The CDC’s Advisory Committee on Immunization Practices has included HEPLISAV-B on its list of recommended products for use to vaccinate adults against hepatitis B.
In a unanimous vote, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) has decided to include Dynavax Technologies Corporation’s recombinant vaccine, Heplisav-B on its list of recommended products for vaccination against hepatitis B virus in adults.
Heplisav-B 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 underwent heavy FDA committee scrutiny over its immunogenicity and safety since 2012. Its initial decision date in August 2018 was delayed until November due to a post-marketing study update.
When it reached the US market in January, it became the first and only two-dose HBV vaccination; previous hepatitis B regimens consisted of 3 shots administered over a 6-month time period. 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 over 10,000 patients.
The studies compared the efficacy between Heplisav-B and Engerix-B over a period of 6 months. In the largest of the 3 trials, Heplisav-B showed a 95% protection rate from the virus, whereas Engerix-B’s protection rate was only 81%. Heplisav-B also showed efficacy in patients with comorbidities; for example, the vaccine’s protection rate from HBV was 90% in patients with type 2 diabetes; Engerix-B’s protection 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.
“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,” Dynavax’s chief executive officer Eddie Gray commented in a press release.