Can a pregnant woman receive the Heplisav‑B (recombinant hepatitis B vaccine)?

Can a Pregnant Woman Receive Heplisav-B?

Direct Answer

No, Heplisav-B is not recommended during pregnancy because it lacks adequate safety data in pregnant women, and standard hepatitis B vaccines (such as Engerix-B or Recombivax HB) should be used instead. 1, 2

Critical Distinction: Heplisav-B vs. Standard Hepatitis B Vaccines

The key issue is that Heplisav-B is a specific adjuvanted hepatitis B vaccine formulation that has not been adequately studied in pregnancy:

• The FDA label for Heplisav-B does not provide pregnancy-specific guidance or safety data, and the product is labeled "For Adult Use Only" without pregnancy category information 3
• The only available pregnancy data for Heplisav-B (HepB-CpG) comes from retrospective chart reviews of women who became pregnant after vaccination, not during intentional administration in pregnancy 4, 5
• In contrast, standard hepatitis B vaccines (HepB-alum formulations like Engerix-B) have extensive safety data demonstrating no increased risk of adverse pregnancy outcomes 1, 6, 7

What Should Be Done Instead

Pregnant women at risk for hepatitis B infection should receive standard hepatitis B vaccines (not Heplisav-B):

• The CDC and ACOG recommend that pregnant women with high-risk exposures (multiple sexual partners, sexually transmitted infections, injection drug use, or HBsAg-positive partner) should receive hepatitis B vaccination during pregnancy 1, 2
• Standard hepatitis B vaccines contain non-infectious HBsAg particles and pose no biological risk to the developing fetus 1, 2
• Extensive clinical experience with standard formulations shows no increased risk of miscarriage, stillbirth, congenital malformations, or sudden infant death syndrome 1, 2, 6, 7
• The standard 3-dose series (0,1, and 6 months) can be safely initiated and completed during pregnancy 1, 2

Why This Distinction Matters

The adjuvant system in Heplisav-B (CpG 1018) differentiates it from standard vaccines:

• Heplisav-B uses a novel CpG oligodeoxynucleotide adjuvant (1018 ISS) that has not been studied in pregnancy with the same rigor as aluminum-adjuvanted vaccines 3
• While limited retrospective data suggest similar pregnancy outcomes between HepB-CpG and HepB-alum when given before pregnancy, these studies explicitly state that "results need to be further verified with larger prospective studies with HBV vaccine administration during pregnancy" 5
• A 2024 post-marketing study found no evidence of adverse outcomes but included only 81 women who received HepB-CpG, which is insufficient to establish safety 4

Clinical Implementation

When a pregnant woman needs hepatitis B vaccination:

• Use standard hepatitis B vaccines (Engerix-B or Recombivax HB), not Heplisav-B 1, 2
• Administer intramuscularly in the deltoid muscle; gluteal administration markedly reduces immunogenicity 1, 2
• Follow the standard 3-dose schedule at 0,1, and 6 months 1, 2
• Do not delay vaccination in at-risk pregnant women due to unfounded safety concerns about standard formulations 1, 2
• All pregnant women should be screened for HBsAg in the first trimester regardless of vaccination history 1, 2

Common Pitfall to Avoid

Do not assume all hepatitis B vaccines are interchangeable in pregnancy. While standard hepatitis B vaccines are safe and recommended during pregnancy, Heplisav-B lacks adequate pregnancy-specific data and should be avoided until after delivery. 1, 2, 3, 4, 5