VBI Is Ready To Take On HBV Vaccine Market
Executive SummaryVBI’s Sci-B-Vac CONSTANT data firmly establishes the hepatitis B vaccine’s advantages over GSK’s longstanding Engerix-B, but it faces a tougher challenge with Heplisav-B from Dynavax.
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Sci-B-Vac was shown more effective at fewer doses than Engerix-B in a Phase III study. VBI Vaccines sees its hepatitis B vaccine hitting potential markets by 2021.
Heplisav-B labeling notes myocardial infarction imbalance in one trial but also apparent absence of a causal relationship; sponsor will conduct a postmarketing safety cohort study involving 50,000 subjects, 10,000 more than initially planned.
Dynavax has already received two complete response letters for its hepatitis B vaccine; more patients who received Heplisav died or experienced cardiovascular events compared with the competitor arm.