Post-approval safety studies of vaccines in pregnancy: available regulatory guidance and next steps towards the more efficient generation of safety evidence
There is wide variation in study designs and approaches for assessing vaccine safety in pregnancy post-approval, influenced by differences in vaccines, target populations, sponsors, and study periods. Harmonizing regulatory guidance and standards will enhance the consistency of data collection, as well as the comparability and validity of study conclusions.
Authors
- Lydie Marcelon
- Shahar Shmuel (ORCID: https://orcid.org/0000-0003-1726-1875)
- Flor M. Muñoz
- Adrienne Guignard (ORCID: https://orcid.org/0000-0002-3899-6902)
- Eileen Dareng (ORCID: https://orcid.org/0000-0003-0802-419X)
- Laura Taddei (ORCID: https://orcid.org/0000-0002-5589-1467)
- Marina Amaral de Ávila Machado (ORCID: https://orcid.org/0000-0002-9625-0340)
- Sarah Macdonald (ORCID: https://orcid.org/0000-0001-6533-152X)
- Kourtney J. Davis
Institutions
- Johnson & Johnson (United States) (US)
- Pfizer (United States) (US)
- Baylor College of Medicine (US)
- Sanofi (France) (FR)
- GlaxoSmithKline (Belgium) (BE)
- GlaxoSmithKline (India) (IN)
- GlaxoSmithKline (Italy) (IT)
- AstraZeneca (Poland) (PL)
- National Patient Safety Foundation (US)
Publication Details
- Journal
- Frontiers in Drug Safety and Regulation
- Published
- 2025-11-26
- DOI
- https://doi.org/10.3389/fdsfr.2025.1648854
- Primary Topic
- Pregnancy and Medication Impact
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi