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Related Experiment Video

Updated: May 17, 2026

Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells

Developmental Toxicity Assay Based on Real-Time Monitoring of Fibroblast Growth Factor Signal Disruption in Human Induced Pluripotent Stem Cells

Published on: October 10, 2025

Developmental toxicity testing of vaccines.

Paul C Barrow¹, Linda Allais

¹CiToxLAB, Evreux, France. paul.barrow@citox.com

Methods in Molecular Biology (Clifton, N.J.)

|November 10, 2012

Summary

Vaccine developmental toxicity testing requires assessing vaccine components and maternal antibodies for potential harm to the fetus. Animal models are chosen based on antibody transfer rates, with non-primate species like rabbits sometimes preferred over rodents.

Area of Science:

Reproductive toxicology
Vaccine development
Immunology

Background:

Vaccines are increasingly administered during pregnancy, necessitating thorough developmental toxicity testing.
Vaccine components (antigens, adjuvants, excipients) and induced maternal antibodies require evaluation for potential adverse effects on fetal development.
Existing FDA guidance (2006) outlines preclinical testing for vaccine developmental toxicity.

Purpose of the Study:

To outline considerations for developmental toxicity testing of vaccines used in pregnancy.
To highlight the importance of evaluating both direct vaccine effects and indirect effects of maternal antibodies.
To discuss the selection of appropriate animal models for these studies.

Main Methods:

Assessing direct effects of vaccine components on the developing conceptus.

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Evaluating the impact of induced maternal antibodies on fetal and postnatal development.

Selecting animal models based on species-specific cross-placental transfer of maternal immunoglobulins.

Considering nonhuman primates for biotechnology-derived vaccines and ICH study designs for novel adjuvants.

Main Results:

Cross-placental transfer of maternal antibodies varies significantly across species, occurring mainly in late gestation.
Rabbits often exhibit higher prenatal antibody transfer rates than rodents.
Nonhuman primates may be essential models for certain novel vaccines due to immunogenicity differences.
Testing adjuvants using conventional pharmaceutical study designs alongside final vaccine formulation studies is advisable.

Conclusions:

Developmental toxicity testing for vaccines in pregnancy must account for vaccine components and maternal antibody transfer.
Animal model selection is critical, with species differences in immunoglobulin transfer influencing study outcomes.
A comprehensive approach, potentially including non-primate and primate models, is necessary for robust vaccine safety assessment.