Heplisav studies put on hold while adverse reaction is investigated

BERKELEY, Calif. & WHITEHOUSE STATION, N.J. Dynavax Technologies and Merck have been informed by the Food and Drug Administration that the agency has put a hold on further studies of their experimental hepatitis B vaccine Heplisav, according to Reuters.

The FDA placed two drug applications for the drug on clinical hold after a patient receiving the vaccine was preliminary diagnosed with Wegener’s granulomatosis, a disease in which the blood vessels become inflamed.

No additional clinical trials with the vaccine will be initiated until the clinical hold has been resolved, the companies said in a joint statement. The companies also said they were investigating whether the patient’s illness stemmed from a pre-existing condition or was related to the vaccine administration.