Europe – EMA proposes revamping COVID-19 vaccine guidance for the post-pandemic era

The European Medicines Agency (EMA) is proposing to update its COVID-19 guidances to reflect new developments in the non-clinical and clinical development areas. It will also address post-approval issues, including changes in antigenic composition and the collection of vaccine effectiveness data. These plans were announced in a concept paper published on 1 July.

EMA said the revised guidance will address “the need for safe and effective coronavirus vaccines including against COVID-19, taking new scientific knowledge and lessons learned from the COVID-19 pandemic into account.”  The proposal is also meant to accommodate a “very different” vaccine development landscape for COVID-19 vaccines.

EMA published a guideline on the regulatory clinical requirements for COVID-19 vaccines in November 2020 and a separate guidance addressing the quality and non-clinical requirements for vaccines to protect against variant strains in February 2021.

The agency would like to merge these two guidances into one document, while issuing a separate document sometime in the future on the quality aspects of COVID-19 vaccine development. The agency said that “it is intended that quality aspects of COVID-19 vaccines will be covered in a separate guideline” and is outside the scope of the concept paper…