VBI Vaccines Inc. reported that the American Medical Association (AMA) Current Procedural Terminology (CPT®) Panel has established a unique CPT code for a 3-antigen (S, Pre-S1, Pre-S2) Hepatitis B (HBV) vaccine. If approved, VBI’s 3-antigen HBV vaccine candidate will be reported using the new code, differentiating it from other single-antigen HBV vaccines. VBI’s 3-antigen HBV vaccine candidate is currently under regulatory review for marketing approval in the U.S. and Europe. The U.S. Food and Drug Administration (FDA) has set the Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2021. CPT codes offer doctors and health care professionals a uniform language for coding medical services and procedures to streamline reporting, increase accuracy and efficiency. CPT Codes are also used for administrative management purposes such as claims processing and developing guidelines for medical care review. The CPT terminology is the most widely accepted medical nomenclature used across the U.S. to report medical, surgical, and diagnostic services and procedures to public and private health insurance programs for the purpose of reimbursement. CPT® is a registered trademark of the American Medical Association, which develops and maintains CPT codes. Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma. VBI’s vaccine candidate is the only 3-antigen hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus, and is approved for use and commercially-available in Israel. In December 2017, VBI initiated patient dosing in a global Phase 3 clinical program that consisted of two concurrent pivotal studies: PROTECT, a safety and immunogenicity study, and CONSTANT, a lot-to-lot consistency study. Data from both the PROTECT study and the CONSTANT study, which were announced in June 2019 and January 2020, respectively, comprise the basis for the regulatory submissions in the U.S., Europe, and Canada. This vaccine is sold under the name Sci-B Vac® in Israel.