Journal article
Regulatory considerations in the clinical development of vaccines indicated for use during pregnancy
Despite supportive public health policies (e.g., ACIP recommendations), the potential for providing clinical benefit through maternal immunization has yet to be fully realized. For vaccines already licensed and approved for use in adults, specific FDA approval for use during pregnancy to prevent disease in the mother and/or infant may have a significant impact on uptake and usage in pregnant women. In addition, for either a licensed vaccine or a novel vaccine, FDA approval for use during pregnancy would result in labeling that would serve as a resource for practitioners and would facilitate the safe and effective use of the vaccine during pregnancy.
In the U.S., while many vaccines are approved for use in adults and most are not contraindicated for use in pregnant women, no vaccine is licensed for use specifically during pregnancy. Among the perceived obstacles hindering the clinical development of vaccines for use in pregnancy, regulatory issues are frequently cited. One aim of this article is to address
Authors
Languages
- English
Publication year
2015
Journal
Vaccine
Volume
8
Type
Journal article
Categories
- Service delivery
Countries
- United States of America
Tags
- Health promotion
- Policy and legislation
WHO Regions
- Region of the Americas
