5

Varicella Virus Vaccine

INTRODUCTION

Varicella, more commonly known as chickenpox, is caused by the human alpha herpesvirus varicella zoster virus (VZV). Transmitted through direct contact with or inhalation of infectious fluid, VZV is highly contagious and infects approximately 90 percent of susceptible household contacts and 10 to 35 percent of individuals with limited exposure (Arvin, 1996; Ross et al., 1962).

The incubation period of VZV from exposure to illness is 10–21 days (Arvin, 1996). During most of this time, the individual is asymptomatic. About 50 percent of cases will experience fever, headache, abdominal pain, or general malaise within 24–48 hours prior to the onset of typical chickenpox rash (Arvin, 1996). The varicella rash is characterized by pruritic, erythematous papules which develop into small, fluid-filled vesicles usually beginning on the scalp, face, or torso before spreading to proximal limbs and mucosal areas such as the conjunctivae (eye), oropharynx (back of the throat), and vagina (Arvin, 1996). In uncomplicated VZV infection, new lesions may form for up to 7 days (Arvin, 1996). The infected individual is considered contagious from 1–2 days prior to the appearance of the first lesion until all lesions have crusted, approximately 24–48 hours after the appearance of the last lesion, and generally within 4–7 days of symptom onset (AAP, 2009; Arvin, 1996).

Possible complications from varicella infection include pneumonia and secondary bacterial infections typically due to Staphylococcus aureus and streptococcus; transient hepatitis; thrombocytopenia; and various neu-



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5 Varicella Virus Vaccine INTRODUCTION Varicella, more commonly known as chickenpox, is caused by the hu- man alpha herpesvirus varicella zoster virus (VZV). Transmitted through direct contact with or inhalation of infectious fluid, VZV is highly con- tagious and infects approximately 90 percent of susceptible household contacts and 10 to 35 percent of individuals with limited exposure (Arvin, 1996; Ross et al., 1962). The incubation period of VZV from exposure to illness is 10–21 days (Arvin, 1996). During most of this time, the individual is asymptomatic. About 50 percent of cases will experience fever, headache, abdominal pain, or general malaise within 24–48 hours prior to the onset of typical chick- enpox rash (Arvin, 1996). The varicella rash is characterized by pruritic, erythematous papules which develop into small, fluid-filled vesicles usually beginning on the scalp, face, or torso before spreading to proximal limbs and mucosal areas such as the conjunctivae (eye), oropharynx (back of the throat), and vagina (Arvin, 1996). In uncomplicated VZV infection, new lesions may form for up to 7 days (Arvin, 1996). The infected individual is considered contagious from 1–2 days prior to the appearance of the first lesion until all lesions have crusted, approximately 24–48 hours after the appearance of the last lesion, and generally within 4–7 days of symptom onset (AAP, 2009; Arvin, 1996). Possible complications from varicella infection include pneumonia and secondary bacterial infections typically due to Staphylococcus aureus and streptococcus; transient hepatitis; thrombocytopenia; and various neu- 239

