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.
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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.
Despite positive results in the latest Phase III PROTECT study of its hepatitis B vaccine, VBI Vaccines failed to show non-inferiority at two doses, leaving it trailing behind competitor Dynavax and its established two-dose product.
Clinical holds by the US FDA have risen 36% since 2014.