HEPLISAV-B Approved by FDA


The vaccine is the only 2-dose regimen for the prevention of infection by all known subtypes of hepatitis b in adults 18 and older.

The first new hepatitis B vaccine in more than 25 years—Dynavax Technologies’ HEPLISAV-B—was approved by the US Food and Drug Administration (FDA) today. The vaccine is the only 2-dose regimen for the prevention of infection by all known subtypes of the virus in adults 18 and older. (Current hepatitis B vaccine regimens include 3 shots over a 6-month period).

Originally scheduled to be approved in August 2017, the FDA requested additional post-marketing study information for the vaccine, causing the delay. The final approval, according to a press release from Dynavax, “was based on data from 3 Phase 3 non-inferiority trials of nearly 10,000 adult participants who received HEPLISAV-B. The pivotal studies compared HEPLISAV-B administered in 2 doses over 1 month to Engerix-B administered in 3 doses over a 6-month schedule. Results from the largest Phase 3 trial, which included 6665 participants, showed that HEPLISAV-B demonstrated a statistically significantly higher rate of protection of 95% compared with 81% for Engerix-B.”

When speaking about the approval of the vaccine in the press release, William Schaffner, MD, professor of Preventive Medicine, Vanderbilt University Medical Center and president of the National Foundation of Infectious Diseases said, “Prevention of hepatitis B in adults through vaccination is more important than ever given the increase in the rate of infections. Too many at-risk adults remain unprotected against this virus. A 2-dose schedule with higher rates of protection, along with other strategies, may help us move closer to the goal of eliminating hepatitis B as a public health problem in the United States."

According to the Centers for Disease Control and Prevention (CDC), “In 2014, a total of 2953 cases of acute hepatitis B were reported from 48 states to CDC. The overall incidence rate for 2014 was 0.9 cases per 100,000 population. After adjusting for under-ascertainment and under-reporting, an estimated 19,200 acute hepatitis B cases occurred in 2014.” The risk of chronic infection is related to age, with about 90% of infected infants becoming chronically infected. The CDC advises that the best way to stay protected is to get vaccinated.

The most common reaction to the HEPLISAV-B vaccine across all 3 trails was injection site pain (23% to 39% of study participants). The most common systemic reactions were fatigue (11% to 17%) and headache (8% to 17%).

The drug is expected to be commercially launched in the United States in the first quarter of 2018. Safety Information for the drug includes the following:

  • Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.
  • Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.
  • Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.
  • Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

Full Prescribing Information for HEPLISAV-B

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