FDA panel concerned about safety of Dynavax's hep B vaccine
A panel voted unanimously to recommend the efficacy of Heplisav but showed concern about the drug's safety. FDA advisers voted that Dynavax did not provide enough safety data to support approval, Bloomberg reports. Data provided compared the safety and immunogenicity of Heplisav with GlaxoSmithKline's ($GSK) Engerix-B.
"The immunogenicity data that was provided by (Dynavax) was excellent, but I have concerns with the population," a panel member said, as quoted by Reuters. "I think what we have here is really, really good but it is not representative of the United States."
An advisory panel voted 13-1 that Heplisav works. But the panel was divided over the safety data; an 8-5 vote with one abstention deemed that safety data was inadequate.
Dynavax studied 2,400 patients. The panel members said Dynavax needs to study a larger database of 10,000 or more ethnically diverse patients from a higher risk population, Reuters reports, to show the benefits of the vaccine.
The FDA will take into consideration the panel's opinion when it's scheduled to decide on granting marketing approval to the vaccine Feb. 24.