for an adverse event not originally assigned by HRSA. These additions were all-cause mortality and seizures following influenza vaccine; optic neuritis following MMR, influenza, hepatitis B, and diphtheria, tetanus, and pertussis (DTaP) vaccines; neuromyelitis optica and meningitis following MMR vaccine; erythema nodosum following hepatitis B vaccine; and stroke and small fiber neuropathy following varicella vaccine.

The committee was also tasked with addressing, as time and evidence allowed, general considerations. These included: underlying (susceptible) populations, “immune dysfunction,” vaccine administration issues, appropriate time intervals for anaphylaxis and autoimmune diseases, and sequential vaccination issues. The committee addressed some of these, as described in Chapters 412. It is important to note that the committee was not tasked with assessing the benefits (effectiveness) of vaccines or any policy issues related to vaccination. The task is clearly focused on an assessment only of the risk of vaccines.

COMMITTEE PROCESS

The committee was composed of individuals with expertise in pediatrics, internal medicine, neurology, immunology, immunotoxicology, neurobiology, rheumatology, epidemiology, biostatistics, and law. Appendix F includes biographical sketches of the committee members. The committee met eight times between April 2009 and March 2011. The committee held open sessions at three of these meetings. Appendix G includes agendas of these open meetings. The committee’s methodology and approach to their task is described in Chapter 2.

OUTLINE OF THE REPORT

Chapter 2 details the committee’s methodology. Chapter 3 discusses generally possible mechanisms of vaccine injury. Chapters 411 present the evidence reviewed by the committee for each of the eight vaccines covered and the conclusions it reaches. Chapter 12 presents causality assessments for adverse events that can occur with any injected vaccine regardless of the vaccine antigen and components. The committee discusses some special considerations of its work in Chapter 13.

REFERENCES

CDC (Centers for Disease Control and Prevention). 2001. Vaccinia (smallpox) vaccine recommendations of the Advisory Committee on Immunization Practices (ACIP), 2001. Morbidity & Mortality Weekly Report 50(RR-10).

CDC. 2008. Human rabies prevention. Morbidity & Mortality Weekly Report 57(RR-3):1-36.



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