This alert follows 4 yellow card reports of neonates who have died from disseminated BCG or tuberculosis infection after exposure to a TNF-alfa antagonist in utero. As a precaution, any infant who has been exposed to immunosuppressive treatment from the mother either in utero during pregnancy or via breastfeeding should have any live attenuated vaccination deferred for as long as a postnatal influence on the immune status of the infant remains possible. In the case of in utero exposure to TNF-alfa antagonists and other biological medicines, this period should be until the infant is age 6 months, after which time vaccination should be considered.
Separately, there have also been yellow card reports of several elderly patients who have received shingles vaccine (Zostavax) at a time when they were possibly immunosuppressed (eg, due to treatment for a transplant or due to lymphoproliferative disorders).