BCG Vaccine and Breastfeeding

Summary of use during lactation

The Centers for Disease Control and Prevention and several health professional organizations state that vaccines given to a nursing mother do not affect the safety of breastfeeding for mothers or infants and that breastfeeding is not a contraindication to the BCG vaccine. Breastfed infants should be vaccinated according to the routine recommended schedules.[1-3] An exception is to avoid BCG vaccine in the first 6 months in infants whose mothers received an anti-TNF immunosuppressant during pregnancy.[4,5] Bladder installation of BCG vaccine is acceptable, but pre-treatment BCG vaccination of the infant may be advisable.

Drug levels in milk and infant serum

Maternal Levels. Relevant published information was not found as of the revision date. Infant Levels. Relevant published information was not found as of the revision date.

Effects in breastfed infants

In one study, breastfeeding improved the cellular immune response to BCG vaccine if the vaccine was given at birth. However, if the vaccine was given at 1 month of age, breastfeeding had no effect.[6] A nursing mother presented with bladder carcinoma 2 months postpartum. After deciding to treat her with intravesicular BCG vaccine, her infant was given the BCG vaccine subcutaneously 2 weeks before the mother’s first treatment. The mother continued to breastfeed her infant throughout 6 courses of induction therapy and the initial 3 weekly maintenance treatments. The infant had no reported adverse effects, such as systemic dissemination of BCG.[7]

Effects on lactation and breastmilk

Relevant published information was not found as of the revision date.

References

1. Kroger A, Bahta L, Long S, et al. CDC. General Best Practices for Immunization. 2024. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html
2. Kimberlin DW, Brady MT, Jackson MA, et al. Red Book: 2018 Report of the Committee on Infectious Diseases. 31st ed. Elk Grove Village, IL: American Academy of Pediatrics. 2018.
3. Gruslin A, Steben M, Halperin S, et al. Immunization in pregnancy: No. 220, December 2008. Int J Gynaecol Obstet 2009;105:187-91.19367691 PubMed
4. Ding N, Zhao L, Zhu L, et al. Management of biologics in pregnant, lactating patients with inflammatory bowel disease and the impact on neonatal vaccination: A systematic review of clinical practice guidelines and consensus statements. J Clin Pharm Ther 2022.36452989 PubMed
5. Gisbert JP, Chaparro M. Vaccines in children exposed to biological agents in utero and/or during breastfeeding: Are they effective and safe? J Crohns Colitis 2023;17:995-1009.36652274 PubMed
6. Pabst HF, Godel J, Grace M, et al. Effect of breast-feeding on immune response to BCG vaccine. Lancet 1989;1:295-7.2563456 PubMed
7. Barbur E, Doganca T, Obek C. Safe use of intravesical bacillus Calmette-Guérin immunotherapy for bladder cancer during breastfeeding: A case report. Immunotherapy 2022;14:759-64.35754395 PubMed