Health Canada approval for PreHevbrio for the prevention of hepatitis B in adults
VBI Vaccines Inc. announced that Health Canada has approved PreHevbrio [3-antigen Hepatitis B Vaccine (Recombinant)] for active immunization against infection caused by all known subtypes of hepatitis B (HBV) virus in adults 18 years of age and older
It can be expected that hepatitis D will also be prevented by immunization with PreHevbrio as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
The approval was based on clinical data in the new drug submission (NDS), which highlighted the positive results from two pivotal, randomized, double-blind, controlled Phase III clinical studies, PROTECT and CONSTANT. Data from these studies were published, respectively, in The Lancet Infectious Diseases in May 2021 and The Journal of the American Medical Association Network Open in October 2021.
See- "Immunogenicity and safety of a tri-antigenic versus a mono-antigenic hepatitis B vaccine in adults (PROTECT): a randomised, double-blind, phase III trial"- The Lancet Infectious Diseases.Vol. 21.No. 9p1271–1281.Published: May 11, 2021 Timo Vesikari,Joanne M Langley,Nathan Segall,Brian J Ward,Curtis Cooper,Guillaume Poliquinand others.
See- "Immunogenicity and Safety of a 3-Antigen Hepatitis B Vaccine vs a Single-Antigen Hepatitis B Vaccine; A Phase III Randomized Clinical Trial": Timo Vesikari, MD; Adam Finn, MD; Pierre van Damme, MD, PhD; et al; for the CONSTANT Study Group;JAMA Netw. Open. 2021;4(10):e2128652. doi:10.1001/jamanetworkopen.2021.28652.
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