Safety and optimal timing of BCG vaccination in infants born to mothers receiving anti-TNF therapy

Backgrounds/aims: To evaluate the safety of Bacille Calmette-Guérin (BCG) vaccination in infants born to mothers receiving anti-TNF therapy for inflammatory bowel disease.

 Methods: Adverse events of BCG vaccination were evaluated in 90 infants who were last exposed to anti-TNF agents at a median gestational week 30.

 Results: After receiving BCG vaccination at a median age of 6 months (range, 0.25-11), three infants (3.3%) showed injection site swelling, two of whom also showed axillar lymphadenopathy. The rates of adverse events were similar between infants who were last exposed to anti-TNF agents before the 3rd trimester (n=35) and those who were last exposed in the 3rd trimester (n=55) (2.9% vs. 3.6%; p=1.00). All adverse events were spontaneously resolved and there were no serious adverse events such as active tuberculosis infection and death.

 Conclusions: BCG vaccination after 6 months of age is of low risk in infants exposed to anti-TNF agents in utero.