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5 Varicella Virus Vaccine
Pages 239-292

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From page 239...
... . 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
From page 240...
... . Additional complications of herpes zoster include herpes ophthalmicus, dissemination, and central nervous system, pulmonary, and hepatic disease (CDC, 2007)
From page 241...
... . 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)
From page 242...
... . 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)
From page 243...
... Thirty-three publications either did not provide evidence beyond temporality 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
From page 244...
... Vaccine-strain varicella virus was demonstrated, 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.
From page 245...
... 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 vaccinestrain varicella virus.
From page 246...
... 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 wildtype varicella virus in three children by restriction endonuclease analysis.
From page 247...
... 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.
From page 248...
... 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.
From page 249...
... The latency between vaccination and development of rash in the publications 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.
From page 250...
... Four studies (Chaves et al., 2008; Goulleret et al., 2010; 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.
From page 251...
... Mechanistic Evidence Pneumonia The committee identified 11 publications reporting disseminated VZV with pneumonia after administration of a varicella vaccine. Four publications did not provide evidence beyond temporality (Chaves et al., 2008; Goulleret et al., 2010; LaRussa et al., 1996; Lohiya et al., 2004)
From page 252...
... Evaluation of bronchoscopy specimens demonstrated multinucleated giant cells with nuclear inclusions. Vaccine-strain varicella virus was demonstrated via PCR in tracheal aspirates and vesicular lesions obtained 7 weeks postvaccination.
From page 253...
... (2000) either did not provide evidence beyond temporality or attributed the disseminated VZV with meningitis to wild-type varicella virus.
From page 254...
... The patient developed maculopapular and vesicular lesions on the extremities and trunk 4 weeks postvaccination. Varicella virus DNA was demonstrated via PCR in the skin lesions and in supernatant of a viral culture of a homogenate of the liver biopsy.
From page 255...
... Vaccine-strain varicella virus was demonstrated in the vesicular fluid, peripheral blood mononuclear cells, liver biopsy supernatant, endotracheal fluid, tracheal aspirates, lung biopsy, and bronchoalveolar lavage fluid in the cases described above. In most cases vaccine-strain varicella virus was demonstrated in a speci
From page 256...
... The committee felt that vaccine strain virus was likely the etiology of the meningitis as it would be unusual to have dermal dissemintation of vaccine virus in an immunodeficient patient who had wild-type virus in the CSF. The latency between vaccination and disseminated Oka VZV with subsequent infection resulting in pneumonia, meningitis, or hepatitis in the publications described above ranged from 10 days to 2 months suggesting direct viral infection as the mechanism.
From page 257...
... The latency between vaccination and presentation of herpes zoster in patients where vaccine-strain varicella virus was demonstrated ranged from 1 to 11 years. One case, reported in detail, was a 5-year-old girl who presented with a zoster-like rash on the right side of the face and right eye 25 days after receiving a varicella vaccine, diphtheria-tetanus-accellular pertussis (DTaP)
From page 258...
... Of these 17 specimens, seven were negative for varicella virus, one was positive for varicella virus but the strain was not determined, one was wild-type varicella virus, and eight were vaccine-strain varicella virus. The latency between vaccination and presentation of herpes zoster in patients where vaccine-strain varicella virus was demonstrated ranged from 89 days to 30 months.
From page 259...
... Varicella virus DNA was demonstrated via PCR in vesicle fluid, and was found to be vaccine strain by restriction endonuclease analysis. One case, a 27-month-old girl presenting with a herpes zoster rash in a C6–C8 dermatomal distribution 16 months after receiving a varicella vaccine, was described in three publications (Sauerbrei et al., 2003, 2004; Uebe et al., 2002)
From page 260...
... Varicella virus DNA was demonstrated in the patient's brother's vesicular fluid and crust specimens; the virus was identified as vaccine-strain varicella by restriction fragment length polymorphism. Weight of Mechanistic Evidence Herpes zoster is characterized by vesicular lesions erupting in a dermatomal distribution upon the reactivation of latent wild-type varicella virus (Whitley, 2010)
From page 261...
... The latency between vaccination and development of herpes zoster in the publications described above ranged from 23 days to 11 years suggesting viral reactivation as the mechanism. The committee assesses the mechanistic evidence regarding an as sociation between varicella vaccine and vaccine-strain viral reacti vation without other organ involvement as strong based on cases2 presenting clinical evidence.
From page 262...
... were not considered in the weight of epidemiologic evidence because they provided data from passive surveillance systems and lacked unvaccinated comparison populations. The one remaining controlled study (Donahue et al., 2009)
From page 263...
... (2000) reported the isolation of wild-type varicella virus in one girl that developed herpes zoster and meningitis 21 months after administration of a varicella vaccine.
From page 264...
... CSF specimens from these cases were negative for varicella virus. Vaccine-strain varicella virus was demonstrated in the herpes zoster lesions in two of the five cases.
From page 265...
... Varicella virus was demonstrated in the CSF by PCR; the strain of virus was not identified. Encephalitis The committee identified three publications reporting the development of encephalitis after administration of a varicella vaccine.
