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Reuters Health Information: More deaths with Dynavax vaccine but overall rate low - FDA

More deaths with Dynavax vaccine but overall rate low - FDA

Last Updated: 2017-07-26

By Reuters Staff

(Reuters) - There were more deaths in patients taking Dynavax Technologies Corp's experimental hepatitis B vaccine than those taking a rival product, but the overall rate of death was low, a preliminary review by Food and Drug Administration reviewers concluded.

The review, posted on Wednesday on the FDA's website, comes two days ahead of a meeting of outside advisors who will discuss the vaccine and recommend whether it should be approved. The FDA is not bound to follow the advice of its advisory panels but typically does so.

The FDA said that there appears to be imbalances in deaths and serious cardiac events with the vaccine, Heplisav-B, but "numbers and rates of events are low, and the lack of prospectively defined monitoring and evaluation of cardiac events limits the causal interpretation of these observations."

 
 
 
 
                         
 
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