The FDA approved the first new vaccine to prevent hepatitis B virus infection in 25 years

The U.S. Food and Drug Administration (FDA) announced the approval of HEPLISAV-B for the prevention of hepatitis B virus (HBV) infection in adults ages 18 and older. HEPLISAV-B is the first new hepatitis B vaccine approved in the U.S. in more than 25 years, and is the only two-dose HBV vaccine approved for adults. The approval of HEPLISAV-B by the FDA was based on data from three Phase 3 clinical trials of nearly 10,000 adult participants who received the HEPLISAV-B vaccine.

Hepatitis B is an infectious disease caused by the hepatitis B virus. It is transmitted when blood, semen, or another body fluid from an infected person enters the body of someone who is not infected. This can happen through sexual contact, sharing needles, syringes, or other drug-injection equipment, or from mother to baby at birth. In the United States, an estimated 850,000 - 2.2 million persons are chronically infected with HBV and infections are on the rise.

Getting vaccinated is the best way to prevent becoming infected with HBV. Unfortunately, many at risk adults are not vaccinated. A 2014 analysis found that vaccination levels for HBV were low among adults 19 years and older. According to the study, only 25% of adults were vaccinated clearly indicating the need for new tools and strategies to improve adult vaccination rates.  

The approval of the new HBV vaccine supports strategies and actions set forth in the National Viral Hepatitis Action Plan that calls for achieving universal hepatitis B vaccination for vulnerable adults. The new vaccine could potentially improve adult vaccination rates because it:

• Requires 2 doses (compared to 3 doses for the previously available vaccines),
• Can be completed in 1 month (compared to 6 months for the previously available vaccines).

Immunization programs are important partners in the fight against viral hepatitis. We encourage all stakeholders to consider how they can join immunization programs, health care providers, and others that serve adults who are recommended to be vaccinated for hepatitis B. Join us as we develop and share strategies to use this new tool in our viral hepatitis prevention arsenal.