The FDA has granted approval to the first three-antigen hepatitis B vaccine for prevention of infection from all known subtypes in adults, reported VBI Vaccines.

The recombinant vaccine contains the S, pre-S1, and pre-S2 hepatitis B virus (HBV) surface antigens. The approval came after positive data from two phase III trials comparing the safety and immunogenicity against the single-antigen Engerix-B vaccine. In the PROTECT trial, the three-antigen vaccine was found to be associated with higher seroprotection rates compared to Engerix-B among all adults (91% vs 77%, respectively) and among those aged 45 years and above (89% vs 73%). In the CONSTANT trial, a pooled analysis of adults who were administered the three-antigen vaccine had higher seroprotection rates in comparison with those who were given Engerix-B (99% vs 95%)… (Medpage Today)