FDA Vaccines and Related Biological Products Advisory Committee voted 12 to one to recommend approval of the new Heplisav-B vaccine for hepatitis B today.
“The safety and the data is reassuring; the company has addressed the issues,” Jay M. Portnoy, MD, from Children’s Mercy Hospital, Kansas City, Missouri, said during the meeting. “In my opinion, part of the safety includes the fact that it is extremely effective. It is safer to get the ... vaccine than it is to get hepatitis B.”
Heplisav-B, developed by Dynavax, consists of antigens produced from yeast cells combined with CPG 1018 adjuvent, which is not contained in any currently licensed vaccine. The vaccine is indicated for adults 18 years and older. The treatment consists of two doses with the second dose provided at 1 month.
In all three trials, the researchers found Heplisav-B to be noninferior compared with Engerix-B (GlaxoSmithKline). In the latest trial, 95% of patients 18 to 39 years of age who received Heplisav-B achieved seroprotection compared with a rate of 81% among those who received Engerix-B. Similarly, 95% of patients 40 to 70 years of age who received Heplisav-B achieved seroprotection compared with a rate of 79% in those who received Engerix-B.
Twelve committee members voted yes, three abstained and one voted no. During the discussion of the benefit-to-risk relationship of the vaccine compared with current vaccines approved for the market, the most common concern the committee members had was the inconsistent results related to myocardial infarction risk.
“My only concern is the signal [for myocardial infarction] that we have all talked about. I suggested that the package insert include a warning or some kind of alert for individuals who have increased cardiovascular risk factors. Increased attention should be paid to these individuals. I don’t think it would be right to withhold these vaccines from the millions of people who could benefit from it,” Portnoy added.
In two earlier studies, the researchers found no significant relationship between the vaccine and risk for myocardial infarction, whereas they found a significant association during the latest study (RR = 3.15; 95% CI, 0.99-23.11).
The committee’s final comments, particularly regarding the post-licensure pharmacological plan, included a recommendation for further studies focused on the potential association between Heplisav-B and increased risk for cardiovascular serious events and further trials in subpopulations, such as Asian patients of which there were few in the original studies. – by Talitha Bennett
Disclosure: The FDA committee reports no relevant financial disclosures.
Reference: FDA Center for Biologics Evaluations and Research. 147th Meeting of the Vaccines and Related Biological Products Advisory Committee. Accessed July 28, 2017.