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Evaluation of non-clinical toxicity studies of COVID-19 vaccines

N K M Schilder1, B Tiesjema2, P T Theunissen2

  • 1Section on Pharmacology, Toxicology and Kinetics, Medicines Evaluation Board, Graadt van Roggenweg 500, 3531AH, Utrecht, the Netherlands; Division of Toxicology, Leiden Academic Center for Drug Research, Einsteinweg 55, 2333CC, Leiden, the Netherlands.

Regulatory Toxicology and Pharmacology : RTP
|June 25, 2023
PubMed

Insights

Non-clinical toxicity studies for SARS-CoV-2 vaccines, including Repeated Dose Toxicity (RDT) and Developmental and Reproductive Toxicity (DART) studies, revealed no adverse effects at human-relevant doses. Findings primarily included expected local reactions and immune responses, supporting vaccine safety.

Area of Science:

  • Vaccinology
  • Toxicology
  • Immunology

Background:

  • Evaluating non-clinical toxicity of SARS-CoV-2 vaccines is crucial for regulatory approval.
  • Different manufacturing technologies may influence vaccine safety profiles.
  • Repeated Dose Toxicity (RDT) and Developmental and Reproductive Toxicity (DART) studies are key components of non-clinical assessments.

Purpose of the Study:

  • To evaluate outcomes of non-clinical toxicity studies for various SARS-CoV-2 vaccines.
  • To assess the safety profile of vaccines across different manufacturing technologies.
  • To review European Medicines Agency (EMA) non-clinical assessment reports.

Main Methods:

  • Analysis of RDT and DART study data for SARS-CoV-2 vaccines.
  • Review of EMA non-clinical assessment reports for market authorization.
  • Evaluation of platform studies submitted as supplementary data.

Main Results:

  • RDT and DART studies at human-relevant doses showed no adverse effects.
  • Observed findings included local reactogenicity, immune response, and injection site reactions.
  • EMA assessments frequently focused on study design, species selection, and data completeness, irrespective of vaccine technology.

Conclusions:

  • Animal model-based toxicity testing demonstrated minimal, non-serious adverse effects for SARS-CoV-2 vaccines.
  • The translational value lies in understanding inflammatory effects, indicating vaccine action.
  • Utilizing existing RDT and DART data from platform technologies is encouraged for vaccine assessment, aligning with the 3Rs principles.
Keywords:
COVID-19 vaccinesDevelopmental and reproductive toxicity (DART) studyRepeated dose toxicity (RDT) studySupportive platform technologyVaccine concept

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