application for Heplisav-B in 2012. A few of the recipients in clinical trials had developed autoimmune diseases and cardiac events, so the FDA asked Dynavax to conduct an additional clinical trial in 2013 to determine if these events were related to the vaccine or just random. The FDA sought more information and analyses again in 2016.
Only large-scale studies could provide a definitive answer, and the company says its Heplisav-B studies included 10,038 patients altogether. According to Carson, an FDA advisory committee concluded that the adverse reactions were no more than could be expected by chance. Nontheless, they asked that Dynavax conduct post-marketing vigilance studies.
Dynavax plans to introduce Heplisav-B as its first commercial product in early 2018. The company managed to sustain itself initially through the support of individual investors and research grants from the National Institutes of Health. The company went public in 2004. “It’s wonderful in the United States that investors will keep pouring money into a company to keep it going,” Carson said.
There is no cure for hepatitis B, an extremely infectious virus that causes serious liver disease. While most people recover, about 15 percent of the cases become chronic—and can lead to liver cirrhosis and even cancer. Dynavax says results from one of its clinical trials (with 6,665 participants) showed that its Heplisav-B vaccine provided a higher rate of protection—95 percent versus 81 percent for Engerix-B, the current standard vaccine marketed by GlaxoSmithKline (NYSE: [[ticker:GSK]]).
In a Nov. 9 conference call with analysts and investors, Dynavax CEO Eddie Gray proclaimed, “This is a great day for our company, for our investors, and also I think for public health.”
Dynavax offers a dosing schedule that some patients may find preferable. The company says its vaccine provides full immunity with two injections over four weeks, compared to Engerix-B, which requires more injections over several months. The goal at Dynavax, Gray said on the conference call, is to make Heplisav-B “the adult hepatitis B vaccine of choice in the United States,” a market that Dynavax estimates at $270 million a year—and growing. In 2012, an advisory committee on immunization practices recommended that the list of population at risk for hepatitis B, and who should be vaccinated, should include people with diabetes.
Despite all that, Carson said, “You do not see a lot of biotechs doing vaccines, because of the longer development time and cost.” The incentives to develop vaccines also are lower, because they are hard to manufacture and generally only administered once.
“Vaccines are miracle drugs, along with antibiotics, in terms of extending our lifespans,” Carson said. “In terms of human health, there’s nothing like them. But they’re not tremendous money-makers because you don’t need to take them every day.”
Colorized electron micrograph image of hepatitis b particles via Wikipedia by Dr. Erskine Palmer / CDC.
