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VBI Is Ready To Take On HBV Vaccine Market

Executive Summary

VBI’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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VBI Looking To Market More Potent, Less Expensive Hepatitis B Vaccine

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.

Dynavax's Hep B Vaccine Finally Clears US FDA With Clean Label But Larger Safety Study

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.

Heplisav Vaccine Postmarketing Study Might Overcome FDA Safety Worries At Panel

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.

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