VBI Vaccines files US application for hep B vaccine

 

• VBI Vaccines (VBIV -0.4%) has submitted marketing application with the FDA seeking approval for Sci-B-Vac, 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.
• Recently, the company filed marketing application to the European Medicines Agency, and expects to submit regulatory approval applications in the U.K. and Canada in Q1 of 2021.
• In October, the company announced presentation of abstracts at the ID Week conference from two Phase 3 trials evaluating the vaccine candidate.
• https://seekingalpha.com/news/3640400-vbi-vaccines-files-us-application-for-hbv-vaccine