From page 266...
... Analysis of serum immunoglobulins and quantification of T cell and B cell subpopulations did not reveal abnormalities of the patient's immune system. Weight of Mechanistic Evidence Herpes zoster is characterized by vesicular lesions erupting in a dermatomal distribution upon the reactivation of latent wild-type varicella virus (Whitley, 2010)
From page 267...
... Viral infection and viral reactivation may contribute to the symptoms of encephalopathy; however, the publications did not provide evidence linking these mechanisms to varicella vaccine. The committee assesses the mechanistic evidence regarding an as sociation between varicella vaccine and encephalopathy as lacking.
From page 268...
... This retrospective cohort study reported potential adverse events following varicella vaccination, obtained from the KPMCP database. The relative risk of febrile seizures in the 1-year age group recorded during hospitalizations within 60 days of varicella vaccination (21 cases)
From page 269...
... The committee assesses the mechanistic evidence regarding an as sociation between varicella vaccine and seizures as weak based on knowledge about the natural infection. Causality Conclusion Conclusion 5.6: The evidence is inadequate to accept or reject a causal relationship between varicella vaccine and seizures.
From page 270...
... Mechanistic Evidence The committee identified five publications reporting cerebellar ataxia developing after administration of a varicella vaccine. Two publications did not provide clinical, diagnostic, or experimental evidence, including the time frame between vaccination and development of ataxia (Chaves et al., 2008; Goulleret et al., 2010)
From page 271...
... Weight of Epidemiologic Evidence The epidemiologic evidence is insufficient or absent to assess an association between varicella vaccine and ADEM. Mechanistic Evidence The committee identified one publication reporting development of ADEM after administration of a varicella vaccine.
From page 272...
... The patient was treated with intravenous methylprednisolone and was asymptomatic 2 months after development of the symptoms. Weight of Mechanistic Evidence On rare occasions transverse myelitis has been associated with herpes zoster and reactivation of latent wild-type varicella viruses (Whitley, 2010)
From page 273...
... Mechanistic Evidence The committee identified one publication reporting development of GBS after administration of a varicella vaccine. The publication reported several cases but did not provide evidence beyond temporality (Wise et al., 2000)
From page 274...
... Mechanistic Evidence The committee identified one publication reporting small fiber neuropathy after administration of a varicella vaccine. The publication did not provide evidence beyond temporality (Souayah et al., 2009)
From page 275...
... This retrospective cohort study reported potential adverse events following varicella vaccination, obtained from the KPMCP database. The relative risk of allergic reactions with or without hives in the 1-year age group recorded during clinic visits within 30 days of varicella vaccination (180 cases)
From page 276...
... (2005) identified anaphylaxis and allergic reactions, after administration of varicella vaccines, reported to the Post-Marketing Surveillance Center of the Research Foundation for Microbial Diseases of Osaka University.
From page 277...
... Three patients had a history of allergies to antibiotics, atropine, or ophthalmic solution. Weight of Mechanistic Evidence The publications described above presented clinical evidence sufficient for the committee to conclude the vaccine was a contributing cause of anaphylaxis after administration of a gelatin-containing varicella vaccine.
From page 278...
... Weight of Epidemiologic Evidence The epidemiologic evidence is insufficient or absent to assess an association between varicella vaccine and onset or exacerbation of arthropathy. Mechanistic Evidence The committee identified three publications reporting onset or exacerbation of arthropathy (arthritis and arthralgia)
From page 279...
... (2009) was described in detail in the section on vaccine strain viral reactivation with subsequent infection resulting in encephalitis.
From page 280...
... . Weight of Mechanistic Evidence Infection with varicella virus has been associated with stroke with an incidence of approximately 1 in 15,000 cases (Nagel et al., 2010)
From page 281...
... Mechanistic Evidence The committee identified six publications reporting thrombocytopenia or idiopathic thrombocytopenic purpura after administration of a varicella vaccine. Chaves et al.
From page 282...
... Weight of Mechanistic Evidence While rare, infection with wild-type varicella virus has been associated with bleeding diathesis (Whitley, 2010)
From page 283...
... 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)
From page 284...
... 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.
From page 285...
... 1996. Live attenuated varicella vaccine.
From page 286...
... 2007. Herpes zoster due to Oka vaccine strain of varicella zoster virus in an immunosuppressed child post cord blood transplant.
From page 287...
... 1987. Molecular epidemiology of live, attenuated varicella virus vaccine in children with leukemia and in normal adults.
From page 288...
... 2009. Herpes zoster and meningitis resulting from reactivation of varicella vaccine virus in an immunocompetent child.
From page 289...
... 2008. Herpes zoster with skin lesions and meningitis caused by 2 different genotypes of the Oka varicella-zoster virus vaccine.
From page 290...
... 2003. Herpes zoster virus sclerokeratitis and anterior uveitis in a child following varicella vaccination.
From page 291...
... 2002. Herpes zoster by reactivated vaccine varicella zoster virus in a healthy child.
From page 292...
... 1994. Attenuated varicella virus vaccine in children with renal transplants.


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