Drugs in Pregnancy and Lactation: Tenth Edition

VACCINE, HEPATITIS B

Vaccine

PREGNANCY RECOMMENDATION: Compatible

BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible

PREGNANCY SUMMARY

Hepatitis B virus vaccine inactivated (recombinant) is a noninfectious surface antigen (HBsAg) vaccine. Animal reproduction studies have not been conducted with the vaccine. No risks to the fetus from maternal vaccination have been reported (1,2).

FETAL RISK SUMMARY

One source recommends administration after the 1st trimester, because of a theoretical risk of teratogenicity (3). However, the CDC states that there is no apparent risk of fetal adverse effects (based on unpublished CDC data) and that pregnancy is not a contraindication to vaccination in women (1,2). Preexposure and postexposure prophylaxis is indicated in pregnant women at high risk of infection (2,4) (see also Immune Globulin, Hepatitis B).

BREASTFEEDING SUMMARY

No data are available, but the vaccine can be used during lactation (1).

References

1.CDC. Hepatitis B virus: a comprehensive strategy for eliminating transmission in the United States through universal childhood vaccination. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(No. RR-13):1–25.

2.CDC. Guidelines for Vaccinating Pregnant Women. Available at http://www.cdc.gov/vaccines/pubs/preg-guide.htm. Accessed May 16, 2010.

3.Linder N, Ohel G. In utero vaccination. Clin Perinatol 1994;21:663–74.

4.Faix RG. Maternal immunization to prevent fetal and neonatal infection. Clin Obstet Gynecol 1991;34:277–87.



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