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240 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY rologic complications including cerebellar ataxia, encephalitis, Guillain- Barré syndrome (GBS), meningitis, and transverse myelitis (Ey et al., 1981; Fleisher et al., 1981; Guess et al., 1986; Jackson et al., 1992; Liu and Urion, 1992; Preblud, 1986). Immunocompromised individuals such as those treated for cancer or with congenital defects in cellular immunity often experience more severe varicella infection and are at greater risk of fatal infection (Whitley, 2010). Following the acute phase of the infection, the primary VZV infection is resolved, and the virus begins a dormant phase in the sensory nerve gan- glia of the individual. The individual usually has lifetime immunity against reinfection, and will not again have an illness that resembles primary chickenpox; however, the latent VZV may be reactivated and cause shingles (also called herpes zoster [HZ]). Shingles (or HZ) is a painful, unilateral, pruritic rash appearing on dermatomal areas of one or more sensory-nerve roots (Arvin, 1996). Risk factors for shingles include aging, immunosup- pression, and VZV infection prior to 12 months of age (Arvin, 1996). An estimated 15 to 30 percent of the population develops shingles, a percentage that is expected to increase with increasing life expectancies (CDC, 2007). Postherpetic neuralgia (PHN) is the most common complication of herpes zoster, especially in older individuals (CDC, 2007). The pain of PHN can last from 4 weeks to 10 years, and in one study, it lasted more than 1 year in 22 percent of study participants (Arvin, 1996; Ragozzino et al., 1982). Additional complications of herpes zoster include herpes ophthalmicus, dissemination, and central nervous system, pulmonary, and hepatic disease (CDC, 2007). Prior to the development and dissemination of the varicella vaccine in 1995, varicella was a common childhood disease in the United States. The Centers for Disease Control and Prevention (CDC) estimates that from 1980 through 1990, 4 million cases of varicella occurred annually with approximately 77 percent of cases in children 9 years old and younger, and more than 90 percent in children less than 15 years of age (CDC, 2007). Furthermore, national seroprevalence data from 1988–1994 showed that 95.5 percent of adults aged 20–29 years, 98.9 percent of adults aged 30–39 years, and 99.6 percent of adults aged 40 years and older were immune to varicella (Kilgore et al., 2003). From 1988 through 1995, hospitalizations due to varicella ranged from 2.3 to 7.0 per 100,000 cases (CDC, 2007). Among those most often hospitalized were adults 20 years of age and older, and children 4 years and younger, respectively representing 31.9 and 44.4 percent of varicella- related hospitalizations (Galil et al., 2002). Despite adults being less likely to require hospitalization due to varicella infection, from 1990 to 1994 adults were 25 times more likely to experience fatal varicella infections than children between the ages of 1 and 4 years (Meyer et al., 2000). Secondary

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241 VARICELLA VIRUS VACCINE infections, central nervous system complications including encephalitis, and pneumonia were among the most common causes of hospitalization and death, and these instances occurred most often in healthy individuals who were not severely immunocompromised or undergoing immunocompromis- ing treatments (Meyer et al., 2000). Since the 1980s, VZV infections in immunocompromised individuals have been treated with acyclovir, a synthetic nucleoside analog that inhibits the replication of human herpes viruses including VZV. In 1992, acyclovir was approved for the treatment of VZV infection in healthy children (CDC, 2007). Used within 24 hours of initial presentation, intravenous acyclovir effectively lessens illness severity and fatality in immunocompromised indi- viduals (Nyerges et al., 1988; Prober et al., 1982). In 1992, oral acyclovir was approved for treatment of varicella in healthy children based on study data indicating favorable clinical outcomes, for example shortening of dis- ease and contagious state, and severity of symptoms, if administered within 24 hours of rash onset (CDC, 2007). However, in 1993, the American Academy of Pediatrics Committee on Infectious Disease issued a statement that the benefit of acyclovir was not sufficient to justify routine administra- tion in healthy children (CDC, 2007). Instead, they recommended that the oral treatment be reserved for otherwise healthy individuals at increased risk for moderate to severe varicella such as individuals 13 years or older and persons with chronic skin or pulmonary disorders (Hall et al., 1993). The first live attenuated varicella vaccine was developed and tested in Japan by Takahashi and colleagues in the 1970s. The virus, designated Oka strain, was isolated from vesicular fluid of a healthy 3-year-old boy infected with VZV (Takahashi et al., 1975). The virus was attenuated through serial passaging through human embryonic lung cells, guinea-pig cells, and human diploid cells (WI-38 and MRC-5) (Arvin and Gershon, 1996). Takahashi et al. inoculated 51 healthy children who subsequently experienced a 92 percent VZV antibody formation rate (Takahashi et al., 1975). Following this study, Takahashi and his associates studied the im- pact of the vaccine on the VZV seroconversion in children with underlying diseases such as nephritis, asthma, and hepatitis. This study showed that the VZV vaccine was safe for children receiving low to moderate doses of steroids (Takahashi et al., 1974, 1975). Reports of varicella vaccination in immunocompromised children showed that with suspended chemotherapy, children with leukemia could be vaccinated successfully against VZV (Arvin and Gershon, 1996). These studies spurred similar studies in the United States and Canada. In 1979, the National Institute of Allergy and Infectious Diseases sponsored the Varicella Vaccine Collaborative Study that looked at the effectiveness of the vaccine on children whose leukemia was in remission. The Collabora- tive Study showed seroconversion in 88 percent of leukemic children after

