Increasing Vaccine Access in a Shorter Time. Discussing Alternative Regulatory Frameworks in Response to Pandemics

To prevent pandemic outbreaks or mitigate an evolving pandemic crisis, it is of utmost importance to guarantee timely and global access to safe and effective vaccines. There are multiple variables that can impede timely and global access, ranging from inability to set up production sites to practices of licensing intellectual property (IP). In this discussion paper, we problematize how the regulatory environment of vaccine development, approval, production, and deployment might have detrimental effects on vaccine access. Thus, we look at vaccine access mainly through the lens of vaccine availability determined by regulatory bodies. While the development of mRNA vaccines against Sars-CoV-2 might serve as a prime example of regulatory acceleration for timely vaccine access, this acceleration has not led to acceptable global vaccination rates within a reasonable timeframe. We argue that regulatory approval practices are a key variable for timely and global vaccine access and that it is necessary to improve their build-up into regulatory frameworks to handle the current pandemic and to be prepared for future pandemics. As one potential starting point for discussion, we suggest a modular approach to vaccine regulation that allows more flexible combinations of existing, unconventional, or even controversial regulatory practices to respond to evolving pandemic threats. We reflect upon how this modular approach might influence vaccine uptake by the public and, thus, the vaccination rate more generally, and discuss whether certain alternative regulatory practices could influence monopoly dynamics in the pharmaceutical industry.