Innovative hep B vaccine under review for US approval

2 February 2021

The US Food and Drug Administration has accepted for review a submission from American biotech VBI Vaccines (Nasdaq: VBIV), for a hepatitis B vaccine candidate.

The company, which is developing next-generation infectious disease and immuno-oncology vaccines, wants to market its 3-antigen vaccine for the prevention of infection caused by all known subtypes of the hepatitis B virus (HBV) in adults.

The submission is backed by data from two Phase III studies – PROTECT and CONSTANT – as well as other relevant data.

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