Dynavax Technologies Corp (DVAX)

[MrGuru]

On Myocardial Infarctions:

Based on this systematic evaluation, we found that myocardial infarctions and MACE outcomes occurred:
• In persons in whom they would be expected, who had a high burden of cardiovascular risk factors with advanced and often multi-vessel obstructive coronary artery disease;
• With no evidence by clinical annotations and cardiac catheterization data for
inflammatory/immune-mediated vasculitides or myocarditis;
• With no evidence of a hypercoagulable state as other venous or arterialthrombotic/thromboembolic events were balanced;
• Without close temporal relationship to vaccination administration;
• At rates in the HEPLISAV-B group that were similar to or lower than predicted background.

The observed numerical difference between treatment groups in the occurrence of events coded to the MedDRA preferred term acute myocardial infarction in HBV-23 is an isolated finding in the HEPLISAV-B database that appears most likely explained by random variation resulting in an unexpectedly low number of events observed in the Engerix-B group in HBV-23.