitant infection with herpes simplex virus (Utumi et al., 2010). These publications did not contribute to the weight of mechanistic evidence. Described below is one publication reporting clinical, diagnostic, or ex- perimental evidence that contributed to the weight of mechanistic evidence. Froissart et al. (1978) described a 29-year-old woman presenting with vomiting, fever, and a stiff neck leading to a diagnosis of meningoencepha- litis 2 days after administration of an influenza vaccine. The previous year the patient presented with similar symptoms 2 days after receiving an influenza vaccine. Weight of Mechanistic Evidence While rare, infection with influenza has been associated with encephali- tis (Treanor, 2010). The committee considers the effects of natural infection one type of mechanistic evidence. The publication, described above, did not present evidence sufficient for the committee to conclude the vaccine may be a contributing cause of encephalitis after administration of an influenza vaccine. The symptoms described in the publications referenced above are consistent with those leading to a diagnosis of encephalitis, but the only evidence that could be attributed to the vaccine was recurrence of symptoms upon vaccine rechal- lenge. Viral infection and viral reactivation may contribute to the symptoms of encephalitis; however, the publications did not provide evidence linking these mechanisms to influenza vaccine. The committee assesses the mechanistic evidence regarding an as- sociation between influenza vaccine and encephalitis as weak based on knowledge about the natural infection and one case. Causality Conclusion Conclusion 6.1: The evidence is inadequate to accept or reject a causal relationship between influenza vaccine and encephalitis.

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300 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY Mechanistic Evidence Regarding Encephalopathy The committee identified five publications reporting encephalopathy after administration of an influenza vaccine. Three publications did not pro- vide evidence beyond temporality and therefore did not contribute to the weight of mechanistic evidence (Ehrengut and Allerdist, 1977; Morimoto et al., 1985; Woods and Ellison, 1964). Described below are two publications reporting clinical, diagnostic, or experimental evidence that contributed to the weight of mechanistic evidence. Boutros and Keck (1993) described a 75-year-old woman presenting with confusion 12 days after receiving an influenza vaccine. Physical ex- amination showed anorexia, insomnia, hallucinations, and delirium. High signal lesions in the white matter were revealed upon magnetic resonance imaging. The symptoms resolved upon treatment with thiothixene. One year prior to the current episode the patient developed similar symptoms 21 days after receiving an influenza vaccine. Warren (1956) described a 19-year-old man presenting with profuse rhinorrhea, wheezing, feverishness, soreness behind the eyes, shaking chills, and aching of the arms, back, and head hours after receiving an influenza vaccine. Two hours later the patient was weak, dizzy, unable to sit upright, and began to black out. Physical examination revealed the patient to be semicomatose and delirious. One year prior to the current episode the pa- tient had presented with severe malaise 2 days after receiving an influenza vaccine. Weight of Mechanistic Evidence The publications described above did not present evidence sufficient for the committee to conclude the vaccine may be a contributing cause of encephalopathy after administration of an influenza vaccine. The symptoms described in the publications referenced above are consistent with those leading to a diagnosis of encephalopathy, but the only evidence that could be attributed to the vaccine was recurrence of symptoms upon vaccine rechallenge. Viral infection and viral reactivation may contribute to the symptoms of encephalopathy; however, the publications did not provide evidence linking these mechanisms to influenza vaccine. The committee assesses the mechanistic evidence regarding an as- sociation between influenza vaccine and encephalopathy as weak based on two cases.

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301 INFLUENZA VACCINE Causality Conclusion Conclusion 6.2: The evidence is inadequate to accept or reject a causal relationship between influenza vaccine and encephalopathy. SEIZURES Epidemiologic Evidence The committee reviewed eight studies to evaluate the risk of seizures after the administration of influenza vaccine. Four studies (D’Heilly et al., 2006; Izurieta et al., 2005; McMahon et al., 2005; Rosenberg et al., 2009) were not considered in the weight of epidemiologic evidence because they provided data from passive surveillance systems and lacked unvaccinated comparison populations. The four remaining controlled studies (France et al., 2004; Goodman et al., 2006; Greene et al., 2010; Hambidge et al., 2006) were included in the weight of epidemiologic evidence and are described below. France et al. (2004) conducted a case-crossover study in 251,600 chil- dren (younger than 18 years of age) enrolled in five health maintenance organizations (HMOs) participating in the Vaccine Safety Datalink (VSD). The study investigated the occurrence of adverse events (reported as out- patient, inpatient, and emergency department visits) within 14 days of TIV administration from January 1993 through December 1999. Two control periods were defined as 15 to 28 days before vaccination (control period 1) and 15 to 28 days after vaccination (control period 2). The inclusion criteria required participants to be enrolled in the HMO 28 days before and 28 days after receiving TIV, and have a record of an adverse event in either the risk period or one of the two control periods. Study participants were excluded from the analysis if they experienced an event during both the risk period and one of the control periods, which limited the analysis to discordant pairs. Multiple vaccinations in an individual were treated as independent in the analysis and the pre- and postvaccination control peri- ods in the same individual were analyzed independently, which would tend to increase the number of associations found to be significant by chance alone (type I error). Seizures were observed in 81 children, but no signifi- cant associations were reported for outpatient, inpatient, and emergency department visits for seizures during the 14-day risk period when compared to the prevaccination control period or postvaccination control period. Ad- ditional analyses with liberalized significance criterion (.05 < p ≤ .20) were used to identify potentially overlooked associations, but seizures remained nonsignificant. Hambidge et al. (2006) conducted case-crossover analysis to examine

