Group A streptococcus vaccine to be given to infants,
Group B streptococcus vaccine to be given to high-risk adults and to either 12-year-old females or to women during first pregnancy (low utilization)
parainfluenza virus vaccine to be given to infants and to women in their first pregnancy, and
rotavirus vaccine to be given to infants.
Seven candidate vaccines fall into the less favorable (IV) category: those with which a vaccination strategy would incur significant costs (more than $100,000 and up to well more than $1 million) per QALY gained. The Level IV vaccine candidates are as follows (in alphabetical order):
Borrelia burgdorferi vaccine to be given to resident infants born in and immigrants of any age into geographically defined high-risk areas,
Coccidioides immitis vaccine to be given to resident infants born in and immigrants of any age into geographically defined high-risk areas,
enterotoxigenic Escherichia coli vaccine to be given to infants and travelers,
Epstein-Barr virus vaccine to be given to 12-year-olds,
Histoplasma capsulatum vaccine to be given to resident infants born in and immigrants of any age into geographically defined high-risk areas,
Neisseria meningitidis type B vaccine to be given to infants, and
Shigella vaccine to be given to infants and travelers or to travelers only.
The application of the committee’s framework and model are both predictable and surprising. On a pragmatic and qualitative level, the framework developed for the assessment of these vaccines is an advance from that developed in 1985. The spreadsheets will be available for anyone who wishes to experiment with the model and change assumptions or data. The measure of health benefits, QALYs, is being used by many in the health field, so it is a much more familiar concept than that used in 1985.
The Level I candidate vaccines include several that were discussed in the 1985 IOM report on vaccine priorities. The four infectious diseases (cytomegalovirus, influenza A/B, Group B streptococcus, and streptococcus pneumoniae) with Level I candidate vaccines continue to have a staggering burden of disease for many reasons: the numbers of infected people, the seriousness of the health states caused by the infection, and the incidence of long-term sequelae (death and permanent impairment) and subsequent loss of quality of life (as measured in QALYs). A common factor in the analysis for these four vaccine strategies is the relatively short interval between vaccine administration and realization of health benefits for many of the affected people.
The inclusion in Level I of candidate therapeutic vaccines suggests that vaccine strategies for noninfectious, chronic conditions hold much promise. These results are seen even though the estimated efficacy (40%) is much less than that for the preventive candidate vaccines (75%). The acceptance, however,