Hepatitis B vaccines for adults: Engerix-B, Recombivax HB, Heplisav-B and PreHevbrio

The disease and why it matters

Hepatitis B is a vaccine-preventable liver disease caused by hepatitis B virus (HBV); for some people it is a short-term illness, while for others it becomes a long-term chronic infection that can lead to liver damage, cirrhosis, liver cancer and death. ^[1]

Risk of chronic infection depends on age at infection: approximately 90% of infected infants and 30% of children infected between 1 and 5 years remain chronically infected, while approximately 95% of infected adults recover completely from acute infection. ^[1]

HBV is highly infectious and is transmitted when blood, semen or other body fluids from an infected person enter the body of someone who is uninfected; people with hepatitis B often do not have symptoms. CDC recommends vaccination for nearly everyone and screening of all adults at least once in their lifetime. ^[1]

The average incubation period is 60 days (range 40 to 90 days) to abnormal ALT and 90 days (range 60 to 150 days) to signs and symptoms; HBV is primarily spread through childbirth, sexual contact and sharing contaminated needles, syringes or other injection equipment. ^[1]

Since HepB vaccine was introduced in 1982, reported hepatitis B cases have declined substantially, but progress on further reducing acute hepatitis B had stalled; in 2019, 3,192 acute cases were reported, an estimated 20,700 acute infections. ^[2]

Video and figures

Video

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Hepatitis: From A to E: everything you need to know
Channel: PAHO TV · Uploaded July 10, 2025 · Confirmed available October 12, 2026 · Open on YouTubeRxEvidence has not checked every statement in this video.

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Products available

FDA has licensed three single-antigen hepatitis B vaccines (Engerix-B, Heplisav-B and Recombivax HB) and three combination vaccines (Pediarix, Vaxelis and Twinrix); all contain yeast protein and an aluminum adjuvant or, for Heplisav-B, a small synthetic nucleotide immunostimulant. CDC notes that PreHevbrio was subject to a voluntary nationwide recall. ^[3]

The PreHevbrio prescribing information posted on FDA's page shows placeholder values ("Revised: M/YYYY" and "Initial U.S. Approval: YYYY"), and FDA's product page is marked content current as of 11/29/2024. ^{[12] [10]}

Who should get it

The court stay context applies here too: CRS reports that the court (American Academy of Pediatrics v. Kennedy, March 16, 2026) stayed the appointments of 13 ACIP members and their votes at prior ACIP meetings in 2025, and reverted the childhood schedule to the version as of May 2025. ^[16]

The ACIP recommendation of 2022 expanded universal HepB vaccination to adults 19 through 59 years, removing the need for risk factor screening and disclosure, which could increase vaccination coverage and decrease hepatitis B cases. ^[2]

CDC lists the risk factors for hepatitis B virus infection: chronic liver disease (including hepatitis C, cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, or ALT or AST more than twice the upper limit of normal), HIV infection, sexual exposure risk, current or recent injection drug use, percutaneous or mucosal exposure risk (household contacts of HBsAg-positive persons, residents and staff of facilities for developmentally disabled persons, health care and public safety personnel with reasonably anticipated exposure to blood, dialysis and predialysis patients, and patients with diabetes), incarceration, and travel in countries with high or intermediate endemic hepatitis B. ^[19]

For adults 60 years and older with diabetes, CDC's notes say vaccination is based on shared clinical decision-making. Prevaccination testing should not be a barrier to vaccination of susceptible people; if testing is not feasible or is refused, the clinician should offer vaccination and offer testing again at future visits. ^{[19] [3]}

Vaccine effectiveness: CDC states each HepB vaccine is highly effective in preventing infection, and studies indicate that immunity persists for at least 30 years among healthy people who initiate vaccination at less than 6 months of age. The Engerix-B label notes that antibody responses are lower in persons older than 60 years than in younger adults. ^{[3] [5]}

Dosing and schedule, including catch-up

CDC's notes state that for adults 20 years and older with an immunocompromising condition a 2-, 3- or 4-dose series applies (Recombivax HB 3 doses at 0, 1, 6 months using the dialysis formulation 1 mL = 40 mcg; Engerix-B 4 doses at 0, 1, 2 and 6 months using a 2 mL dose; Heplisav-B 2 doses at 0 and 1 month), and that patients on dialysis complete a 3- or 4-dose series. ^[19]

CDC advises that adult hemodialysis patients needing HepB vaccination receive high-dose (40 µg) Engerix-B or Recombivax HB; the safety and effectiveness of Heplisav-B has not been established in adults on hemodialysis. ^[3]

Interchangeability: no differences in immunogenicity have been observed when one or 2 doses from one manufacturer are followed by doses from a different manufacturer; whenever feasible the same vaccine should be used, but if a different brand is given the dose(s) should be considered valid and do not need to be repeated. Vaccination should not be deferred when the manufacturer of previous doses is unknown or unavailable. ^[3]

