14a ET 3/29/2022 - Benzinga
VBI Vaccines Announces PreHevbrio Is Now Available In The United States For The Prevention Of Hepatitis B In Adults
Mentioned: VBIV
- PreHevbrioâ?¢ [Hepatitis B Vaccine (Recombinant)] is the only approved 3-antigen hepatitis B vaccine for adults in the U.S.
- FDA approval of PreHevbrio received in November 2021
- PreHevbrio added to ACIP list of recommended adult HBV vaccines in February 2022
- Wholesale Acquisition Cost (WAC) set at $64.75/dose
VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that PreHevbrioâ?¢ [Hepatitis B Vaccine (Recombinant)] is now available in the United States for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults age 18 years and older. PreHevbrio was approved by the U.S. Food and Drug Administration (FDA) on November 30, 2021, and is the only approved 3-antigen HBV vaccine for adults.
"We are proud to announce the U.S. availability of PreHevbrio, a significant milestone in our effort to be part of the fight against hepatitis B," said Jeff Baxter, VBI's President and CEO. "This launch coincides with the swell of momentum following the ACIP's November 2021 unanimous vote to move to a universal HBV vaccination recommendation for all adults age 19-59, and its February 2022 decision to include PreHevbrio in its list of recommended adult HBV vaccines. With new guidelines and new tools, U.S. healthcare providers have more support than ever to increase vaccination rates and protect more of their adult patients against HBV."
VBI is working with a network of wholesalers, distributors, group purchasing organizations, and federal accounts to enable broad access to PreHevbrio, and the Company expects to further build out this network in the coming weeks. The Wholesale Acquisition Cost (WAC) for PreHevbrio has been set at $64.75 per dose. For information on the list of current distributors, please request to speak with a VBI Vaccine Specialist (at www.prehevbrio.com) or email distribution-us@vbivaccines.com.
In July 2021, the American Medical Association established a unique Current Procedural Terminology (CPT) code for a 3-antigen (S, Pre-S1, Pre-S2) Hepatitis B (HBV) vaccine. This is the code PreHevbrio will be reported under and it differentiates PreHevbrio from other approved single-antigen HBV vaccines. Many insurance plans and institutions also require recommendation from the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) in order to provide reimbursement coverage. Following the February 2022 ACIP meeting, PreHevbrio was added to the list of ACIP-recommended products for prophylactic adult vaccination against HBV infection without the need for a formal vote. Additionally, VBI, in partnership with Syneos Health, has now deployed a field team of nearly 80 individuals devoted to PreHevbrio, including more than 50 vaccine sales specialists.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved
