In addition, vaccines with novel adjuvants enhance the presentation of antigen, and a more specific modulation of the adaptive immune response. This evidence is further supported by the clinical profiles of licensed vaccines, which show no evidence of AI disease induction in vaccinees (see case study 1 and Chapter 4 – Vaccine adjuvants). Although there are case reports of temporal associations between the administration of vaccines (or common vaccine components) and

events that trigger safety alerts, these associations alone do not establish a causal link. Vaccine manufacturers and regulatory bodies must be careful to monitor reports of temporally associated events so that these can serve as possible signals for unexpected HSP inhibitor www.selleckchem.com/products/ABT-263.html rare AEs. These signals can then be further evaluated by additional data collection and appropriate analyses. With the objective of further improving the safety profile of a vaccine, action may be taken as a precautionary or definitive measure as illustrated in the case of the rhesus rotavirus (RRV-TV) vaccine (case study 3). Some of the specific issues that have arisen in relation to vaccines and vaccine components are described here, along with action taken by vaccine manufacturers and regulatory authorities to address concerns. Case study 5.  A temporal association between an adverse event

and vaccine is not sufficient to establish a cause and effect relationship Measles is a virus that causes a rash, cough and fever in the majority of patients, but can less commonly lead to pneumonia, seizures, encephalitis and even death. Mumps is a virus that causes fever, headache and swollen salivary glands (mainly

parotid glands), but in more serious cases can lead to deafness, viral meningitis and orchitis. Rubella, also known as German measles, is generally a mild disease, but can result in serious birth defects in children born to mothers infected in the early stages of pregnancy. The MMR three-component live-virus vaccine is a combination vaccine delivered in a single injection, designed to provide protection against measles, mumps and rubella. Originally developed in the 1970s, the MMR vaccine is currently used Paclitaxel clinical trial in over 100 countries. A small minority of vaccinees experience minor-to-moderate side effects including fever, rash and joint pain, which subside within a few days. Since the MMR vaccine was introduced in the early 1970s, the number of children experiencing each of the diseases and their complications has dramatically decreased. However, controversy ensued upon publication of a paper in The Lancet in 1998, which hypothesised a potential association between receiving the MMR vaccine and the subsequent development of autism in children in their second year of life. This was published by the primary author, after observing a small number of children with inflammatory bowel disorders and neurological development disorder a few weeks or months after they had received the MMR vaccination.