Hepatitis B Vaccination in Pregnancy
Yes, pregnant women can and should be given Hepatitis B vaccine when indicated, specifically using Engerix-B or Recombivax HB. 1
Recommended Vaccines for Pregnant Women
Pregnant women requiring HBV vaccination must receive either Engerix-B, Recombivax HB, or Twinrix — the ACIP explicitly states that Heplisav-B and PreHevbrio have insufficient data to inform vaccine-associated risks in pregnancy and should not be used. 1
Who Should Receive HBV Vaccine During Pregnancy
Pregnant women identified as being at risk for HBV infection during pregnancy should be vaccinated, including those who: 1
- Have had more than one sex partner during the previous 6 months
- Have been evaluated or treated for a sexually transmitted infection
- Have recent or current injection-drug use
- Have an HBsAg-positive sex partner
The ACIP recommends vaccination for any pregnant woman at risk, and acknowledgment of a specific risk factor should not be a requirement — pregnant women requesting protection from HBV infection can receive the vaccine. 1
Safety Profile
The safety data strongly support HBV vaccination in pregnancy:
Large-scale post-marketing surveillance of Engerix-B showed no concerning pattern of adverse pregnancy outcomes among 339 analyzed pregnancies, with the most common outcomes being live births (223 cases), and no maternal deaths reported. 2
A Vaccine Safety Datalink study examining over 1,399 pregnancies with HepB exposure found no significant associations with gestational hypertension, gestational diabetes, pre-eclampsia/eclampsia, cesarean delivery, pre-term delivery, low birthweight, or small for gestational age infants. 3
The FDA label for Engerix-B classifies it as Pregnancy Category C, stating it should be given to pregnant women "only if clearly needed," but this conservative language reflects the standard regulatory approach rather than evidence of harm. 4
Dosing and Administration
Standard adult dosing applies during pregnancy: 1
- Recombivax HB: 10 μg (1 mL) at 0,1, and 6 months
- Engerix-B: 20 μg (1 mL) at 0,1, and 6 months
- Twinrix: 20 μg HBV component (1 mL) at 0,1, and 6 months (standard schedule) or 0 days, 7 days, 21-30 days, and 12 months (accelerated schedule)
If the vaccination schedule is interrupted, the series does not need to be restarted — simply continue with the next dose as soon as possible. 1
Critical Screening Requirements
All pregnant women must be tested for HBsAg during an early prenatal visit in each pregnancy, even if previously vaccinated or tested — this is a universal screening recommendation that takes precedence over selective vaccination. 1
Women not tested prenatally who have clinical hepatitis or high-risk behaviors should be tested at hospital admission for delivery. 1
Common Pitfalls to Avoid
Do not use Heplisav-B or PreHevbrio in pregnant women — insufficient safety data exist for these newer formulations. 1
Do not delay vaccination in pregnant women at risk while waiting for "more data" — the established safety profile of Engerix-B and Recombivax HB, combined with the significant risk of perinatal HBV transmission (60% transmission rate if acute infection occurs near delivery), strongly favors vaccination. 1, 5, 6
Do not assume vaccination prevents infant infection from a chronically infected mother — while HBV vaccine is safe in pregnancy, there is no evidence it prevents perinatal transmission; infants born to HBsAg-positive mothers require both HepB vaccine and HBIG within 12 hours of birth. 1