Effect of package insert language on health-care providers' perceptions of influenza vaccination safety during pregnancy

Abstract

Despite national and international recommendations that support influenza immunisation in pregnant women, global adoption of these programmes is inadequate.1 Reviews by public health experts of inactivated influenza vaccines have not identified safety concerns in pregnant women or their offspring.2 These reviews were based largely on non-product-specific data and observational studies because data from product-specific, randomised controlled trials in pregnant women are scarce. However, clinical trial data are the basis for the language of the vaccine product information and package inserts approved by regulatory authorities regarding indications, safety, and use in specific populations.

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