A woman in our practice received infliximab (Remicade, Janssen Pharmaceuticals) for treatment of Crohn’s Disease while she was pregnant. Should we modify her infant’s vaccination schedule because of this treatment?

Infliximab is an IgG monoclonal antibody that neutralizes the biological activity of tumor necrosis factor-alpha. Like other IgG antibodies infliximab crosses the placenta. Infliximab has been detected in the blood of infants up to 6 months following birth. Consequently, these infants may be at increased risk of serious infection.

Neither ACIP nor CDC provides specific guidance on this issue because there are few data on safety or efficacy in children exposed to potentially immunosuppressive biologics during pregnancy. As noted above, practitioners should consider the potential risks and benefits of administering rotavirus vaccine to infants with known or suspected altered immunocompetence. Consultation with an immunologist or infectious diseases specialist is advised.

The manufacturer recommends that live vaccines (rotavirus and BCG) be deferred for at least six months after birth for infants whose mothers received infliximab during pregnancy. Hence, if a practitioner follows the manufacturer’s recommendation the child would not be eligible to receive rotavirus vaccine because according to ACIP guidelines the rotavirus vaccine series should not to be started after age 15 weeks 0 days.

Inactivated vaccines should be given on schedule.