Summary of 2025 Society of Toxicology Workshop "Vaccine Toxicology in the Post-COVID Era".

Sarah Gould¹, Cynthia M Rohde², Eric Destexhe³, Birgitte Tiesjema⁴, Lawrence Segal⁵

¹Charles River Laboratories, Lyon, France.

²Drug Safety Research and Development, Pfizer Worldwide Research, Development & Medicine, Pearl River, NY, USA.

³Vaccine Toxicology Center of Excellence, GSK Vaccines R&D, Rixensart, Belgium.

⁴Section on Pharmacology, Toxicology and Kinetics, Medicines Evaluation Board, Utrecht, The Netherlands.

⁵Coalition for Epidemic Preparedness Innovations (CEPI), London, UK. Electronic address: lawrence.segal@cepi.net.

PubMed DOI

Abstract

Nonclinical safety studies to support clinical development and registration of vaccines is a specialized area within pharmaceutical regulatory toxicology. Toxicology testing for vaccines has been required since the mid-1990s, starting with the publication of the European Medicines Evaluation Agency (EMEA) Note for guidance on preclinical pharmacological and toxicological testing of vaccines (CPMP/…

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