Each week, we will be publishing layman’s abstracts of new articles from our prestigious portfolio of journals in statistics. The aim is to highlight the latest research to a broader audience in an accessible format.
Callegaro, A, Curran, D, Matthews, S. Burden‐of‐illness vaccine efficacy. Pharmaceutical Statistics. 2020; 1– 10. https://doi.org/10.1002/pst.2020
Many vaccines have been developed to prevent disease. Although the objective is to develop vaccines that are 100% effective, in reality this does not always happen. Some may have vaccine efficacy as low as 40 or 50%. Consequently, individuals may develop disease despite having been vaccinated. In addition to preventing disease, vaccines may reduce the severity and duration of disease in those who still get infected. Consequently, a burden of illness score has been developed as a composite endpoint that combines the frequency (or incidence) of disease with the severity and duration of disease, to assess the overall benefit of a vaccine. In this manuscript we show how an estimate of vaccine efficacy and its range (confidence intervals) can be generated for the burden of illness score. Data from a clinical trial (in this case, one evaluating the efficacy of a Herpes Zoster vaccine) was evaluated. The use of this methodology will grow in future due to (1) the increased inclusion of patient reported outcomes to assess disease severity and duration within vaccine clinical trials, (2) acceleration in the development of vaccines associated with the identification of new viruses, ongoing global immunization campaigns, global population growth, ageing populations, and the development of therapeutic vaccines.