BERKELEY, Calif., Feb. 21, 2018 (GLOBE NEWSWIRE) -- Dynavax Technologies Corporation (NASDAQ:DVAX) today announced that the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously in favor of including HEPLISAV-B on its list of ACIP recommended products for use to vaccinate adults against hepatitis B. HEPLISAV-B was approved by the U.S. Food and Drug Administration (FDA) in November 2017 for the prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.
"With the ACIP's recommendation, HEPLISAV-B has cleared an important milestone needed to position Dynavax to meet our 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," said Eddie Gray, chief executive officer of Dynavax.
The receipt of the ACIP recommendation is a key step in providing patients with broad access to HEPLISAV-B. Medical policies of many insurance plans and institutions require ACIP recommendation before a vaccine is covered or available to their patients. Dynavax commercially launched HEPLISAV-B in the United States in January 2018, and announced yesterday that the field sales team will actively begin selling HEPLISAV-B next week. The vaccine can be ordered through a network of distributors. The company is working with an extensive network of group purchasing organizations and government entities to help ensure adult patients have access to HEPLISAV-B. A list of the current distributors in the Dynavax network can be accessed by calling 1-84-HEPLISAV (1-844-375-4728). Dynavax is also working to support broad reimbursement of HEPLISAV-B by insurance plans. Proactive payer outreach is currently ongoing and will include the ACIP recommendation for HEPLISAV-B once it is approved by the CDC and U.S. Department of Health and Human Services (HHS).
The ACIP recommendation will be reviewed and approved by the CDC before being published in the Morbidity and Mortality Weekly Report (MMWR).
Please see Important Safety Information below. For more information about HEPLISAV-B, visit http://heplisavb.com/.