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242 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY the first dose and a 98 percent conversion after the second dose (Gershon and Steinberg, 1989). In 1995, the live, attenuated virus vaccine, Varivax (Merck & Co., Inc.) was licensed in the United States for use in healthy individuals greater than 12 months of age (CDC, 2007). The vaccine contains 1,350 plaque- forming units (PFUs) of Oka/Merck VZV; 25 mg of sucrose; 12.5 mg of hydrolyzed gelatin; and trace amounts of neomycin, fetal bovine serum, and residual components of MRC-5 (CDC, 2007). In 2005, Merck received licensure from the Food and Drug Administration to release the combina- tion measles, mumps, rubella, and varicella (MMRV) vaccine ProQuad (Merck) for use among healthy children aged 12 months through 12 years (CDC, 2007). Each dose of ProQuad contains at least 3.0 log10 TCID50 of measles virus, 4.3 log10 TCID50 of mumps virus, and 3.0 log10 TCID50 of rubella virus in addition to 3.99 log10 PFUs of the attenuated varicella virus (Merck & Co., Inc., 2009). Currently, two 0.5-mL doses of varicella vaccine are recommended for children older than 12 months, adolescents, and adults who show no evidence of prior immunity (CDC, 2007). For children aged 12 months to 12 years, the recommended minimum interval between the two doses is 3 months (CDC, 2007). For persons greater than 13 years of age, the recom- mended minimum interval is 4 weeks (CDC, 2007). Because of greater as- sociation with fevers and febrile seizures after MMRV vaccine as compared to the MMR and monovalent varicella vaccines as separate injections, the Advisory Committee on Immunization Practices recommends that indi- viduals between 12 and 47 months of age receive the MMR and monova- lent varicella vaccines as separate injections or MMRV for the first dose of the vaccines at the discretion of the administering physician and the parents (CDC, 2010b). The combination MMRV vaccine is preferred as a second dose for individuals aged between 12 months and 12 years, and as a first dose for individuals greater than 4 years of age when all four vaccines are needed and none are contraindicated (CDC, 2006, 2010b). Since 2005, about 90 percent of U.S. children aged 19–35 months have received at least one dose of varicella vaccine (CDC, 2010a). DISSEMINATED OKA VZV WITHOUT OTHER ORGAN INVOLVEMENT This review of adverse events related to disseminated Oka VZV or vaccine-strain viral reactivation is divided into four sections. Two sections deal with initial adverse events (1) limited to the skin or (2) involving dis- semination to other organs. The other two sections report cases of VZV reactivation as zoster either (1) involving dissemination limited to the skin or (2) involving dissemination to other organs. In the cases limited to the

