FDA expands age range for Dynavax hepatitis B vaccine

Dynavax Technologies Corp. said the Food and Drug Administration agreed to expand the age range for use of the company’s Heplisav vaccine for hepatitis B.
Berkeley-based Dynavax (NASDAQ: DVAX) had expected it would only be able to use the vaccine on healthy adults 40 years old or older. But the FDA agreed to allow use in healthy adults age 18 to 70 years.
Dynavax, which has struggled to seek approval in the United States for Heplisav, called the change “a significant expansion.” It had once hoped to submit the application to the FDA in the third quarter of 2011.