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.