VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of the Company’s 3-antigen prophylactic hepatitis B vaccine candidate, for the prevention of infection caused by all known subtypes of the hepatitis B virus in adults.
“The completion of the BLA submission is a significant milestone for us as we work to provide access to our 3-antigen hepatitis B vaccine for adults in the U.S.,” said Jeff Baxter, President & CEO. “In the U.S., hepatitis B infection persists as a public health threat, with increased rates of acute infection in recent years and estimates of up to 2.2 million chronically-infected individuals throughout the country. We look forward to working with the FDA during the review process as we seek marketing approval in the U.S., and we remain committed public health partners in the fight to eliminate hepatitis B.”
VBI previously announced the submission of the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) on November 23, 2020, and the Company expects to submit regulatory approval applications to the United Kingdom Medicines and Healthcare products, Regulatory Agency (MHRA) and to Health Canada by the end of the first quarter of 2021.
About Hepatitis B
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 no available functional cure, many patients go on to develop liver cancers. An estimated 780,000 people die each year from complications of chronic HBV such as liver decompensation and hepatocellular carcinoma.
About VBI’s 3-Antigen Hepatitis B Vaccine
This vaccine is a 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, under the name Sci-B-Vac®. 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.
To learn more about VBI’s 3-antigen Hepatitis B vaccine visit: https://www.vbivaccines.com/sci-b-vac/