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243 VARICELLA VIRUS VACCINE skin, the committee reports cases in which the rash appeared in more than one dermatome and, hence, had disseminated beyond the site of the initial vaccination. Not all cases could easily be assigned to one or another sec- tion. The committee arbitrarily placed all cases reporting herpes zoster in the viral reactivation sections even when these rashes appeared early after administration of the vaccine. “Disseminated” in this section refers to the spreading of the rash be- yond the dermatome involved in the vaccination. Reports in which there were a few vesicles at the site of the injection were not included. The cases that were used to definitively show the association were those in which (i) the patient received the varicella vaccine currently in use in the United States or one similar, (ii) the rash extended to dermatomes beyond that of the initial injection, and (iii) vaccine virus was demonstrated in skin lesions. Epidemiologic Evidence The committee reviewed three studies to evaluate the risk of dissemi- nated Oka VZV without other organ involvement after the administration of varicella vaccine. These three studies (Chaves et al., 2008; Sharrar et al., 2001; Wise et al., 2000) were not considered in the weight of epidemiologic evidence because they provided data from passive surveillance systems and lacked unvaccinated comparison populations. Weight of Epidemiologic Evidence The epidemiologic evidence is insufficient or absent to assess an association between varicella vaccine and disseminated Oka VZV without other organ involvement. Mechanistic Evidence The committee identified 54 publications reporting disseminated Oka VZV without other organ involvement after vaccination against varicella. Thirty-three publications either did not provide evidence beyond temporal- ity or demonstrated wild-type varicella virus in the vesicles (Alpay et al., 2002; Austgulen, 1985; Barton et al., 2009; Barzaga et al., 2002; Brunell et al., 1982; Chaves et al., 2005; Diaz et al., 1991; Donati et al., 2000; Haas et al., 1985a,b; Hadinegoro et al., 2009; Heath and Malpas, 1985; Heller et al., 1985; Kamiya et al., 1984; Katsushima et al., 1982; Konno et al., 1984; Kreth and Hoeger, 2006; Lassker et al., 2002; Leung et al., 2004; Lydick et al., 1989; Minamitani et al., 1982; Nunoue, 1984; Oka et al., 1984; Quinlivan et al., 2009; Shah et al., 2007; Shiow et al., 2009; Slordahl et al., 1984, 1985; Sorensen et al., 2009; Sugino et al., 1984; Takahashi

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244 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY et al., 1985; Ueda et al., 1977; Zamora et al., 1994). These publications did not contribute to the weight of mechanistic evidence. Described below are 21 publications reporting clinical, diagnostic, or experimental evidence that contributed to the weight of mechanistic evi- dence. The studies are grouped to indicate the certainty that the vaccine was sufficiently similar to that used currently in the United States and that there was primary dermal dissemination of vaccine virus. The vaccine which has been in use in the United States since 1995 contains a minimum of 1,350 PFUs of Oka VZV virus. Studies from prior to general use of the vaccine report many rashes and other adverse events associated with wild-type varicella virus because of the high prevalence of wild-type disease. Cases of Primary Dermal Dissemination of Vaccine Virus Jean-Philippe et al. (2007) describe an 18-month-old girl, subsequently diagnosed with a T cell dysfunction, presenting with fever and papulo- vesicular/pustular skin lesions beginning on the trunk and spreading to cover the patient’s entire body including the soles, palms, and scalp five weeks after receiving a varicella vaccine. New lesions continued to appear for more than 14 days after the appearance of the initial lesions. Vaccine- strain varicella was demonstrated, by polymerase chain reaction (PCR), in a biopsy of the skin lesions. Angelini et al. (2009) describe a 17-month-old girl presenting with fever and vesicular-hemorrhagic lesions on the entire body 23 days after receiving a varicella vaccine. Laboratory tests showed pancytopenia re- flecting macrocytic-normochromic-hyporegenerative anemia. Vaccine-strain varicella virus was demonstrated, by PCR, in skin lesions. Kraft and Shaw (2006) described a 36-year-old man presenting with pruritic lesions on the face, limbs, and trunk 24 days after receiving a varicella vaccine and 2 years after undergoing a heart transplant. The pa- tient was taking mycophenylate mofetil and cyclosporine twice daily. New lesions developed 3 days later. Vaccine-strain varicella virus was demon- strated, by PCR, in the lesions. Other Cases There were five publications describing reports submitted to passive surveillance systems regarding rash associated with vaccine virus without other organ involvement in the first 42 days after vaccination. The limita- tion of these publications is that the distribution of the rash is not reported, so the committee cannot conclude that the rash disseminated beyond the site of the initial injection. Chaves et al. (2008), Galea et al. (2008), Sharrar et al. (2001), and Wise et al. (2000) described the development of rashes after administration of a varicella vaccine reported to either the Vaccine

