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Updated: Sep 23, 2025

Intranasal Immunization and Milk Collection in Studies of Maternal Immunization in New Zealand White Rabbits Oryctolagus cuniculus
Published on: July 31, 2021
Regulatory considerations for study of infant protection through maternal immunization
Jane Namangolwa Mutanga1, Barbee I Whitaker1, Richard A Forshee1
1US Food and Drug Administration, Center for Biologics Evaluation and Research, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA.
Maternal immunization during pregnancy transfers antibodies to infants, offering crucial protection against diseases. However, challenges in clinical trials limit data on vaccine safety and effectiveness for infants and mothers.
Area of Science:
- Immunology
- Public Health
- Clinical Research
Background:
- Childhood immunization schedules begin at 2 months, leaving infants vulnerable to infectious diseases.
- Maternal immunization offers a strategy to protect infants by transferring antibodies during pregnancy.
- Challenges in including pregnant individuals and infants in clinical trials hinder vaccine development.
Purpose of the Study:
- To discuss regulatory considerations for clinical research evaluating vaccines administered during pregnancy.
- To inform future vaccine trials aimed at protecting infants from disease through maternal immunization.
- To address the paucity of evidence regarding the safety and effectiveness of vaccines for use in pregnancy.
Main Methods:
- Review of general regulatory considerations for clinical research in pregnancy.
- Discussion of challenges in conducting randomized controlled trials for vaccines in pregnant individuals.
- Emphasis on safety monitoring for mother, fetus, and infant with long-term follow-up.
Main Results:
- Limited evidence exists on the safety and effectiveness of vaccines for use during pregnancy and lactation.
- Experimental vaccines, like those for Respiratory Syncytial Virus, face complexities in clinical study design.
- Long-term follow-up is necessary to assess health outcomes associated with peripartum vaccine exposure.
Conclusions:
- Regulatory frameworks need to support robust clinical research for maternal and infant vaccines.
- Addressing challenges in trial inclusion and data collection is vital for vaccine licensure.
- Further research is essential to establish safety and efficacy of vaccines administered during pregnancy for infant protection.
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