By Staff Writer
Dynavax Technologies and Merck & Co. have announced that the FDA has placed a clinical hold on the two investigational new drug applications for Heplisav, an investigational hepatitis B vaccine that is being developed for use in adults.
A clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical trial or suspend an ongoing clinical trial. The FDA has placed the clinical hold on the investigational vaccine because of a serious adverse event (SAE) that occurred in one subject who received Heplisav in a Phase III study being conducted outside the US. The subject was preliminarily diagnosed as having Wegener’s granulomatosis, an uncommon disease in which the blood vessels are inflamed. All subjects in this Phase III study have received all doses per the study protocol and all will continue to be monitored.
My Analysis: Many WG patients (some are sure that their triggers are virus or bacterial) have been sure that their triggers have been caused by organic chemicals or other industrial waste. But, because we are not always coherent because of medical treatment, we have been discounted. Here is an epiphany for the research community. Will they listen?
The rest of this article is here.
Update: Unfortunately, they have left themselves an out “pre-existing condition.”