Adverse Effects of Vaccines Evidence and Causality (2012) / Chapter Skim
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From page 1... ...
The legislation was also intended to address concerns about the safety of vaccines through a multipronged approach involving instituting a compensation program financed by an excise tax on covered vaccines, setting up a passive surveillance system for vaccine adverse events, and providing information to consumers. Sections 312 and 313 of the legislation required the secretary of the U.S.
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The vaccines to be reviewed included varicella zoster vaccine; influenza vaccines;5 hepatitis B vaccine; human papillomavirus vaccine (HPV) ; tetanus toxoid–containing vaccines other than those containing the whole cell pertussis component; measles, mumps, and rubella vaccines; hepatitis A vaccine; and meningococcal vaccines.
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TABLE S-1 Adverse Events and Causality Conclusions Included in the Vaccine Chapters DT–, TT–, and aP– Injection MMR Varicella Influenza Hepatitis Hepatitis HPV Containing Meningococcal Related Vaccine Vaccine Vaccine A Vaccine B Vaccine Vaccine Vaccines Vaccine Events Adverse Event Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Chapter 9 Chapter 10 Chapter 11 Chapter 12 Disseminated Oka VZV CS without Other Organ Involvement Disseminated Oka VZV CSa with Subsequent Infection Resulting in Pneumonia, Meningitis, or Hepatitis Vaccine Strain Viral CS Reactivation without Other Organ Involvement Vaccine Strain Viral CS Reactivation with Subsequent Infection Resulting in Meningitis or Encephalitis Measles Inclusion Body CSa,b Encephalitis Encephalitis I I I I I Encephalopathy I I I I I I Infantile Spasms I 3 continued
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4 TABLE S-1 Continued DT–, TT–, and aP– Injection MMR Varicella Influenza Hepatitis Hepatitis HPV Containing Meningococcal Related Vaccine Vaccine Vaccine A Vaccine B Vaccine Vaccine Vaccines Vaccine Events Adverse Event Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Chapter 9 Chapter 10 Chapter 11 Chapter 12 Febrile Seizures CS Afebrile Seizures I Seizures I Ic I I Meningitis Ic Cerebellar Ataxia I Ataxia I I Autism FR I Acute Disseminated I I I I I I I I Encephalomyelitis Transverse Myelitis I I I I I I I I Optic Neuritis Ic Ic Ic Ic Neuromyelitis Optica Ic I I I Multiple Sclerosis Onset in I I I I Adults Multiple Sclerosis Onset in I I Children Multiple Sclerosis Relapse I I I in Adults
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Multiple Sclerosis Relapse I I in Children Multiple Sclerosis I I I First Demyelinating Event I in Adults First Demyelinating Event I in Children Guillain-Barré Syndrome I I I I I I I I Chronic Inflammatory I I I I I I I Disseminated Polyneuropathy Opsoclonus Myoclonus I I Syndrome Bell's Palsy FR I I Brachial Neuritis I I I I Amyotrophic Lateral I Sclerosis Small Fiber Neuropathy Ic I Anaphylaxis CS CS CS I CSd FA CSe CS Chronic Urticaria I Serum Sickness I 5 continued
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6 TABLE S-1 Continued DT–, TT–, and aP– Injection MMR Varicella Influenza Hepatitis Hepatitis HPV Containing Meningococcal Related Vaccine Vaccine Vaccine A Vaccine B Vaccine Vaccine Vaccines Vaccine Events Adverse Event Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Chapter 9 Chapter 10 Chapter 11 Chapter 12 Inactivated Influenza FR Vaccine and Asthma Exacerbation or Reactive Airway Disease Episodes in Children and Adults Live Attenuated Influenza I Vaccine and Asthma Exacerbation or Reactive Airway Disease Episodes in Children Younger Than 5 Years of Age Live Attenuated Influenza I Vaccine and Asthma Exacerbation or Reactive Airway Disease Episodes in Persons 5 Years of Age or Older Erythema Nodosum Ic Systemic Lupus I I Erythematosus Vasculitis I I Polyarteritis Nodosa I I
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Psoriatic Arthritis I Reactive Arthritis I Rheumatoid Arthritis I Juvenile Idiopathic I Arthritis Transient Arthralgia in FAf Women Transient Arthralgia in FA Children Transient Arthralgia I Chronic Arthralgia in I Women Chronic Arthritis in I Women Chronic Arthropathy in I Children Arthropathy in Men I Arthropathy I I I Type 1 Diabetes FR I FR Autoimmune Hepatitis I Myocarditis I Pancreatitis I 7 continued
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From page 8... ...
8 TABLE S-1 Continued DT–, TT–, and aP– Injection MMR Varicella Influenza Hepatitis Hepatitis HPV Containing Meningococcal Related Vaccine Vaccine Vaccine A Vaccine B Vaccine Vaccine Vaccines Vaccine Events Adverse Event Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Chapter 9 Chapter 10 Chapter 11 Chapter 12 Hepatitis I Thromboembolic Events I Stroke Ic I Hypercoagulable States I Myocardial Infarction I Chronic Fatigue Syndrome I Chronic Headache I Fibromyalgia I I I I Sudden Infant Death I Syndrome Hearing Loss I All Cause Mortality Ic Oculorespiratory Syndrome FAg Thrombocytopenia I Immune Thrombocytopenic I Purpura Complex Regional Pain I Syndrome
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The evidence is inadequate to accept or reject a causal relationship between anaphylaxis and diphtheria toxoid or acellular pertussis vaccine. f The committee attributes causation to the rubella component of the vaccine.
