Increases in the world’s population and population density promote the spread of emerging pathogens. Vaccines are the most cost-effective means of preventing this spread. Traditional methods used to identify and produce new vaccines are not adequate, in most instances, to ensure global protection. New technologies are urgently needed to expedite large scale vaccine development. mRNA-based vaccines promise to meet this need. mRNA-based vaccines exhibit a number of potential advantages relative to conventional vaccines, namely they (1) involve neither infectious elements nor a risk of stable integration into the host cell genome; (2) generate humoral and cell-mediated immunity; (3) are well-tolerated by healthy individuals; and (4) are less expensive and produced more rapidly by processes that are readily standardized and scaled-up, improving responsiveness to large emerging outbreaks. Multiple mRNA vaccine platforms have demonstrated efficacy in preventing infectious diseases and treating several types of cancers in humans as well as animal models. This review describes the factors that contribute to maximizing the production of effective mRNA vaccine transcripts and delivery systems, and the clinical applications are discussed in detail.
Noroviruses (NoVs) are the leading cause of acute gastroenteritis across all age groups. Because a vaccine is in clinical development, burden of disease data are required to guide the eventual introduction of this vaccine. In this study, we estimate the burden of NoV disease in children less than 5 years of age in the European Union (EU). We carried out a literature search using PubMed to identify studies providing incidence or prevalence data for NoV disease in the EU. We applied the pooled average NoV incidence and prevalence rates to the EU population less than 5 years of age to obtain the annual number of NoV illnesses, medical visits, hospitalizations and deaths occurring in the EU among children younger than 5 years. Data from 12 studies were included. We estimate that NoV infection may cause up to 5.7 million illnesses in the community, 800,000 medical visits, 53,000 hospitalizations and 102 deaths every year in children younger than 5 years in the EU. The burden of NoV disease in children in the EU is substantial, and will grow in relative importance as rotavirus (RV) vaccines are rolled out in the EU. This burden of disease is comparable with the burden of RV disease in the EU before RV vaccine introduction. More country-specific studies are needed to better assess this burden and guide the potential introduction of a vaccine against NoV at the national level.
We estimated numbers of hospitalizations for norovirus gastroenteritis (NGE) and associated medical costs in Germany, where norovirus testing is high because reimbursement is affected. We extracted aggregate data for patients hospitalized with a primary or secondary code from the International Classification of Diseases, 10th Revision (ICD-10), NGE diagnosis during 2007–2012 from the German Federal Statistics Office. We assessed reliability of the coding system in patient records from a large academic hospital. Approximately 53,000–90,000 NGE hospitalizations occurred annually in Germany (21,000–33,000 with primary and 32,000–57,000 with secondary ICD-10–coded NGE diagnoses). Rates of hospitalization with NGE as primary diagnosis were highest in children 85 years of age. The average annual reimbursed direct medical cost of NGE hospitalizations was €31–43 million. Among patients with a NGE ICD-10 code, 87.6% had positive norovirus laboratory results.
1 January 2016 in The Pediatric Infectious Disease Journal
Background: Representative, population-based epidemiologic data for gastroenteritis caused by rotavirus (RV) are rare. RV vaccines were first licensed in Europe in 2006 and recommended in 5 western federal states in 2008 or thereafter. This study establishes a baseline for assessing the impact of vaccination and delineates the RV disease burden in Germany today. Methods: Nationwide data obtained from hospitals for children 0 to 10 years of age and transferred to the Federal Statistical Office were analyzed retrospectively. Acute gastroenteritis cases because of RV were identified by the International Classification of Diseases code (ICD-10) combined with the referring diagnosis-related group code. Coding quality was validated by random sampling the patient records (n=1003). Crude and age-standardized rates per 100,000 person-years were calculated. The rate ratios of seasonal effects and recommended immunization adjusted for year, federal state and age were estimated using Poisson regression. Results: Between 2005 and 2010, 5,843,730 children were hospitalized; 520,606 cases were hospitalized because of acute gastroenteritis. RV caused 152,636 of these cases or an age-standardized rate of 302 hospitalizations per 100,000 person-years. Rates were slightly higher in boys than girls, decreased with age, and differed by federal state, year and season. Rate ratios decreased in those western federal states that recommended immunization and were inversely associated with vaccine doses sold. Conclusions: With an average of 25,440 children hospitalized yearly, RV infection has a great impact on the German healthcare system. Our findings indicate that RV immunization will lead to a decline in in-patient treatment and associated costs.