WHO Informal consultation on labelling information of influenza vaccines intended to be used in pregnant women

Overview

Vaccination during pregnancy is important to improve maternal and child health. WHO recommended the immunization of pregnant women with inactivated influenza vaccines (IIVs) based on evidence of the safety of maternal immunization. WHO Technologies, Standards, and Norms Team organized an informal consultation in 2014 and a working group meeting in 2015: (a) to review current approaches for and wording in labelling information of IIVs intended for use in pregnancy; and (b) to explore the possibility of providing a guidance document to help clarification and interpretation of the information in order to facilitate maternal immunization.

WHO Technologies, Standards, and Norms Team organized an informal consultation in 2014 and a working group meeting in 2015: (a) to review current approaches for and wording in labelling information of IIVs intended for use in pregnancy; and (b) to explore the possibility of providing a guidance document to help clarification and interpretation of the information in order to facilitate maternal immunization.

WHO Recommendations for the production and control of inactivated influenza vaccine were published in the Annex 3 of WHO Technical Report Series No. 927, 2005. Since it was agreed in the working group meeting and recommended by the WHO Expert Committee on Biological Standardization in its 2015 meeting to prepare an addendum to the existing Annex 3 on IIVs in order to help the interpretation of labelling information, a draft document was prepared and subjected to the public consultation in Jan – Feb 2016. The purpose of this April 2016 meeting was: (a) to share the updates since the last meeting in 2015; (b) to review the comments received from the public consultation; and (c) to discuss the major issues to be resolved for next revision.