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245 VARICELLA VIRUS VACCINE Adverse Event Reporting System (VAERS) or Merck’s Worldwide Adverse Experience System (WAES). Sharrar et al. (2001) report that all of the reports submitted to WAES are submitted to VAERS. Due to the use of the same databases, it is likely that many of the cases overlap in the four publications. Chaves et al. (2008) identified 8,262 reports of rash submitted to VAERS from May 1995 through December 2005. The authors reported that of 209 specimens, submitted to the National VZV Laboratory at the CDC, 55 were wild-type varicella virus and 37 were vaccine-strain varicella virus. The remaining specimens either tested negative for varicella virus or were inadequate for testing. Galea et al. (2008) identified 3,192 reports of rash developing within 42 days of vaccination submitted to WAES in the first 10 years of the licensure of the varicella vaccine in the United States. The authors report that of 130 specimens submitted to the Varicella Zoster Virus Identification Program (VZVIP), 42 were wild-type varicella virus and 37 were vaccine- strain varicella virus. The remaining specimens were negative for varicella virus, positive for varicella virus but untypable, or inadequate samples. Sharrar et al. (2001) identified 1,349 reports of rash developing within 42 days of vaccination submitted to VAERS and WAES during the first 4 years of marketing the varicella vaccine licensed in the United States. Ninety-seven specimens were available for analysis by PCR. Of these, 38 were wild-type varicella virus, 24 were vaccine-strain varicella virus, 19 were inadequate, 8 were negative for varicella virus, and 8 were positive for varicella virus but the strain was not identified. Wise et al. (2000) identified 3,640 reports of rash submitted to VAERS from March 1995 through July 1998. Varicella virus was demonstrated, by PCR, in 70 rash specimens. Of these, the strain was not identified in 5, 43 were wild-type varicella virus, and 22 were vaccine-strain varicella virus. Goulleret and colleagues (2010) used data from the European VZVIP to study adverse events reported after vaccination against varicella after introduction of the varicella vaccine, licensed for use in the United States, in Europe. The authors identified 259 reports of rash developing within 42 days after vaccination. Specimens were collected from 44 of these cases and analyzed by PCR. Of these, 3 were inadequate samples, 4 were negative for varicella virus, 32 were wild-type varicella virus, and 5 were vaccine-strain varicella virus. Described below are 13 publications in which vaccine-strain varicella was demonstrated in the skin in individuals after vaccination. However, the vaccine was either not that used in the United States, it is unclear which vaccine was used, or it is unclear that the rash was disseminated beyond the dermatome in which the vaccine was administered. Bancillon et al. (1991) administered a varicella vaccine to 33 acute lymphoblastic leukemia (ALL) and 4 acute myeloblastic leukemia children.

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246 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY Maintenance therapy consisting of 6-mercaptopurine, methotrexate, vincristine, and prednisolone for ALL patients and 6-mercaptopurine and cytosine arabinoside for acute myeloid leukemia patients was suspended 8 days before and 8 days after vaccination. Eight of the children experi- enced varicella developing 21 to 87 days postvaccination. Vaccine-strain varicella virus was demonstrated in one patient. This report is included in the “primary infection” section despite the length of days (up to 87) in which the rashes appeared because these children were immunosuppressed. It is likely that primary infection could manifest itself with a different time course than that of normal healthy children. Brunell et al. (1987) administered a varicella vaccine (from three sources) to 52 children with acute lymphocytic leukemia. In children receiv- ing chemotherapy the treatment was suspended 1 week prior to vaccination and 1 week after vaccination. The authors reported fever, lymphadenopa- thy, malaise, back and joint pain, and vesicular rashes after vaccination. Vesicular lesions developed between 18 and 36 days after vaccination in 5 of the 52 children immunized. Vaccine-strain varicella virus was dem- onstrated, by restriction endonuclease analysis, in vesicular fluid isolated from two of the five children presenting with vesicular rashes. In the three remaining children either no virus was demonstrated in vesicular fluid or specimens were not obtained. Christensen et al. (1999) describe a girl 3 years, 6 months old with acute lymphocytic leukemia presenting with typical varicella 32 days after vaccination and 29 days after receiving a bolus of vincristine. Maintenance chemotherapy consisting of 6-mercaptopurine and methotrexate was sus- pended before and after vaccination. Vaccine-strain varicella virus was demonstrated in vesicular fluid by restriction endonucelase analysis. Gelb et al. (1987) administered a varicella vaccine (“research” and “consistency” lots) to 350 children with acute lymphocytic leukemia in remission for at least 1 year and 117 normal adults. The authors report that rashes were more common in children receiving chemotherapy than in those who completed chemotherapy. The rashes developed between 1 and 6 weeks after vaccination. Varicella virus demonstrated in eight children was determined to be vaccine-strain varicella virus in three children and wild- type varicella virus in three children by restriction endonuclease analysis. In two children the type of varicella virus was not determined. Gershon et al. (1984a) administered a varicella vaccine to 191 children with acute leukemia in remission for 1 year or more. Of the children, 53 were no longer receiving chemotherapy while chemotherapy was suspended in 138. Two of the 53 children no longer receiving chemotherapy and 49 of the 138 children whose chemotherapy was suspended developed rashes after vaccination. Vaccine-strain varicella virus was demonstrated in two of these children by restriction endonuclease analysis. A follow-up publi-

