The ADVANCE vision is focused on “timely and best evidence on vaccine benefits and risks”. Our mission is to establish a Blueprint for a validated and tested best practice framework that could rapidly provide robust data on vaccine benefits and risks to support accelerated decision making. Ultimately, in Europe we need to achieve continuous benefit-risk monitoring throughout the life cycle of vaccines to fulfill the needs of different target groups and stakeholders (e.g. Ministries of health, insurance companies, regulatory agencies, public health agencies, vaccine manufacturers, health care providers, consumers etc.). This would encompass:
1) Pre-licensure vaccine efficacy and safety monitoring 2) Safety signal detection based on spontaneous reporting 3) Safety signal generation from electronic health care records 4) Rapid verification of safety issues (including monitoring for risk management activities) with a prior hypothesis utilizing all available information sources (e.g. clinical trial data, spontaneous reporting data, data from electronic health care records) 5) Thorough signal substantiation (hypothesis testing studies) 6) Effectiveness of vaccine utilizing available data sources (e.g. clinical trial data, pathogen/vaccine targeted disease surveillance data and data from electronic health care records) 7) Population impact monitoring of intended vaccine effect utilizing available data sources (e.g. clinical trial data, pathogen/vaccine targeted disease surveillance data, data from electronic health care records) 8) Integrated vaccine benefit-risk monitoring with the option for cyclical updates during the vaccine life cycle.
ADVANCE is focusing on items 4-8 as items 1-3 have been developed or are the focus of other systems / projects. To achieve this vision, ADVANCE implements an efficient collaborative approach for public-private interaction through the following innovative scientific program in the different work packages (WPs):
1) Establishing best practice rules for interaction between public-public and public-private stakeholders for best practice conduct of studies on the benefit-risk of vaccines (WP1). 2) Mapping and promotion of synergies with pertinent other initiatives (e.g., PROTECT, I-MOVE, BCoDE, ESEN2, VENICE, GRIP, EMIF, VAESCO, EU-ADR Alliance, VACCINE.GRID) to maximize utilisation of foreground and identification of gaps for program strengthening (WP2). 3) Profiling of data sources that will yield rapid access to burden of disease, vaccine coverage, and benefits and risks of vaccines (WP3). 4) Adaptation and development of new methods for monitoring of vaccine benefits, risks and their integrated analysis (WP4) 5) Creation of the ADVANCE data platform and evaluation of code of conduct, data sources, and methods developed in other WPs via a series of public-private cooperative proof of concept studies (WP5). 6) Development of the Blueprint involving an independent consultation on expanded and sustainable framework implementability in European member states. The blueprint will be based on the white papers that will be generated in each of the work packages.
PEDIANET will provide access to children caring sites in WP5, thus providing clinical data on the paediatric population useful for rapid effectiveness and safety monitoring – both for healthy as wellas special populations. PEDIANET will also contribute to the needs assessment and landscape analysis of WP1 by representing the health care provider view, and in the WP3.