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.

Vaccine
|May 15, 2022
PubMed
Summary

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.

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