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247 VARICELLA VIRUS VACCINE cation on the same group of children had similar results (Gershon et al., 1984b). Gershon et al. (1985) presented data from this collaborative study after the total enrollment had increased to 240 children. They reported that vaccine-strain varicella virus was demonstrated by restriction endonuclease analysis in rashes in four children undergoing maintenance chemotherapy. After the enrollment had increased to 307 children with acute lymphocytic leukemia, Gershon et al. (1986) published updated follow-up results. At this time point, the children had been in remission from 9 to 52 months. The authors reported maculopapular or papulovesicular rashes developing about 1 month after vaccination in three children not receiving maintenance chemotherapy and 100 children receiving maintenance chemotherapy. Vaccine-strain varicella virus was demonstrated, by restriction endonuclease analysis, in eight children. When enrollment had reached 437 children with leukemia in remission for 1 year or more, Gershon et al. (1989) published another follow-up report. As reported in the previous publications, for those patients receiving maintenance chemotherapy, therapy was suspended 1 week before and after vaccination. Seven of the 65 patients no longer receiving chemotherapy and 149 of the 372 patients whose chemotherapy was stopped for the vaccination developed rashes. Vaccine-strain varicella virus was demonstrated in 17 of these children by restriction endonuclease analysis. In this report, Gershon et al. (1989) reported that the source of vaccine for the entire study to that time included multiple lots from two different companies. Ninane et al. (1985) administered a varicella vaccine to 45 children with either acute leukemia or solid malignant tumors. In leukemia patients maintenance therapy was suspended 1 week before and 1 week after vac- cination. In patients with solid tumors the vaccine was administered in the middle of a 4-week interval in their therapy. Clinical varicella developed in 8 of the 45 children. Vaccine-strain varicella virus was demonstrated in a vesicle in one of the eight children. In the remaining seven children, wild-type varicella virus was demonstrated in four and no virus was dem- onstrated in three. White et al. (1991) reviewed data from a multicenter trial of five pro- duction lots of vaccine in 3,303 children and adolescents. Three of the five lots had fewer than the current minimum 1,350 PFUs per dose. The authors reported cases of injection site complaints and rashes developing after vac- cination. Specimens were collected from 32 patients for analysis. Of these, 11 were varicella virus. Nine of these samples were further analyzed by restriction endonuclease analysis. Of these nine specimens, eight were wild- type varicella virus and one was vaccine-strain varicella virus. Hughes et al. (1994) describe a 5-year-old boy, diagnosed with ALL, presenting with maculopapular lesions on the right cheek and right leg 8 days after receiving a varicella vaccine and 2 years after remission was

