WHO working group meeting on labelling information of influenza vaccines intended to be used in pregnant women

Overview

Activities that support evidence based use of vaccines during pregnancy are important elements of the WHO initiative to improve maternal and child health. Existing inactivated influenza vaccines (IIV) have been shown to be safe and effective in healthy adults and children. Maternal influenza immunization has been also shown to protect pregnant women and their infants in the first few months of life. Nevertheless, there is reluctance on the part of many vaccine program administrators and expectant mothers to use these vaccines.

This is, at least in part, due to the fact that the approved labelling information and package insert (PI) do not include an indication for use during pregnancy. There is no international standard for layout and content of the PI. Where the PI addresses the use of IIVs in pregnant women, it is in a section on special populations and the wording usually recommends caution. This meeting was called to review the wording in several PIs and to explore the possibility of providing a guidance document to help the interpretation of the information in Pregnancy subsection of IIV PIs.