FDA: experimental hepatitis B vaccine effective
Dynavax Technologies Corp’s experimental hepatitis B vaccine is effective, but there were more deaths and serious cardiac events in patients given the vaccine than in those given a rival product, according to a preliminary Food and Drug Administration report published today.
However, they said overall numbers and rates of events were low.
The review, posted on the company’s website, comes two days ahead of a meeting of outside advisors who will discuss the vaccine, Heplisav-B, and recommend whether it should be approved. The FDA is not bound to follow the advice of its advisory panels but typically does so.