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The FDA recommends approving a new HBV vaccine for adults.

Release date:

2017-09-26

Author:

Excerpted from BioValley

Source:

BioValley

Abstract

The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee voted 12 to 1 to recommend approval of a new hepatitis B vaccine for the prevention of hepatitis B. Dr. Jay M. Portnoy of Children’s Mercy Hospital in Kansas City, Missouri, noted, “The vaccine’s safety and efficacy data are reassuring.” Hepatitis B is a global epidemic with widespread impact. Currently, approximately 240 million people worldwide are chronically infected with HBV, and each year about 650,000 individuals die from liver failure, cirrhosis, and hepatocellular carcinoma (HCC) caused by HBV infection.

　　The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee recommended, by a vote of 12 to 1, the approval of a new hepatitis B vaccine for the prevention of hepatitis B.

　　Dr. Jay M. Portnoy of Children’s Mercy Hospital in Kansas City, Missouri, stated, “The safety and efficacy data for the vaccine are reassuring.”

　　Hepatitis B is a global epidemic with widespread impact. Currently, approximately 240 million people worldwide are chronically infected with HBV, and each year about 650,000 individuals die from liver failure, cirrhosis, and hepatocellular carcinoma (HCC) caused by HBV infection. Although several new anti‑hepatitis B drugs are under development, a cure for hepatitis B remains a significant distance away.

　　Heplisav‑B, a hepatitis B vaccine developed by Dynavax, combines the hepatitis B surface antigen with a Toll‑like receptor 9 (TLR9) agonist. It is indicated for adults aged 18 years and older. Heplisav‑B consists of two doses, with the second dose administered one month after the first. In contrast, currently available hepatitis B vaccines require three doses over six months. Moreover, only 54% of adults complete the standard three‑dose hepatitis B vaccination series within one year.

　　In all three trials, researchers found that Heplisav‑B was non‑inferior to the Engerix‑B vaccine. In the most recent trial, 95% of participants aged 18–39 who received Heplisav‑B achieved seroprotection, compared with 81% of those receiving Engerix‑B. Similarly, among participants aged 40–70, 95% of those vaccinated with Heplisav‑B attained seroprotection, versus 79% in the Engerix‑B group.

　　Twelve committee members voted in favor, three abstained, and one voted against. Compared with currently approved vaccines, the committee members’ discussion of the vaccine’s benefit–risk profile focused most on the inconsistent findings regarding the risk of myocardial infarction.

　　In two earlier studies, researchers found no significant association between the vaccine and the risk of myocardial infarction, whereas the most recent study did identify a significant link (RR = 3.15; 95% CI, 0.99–23.11). Portnoy added, “My primary concern is the signal regarding myocardial infarction that we have been discussing. I would recommend issuing warnings or advisories for individuals with high cardiovascular risk factors, and greater attention should be directed toward this population.”

　　The committee’s final opinion, particularly its recommendations regarding the licensed‑drug program, includes calls for additional research into the potential association between Heplisav‑B and an increased risk of serious cardiovascular events, as well as further studies in specific subpopulations.

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