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248 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY achieved. He was given the varicella vaccine as part of the vaccine study de- scribed by Gershon et al. (1984a,b, 1985, 1989). The source of the vaccine was not listed in the report. Maintenance chemotherapy was suspended for the week before and week after vaccination. New skin lesions continued to appear over the next 10 days. The patient had more than 200 skin lesions 32 days after vaccination. The 3-year-old sister of the vaccinee developed vesicles on her face and trunk 14 days after the vaccinee was hospitalized. Furthermore, 16 days after the vaccinee’s hospitalization the 22-month-old brother of the vaccinee developed vesicles on his scalp and trunk. Vaccine- strain varicella was demonstrated, by PCR, in the lesions developing on the vaccinee’s siblings. Although vaccine virus was not demonstrated in the vaccine recipient, this report is included because the siblings developed a rash associated with vaccine virus. One case describes primary dissemination of vaccine virus, but it is not proven that vaccine virus was involved. Levitsky et al. (2002) described a 60-year-old woman who received a varicella vaccine 11 months after undergoing an orthotopic liver transplant. At the time of vaccination she was taking tacrolimus, sirolimus, and prednisone daily. Three weeks after vaccination she presented with small blisters on her abdomen, back, and shoulders. The blisters resolved after undergoing treatment with acyclovir. Two days after completing the acyclovir treatment a pruritic erythema- tous rash developed on her legs and abdomen followed by the eruption of clear vesicles in a multidermatomal distribution. The vesicles resolved after undergoing treatment with acyclovir. Varicella virus was detected, by a direct fluorescent antibody test and rapid shell vial test, in scrapings of the vesicles. The virus was unable to be cultured and was not typed. Given the age of this subject, even though she did not remember having had varicella, it is possible that the rash was wild type, not vaccine related. Weight of Mechanistic Evidence Infection with varicella zoster virus manifests as a rash, malaise, and low-grade fever (Whitley, 2010). The rash, which is a hallmark of infection, consists of vesicles, maculopapules, and scabs in varying stages (Whitley, 2010). The committee considers the effects of natural infection one type of mechanistic evidence. In addition, the 21 publications described above presented clinical evidence sufficient for the committee to conclude the vaccine was a contrib- uting cause of disseminated Oka VZV without other organ involvement. There were three cases that unequivocally showed that vaccination with the current vaccine caused a rash that spread beyond the injection dermatome without involvement of other organs. These rashes occurred in immunode- ficient patients. In five publications describing reports submitted to passive

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249 VARICELLA VIRUS VACCINE surveillance systems it was unclear if the rash extended beyond the derma- tome in which the vaccine was administered, but vaccine virus was demon- strated in the rash from some of the subjects. In nine case reports and five publications from a large study of children with leukemia it was not clear that the vaccine administered was equivalent to that currently used in the United States. In one case of dermal dissemination in an immunosuppressed adult, it was not proven that vaccine virus was involved in the rash. In all publications described above the vaccine administered contained the Oka varicella strain described in the introduction to the chapter. Rashes were reported in individuals with and without demonstrated immunodeficien- cies (e.g., genetic or acquired). Vaccine-strain varicella was demonstrated in skin biopsy and vesicular fluid in 20 of the publications described above although it should be noted that five publications represent reports over time of the same multicenter study. The latency between vaccination and development of rash in the pub- lications described above ranged from 8 to 87 days suggesting direct viral infection as the mechanism responsible for disseminated Oka VZV without other organ involvement, It should be noted that the publications did not provide evidence linking autoantibodies, T cells, or complement activation to disseminated rash after varicella vaccination. The committee assesses the mechanistic evidence regarding an as- sociation between varicella vaccine and disseminated Oka VZV without other organ involvement in individuals with or without demonstrated immunodeficieincies as strong based on cases1 pre- senting definitive clinical evidence. Causality Conclusion Conclusion 5.1: The evidence convincingly supports a causal re- lationship between varicella vaccine and disseminated Oka VZV without other organ involvement. DISSEMINATED OKA VZV WITH OTHER ORGAN INVOLVEMENT “Disseminated” in this section refers to disease present in organs in ad- dition to the skin in a time frame associated with acute infection. The cases that were used to definitively show the association were those in which (1) the patient received the vaccine currently in use in the United States, 1 Due to the use of the same surveillance systems in some publications it is likely that some of the cases were presented more than once, thus it is difficult to determine the number of unique cases.

