Cost-effectiveness of routine vaccination of adolescent females against cytomegalovirus.

BACKGROUND: Congenital cytomegalovirus (CMV) infection is associated with significant infant morbidity and mortality. A prophylactic vaccine to prevent congenital CMV infection is expected to be available in the near future, and will likely be targeted to adolescent females. METHODS: Using a decision tree, we compared the costs, potential clinical impacts, and cost-effectiveness of the current strategy of no CMV vaccination versus a strategy where all adolescent females are vaccinated against CMV prior to their first pregnancy. Both maternal outcomes related to vaccination, and infant outcomes related to congenital CMV infection, were considered in the model. RESULTS: Under base-case conditions, our analysis suggested that vaccinating all adolescent females against cytomegalovirus would be both less costly and with greater clinical benefits than not vaccinating. Among a population of 100,000 adolescent females, the vaccination strategy cost $32.3 million dollars less than not vaccinating, and avoided substantial numbers of infants affected with hearing loss, vision loss, and mental retardation, and 8 infant deaths. Our model was most sensitive to variations in vaccine efficacy. When vaccine efficacy against disease was less than 61%, not vaccinating became the preferred strategy because it was less expensive than vaccinating, without substantial changes in clinical benefits to the population. CONCLUSIONS: Under a wide variety of conditions, universal vaccination of adolescent females to protect their future children against congenital CMV infection was cost effective. However, for this to be preferred over not vaccinating, our results suggest that vaccine efficacy against disease would need to be at least 61%.

CMV vaccine trial endpoints.

BACKGROUND: Despite some significant challenges, there are several reasons for being optimistic about the prospect of developing vaccines against cytomegalovirus (CMV). The aim of this paper is to anticipate how positive results might be interpreted by those charged with making recommendations about universal immunisation, given that vaccines are normally expected to be highly cost-effective. PERSPECTIVE: The cost effectiveness of a CMV vaccine will be assessed by means of quality adjusted life years gained, so we should design Phase III trials to capture the required evidence directly. Given a vaccine which is equally effective in all age groups at preventing primary CMV infection, immunisation of teenagers will be more cost-effective than immunisation of toddlers, because benefits which accrue in the future are discounted financially. Protection of women of childbearing age against primary infection is important, but may fail to convince sceptics because of the need to extrapolate to protection against transmission of virus to the fetus. The preference of this author is therefore to select congenital CMV infection as the primary endpoint of a Phase III study. We should also ensure that the primary endpoint of a study immunising seronegative women is congenital CMV infection in babies born to those women, not to women in general, because of the large number of babies born to seropositives.

[Sensorineural hearing loss in childhood: evaluation of economic impact in view of vaccine prevention of cases due to congenital cytomegalovirus infection]. / Sordità neurosensoriale infantile: valutazione dell'impatto economico nella prospettiva della prevenzione vaccinale dei casi da infezione congenita da Cytomegalovirus.

Sensorineural hearing loss (SNHL) is a serious public health problem which affects 1-3% per hundred live born babies in developed countries. The congenital cytomegalovirus (CMV) infection is its most important non-genetic cause. The evaluation of the effectiveness of future programs of anti-CMV vaccination requires an assessment of the present costs of SNHL. Direct costs for the Italian public system were calculated per prosthesis child until his full age and turned out to add up to 260,000 euro. Private costs are difficult to be assessed and anyhow are highly dependent from the socio-economic level. This preliminary assessment suggests that the vaccination would be cost-saving if SNHL cases due to congenital CMV were more than 21 per year, corresponding to a congenital infection prevalence higher than 0.21%o.