REVIEW article
Front. Immunol.
Sec. Vaccines and Molecular Therapeutics
Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1584738
This article is part of the Research TopicCommunity Series in Development and Harmonization of Assays and Models to Assess Immunogenicity and Correlates of Protection of Vaccines Against Pathogens Causing Respiratory Infections: Volume 2View all 5 articles
T cells responses after vaccination: a regulatory perspective
Provisionally accepted
- European Medicines Agency, Amsterdam, Netherlands
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Vaccines are complex biological medicinal products developed with the aim to generate protective immunity against specific infectious diseases in a particular target population. Regulatory authorities, who have the role of approving vaccines, ensure that these meet the agreed criteria for quality, safety and efficacy, and assess their benefit and risk profile before and after a marketing authorization is granted.In the European Union/European Economic Area, the vast majority of the vaccines currently available has been approved on the basis of clinical efficacy or immunogenicity data relying on humoral immune responses. Per contrary, there are no vaccines approved based on immunogenicity endpoints exclusively focused on cell mediated immunity, despite the known relevance of T cells immunity for protection against a variety of infectious diseases.We here review a few relevant cases of vaccines targeting infectious diseases for which data on cell mediated immunity have been considered in the context of regulatory filing, and provide our perspective on the way forward.
Keywords: Vaccines, T cells, Assays, regulatory approval, Decision Making, pathogens
Received: 27 Feb 2025; Accepted: 26 May 2025.
Copyright: © 2025 Buoninfante and Cavaleri. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Alessandra Buoninfante, European Medicines Agency, Amsterdam, Netherlands
Marco Cavaleri, European Medicines Agency, Amsterdam, Netherlands
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.