FDA accepts VBI's hepatitis B vaccine BLA

By The Science Advisory Board staff writers

February 2, 2021 -- The U.S. Food and Drug Administration (FDA) has accepted the biologics license application (BLA) submitted by VBI Vaccines for its 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 FDA has set a prescription drug user fee act (PDUFA) target action date, the deadline by which the FDA must review the application, of November 30, 2021. In the filing notification letter, the FDA noted that it will not hold an advisory committee meeting to discuss the application.

The BLA is supported by data from two phase III clinical trials that were designed to assess the efficacy and safety of the vaccine candidate, as well as its lot-to-lot manufacturing consistency.

VBI provides COVID-19 vaccine updates amid supply chain delays
VBI Vaccines has provided preclinical updates on its two COVID-19 vaccine programs: VBI-2901, a trivalent pan-coronavirus vaccine candidate, and VBI-2902,...
Regulatory Roundup: Designations come through before year's end
This week's Regulatory Roundup covers activities from November 30 to December 4 and is filled with breakthrough, orphan, and rare disease designations...
VBI Vaccines move two COVID-19 vaccines to clinical trials
VBI Vaccines said that it has selected two of its COVID-19 vaccine candidates to proceed to a phase I/II clinical study expected to begin around the end...

Copyright © 2021 scienceboard.net

Science Advisory Board on LinkedIn
Science Advisory Board on Facebook
Science Advisory Board on Twitter