PIANO Global Consensus: Maria Chaparro, MD, on Vaccines During Pregnancy

Dr Chaparro reviews the work of her PIANO working group on vaccines among pregnant women with IBD, including issues surrounding safety, timing, and the use of live vaccines.

Maria Chaparro, MD, PhD, is a gastroenterologist with the IBD Unit at Hospital Universitario de La Princesa in Madrid, Spain.

TRANSCRIPT:

Hello, my name is Maria Chaparro from Hospital University, Madrid, Spain, and I had the privilege of coordinating the vaccination working group as part of the global consensus for the management of IBD in pregnancy. As part of this initiative, we evaluated the safety and timing of types of vaccination in infants exposed to immunosuppressive therapies used for inflammatory bowel disease, either neutral or via breastfeeding. Our aim is to provide clinicians with clear evidence-based based guidance for this increasingly common clinical scenario.

First, we strongly recommend that inactive vaccines be administered on schedule to infants born to mothers with IBD who were treated with anti-TNF agents during pregnancy. This is a strong recommendation supported by very low quality evidence. Nevertheless, the consensus among experts is clear the benefits of routine immunization with inactive vaccines outweigh any theoretical risk even in the context of biological exposure.

Regarding live vaccines, we suggest that live attenuated rotavirus vaccine may be administered to infants exposed in utero to biologics. This is a conditional recommendation based on very low quality evidence and is supported by robust real world data. Evidence from multiple studies, including registries and systematic reviews, suggests that rotavirus vaccination is safe in infants born to mothers treated with anti-TNF agents or any other biologic during pregnancy. We have data from a total of 309 infants who receive live attenuated vaccine and being exposed in utero to biologics, and there was no serious adverse event. A systematic review showed a low risk of minor adverse events, for instance, fever or diarrhea, in a small proportion of cases.

And finally, the only prospective study performed by Canadian Immunization Research Network reported that of 191 exposed children mainly during the third trimester of gestation exposed to infliximab, adalimumab, ustekinumab, and vedolizumab, 168 initiated rotavirus vaccine and there was no serious adverse event reported. In a substudy of this trial, 52 mothers with inflammatory bowel disease and 57 children were evaluated. All infants had been exposed in utero to biological therapies, including infliximab, adalimumab, vedolizumab, and ustekinumab. All infants underwent assessment at a specialized immunization clinic, and despite having detectable monoclonal antibody levels in infants, clinical and immunological evaluations were normal after receiving rotavirus vaccine.

In contrast, we recommend the vaccine to be avoided in the first 6 months of life in infants exposed utero to anti-TNF therapy. This is a strong recommendation based on case reports and expert consensus indicating a risk of disseminated tuberculosis and mortality. In this context, the regional tuberculosis risk should be taken into account when applying this recommendation to clinical practice. Unlike the rotavirus vaccine, the vaccine gal query vaccine is more vital in some parts of the world where it is given within the first month of life, as well as more dangerous to the biologic-exposed infants In cair Kyrie's countries where the vall carrying must be given early serum concentration of the drug can be measured prior to vaccination, and consideration can be given to holding the biologic in the mother emit pregnancy to reduce the transfer of the drug to the infant.

We also reach agreement on the following points based on expert consensus and available data. First, inactive vaccines should be administered on a schedule to all infants of mothers with IBD regardless of the IV specific medication exposure during pregnancy. This provide reassurance that the standard immunization protocols remain appropriate even in the context of in utero exposure to various immunosuppressants. Secondly, infants exposing utero to Janus kinase inhibitors or ingin one phosphate receptor modulator in utero may receive live vaccines after one month of age. Although the evidence in this setting is quite limited, this timing provides a balance between immunogenicity and safety based on what is known about the immune system development in these infants. And finally, live vaccines may also be safely administered to infants who are breastfed by mothers receiving biologic therapy as transfer of the drug through breast milk does not appear to cause clinically relevant immunosuppress suppression in the infant. Each of this recommendation reflects the consensus of international experts and is intending to provide clarity for clinical decision making in diverse healthcare setting. In summary, our working group supports a standard immunization practices in most infant born two mother with IBD receiving immunosuppressive therapy with a few key exceptions related to live vaccines. We believe that with appropriate attention to therapy, specific considerations and regional infectious risks, infants can be safely and effectively protected through vaccination. And thank you very much for your attention.