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302 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY the risk of seizures after influenza vaccination in 45,356 children (6 to 23 months of age) enrolled in eight medical care organizations (MCOs) partici- pating in the VSD. The study investigated the occurrence of adverse events (reported as outpatient, inpatient, and emergency department visits) within 14 days (primary analysis) of TIV administration from 1991 through 2003. Two control periods were defined as 15 to 28 days before vaccination (con- trol period 1) and 15 to 28 days after vaccination (control period 2). Only discordant pairs were analyzed, and participants that experienced an event during both the risk period and one of the control periods were excluded. Half of the study population overlapped the patients observed in the study by France et al. (2004), but separate analyses for the unique subgroups presented in this paper (1991–1992 and 2000–2003) were not performed. A total of 24 seizures were observed in the 14-day risk window; 22 were found to be febrile seizures, and 17 were reported during the same period that has been associated with febrile seizures following measles, mumps, and rubella (MMR) immunization (7–14 days postvaccination). Children who received MMR vaccine on the same day as TIV were excluded from the analysis (nine cases and one control). The matched odds ratio for sei- zures within 14 days of TIV administration was 1.36 (95% CI, 0.63–2.97). The authors concluded that after excluding children who received MMR vaccine on the same day, TIV administration was not associated with an increased risk in febrile seizures. They also noted that no signal of seizures within 3 days of TIV administration was observed. Goodman et al. (2006) conducted a nested case-control study in children (6 to 23 months of age) enrolled in the HealthPartners Medical Group (HPMG) during the 2002–2003 and 2003–2004 influenza seasons. Vaccination histories were obtained from the HPMG vaccine registry and the investigators coded whether the TIV injection was a first or second dose during the given influenza season. Seizure diagnoses were verified by reviewing the medical charts. The risk window was defined as 0–42 days following vaccination, but the investigators also analyzed 0–3-day, 4–14-day, and 14–42-day windows. The cohort included 13,383 children, of whom 3,697 received TIV during the study period. Cases were matched to three controls (children who did not have the outcome of interest) on date of birth and gender; the index date for the controls was the date the event was observed in the matched case. The authors did not report how many cases and controls were included in the seizure analysis or list characteristics of these two groups. The hazard ratio for seizures within 42 days of a first dose of TIV was 1.17 (95% CI, 0.36–3.86), and within 42 days of a second dose of TIV the hazard ratio was 1.026 (95% CI, 0.19–5.56). Shorter time windows did not have the power to assess the hazard ratio for seizures following TIV and were not listed in the study.

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303 INFLUENZA VACCINE The authors concluded that TIV administration is not associated with an increased rate of seizures. Greene et al. (2010) conducted a retrospective cohort study in children (6 months to 17 years of age) and adults (≥ 18 years of age) enrolled in eight MCOs participating in the VSD. The study investigated the occur- rence of adverse events (reported as inpatient and emergency department visits) after receipt of influenza vaccine from September through April of the 2005–2006, 2006–2007, and 2007–2008 influenza seasons. The risk period for the seizures analysis (0 to 7 days after vaccination) of the given season was compared to the control period (8 to 15 days after vaccination) of the same season. The number of vaccine doses administered to children during the 2005–2006 season was 317,108; during the 2006–2007 season was 415,446; and during the 2007–2008 season was 462,998. The relative risk of seizures in children within 7 days of influenza vaccination was 1.35, 0.80, and 0.98 for the 2005–2006, 2006–2007, and 2007–2008 influenza seasons, respectively. The number of vaccine doses administered to adults during the 2005–2006 season was 1,429,974; during the 2006–2007 season it was 1,598,880; and during the 2007–2008 season it was 1,742,858. The relative risk of seizures in adults within 7 days of influenza vaccination was 0.99, 0.96, and 1.09 for the 2005–2006, 2006–2007, and 2007–2008 influenza seasons, respectively. None of the associations reached the criti- cal value of the log-likelihood ratio, and none of the relative risks achieved statistical significance. This paper also included an analysis comparing rate ratios in the current year with the cumulative ratios in prior comparison years. All of these comparisons also found no increase in seizures in the risk period. Weight of Epidemiologic Evidence Analyses from four studies (one retrospective cohort, one case-control, and two case-crossover designs) were included in the epidemiologic evi- dence. France et al. (2004) did not find a statistically significant association between seizures and TIV, even with liberalized significance criterion (.05 < p ≤ .20). The study by Hambidge et al. (2006) observed a null association in seizures within 14 days of TIV administration when children who received MMR simultaneously with TIV were removed from the case-crossover analysis. The case-control study by Goodman et al. (2006) found no asso- ciation between seizures and TIV, but the precision was low. Greene et al. (2010) did not find a statistically significant association among the analyses for children and adults; however, the control period was within the risk period of the other papers. Although power was limited in all the studies, they were generally well done and results were consistent, supporting the

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