For a series started with PreHevbrio as dose 1 (or doses 1 and 2), vaccine from a different manufacturer should follow the 3-dose schedule: Engerix-B or Recombivax HB for dose 2 and dose 3, or the 2-dose Heplisav-B series can be given as dose 2 and dose 3 to complete a 3-dose series. ^[3]

Administration

All adult hepatitis B vaccines are given by intramuscular injection; Heplisav-B is administered in the deltoid region using a sterile needle and syringe, and the vaccine is a clear to slightly opalescent, colorless to slightly yellow solution that should be inspected for particulate matter and discoloration. ^[9]

Engerix-B should not be diluted; Recombivax HB should not be mixed with any other vaccine in the same syringe or vial; syncope can occur with injectable vaccines and procedures should be in place to avoid injury from fainting. ^{[5] [7]}

Hepatitis B vaccine may be given at the same time as other vaccines. ^[20]

Storage and handling

Latex: the Recombivax HB vial stopper, syringe plunger stopper and tip cap contain dry natural latex rubber, which may cause allergic reactions in latex-sensitive individuals; the Engerix-B vial stoppers and prefilled syringe tip cap and plunger stopper, and the Heplisav-B prefilled syringe tip caps and stoppers, are not made with natural rubber latex. ^{[7] [5] [9]}

Contraindications and precautions

• Contraindication: a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B-containing vaccine or to any component, including yeast (Engerix-B, Recombivax HB, Heplisav-B and PreHevbrio labels; CDC appendix). ^{[5] [7] [9] [21]}
• Precaution: moderate or severe acute illness with or without fever; people with minor illnesses such as a cold may be vaccinated. ^{[21] [20]}
• CDC advises clinicians to ask the person getting the vaccine whether they have had an allergic reaction to a previous dose of HepB vaccine, any part of HepB vaccine, or yeast. ^[3]
• Heplisav-B: immunocompromised persons may have a diminished immune response to the vaccine. ^[9]

Safety and adverse events

CDC states that scientific evidence overwhelmingly supports the safety of HepB vaccines. ^[3]

Hepatitis B vaccine cannot cause hepatitis B infection: the Heplisav-B label tells prescribers to emphasize that it contains non-infectious purified HBsAg. ^[9]

CDC's VIS lists the reactions after vaccination and notes that people sometimes faint after medical procedures including vaccination. ^[20]

Special populations

Pregnancy: CDC says providers should vaccinate pregnant patients needing HepB vaccination with Engerix-B, Heplisav-B, Recombivax HB or Twinrix; PreHevbrio is not recommended in pregnancy because of lack of safety data in pregnant women. The VIS states that pregnancy or breastfeeding are not reasons to avoid hepatitis B vaccination. ^{[3] [19] [20]}

Health care and public safety personnel with reasonably anticipated risk for exposure to blood or blood-contaminated body fluids, residents and staff of facilities for people with developmental disabilities, and international travelers to countries with high or intermediate levels of endemic HBV infection are among groups with additional risk factors for whom CDC recommends vaccination (and triple-panel testing if never screened, unless under 18 and vaccinated as infants). ^[3]

Adults 60 years and older: antibody responses to Engerix-B are lower than in younger adults; CDC's guidance is vaccination for those with known risk factors and optional vaccination for those without. ^{[5] [3]}

Counseling pearls for the pharmacy counter

• Hepatitis B vaccine is usually given as 2, 3 or 4 shots, may be given at the same time as other vaccines, and most people who are vaccinated are immune for life. ^[20]
• Explain that the vaccine cannot cause hepatitis B and that completing the series matters. ^[9]
• Ask about allergy to a previous dose, to yeast, or any severe life-threatening allergy. ^[20]
• If the patient started a series with PreHevbrio, do not defer vaccination: complete the series with a vaccine from a different manufacturer on the 3-dose schedule. ^[3]

