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Disclaimer and Terms of Use

VBI Vaccines Inc. (“VBI” or the “Company”) is pleased to provide you with the materials on this website for informational purposes. Any visit to the VBI website pages, or use of this website, constitutes an agreement by you to abide by these terms of use. VBI reserves the right to delete, modify, or supplement the content of this website at any time for any reason without notification. You are bound by any such revisions and should therefore periodically visit this page to review the then-current terms of use.

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VBI Wire

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Indication & Important Safety Info

PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.


Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.


PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.


Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio.

Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio.

PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact or call 1-888-421-8808 (toll-free).

To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or

Please see Full Prescribing Information.


VBI Vaccines provides this link as a service to website visitors. VBI Vaccines is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.

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Demographic and baseline characteristics were similar in both vaccine groups.



The primary objective was to demonstrate consistency of immune response as measured by geometric mean concentration of antibodies across three consecutively manufactured lots of PreHevbrio 10 μg. The secondary objective was to demonstrate non-inferiority of SPR (% of subjects achieving anti-HBs titers ≥10 mIU/mL) of PreHevbrio (pooled) compared to Engerix-B at Day 196.


Demographic and baseline characteristics were similar in both vaccine groups.



The two co-primary objectives of comparing SPR (% of subjects achieving anti-HBs titers ≥10 mIU/mL) at 4 weeks after receiving the third dose of PreHevbrio or Engerix-B were non-inferiority in adults ≥18 years of age and superiority in adults ≥45 years of age for PreHevbrio 10 μg compared to Engerix-B 20 μg. Key secondary endpoints included SPRs for PreHevbrio at days 56 and 168 and for Engerix-B at day 196; local and systemic solicited adverse events; and unsolicited adverse events. Key exploratory endpoints included SPRs for both study groups at days 0, 28, 56, 168, and 336; geometric mean concentration of anti-HBs antibody titers; and the proportion of participants having anti-HBs titers ≥100 mIU/mL at days 28, 56, 168, 196, and 336.