(MMR) vaccines; Haemophilus influenzae type B vaccine; hepatitis B vaccine; and both inactivated and oral polio vaccines.3 The reports informed the secretary’s review of the Vaccine Injury Table. The reports have also been referenced extensively as a source of definitive scientific understanding of the evidence by Special Masters in decisions regarding injuries not listed on the Vaccine Injury Table.
The IOM was subsequently asked to review specific vaccine safety concerns in a series of reports requested by the Centers for Disease Control and Prevention (CDC). These reports (IOM, 2001a,b, 2002a,b, 2003a,b, 2004a,b) included causality assessments similar to the previous IOM reports, but included other conclusions and recommendations regarding research, communications, and policy review.
In 2009 the IOM entered into a contract with the Health Resources and Services Administration (HRSA)4 to convene a committee of experts to review the epidemiologic, clinical, and biological evidence regarding adverse health events associated with specific vaccines covered by the VICP. The committee was composed of individuals with expertise in pediatrics, internal medicine, neurology, immunology, immunotoxicology, neurobiol-ogy, rheumatology, epidemiology, biostatistics, and law.
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. It is expected that the report will provide the scientific basis for review and adjudication of claims of vaccine injury by the VICP.
HRSA presented a list of specific adverse events for the committee to review (see Table S-1). The selection criteria was described at the first committee meeting (Johann-Liang, 2009) as including the vast majority of adverse events in the claims for compensation. The committee added adverse events to the list if it identified epidemiologic studies or case reports for an adverse event not originally assigned by HRSA. These additions were all-cause mortality and seizures following influenza vaccine; optic neuritis
3 Vaccines are included in the VICP if they are recommended by the CDC for routine ad ministration in children and are subject to an excise tax. Adults who experience an adverse reaction to one of these “childhood” vaccines are also covered by the program.
4 The CDC and the National Vaccine Program Office also provided funds for the project via the contract with HRSA.
5 The 2009 H1N1 influenza vaccine is covered by the Countermeasures Injury Compensation Program, and evidence about its safety is not covered in this report.