The Food and Drug Administration recently had a very important question about a new hepatitis vaccine and wanted advice.
Hepatitis B 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 unique adjuvant — a substance that improves the body’s immune response to the virus. The advantages of the Dynavax vaccine were demonstrated in a randomized trial of more than 8,000 patients: About 5,600 received the new vaccine and about 2,800 received the existing standard hepatitis B vaccine.