• A Canadian prospective cohort study investigated the efficacy of giving live rotavirus vaccine to infants exposed to immunomodulatory biologics during pregnancy.

• Of the 202 assessed infants, 191 were enrolled, with exposure to various biologic agents.

• In most cases, exposure to the biological agent continued into the third trimester.

• There were no detectable abnormalities in the mitogen responses, quantitative immunoglobulins, or lymphocyte subsets that were clinically significant.

• After the assessment, 98% of infants were recommended for rotavirus vaccination, of whom 80% completed the series.

• No serious adverse events were reported, indicating that rotavirus vaccination is generally safe for infants exposed to anti-TNF agents in utero.

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