Recent years have brought new challenges to the field of vaccine safety surveillance. Direct introduction of new vaccines into areas with emergent need has begun with the development of vaccines against dengue fever, ebola, and malaria, leading to a shift in the burden of responsibility in the detection of safety signals in the early post-marketing period to pharmacovigilance systems with more limited resources. A number of recent vaccine related safety concerns which have received substantial public attention (Pandemrix and narcolepsy, Dengvaxia and severe dengue) have suggested the presence of individual-level risk factors for the occurrence of these adverse outcomes, and the field of systems immunology has emerged to describe the complexity of the immune system which may allow us to further understand how vaccines can cause adverse events. And lastly, recent surveys have documented concerning decreases in public confidence in vaccine safety, and the WHO has declared vaccine hesitancy as one of the ten threats to global public health in 2019.
Another important issue in global vaccine safety surveillance is separation of responsibilities of national pharmacovigilance centres and national immunisation programs in those countries in which vaccines are administered via WHO sponsored public health programmes. A consequence of this separation can be that reports of AEFI are not pooled within one national database for optimal signal detection work and sharing with the global safety community.
Against this background, in 2019, the ISoP Executive Committee has encouraged the creation and development of a new SIG in ISoP dedicated to exploring issues relating to vaccine pharmacovigilance. It is planned to formally launch the SIG at the 19th annual meeting of ISoP in Bogotá in October 2019.
The members of this group have a specific interest in vaccine safety.
The overall aim of the Vaccines SIG is to provide a focal point for ISoP members interested in vaccine safety to share and provide information on relevant issues and developments and to support vaccine pharmacovigilance
The key objectives are:
.To provide bi-monthly news and information bulletins by email to Vaccine SIG members
.To organise, where possible, a session at the ISoP annual meeting each year on the topic of vaccine safety
.To advise the ISoP Executive Committee, where required, on issues relating to vaccine safety
.To foster collaboration between national pharmacovigilance centres and national immunisation programmes
.To encourage collaboration with persons working within the field of vaccinology to expand knowledge of how vaccines cause adverse reactions
.To develop and support improved approaches to communication regarding benefits and risk of vaccines, in particular as our knowledge of inter-individual variation in immune responses, and risk for AEFI, grows