Why We Need More Collaboration in Europe to Enhance Post-marketing Surveillance of Vaccines

"The influenza A/H1N1 pandemic in 2009 taught us that the monitoring of vaccine benefits and risks in Europe had potential for improvement if different public and private stakeholders would collaborate better..."

In 2016, a global survey in 67 countries on vaccine hesitancy indicated that Europe was the region in the world with the least confidence in vaccine importance, safety, and effectiveness. Indeed, some population groups in a number of European countries are hesitant about vaccination, reporting mistrust in vaccine safety and questioning the trustworthiness of government, regulatory and public health authorities, and pharmaceutical companies. In this context, continuous post-marketing monitoring of vaccine safety is needed to identify and evaluate potentially rare adverse events and to enable re-assessment of vaccine benefit-risk. This paper describes the perspectives of key stakeholder groups of the ADVANCE (Accelerated Development of Vaccine benefit-risk Collaboration in Europe) consortium for vaccine benefit-risk monitoring and their views on how to build a European system addressing the needs and challenges of such monitoring.

As the authors explain, during the 2009 influenza pandemic, several new vaccines were licensed and used in large populations. This situation highlighted the need for collaboration at many levels, indicating how post-marketing monitoring systems in the European Union (EU) could be improved by developing increased and transparent interactions between public and private stakeholders, better communication on the respective roles and responsibilities of the various European bodies and agencies (i.e., European Commission (EC), European Medicines Agency (EMA), and European Centre for Disease Prevention and Control (ECDC)), common approaches to studies for readiness to respond, and better communication strategies to share new data promptly and transparently. The idea was that collaboration and sharing of data could increase the capacity to quantify risks and benefits, allow comparisons between product brands and vaccination schedules, and promote knowledge sharing.

The ADVANCE consortium comprises key public and private vaccine stakeholders in Europe including the ECDC and EMA, with 47 full and associate partners in multiple domains (16 academic/public research institutions, 3 small medium enterprises (SMEs), 2 charities, 10 public health organisations, 9 medicines regulatory authorities, and 7 vaccine manufacturers). ADVANCE focuses on the secondary use of available, existing EU healthcare data, which could provide real-world evidence on vaccine benefit-risk to inform on the best use of vaccines. Social media data are used to listen to the public prior to communication. The conviction is that readily accessible information might help to build and maintain public trust in vaccines and facilitate informed decision-making for the regulation of vaccines, immunisation policies, and vaccination of individuals.

Participants' perspectives and needs were assessed at the start of the ADVANCE project by the EMA together with representatives of the main stakeholders in the field of vaccines within and outside the ADVANCE consortium (i.e., research institutes, public health institutes (PHIs), medicines regulatory authorities, vaccine manufacturers, and patient associations). Although all stakeholder representatives stated they conduct vaccine benefit-risk monitoring according to their own remit, needs, and obligations, they are faced with similar challenges and needs for improved collaboration. These challenges include, for example, trust in the quality of the data and the interpretation, the speed at which evidence can be made available, and the methods for pooling evidence.

In response to the stakeholders' expressed needs, the ADVANCE consortium developed various tools, methods, and best practice guidance specific to vaccine benefit-risk monitoring. In an effort to support decision-making, ADVANCE also designed a system meant to yield high-quality information on the benefits and risks of vaccines and has tested its performance in a series of proof of concept (POC) studies.

Since the project and funding ended in March 2019, the ADVANCE system, methods, and tools are being implemented by the non-profit organisation VAccine monitoring Collaboration for Europe (VAC4EU). Uniting the ADVANCE stakeholders in a different governance structure, this legal entity is open to new partners (research organisations and PHIs) and aims to collaborate with the Global Vaccine Data Network and other initiatives that focus on primary data collection, to rapidly monitor vaccine benefits and risks across continents.

In conclusion: "Although evidence on benefits and risks is not, by itself, enough to build trust when safety concerns arise, the absence of evidence and answers may generate mistrust....The rapid availability of such evidence will therefore ultimately serve society as a whole."