The majority of influenza vaccines were initially designated as Category B or C pharmaceutical products. This means that adequate and well-controlled studies on pregnant women were not conducted prior to licensure of influenza vaccines and it is not known whether the vaccines can cause fetal harm when administered to a pregnant woman or can affect fertility and the reproduction capacity of a woman.
In 2015, the FDA removed pregnancy categories and replaced it with a Pregnancy and Lactation Labeling Rule. This rule affects all influenza vaccine products submitted after June 30, 2015. As new language is phased in, information on risks associated with vaccinating while pregnant will appear in 8.1 of each vaccine’s product insert under Risk Summary. NVIC encourages pregnant women to read this information carefully prior to receiving influenza vaccine or any other vaccine.
