Position paper 8 February 2024

Regulatory agilities applied to vaccines during the COVID-19 pandemic and recommendations for the future

During the COVID-19 pandemic, National Regulatory Authorities (NRAs) and the biopharmaceutical industry applied a variety of regulatory agilities to accelerate the development, evaluation, authorization, and supply of COVID-19 vaccines. These agilities were a key factor in enabling rapid patient access to vaccines.

Experience from the pandemic and the use of regulatory agilities offers valuable insights on how regulatory systems may be adapted to further support innovation and timely patient access to vaccines at all times, not just during emergencies.

This position paper outlines some key regulatory agilities implemented in areas such as research and development, regulatory evaluations, authorizations, and post-approval changes (PACs) and labelling. Key learnings and recommendations to enhance regulatory frameworks in the future are also included.