The authors declare no other conflicts BI 2536 research buy of interest. “
“Evaluation of the safety of rotavirus vaccines, particularly with respect to the risk of intussusception, has been a major influence in the approach to clinical development

and implementation of rotavirus vaccines [1], [2], [3] and [4]. When the World Health Organization (WHO) Special Advisory Group of Experts (SAGE) made the global recommendation for rotavirus vaccines in July 2009, it was recommended that post-marketing surveillance activities to detect rare adverse events, including intussusception, should be conducted or strengthened [5] and [6]. This recommendation was based on the previous experience with the first rotavirus vaccine to be licensed in the USA, the Rotashield vaccine (RRV-TV; Wyeth-Lederle, USA)[2] and [7]. In hindsight, early clinical trials of the Rotashield vaccine did hint at a possible association with intussusception although these studies were not powered to detect a statistically significant association of a rare association [8]. However, implementation of this vaccine within the National Immunisation Program in the Selleck C59 wnt US was associated with the detection

of a rare association between intussusception and Rotashield® vaccine and the recommendation for the vaccine was suspended 9 months after its introduction [8]. The size of the large clinical trials of Rotarix® (RV1; GlaxosmithKline, Belgium) and RotaTeq® (RV5; Merck, USA) were driven by the need to exclude a risk of intussusception of >1 in 30,000 vaccine recipients [3] and [4].

Both Montelukast Sodium vaccines were found to be safe and effective [3] and [4] in the large Phase III clinical trials, however, there remains a concern regarding the risk of rare adverse events, including intussusception, when the vaccines are administered outside the strict administration guidelines of a clinical trial and in regions where the baseline risk of intussusception is high or is unknown [6]. The aim of post-marketing surveillance activities is to detect rare adverse events related to vaccination but that had not been identified or comprehensively evaluated in pre-licensure clinical trials. Although it would be ideal to conduct post-marketing surveillance activities to determine the impact and safety profile of a new vaccine within each local regional context, these studies are expensive and require specific expertise if they are to provide complete and accurate data. Therefore, it is unrealistic to expect all countries that plan to implement rotavirus vaccines into the National Immunisation Program to have the resources needed to conduct post-marketing surveillance of sufficient quality to provide meaningful data [6] and [9]. One of the challenges facing new vaccines is the assessment of risk in regions where there is limited data on the baseline incidence and severity of diseases that may become the focus of safety investigations.