The Motley Fool Previous Page

Safety Matters (to a Point)

Brian Orelli
November 16, 2012

Side effects always come back to bite a drug.

Four years ago, Dynavax Technologies' (Nasdaq: DVAX  ) hepatitis B vaccine Heplisav was put on clinical hold because one patient was preliminarily diagnosed with Wegener's granulomatosis. It's an uncommon inflammation of blood vessels, and it wasn't even clear if Heplisav was the cause.

The Food and Drug Administration eventually let the trial resume, and Heplisav invoked a better immune response than GlaxoSmithKline's (NYSE: GSK  ) hepatitis B vaccine, Engerix-B, with one less shot.

Fast forward to yesterday when an FDA advisory committee reviewed the vaccine. The panel of outside experts agreed that the vaccine produced an immune response, voting 13-1 on the question of efficacy.

On the safety front, the results were substantially different. The committee voted 8-5 that there