Heplisav-B, Dynavax Technology’s experimental hepatitis B vaccine, was recommended for licensing at a meeting Friday of the US Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee.
The committee voted 11-1 (with 3 abstentions) that the available data support administration of Heplisav-B to adults aged 18 years and older.
Much of the praise was for Heplisav’s shorter schedule: it is given twice over 1 month instead of rivals’ three doses over 6 months, important because of the low percentage of patients who currently complete all three doses. […]
A surprise finding from a clinical trial showed there were more deaths and serious heart problems, including myocardial infarction, among patients who received that vaccine than those given a rival product, Endrix B, according to the FDA report, but the numbers were small and hard to assess. […]
Almost all of the public comment portion of the meeting was positive concerning the vaccine.
However, Megan Polanin, PhD, a senior fellow at the National Center for Health Research in Washington, DC, said, “The clinical trials have raised serious concerns about safety for some patients.
“Asians living in the United States account for more than half of the 1 million Americans living with chronic hepatitis. Chronic infection is responsible for most HBV-related morbidity and mortality. Clearly Asians are not adequately represented in the company’s pivotal trials.”
She said that because so few Asians were included in the study, there is no way to know whether they would be affected differently by the vaccine.
The US Centers for Disease Control and Prevention estimates that up to 2.2 million people in the United States have chronic hepatitis B virus infection and that about 786,000 people worldwide die each year from hepatitis B virus–related liver disease. There is no cure for hepatitis B, and disease prevention through more effective vaccines is critical to reducing the spread of the disease.
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