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U.S. FDA Approved 3-Antigen Hepatitis B Vaccine in the U.S.
December 1, 2021 • 12:01 pm CST
(Precision Vaccinations)
Massachusetts-based VBI Vaccines Inc. today announced that the U.S. Food and Drug Administration (FDA) had approved the PreHevbrio™ vaccine for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults age 18 years and older.
PreHevbrio contains the S, pre-S2, and pre-S1 HBV surface antigens.
It is the only Approved 3-antigen HBV vaccine for adults in the U.S. and is commercially available in Israel under the brand name Sci-B-Vac®.
VBI expects to make PreHevbrio available in the U.S. in the first quarter of 2022 and has partnered with Syneos Health to ensure commercial readiness.
Chari Cohen, DrPH, MPH, Senior Vice President of the Hepatitis B Foundation, stated in a press release, “Having more vaccine options will help us effectively expand vaccine uptake, ensure more people are protected from hepatitis B infection, and reach the 2030 goal of eliminating hepatitis B in the U.S.”
The approval of PreHevbrio was based on the results from two Phase 3 clinical studies, PROTECT and CONSTANT, data from which were published, respectively, in The Lancet Infectious Diseases in May 2021 and The Journal of the American Medical Association Network Open in October 2021.
Outside of the U.S., VBI continues to support the European Medicines Agency’s ongoing review of the marketing authorization application for the E.U.
And VBI expects to complete regulatory submissions to the U.K.’s Medicines and Healthcare products Regulatory Agency and Health Canada in 2022.
VBI is a biopharmaceutical company located in Cambridge, MA, driven by immunology to pursue powerful prevention and treatment of disease.
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Karen McClorey Hackett |
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