Labelling information of inactivated influenza vaccines for use in pregnant women, Annex 8, TRS No 1004

Overview

This recommendation is based on evidence of a substantial risk of severe disease in this population group and on evidence that the use of seasonal influenza vaccine is both safe throughout pregnancy and effective in preventing influenza in women as well as in their young infants in whom the disease burden is also high. The development of this explanatory addendum arises from the recommendations of SAGE regarding the immunization of pregnant women with IIV and the resulting discussions at several WHO consultations, as well as discussions held during the 2015 meeting of the WHO Expert Committee on Biological Standardization. 

The aim of this addendum is to provide clarification and interpretation of the labelling information provided in the product insert of IIVs in order to facilitate maternal immunization programmes. It is also intended to raise awareness of the convergence of regulatory positions in spite of differing approaches to labelling and regulatory language regarding the use of these vaccines in pregnant women. On the basis of current evidence, the use of IIV in pregnant women is not contraindicated. This addendum applies to inactivated trivalent and quadrivalent (tetravalent) influenza vaccines for which sufficient safety data are available. It is intended for NRAs, manufacturers, end-user programme managers and NITAGs.

Full version of the WHO Technical Report Series N° 1004