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ASSESSING THE WEIGHT OF EVIDENCE Two streams of evidence support the committee's causality conclusions: epidemiologic evidence derived from studies of populations (most often based on observational designs but randomized trials when available) , and mechanistic evidence derived primarily from biological and clinical studies in animals and individual humans (see Figure S-1)
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CAUSALITY CONCLUSION 11 FIGURE S-1 Epidemiologic and mechanistic evidence reviewed by the committee.
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These are to indicate increased risk of the adverse event, decreased risk of the adverse event, or no change in risk of the adverse event or "null." Assessments of limited or insufficient include no direction of effect. Weight of Mechanistic Evidence The committee assessed the mechanisms by which the vaccine could cause a specific adverse event by identifying and evaluating clinical and biological evidence.
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Chapter 3 contains a discussion of the major mechanisms the committee invokes as possible explanations of how a given adverse event can occur after vaccination. The committee identified many case reports in the literature describing adverse events following vaccination.
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The four weight-of-evidence assessments for the mechanistic evidence are • Strong: One or more cases in the literature, for which the commit tee concludes the vaccine was a contributing cause of the adverse event, based on an overall assessment of attribution in the available cases and clinical, diagnostic, or experimental evidence consistent with relevant biological response to vaccine. • Intermediate: At least two cases, taken together, for which the committee concludes the vaccine may be a contributing cause of the adverse event, based on an overall assessment of attribution in the available cases and clinical, diagnostic, or experimental evi dence consistent with relevant biological response to vaccine.
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Thus, the framework for this and previous IOM reports on vaccine safety is asymmetrical. The committee began not by assuming the causal relationship does not exist, but by requiring evidence to shift away from the neutral position that the evidence is "inadequate to accept or reject" a causal relationship.
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* Causality conclusion is favors rejection only if mechanistic assessment is not strong or intermediate.
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The committee does not consider a single epidemiologic study -- regardless of how well it is designed, the size of the estimated effect, or the narrowness of the confidence interval -- sufficient to merit a weight of "high" or, in the absence of strong or intermediate mechanistic evidence, sufficient evidence to support a causality conclusion other than "inadequate to accept or reject a causal relationship." This requirement might seem overly rigorous to some readers. However, the Agency for Healthcare Research and Quality advises the Evidence-based Practice Centers that it has funded to produce evidence reports on important issues in health care to view an evidence base of a single study with caution (Owens et al., 2010)
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From page 18... ...
and Oka VZV viral reactivation depended on identification of vaccine-strain virus as documented by polymerase chain reaction, as was the evidence regarding MMR vaccine and measles inclusion body encephalitis. Epidemiologic evidence, as well as mechanistic evidence, convincingly supported the causal relationship between MMR vaccine and febrile seizures.
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infection resulting in Hepatitis meningitis or hepatitis) b 5 Varicella Vaccine Strain Insufficient None Strong – Convincingly Viral Reactivation Supports without Other Organ Involvement 5 Varicella Vaccine Strain Viral Limited (subsequent 1 Strong 6 Convincingly Reactivation with infection resulting in Supports Subsequent Infection encephalitis)
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4 MMR Febrile Seizures High (increase) 7 Intermediate 12 Convincingly Supports 4 MMR Anaphylaxis Insufficient None Strong 43e Convincingly Supports 5 Varicella Anaphylaxis Limited 1 Strong 76f Convincingly Supports 6 Influenza Anaphylaxis Limited 1 Strong 22 Convincingly Supports 8 Hepatitis B Anaphylaxis Insufficient None Strong 10 Convincingly (in yeast-sensitive Supportsg individuals)
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4 Lacking None Favors Rejection 6 Influenza Inactivated Influenza High (null) 2 Lacking None Favors Vaccine and Bell's Rejection palsy 21 continued
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5 Lacking None Favors Rejection 10 DT, TT, or aP Type 1 Diabetes High (null) 5 Lacking None Favors containing Rejection a All other causality conclusions are the evidence is inadequate to accept or reject a causal relationship.
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From page 23... ...
or of decreased risk and in the absence of strong or intermediate mechanistic evidence in support of a causal relationship. The committee concluded the evidence favors rejection of five vaccine–adverse event relationships.
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A list of all conclusions, including the weights of evidence for both the epidemiologic evidence and the mechanistic evidence, can be found in Appendix D SUSCEPTIBILITY The literature supporting several of the causality conclusions discussed in the previous section indicates that individuals with certain characteristics are more likely to suffer adverse effects from particular immunizations.
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Paper read at the Meeting of the Institute of Medicine Committee to Review Adverse Effects of Vaccines, Washington, DC. Miller, F
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