VBI Vaccines: Hepatitis B Vaccine (Recombinant)] Recommended by CDC Ad Comm

 - PreHevbrio™ is the only approved 3-antigen hepatitis B vaccine for adults in the U.S.

- Vaccine availability is expected to begin later in Q1 2022

 

VBI Vaccines (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today 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.

“Today’s ACIP recommendation, in-line with our expectation, will significantly support our efforts to provide broad access to PreHevbrio as this achievement is a stage gate for reimbursement and coverage,” said Jeff Baxter, President and CEO. “Recently, the ACIP has made meaningful changes in the recommendations and guidelines for adult HBV vaccination, notably with the move to a universal recommendation for adults age 19-59. We echo the sentiment from today’s presentation that the inclusion of PreHevbrio in the ACIP list of recommended products could be a beneficial adjunct in achieving HHS goals of eliminating hepatitis B as a public health threat in the U.S. by 2030. We look forward to continuing to support the efforts of the CDC, the ACIP, and other public health and advocacy partners in this endeavor.”

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.

https://www.biospace.com/article/releases/vbi-vaccines-announces-prehevbrio-hepatitis-b-vaccine-recombinant-recommended-by-cdc-advisory-committee-on-immunization-practices-for-the-prevention-of-hepatitis-b-in-adults/