Summary of Use during Lactation

Breastfeeding results in a markedly decreased risk of severe cholera in breastfed infants and maternal cholera vaccination increases it further. 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 cholera vaccine. Breastfed infants should be vaccinated according to the routine recommended schedules.[1,2]

Drug Levels

Maternal Levels. Administration of injectable cholera vaccine increases milk secretory IgA antibodies against cholera in the breastmilk in some reports.[3,4] Oral cholera vaccines result in a much lower increase in breastmilk anticholera antibodies.[5,6]

Ten nursing women in Sweden and ten in Pakistan were given subcutaneous injections of bivalent whole-cell cholera vaccine (Swedish National Bacteriological Laboratory) between 1 and 10 months postpartum, followed by a booster dose 14 days later. Before immunization only two of the Swedish women had detectable levels of antibodies against V. cholerae lipopolysaccharide in milk, and then in low titer. In the Pakistani women, titers of IgA antibodies against this antigen were found in 6 out of 10 of the prevaccination milk samples, suggesting earlier natural exposure. Vaccination did not result in greater than twofold rises of specific lgA,-lgG, or IgM antibodies in the milk of any of the Swedish women, nor did the booster immunization induce any milk antibody response. In the Pakistani women, the first dose of vaccine gave rise to significantly increased lgA antibody titers in 7 out of 10 of the milk samples. No significant increase was seen in IgG or IgM antibodies. This suggests that vaccination against cholera in persons living in nonendemic areas should include one or more oral doses of antigen for priming.[7]

Six mothers were given 3 doses of injectable inactivated whole cholera vaccine (Swedish National Bacteriological Laboratory) at 3-week intervals. Milk IgA antibody titers peaked in the first milk sample taken 2 weeks after the first vaccination. Only one of the 6 mothers had an enhanced response after the second vaccination. IgA antibodies were polymeric and short-lived (4 to 6 weeks).[8]

Twenty-one lactating Pakistani women were vaccinated with 3 doses of injectable inactivated whole cholera vaccine (Swedish National Bacteriological Laboratory) at 3-week intervals alone or in combination with oral Salmonella typhi vaccine. Milk IgA antibodies to V. cholerae LPS increased for 2 to 4 weeks in those given one or both vaccines. Combination of the 2 vaccines did not have any untoward effect on the antibody response in serum or in secretions against V. cholerae or S. typhi.[9]

Infant Levels. An open-label study in Bangladesh compared the serum immune response to administration of an oral cholera vaccine (Dukoral; containing killed cholera organisms and cholera subunit B) found that withholding breastfeeding for 3 hours before giving the vaccine resulted in a greater antibody response in infants between 10 and 18 months of age. In infants between 6 and 9 months of age, no difference in antibody response was seen between infants who had breastfeeding withheld and those who did not.[10]

Effects in Breastfed Infants

Limited data indicate that breastfeeding can enhance the response of the infant to certain vaccine antigens.[2,11] Breastfeeding alone results in a 70% lower risk of severe cholera among breastfed infants up to 30 months with continued breastfeeding.[12]

Administration of oral cholera vaccine to the mother decreased the risk of cholera in their breastfed infants by 47% in one study. The authors hypothesized that vaccination of the mothers reduced their transmission of cholera to their infants.[5]

Effects on Lactation and Breastmilk

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

References

1.

Gruslin A, Steben M, Halperin S, et al. Immunization in pregnancy: No. 220, December 2008. Int J Gynaecol Obstet 2009;105:187–91. [PubMed: 19367691]

2.

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

3.

Merson MH, Black RE, Sack DA, et al. Maternal cholera immunisation and scecretory IgA in breast milk. Lancet 1980;1:931–2. [PubMed: 6103281]

4.

Svennerholm AM, Holmgren J, Hanson LA, et al. Boosting of secretory IgA antibody responses in man by parenteral cholera vaccination. Scand J Immunol 1977;6:1345–9. [PubMed: 605366]

5.

Clemens JD, Sack DA, Chakraborty J, et al. Field trial of oral cholera vaccines in Bangladesh: Evaluation of anti-bacterial and anti-toxic breast-milk immunity in response to ingestion of the vaccines. Vaccine 1990;8:469–72. [PubMed: 2251873]

6.

Jertborn M, Svennerholm AM, Holmgren J. Saliva, breast milk, and serum antibody responses as indirect measures of intestinal immunity after oral cholera vaccination or natural disease. J Clin Microbiol 1986;24:203–9. [PMC free article: PMC268875] [PubMed: 3528211]

7.

Svennerholm AM, Hanson LA, Holmgren J, et al. Different secretory immunoglobulin A antibody responses to cholera vaccination in Swedish and Pakistani women. Infect Immun 1980;30:427–30. [PMC free article: PMC551330] [PubMed: 7439987]

8.

Mascart-Lemone F, Carlsson B, Jalil F, et al. Polymeric and monomeric IgA response in serum and milk after parenteral cholera and oral typhoid vaccination. Scand J Immunol 1988;28:443–8. [PubMed: 3194704]

9.

Hahn-Zoric M, Carlsson B, Jalil F, et al. The influence on the secretory IgA antibody levels in lactating women of oral typhoid and parenteral cholera vaccines given alone or in combination. Scand J Infect Dis 1989;21:421–6. [PubMed: 2587944]

10.

Ahmed T, Svennerholm AM, Al Tarique A, et al. Enhanced immunogenicity of an oral inactivated cholera vaccine in infants in Bangladesh obtained by zinc supplementation and by temporary withholding breast-feeding. Vaccine 2009;27:1433–9. [PubMed: 19146904]

11.

Pabst HF. Immunomodulation by breast-feeding. Pediatr Infect Dis J 1997;16:991–5. [PubMed: 9380478]

12.

Clemens JD, Sack DA, Harris JR, et al. Breast feeding and the risk of severe cholera in rural Bangladeshi children. Am J Epidemiol 1990;131:400–11. [PubMed: 2301350]

Substance Name

Cholera Vaccine

Drug Class

Breast Feeding

Lactation

Milk, Human

Vaccines