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282 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY tests during hospitalization revealed a platelet count of 29,000 on day 1 and 62,000 on day 3. The patient’s platelet count was 198,000 on day 6. Weight of Mechanistic Evidence While rare, infection with wild-type varicella virus has been associated with bleeding diathesis (Whitley, 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 thrombocytopenia. The symptoms described in the publications referenced above are consistent with those leading to a diagnosis of thrombocytopenia, but the only evidence that could be attributed to the vaccine was recurrence of symptoms upon vaccine rechallenge. Autoantibodies and complement activation may contribute to the symptoms of thrombocytopenia; however, the publications did not provide evidence linking these mechanisms to varicella vaccine. The committee assesses the mechanistic evidence regarding an asso- ciation between varicella vaccine and thrombocytopenia as weak based on knowledge about the natural infection and one case. Causality Conclusion Conclusion 5.15: The evidence is inadequate to accept or r eject a causal relationship between varicella vaccine and thrombocytopenia. CONCLUDING SECTION Table 5-1 provides a summary of the epidemiologic assessments, mech- anistic assessments, and causality conclusions for varicella vaccine.

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TABLE 5-1 Summary of Epidemiologic Assessments, Mechanistic Assessments, and Causality Conclusions for Varicella Vaccine Studies Cases Contributing to Contributing to Epidemiologic the Epidemiologic Mechanistic the Mechanistic Causality Vaccine Adverse Event Assessment Assessment Assessment Assessment Conclusion a Varicella Disseminated Oka VZV Insufficient None Strong – Convincingly without Other Organ Supports Involvement Varicella Disseminated Oka VZV Limited 1 Strong 9 Convincingly with Subsequent Infection (subsequent infection (in individuals Supports Resulting in Pneumonia, resulting in pneumonia) with demonstrated (in individuals Meningitis, or Hepatitis immunodeficiencies) with demonstrated Insufficient None immunodeficiencies) (subsequent infection resulting in meningitis or hepatitis) a Varicella Vaccine-Strain Viral Insufficient None Strong – Convincingly Reactivation without Supports Other Organ Involvement Varicella Vaccine-Strain Viral Limited 1 Strong 6 Convincingly Reactivation with (subsequent infection Supports Subsequent Infection resulting in encephalitis) Resulting in Meningitis Insufficient None or Encephalitis (subsequent infection resulting in meningitis) Varicella Encephalopathy Insufficient None Lacking None Inadequate Varicella Seizures Limited 1 Weak None Inadequate 283 continued

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TABLE 5-1 Continued 284 Studies Cases Contributing to Contributing to Epidemiologic the Epidemiologic Mechanistic the Mechanistic Causality Vaccine Adverse Event Assessment Assessment Assessment Assessment Conclusion Varicella Cerebellar Ataxia Insufficient None Weak None Inadequate Varicella Acute Disseminated Insufficient None Weak None Inadequate Encephalomyelitis Varicella Transverse Myelitis Insufficient None Weak 1 Inadequate Varicella Guillain-Barré Syndrome Insufficient None Weak None Inadequate Varicella Small Fiber Neuropathyb Insufficient None Lacking None Inadequate Varicella Anaphylaxis Limited 1 Strong 76c Convincingly Supports Varicella Onset or Exacerbation of Insufficient None Lacking None Inadequate Arthropathy Varicella Strokeb Limited 1 Weak None Inadequate Varicella Thrombocytopenia Insufficient None Weak 1 Inadequate aDue to the use of the same surveillance systems in some publications it is likely that some of the cases were presented more than once; thus, it is difficult to determine the number of unique cases. bAlthough not originally charged to the committee by the sponsor, the committee considered this adverse event in its review of the literature. cIn addition, at least 30 cases were reported to passive surveillance systems; however, it was not possible to know how many represented unique cases or were reported elsewhere.

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