Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Exceptional regulatory provisions governing vaccine development and approval in a pandemic situation - a model for the regulatory future

Dr. Maria Cristina Bolanos Vasquez (Abschlußjahr: 2021)

Summary
Language: English
The coronavirus pandemic unfolding during the first months of 2020 has produced a devastating impact on countries worldwide: it has hit health systems, it has shattered economies, and it has produced human suffering on a scale never seen before in peace time. As politicians, administrators and public health managers struggled to contain and mitigate the spread of the virus, attention shifted towards the development of successful treatment options, and ultimately, of effective vaccines to stop the pandemic. With traditional paradigms of vaccine development due to their associated long development times not being applicable to a pandemic situation, regulators in major jurisdictions undertook to modify regulatory provisions to create a new pandemic paradigm of overlapping phases of development. In this process, they had to strike a fine balance between accelerated speed of development – the major benefit to be reaped - on the one hand, while controlling for risks potentially endangering the quality, safety and efficacy of the new vaccines on the other hand. The main focus of this thesis is on the regulatory adaptations implemented in the two major regulatory jurisdictions, the United States and the European Union, respectively, which proved to contribute substantially to an unprecedentedly rapid approval of new vaccines. Both regulators chose a similar regulatory pathway, the Conditional Marketing Authorisation (EMA) and the Emergency Use Authorization (FDA), which allowed developers to base their submissions on one large pivotal phase 3 study to demonstrate vaccine efficacy, while giving the regulator the means to attach specific conditions for the collection of further post-licensure data. Apart from vastly compressed review meeting schedules, three instruments played a major role in the acceleration of approval procedures: the extensive use of adaptive clinical trial designs, combined with rapid scientific advice and the rolling review of study data. In addition, abrogation of environmental risk assessments and deferral of paediatric study plans reduced the workload for vaccine developers. The relaxation of rules for on-site inspections, however, proved to be more controversial. Finally, the regulatory approaches of two other groups of countries, viz. vaccine exporters and vaccine importers, are also briefly discussed.
Pages: 82 (including figures, tables and references)