Common patient questions

References

1. Centers for Disease Control and Prevention. Clinical overview of hepatitis B. Accessed October 11, 2026. https://www.cdc.gov/hepatitis-b/hcp/clinical-overview/index.html. Accessed October 11, 2026.
2. Weng MK, Doshani M, Khan MA, et al. Universal hepatitis B vaccination in adults aged 19–59 years: updated recommendations of the Advisory Committee on Immunization Practices, United States, 2022. MMWR Morb Mortal Wkly Rep. 2022;71(13):477-483. Accessed October 11, 2026. https://www.cdc.gov/mmwr/volumes/71/wr/mm7113a1.htm. Accessed October 11, 2026.
3. Centers for Disease Control and Prevention. Hepatitis B vaccine administration. Page dated September 18, 2025. Accessed October 11, 2026. https://www.cdc.gov/hepatitis-b/hcp/vaccine-administration/index.html. Accessed October 11, 2026.
4. U.S. Food and Drug Administration. ENGERIX-B product page (content current as of 05/15/2026). Accessed October 11, 2026. https://www.fda.gov/vaccines-blood-biologics/vaccines/engerix-b. Accessed October 11, 2026.
5. ENGERIX-B (hepatitis B vaccine, recombinant) injectable suspension, for intramuscular use: prescribing information. GlaxoSmithKline Biologicals; revised 5/2026. U.S. Food and Drug Administration. Accessed October 11, 2026. https://www.fda.gov/media/119403/download?attachment. Accessed October 11, 2026.
6. U.S. Food and Drug Administration. RECOMBIVAX HB product page (content current as of 04/24/2019). Accessed October 11, 2026. https://www.fda.gov/vaccines-blood-biologics/vaccines/recombivax-hb. Accessed October 11, 2026.
7. RECOMBIVAX HB (hepatitis B vaccine, recombinant) suspension for intramuscular injection: prescribing information. Merck Sharp & Dohme Corp.; revised 12/2018. U.S. Food and Drug Administration. Accessed October 11, 2026. https://www.fda.gov/media/74274/download?attachment. Accessed October 11, 2026.
8. U.S. Food and Drug Administration. HEPLISAV-B product page (content current as of 09/12/2024). Accessed October 11, 2026. https://www.fda.gov/vaccines-blood-biologics/vaccines/heplisav-b. Accessed October 11, 2026.
9. HEPLISAV-B (hepatitis B vaccine, recombinant, adjuvanted) injection, for intramuscular use: prescribing information. Dynavax Technologies Corporation; revised 09/2024. U.S. Food and Drug Administration. Accessed October 11, 2026. https://www.fda.gov/media/108745/download?attachment. Accessed October 11, 2026.
10. U.S. Food and Drug Administration. PREHEVBRIO product page (content current as of 11/29/2024). Accessed October 11, 2026. https://www.fda.gov/vaccines-blood-biologics/prehevbrio. Accessed October 11, 2026.
11. U.S. Food and Drug Administration. BLA approval letter, Hepatitis B Vaccine (Recombinant) (PREHEVBRIO), STN BL 125737/0. November 30, 2021. Accessed October 11, 2026. https://www.fda.gov/media/154560/download?attachment. Accessed October 11, 2026.
12. PREHEVBRIO (hepatitis B vaccine, recombinant) injectable suspension, for intramuscular use: prescribing information as posted on FDA's product page (revision date and approval year shown as placeholders). VBI Vaccines (Delaware) Inc. U.S. Food and Drug Administration. Accessed October 11, 2026. https://www.fda.gov/media/154561/download?attachment. Accessed October 11, 2026.
13. American Academy of Family Physicians. Adults 19 and older immunization schedules (adopted version; page shows no version date). Accessed October 11, 2026. https://www.aafp.org/clinical-insights/immunizations-and-vaccines/immunizations-schedules-resources/adult-immunization-schedules. Accessed October 11, 2026.
14. Centers for Disease Control and Prevention. Fact sheet: hepatitis B immunization. News release, December 16, 2025. Accessed October 11, 2026. https://www.cdc.gov/media/releases/2025/fact-sheet-hepatitis-b-immunization.html. Accessed October 11, 2026.
15. American Academy of Pediatrics. AAP releases recommended childhood and adolescent immunization schedule for 2026. HealthyChildren.org news. Accessed October 11, 2026. https://healthychildren.org/English/news/Pages/AAPs-recommended-childhood-and-adolescent-immunization-schedule-for-2026.aspx. Accessed October 11, 2026.
16. Congressional Research Service. The 2026 Childhood Immunization Schedule (R48982). June 11, 2026. Accessed October 11, 2026. https://www.congress.gov/crs_external_products/R/PDF/R48982/R48982.1.pdf. Accessed October 11, 2026.
17. Centers for Disease Control and Prevention. CDC acts on Presidential Memorandum to update childhood immunization schedule. News release, January 5, 2026. Accessed October 11, 2026. https://www.cdc.gov/media/releases/2026/2026-cdc-acts-on-presidential-memorandum-to-update-childhood-immunization-schedule.html. Accessed October 11, 2026.
18. Centers for Disease Control and Prevention. Healthcare professionals: immunization schedules. Accessed October 11, 2026. https://www.cdc.gov/vaccines/hcp/imz-schedules/index.html. Accessed October 11, 2026.
19. Centers for Disease Control and Prevention. Adult immunization schedule notes: recommendations for ages 19 years or older, United States, 2025. July 2, 2025. Accessed October 11, 2026. https://www.cdc.gov/vaccines/hcp/imz-schedules/adult-notes.html. Accessed October 11, 2026.
20. Centers for Disease Control and Prevention. Hepatitis B vaccine: what you need to know. Vaccine Information Statement, January 31, 2025. Accessed October 11, 2026. https://www.cdc.gov/vaccines/hcp/current-vis/hepatitis-b.html. Accessed October 11, 2026.
21. Centers for Disease Control and Prevention. Adult immunization schedule appendix: guide to contraindications and precautions, United States, 2025. July 2, 2025. Accessed October 11, 2026. https://www.cdc.gov/vaccines/hcp/imz-schedules/adult-appendix.html. Accessed October 11, 2026.