Rethinking Vaccine Development as Integral Part of Preparedness in the European Health Union

Abstract

This opinion piece puts forward a critique of the policy and regulatory frameworks governing vaccines, understood as tools to confront pandemic and epidemic diseases (PEDs). Specifically, it discusses what appears to be a hiatus between the nature of transnational and European regulatory frameworks governing the complex process leading to the marketing authorisation of new vaccines, which are largely inspired by market-oriented logics, and the guidelines, decisions and policies adopted by Public Health institutions to face emergent health threats, including PEDs. Vaccines being the universally recognised prime method of prevention, immunization campaigns and vaccine R&D could reasonably be expected to feature prominently in any policy and/or strategic document addressing emerging health threats. Yet vaccination occupies a relatively subsidiary role, with a prevalent focus on risk management mechanisms. This piece outlines the main characteristics of preparedness frameworks, and looks at vaccine development in the course of recent PED outbreaks, to conclude that the COVID-19 pandemic calls for a paradigm shift in vaccine R&D, which should become integral to public health preparedness.