VBI Vaccines Inc. announced that, following discussion at this afternoon's meeting of the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP), PreHevbrio™ [Hepatitis B Vaccine (Recombinant)] now joins the list of recommended products for prophylactic adult vaccination against hepatitis B (HBV) infection. This recommendation follows the approval of PreHevbrio by the U.S. Food and Drug Administration (FDA) on November 30, 2021. The inclusion of PreHevbrio in the ACIP recommendations will be reflected in a future CDC publication and is a notable milestone as many insurance plans and institutions require an ACIP recommendation before a vaccine is able to be reimbursed or is made available to patients.

Additionally, PreHevbrio will be included in the next annual update of the ACIP Adult Immunization Schedule in 2023, which will summarize changes that occur throughout the coming year. VBI expects to commercially launch PreHevbrio in the U.S. by the end of the first quarter of 2022. Once available, PreHevbrio will be available for purchase through a network of distribution partners.

Indication and Use: 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. Important Safety Information (ISI): 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.