GlobalData Heplisav Needs Adult Vaccine Uptake
- Dynavax seizes untapped market opportunity presented by HBV vaccine “non-responders”
- A solution to improve vaccine uptake is ‘the only way in which Heplisav can achieve commercial success,’ says analyst
Dynavax Taps into Hepatitis B Unmet Need with Heplisav, but only Adult Vaccine Uptake can Spell True Success, says GlobalData Analyst
LONDON, UK (GlobalData), 30 October 2013 - While optimism has surrounded the recently announced plans for a large Phase III clinical trial of Dynavax Technologies Corporation’s much-anticipated hepatitis B virus (HBV) vaccine, Heplisav, the company’s commercialization efforts will fail unless it focuses on increasing vaccine uptake in the adult population, says an analyst with research and consulting firm GlobalData.
According to Christopher J. Pace, Ph.D., GlobalData’s Analyst covering Infectious Diseases, Dynavax has seized upon the untapped market opportunity presented by “non-responders” – HBV patients who fail to achieve high levels of seroconversion when administered the currently marketed HBV vaccines.
To meet the needs of this patient population, Dynavax focused Heplisav’s initial Phase III clinical trials on specific groups of non-responders, such as those with chronic kidney disease (CKD). With the recently announced Phase III Study, HBV-23, Dynavax hopes to generate safety data required by the FDA, as well as to investigate the vaccine’s immunogenicity in adults with diabetes mellitus. This population represents an enormous, yet largely untapped, segment of the HBV vaccine market when combined with other non-responders.
However, Pace says: “Despite the fact that Dynavax is positioning Heplisav to effectively fill these gaps in the treatment algorithm, we believe that the firm must still overcome a number of formidable non-clinical barriers to the widespread uptake of HBV vaccines in adults.
“One of the main challenges to the vaccine’s adoption is the failure to properly educate patients and physicians on the benefits of adult HBV immunization. However, even with increased awareness, the current reimbursement framework requires patients to disclose an HBV risk factor, which prevents prescribers from being able to administer the vaccine to those who need it most while protecting their privacy at the same time.”
One approach to overcoming these obstacles, according to GlobalData, would be to push for the universal immunization of adults against HBV, as this would provide a stable funding mechanism for vaccine administration while simultaneously easing the pressure on physicians and patients alike.
“At the end of the day, the only way in which Heplisav can achieve commercial success is if Dynavax works with regulators and healthcare providers towards finding a solution to improve HBV vaccine uptake in the adult population,” Pace concludes.
-NOTES TO EDITORS-
- Comment provided by Christopher J. Pace, Ph.D., GlobalData’s Analyst covering Infectious Diseases.
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Posted: October 2013