Adverse Effects of Vaccines Evidence and Causality (2012) / Chapter Skim
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9 Human Papillomavirus Vaccine
9 Human Papillomavirus Vaccine
Pages 505-524
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From page 505... ...
. Genital warts and high-risk genital HPV infections, caused by HPV6 and 11 and HPV16, 18, 33, and 65 respectively, occur in an estimated 6.2 million people every year in persons aged 14 to 44 years, 74 percent among individuals between 15 and 24 years (Schiller et al., 2008; Weinstock et al., 2004)
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From page 506... ...
. In 2009, Gardasil was also approved for use in males aged 9–26 years for the prevention of anal cancer and genital warts; however, although it is licensed for use in the same schedule and composition, as of May 2010, the Advisory Committee on Immunization Practices did not recommend routine vaccination in this population (CDC, 2010b)
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From page 507... ...
Mechanistic Evidence The committee identified four publications reporting ADEM after administration of HPV vaccine. The publications did not provide evidence beyond temporality (Borja-Hart et al., 2009; Mendoza Plasencia et al., 2010; Schaffer et al., 2008; Wildemann et al., 2009)
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Autoantibodies, T cells, and molecular mimicry may contribute to the symptoms of transverse myelitis; however, the publications did not provide evidence linking these mechanisms to HPV vaccine. The committee assesses the mechanistic evidence regarding an as sociation between HPV vaccine and transverse myelitis as lacking.
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The committee assesses the mechanistic evidence regarding an as sociation between HPV vaccine and NMO as lacking. Causality Conclusion Conclusion 9.3: The evidence is inadequate to accept or reject a causal relationship between HPV vaccine and NMO.
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Autoantibodies, T cells, and molecular mimicry may contribute to the symptoms of MS; however, the publications did not provide evidence linking these mechanisms to HPV vaccine. The committee assesses the mechanistic evidence regarding an as sociation between HPV vaccine and MS as lacking.
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From page 511... ...
Weight of Mechanistic Evidence The symptoms described in the publications referenced above are consistent with those leading to a diagnosis of GBS. Autoantibodies, complement activation, immune complexes, T cells, and molecular mimicry may contribute to the symptoms of GBS; however, the publications did not provide evidence linking these mechanisms to HPV vaccine.
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The committee assesses the mechanistic evidence regarding an as sociation between HPV vaccine and CIDP as lacking. Causality Conclusion Conclusion 9.6: The evidence is inadequate to accept or reject a causal relationship between HPV vaccine and CIDP.
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Causality Conclusion Conclusion 9.7: The evidence is inadequate to accept or reject a causal relationship between HPV vaccine and brachial neuritis. AMYOTROPHIC LATERAL SCLEROSIS Epidemiologic Evidence No studies were identified in the literature for the committee to evaluate the risk of amyotrophic lateral sclerosis (ALS)
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From page 514... ...
Based on the genetic analysis and neuropathology, the authors did not attribute the rapidly progressive form of juvenile ALS in the patient to vaccination against HPV using the quadrivalent vaccine Gardasil.1 Weight of Mechanistic Evidence The symptoms described in the publication referenced above are consistent with those leading to a diagnosis of ALS. Autoantibodies, T cells, and molecular mimicry may contribute to the symptoms of ALS; however, the publications did not provide evidence linking these mechanisms to HPV vaccine.
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Weight of Epidemiologic Evidence The epidemiologic evidence is insufficient or absent to assess an association between HPV vaccine and anaphylaxis. Mechanistic Evidence The committee identified three publications describing clinical, diagnostic, or experimental evidence of anaphylaxis after administration of HPV vaccine.
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The committee assesses the mechanistic evidence regarding an as sociation between HPV vaccine and anaphylaxis as intermediate based on 36 cases presenting temporality and clinical symptoms consistent with anaphylaxis. Causality Conclusion Conclusion 9.9: The committee concludes that the evidence fa vors acceptance of a causal relationship between HPV vaccine and anaphylaxis.
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The committee assesses the mechanistic evidence regarding an as sociation between HPV vaccine and transient arthralgia as lacking. Causality Conclusion Conclusion 9.10: The evidence is inadequate to accept or reject a causal relationship between HPV vaccine and transient arthralgia.
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The committee assesses the mechanistic evidence regarding an as sociation between HPV vaccine and pancreatitis as lacking. Causality Conclusion Conclusion 9.11: The evidence is inadequate to accept or reject a causal relationship between HPV vaccine and pancreatitis.
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From page 519... ...
Mechanistic Evidence The committee identified two publications reporting thromboembolic events after administration of HPV vaccine. The publications did not provide evidence beyond temporality, some too short or too long based on the possible mechanisms involved (Borja-Hart et al., 2009; Slade et al., 2009)
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From page 520... ...
Causality Conclusion Conclusion 9.13: The evidence is inadequate to accept or reject a causal relationship between HPV vaccine and hypercoagulable states. CONCLUDING SECTION Table 9-1 provides a summary of the epidemiologic assessments, mechanistic assessments, and causality conclusions for HPV vaccine.
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From page 521... ...
TABLE 9-1 Summary of Epidemiologic Assessments, Mechanistic Assessments, and Causality Conclusions for HPV Vaccine Studies Contributing Cases Contributing Epidemiologic to the Epidemiologic Mechanistic to the Mechanistic Causality Vaccine Adverse Event Assessment Assessment Assessment Assessment Conclusion HPV Acute Disseminated Encephalomyelitis Insufficient None Lacking None Inadequate HPV Transverse Myelitis Insufficient None Lacking None Inadequate HPV Neuromyelitis Optica Insufficient None Lacking None Inadequate HPV Multiple Sclerosis Insufficient None Lacking None Inadequate HPV Guillain-Barré Syndrome Insufficient None Lacking None Inadequate HPV Chronic Inflammatory Disseminated Insufficient None Lacking None Inadequate Polyneuropathy HPV Brachial Neuritis Insufficient None Lacking None Inadequate HPV Amyotrophic Lateral Sclerosis Insufficient None Lacking None Inadequate HPV Anaphylaxis Insufficient None Intermediate 36 Favors Acceptance HPV Transient Arthralgia Limited 1 Lacking None Inadequate HPV Pancreatitis Insufficient None Lacking None Inadequate HPV Thromboembolic Events Insufficient None Lacking None Inadequate HPV Hypercoagulable States Insufficient None Lacking None Inadequate 521
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From page 522... ...
2007. Quadrivalent human papillomavirus vaccine -- recommendations of the Advisory Committee on Immunization Practices (ACIP)
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From page 523... ...
2008. Hypersensitivity reactions to human papillomavirus vaccine in Australian schoolgirls: Retrospective cohort study.
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From page 524... ...
2003. Genital human papillomavirus infection: Incidence and risk factors in a cohort of female university students.
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