Is the new Dynavax hepatitis vaccine safe? I couldn’t tell — and I was advising the FDA
I abstained from an FDA committee vote on the safety of a new vaccine because it was impossible to tell if the vaccine increases heart attack risk.
The Food and Drug Administration recently had a very important question about a new hepatitis vaccine and wanted advice.
is a serious disease that can damage the liver. A company called Dynavax has developed a new vaccine that stimulates the body to produce antibodies against the hepatitis B virus more vigorously than existing vaccines do, and with just two doses instead of the usual three. The vaccine works through a — a substance that improves the body’s immune response to the virus. The advantages of the Dynavax vaccine were demonstrated of more than 8,000 patients: About 5,600 received the new vaccine and about 2,800 received the existing standard hepatitis B vaccine.
