Value of an in-depth analysis of unpublished data on the safety of influenza vaccines in pregnant women.

ABSTRACT:

Background

Unpublished data can sometimes provide valuable information on the safety of biologic products.

Methods

We assessed information potentially available from regulatory authorities, manufacturers, and public health agencies. We explored 4 recently established vaccine registries, reviewed package inserts from 99 influenza vaccines, and contacted vaccine manufacturers and regulatory agencies for data on influenza vaccine safety in pregnant women.

Results

The vaccine registries did not have sufficient data to analyze and there are problems with the quality of the information. The majority of package inserts provided no product-specific safety information for pregnant women, especially in less developed countries. The majority of available data come from reports g

SUBMITTER: Halsey NA 

PROVIDER: S-EPMC5647814 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature