Adverse Effects of Vaccines Evidence and Causality (2012) / Chapter Skim
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11 Meningococcal Vaccine
11 Meningococcal Vaccine
Pages 599-614
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. In the United States in 2004, 1,400–2,800 cases of invasive meningococcal disease were reported (CDC, 2005)
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. Ten to 20 percent of meningococcal disease survivors experience permanent sequelae such as limb loss, hearing loss, neurologic disability, and scarring (Granoff et al., 2008)
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is licensed in the United States. Menomune contains 50 µg each of lyophilized powder that is reconstituted prior to administration with sterile, pyrogen-free distilled water without preservative in the single-dose presentation and with sterile, pyrogen-free distilled water and thimerosal, a mercury derivative added as a preservative in the multidose presentation (Sanofi Pasteur, Inc., 2009)
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. ENCEPHALITIS AND ENCEPHALOPATHY Epidemiologic Evidence The committee reviewed one study to evaluate the risk of encephalitis or encephalopathy after the administration of meningococcal vaccine.
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Weight of Mechanistic Evidence T cells and complement activation may contribute to the symptoms of encephalitis or encephalopathy; however, the committee did not identify literature reporting evidence of these mechanisms after administration of meningococcal vaccine. The committee assesses the mechanistic evidence regarding an as sociation between meningococcal vaccine and encephalitis or en cephalopathy as lacking.
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The committee assesses the mechanistic evidence regarding an as sociation between meningococcal vaccine and ADEM as lacking. Causality Conclusion Conclusion 11.3: The evidence is inadequate to accept or reject a causal relationship between meningococcal vaccine and ADEM.
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The committee assesses the mechanistic evidence regarding an as sociation between meningococcal vaccine and transverse myelitis as lacking. Causality Conclusion Conclusion 11.4: The evidence is inadequate to accept or reject a causal relationship between meningococcal vaccine and transverse myelitis.
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Causality Conclusion Conclusion 11.5: The evidence is inadequate to accept or reject a causal relationship between meningococcal vaccine and MS. GUILLAIN-BARRÉ SYNDROME Epidemiologic Evidence The committee reviewed two studies to evaluate the risk of GuillainBarré syndrome (GBS)
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Causality Conclusion Conclusion 11.6: The evidence is inadequate to accept or reject a causal relationship between meningococcal vaccine and GBS. CHRONIC INFLAMMATORY DISSEMINATED POLYNEUROPATHY Epidemiologic Evidence No studies were identified in the literature for the committee to evaluate the risk of chronic inflammatory disseminated polyneuropathy (CIDP)
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Causality Conclusion Conclusion 11.7: The evidence is inadequate to accept or reject a causal relationship between meningococcal vaccine and CIDP. ANAPHYLAXIS Epidemiologic Evidence The committee reviewed three studies to evaluate the risk of anaphylaxis after the administration of meningococcal vaccine.
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Described below is one publication reporting clinical, diagnostic, or experimental evidence that contributed to the weight of mechanistic evidence. Yergeau et.
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Weight of Mechanistic Evidence The committee assesses the mechanistic evidence regarding an as sociation between meningococcal vaccine and chronic headaches as lacking. Causality Conclusion Conclusion 11.9: The evidence is inadequate to accept or reject a causal relationship between meningococcal vaccine and chronic headache.
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TABLE 11-1 Summary of Epidemiologic Assessments, Mechanistic Assessments, and Causality Conclusions for Meningococcal Vaccine Studies Contributing Cases Contributing Epidemiologic to the Epidemiologic Mechanistic to the Mechanistic Vaccine Adverse Event Assessment Assessment Assessment Assessment Causality Conclusion Meningococcal Encephalitis Limited 1 Lacking None Inadequate Meningococcal Encephalopathy Limited 1 Lacking None Inadequate Meningococcal Acute Disseminated Insufficient None Lacking None Inadequate Encephalomyelitis Meningococcal Transverse Myelitis Insufficient None Lacking None Inadequate Meningococcal Multiple Sclerosis Insufficient None Lacking None Inadequate Meningococcal Guillain-Barré Syndrome Limited 1 Lacking None Inadequate Meningococcal Chronic Inflammatory Insufficient None Lacking None Inadequate Disseminated Polyneuropathy Meningococcal Anaphylaxis Insufficient None Strong 1 Convincingly Supports Meningococcal Chronic Headache Insufficient None Lacking None Inadequate 611
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Journal of the American Medical Association 294(23)
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Journal of the American Medical Association 276(14)
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Canadian Medical Association Journal 154(4)
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