VBI Vaccines announces positive top-line results from PROTECT, a pivotal Phase 3 study of Sci-B-Vac®
— Both co-primary endpoints successfully met – including non-inferiority in all adults age ≥18 years, and superiority in adults age ≥ 45 years
— Seroprotection rates four weeks post-3rd vaccination of Sci-B-Vac® vs. Engerix-B® were statistically significantly higher in key subgroup analyses of adults age ≥ 18 years
— No safety signals observed – safety and tolerability consistent with known profile of the vaccine
— With positive PROTECT data, pending successful completion of CONSTANT study, submissions of BLA/MAA for approval in U.S., Europe, and Canada expected to begin mid-year 2020
Read the full press release here.