WHO consultation on influenza vaccines for pregnant and lactating women: Clinical data requirements for product labelling

Overview

The Consultation held at WHO Headquarters on 15-16 July 2014 was organized by the Technology, Norms and Standards team and Initiative for Vaccine Research team to review current approaches for labelling of inactivated influenza virus (IIV) vaccines intended for use in pregnant and lactating women. The current style of the wording for labelling, package insert and prescribing information of pregnancy and lactation (PI P&L) was discussed in the context of regulatory and manufacturing practices. The similarity of the IIV product quality, immunogenicity and reactogenicity was explored to identify possible classes of IIV vaccines that could share similar PI P&L advice. The meeting reviewed current approaches for clinical data submission for labelling, and it explored the possibility of using data from prelicensure clinical trials and from other sources such as postmarketing surveillance, pregnancy registries and observational studies – even with other makes of IIV. In addition relevant WHO guidance documents were reviewed to identify gaps in the guidance for product labelling regarding the use of vaccines in pregnant and lactating women. Although the discussion was focused on the situation with the IIV vaccines, it was recognized that other vaccines such as acellular pertussis also need to be addressed by WHO in future.