The CDC's committee voted unanimously to support the vaccine, widening its availability to patients through health care coverage and plans.
The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has voted unanimously in favor of including recombinant vaccination Heplisav-B on its list of recommended products for adult vaccination against hepatitis B (HBV).
The vaccination, from Dynavax Technologies, was previously approved by the US Food and Drug Administration (FDA) for HBV vaccination in adults aged 18 years and older in early November. The ACIP’s recommendation brings the vaccine closer to the forefront of patient access, as various insurance plans and institutions rely on ACIP recommendation for vaccine coverage and availability.
Heplisav-B’s venture to the US market was a long one, as the vaccine was put through various FDA committee scrutiny over its immunogenicity and safety since 2012. Its initial decision date in August 2017 was delayed until November due to a post-marketing study update, and was only then approved for the prevention of all HBV subtypes in adults.
When it reached the US market in January, it became the first and only two-dose HBV vaccination. It combines surface antigen with Dynavax’s proprietary Toll-like Receptor 9 agonist to enhance immune response, as evidenced in 3 pre-approval phase 3 non-inferiority trials that included 10,000-plus patients.
The studies, a comparison between the Heplisav-B and Engerix-B, observed its efficacy over 6 months. In the largest of the 3 trials, Heplisav-B reported a 95% protection rate from the virus, versus Engerix-B’s 81% rate. It also showed efficacy in patients with comorbidities: the vaccine’s protection rate from HBV was 90% in patients with type 2 diabetes. Engerix-B’s rate was 65%.
There is currently no cure for HBV, and recent rates show it could be on the rise. New cases of acute HBV increased by more than 20% in the US in 2015, adding to a population of about 850,000 patients. It is 50 to 100 times more infectious than HIV, according to Dynavax, and is linked to possibly lethal liver complications and conditions.
Eddie Gray, chief executive officer of Dynavax, said in a statement the ACIP’s recommendation represents an important milestone towards the company’s long-term commercial goals.
“Additionally, this recognition emphasizes the important role of Heplisav-B in the prevention of hepatitis B infection in adults, reinforcing our belief that our unique two-dose vaccine with demonstrated higher rates of protection versus Engerix-B, and a safety profile similar to three-dose vaccines, will become the new standard of care for adults,” Gray said.
The news follows Dynavax’s announcement on Tuesday that its sales team will begin actively selling the vaccine next week. It will be accessible through a network of distributors, and the company is working with group purchasing organizations and government agencies to ensure patient access to Heplisav-B.
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