EMA Launches Vaccine Monitoring Project

The European Medicines Agency (EMA) has announced the launch of Accelerated development of vaccine benefit-risk collaboration in Europe (ADVANCE), a vaccine monitoring project. EMA, in collaboration with organizations involved in assessing the benefits and risks of vaccines, expects the project to “deliver a blueprint for a pan-European framework for monitoring the benefits and risks of vaccines throughout their lifecycle, and for communicating these benefits and risks,” according to an EMA press release. 

According to EMA, efforts to monitor vaccination coverage and the benefits and risks of vaccines after approval have been fragmented, and the goal of ADVANCE is to review, develop, and test methods, data sources, and procedures that will help to provide data for the assessment of vaccines. It is EMA’s hope that the project will provide health professionals, regulatory agencies, public health institutions, and the general public with the information needed to make better decisions regarding the use of vaccines.

The five-year project is supported by the Innovative Medicines Initiative (IMI) and involves EMA, the European Centre for Disease Prevention and Control, pharmaceutical companies, national public health and regulatory bodies, academic experts, and small and medium-sized enterprises. EMA will be responsible for developing and testing guidance that will include methodological standards, governance rules, a code of conduct, and a communication strategy. ADVANCE will be coordinated by the Erasmus Medical Center in the Netherlands and the Children’s Hospital Basel, University of Basel, Switzerland.