Vaccines are different from most medicines in that they are administered to large and mostly healthy populations including infants and children, so there is a low tolerance for potential risks or side-effects. In addition, the long-term benefits of immunisation in reducing or eliminating infectious diseases may induce complacency due to the absence of cases. However, as demonstrated in recent measles outbreaks in Europe and United States, reappearance of the disease occurs as soon as vaccine coverage falls. Unfounded vaccine scares such as those associating the combined measles-mumps-rubella vaccine with autism, and whole-cell pertussis vaccines with encephalopathy, can also have massive impacts, resulting in reduced vaccine uptake and disease resurgence. The safety assessment of vaccines is exhaustive and continuous; beginning with non-clinical evaluation of their individual components in terms of purity, stability and sterility, continuing throughout the clinical development phase and entire duration of use of the vaccine; including post-approval. The breadth and depth of safety assessments conducted at multiple levels by a range of independent organizations increases confidence in the rigour with which any potential risks or side-effects are investigated and managed. Industry, regulatory agencies, academia, the medical community and the general public all play a role in monitoring vaccine safety. Within these stakeholder groups, the healthcare professional and vaccine provider have key roles in the prevention, identification, investigation and management of adverse events following immunisation (AEFI). Guidelines and algorithms aid in determining whether AEFI may have been caused by the vaccine, or whether it is coincidental to it. Healthcare providers are encouraged to rigorously investigate AEFIs and to report them via local reporting processes. The ultimate objective for all parties is to ensure vaccines have a favourable benefit-risk profile.

The aim of this work was to measure peripheral lymphocyte apoptosis during IBD flare and remission. Subjects and Methods. Flow-cytometric assessment of apoptosis of peripheral blood lymphocytes (PBL) was assessed in 30 children with IBD (16 with ulcerative colitis and 14 with Crohn’s disease) compared to 22, age and sex matched, healthy children. This was carried out during a flare, whether in newly diagnosed or relapsing patients, and after achievement of remission. Clinical findings, complete blood count, liver transaminases, and kidney functions were assessed. Results. Early apoptotic and late apoptotic/necrotic lymphocytes were significantly higher during IBD flare compared to controls (P≤0.01 and <0.01, resp., in ulcerative colitis and P≤0.01 and <0.01, resp., in Crohn’s disease patients). Remission values were significantly decreased but did not come back to the control levels. Early apoptotic values were significantly related to joint involvement in IBD patients (P<0.0001). Conclusions. We can speculate a systemic nature of IBD as evident by enhanced peripheral lymphocyte apoptosis. This is related, to a great extent, to the disease process as it is more deranged in flare than in remission. Relation of this derangement to extraintestinal manifestations needs a special attention.