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.
EMA states that the vaccine development landscape is now “very different” then when the guidance documents were published and need to be updated to align with current epidemiological data and need to reflect the most recent variants.
Such changes include the following: placebo-controlled efficacy trials are no longer possible in certain subpopulations, and there are situations in which it may not be necessary to conduct clinical trials prior to approval. In addition, there have been new vaccine constructs proposed since 2021, including the development of mucosal, or nasally administered vaccines and vaccines based on other platforms.
An updated guidance will accommodate the new novel platforms under development for SARS-CoV-2 vaccines, including new routes of administration; the changing antigen composition of antigens expressed by approved vaccines; and inferring efficacy through immunobridging studies.
An update will also address vaccines intended to protect against several related sarbecoviruses, vaccine effectiveness studies, non-clinical studies, and, where ethically feasible, human challenge studies to support vaccine efficacy. Requirements for pediatric development of SARS-CoV-2 vaccines will also be covered.
The proposed guideline will replace the EMA considerations on COVID-19 vaccine approval (EMA/592928/2020) and the reflection paper on the regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2 (EMA/117973/2021).
EMA plans to adopt the paper in November 2024 and to finalize a guidance sometime in 2025.
The deadline for sending comments is 30 September 2024.
Concept paper
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