Hepatitis B Vaccine Approved On Third Attempt
HEPLISAV-B is the only two-dose vaccine for Hepatitis B in adults
The first hepatitis B vaccine to win the U.S. Food and Drug Administration’s (FDA) approval in 25 years, will launch in early 2018.
The two-dose vaccine, HEPLISAV-B, approval comes after two FDA rejections, first in 2013 and then in 2016.
There is no cure for hepatitis B, but effective vaccination can prevent the disease.
HEPLISAV-B, an adult hepatitis B vaccine, is indicated for active immunization against all known subtypes of hepatitis B virus.
HEPLISAV-B will compete with Engerix-B, which is a three-dose vaccine delivered over a six-month period.
However, almost 50 percent of adults fail to complete the Engerix-B vaccine series within one year, according to previous research.
Results from a Phase 3 trial, which included 6,665 participants, showed that HEPLISAV-B demonstrated a statistically significantly higher rate of protection, 95% compared with 81% for Engerix-B.
Hepatitis B is an extremely infectious and potentially deadly virus affecting a wide range of adults in the United States. There is no cure for hepatitis B, and infections are on the rise.
In 2015, new cases of acute hepatitis B increased by more than 20 percent nationally,according to the Centers for Disease Control and Prevention (CDC).
"Prevention of hepatitis B in adults through vaccination is more important than ever given the increase in the rate of infections," said William Schaffner, M.D., professor of Preventive Medicine, Vanderbilt University Medical Center.
"Too many at-risk adults remain unprotected against this virus. A two-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," said Dr. Schaffner.
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV.
In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person.
Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician's discretion.
For full Prescribing Information for HEPLISAV-B, click here.
Most pharmacies offer the hepatitis B vaccine. The price for this vaccine varies by state, and the CDC vaccine price list can be found here.
Vaccine discounts can be found at this page.
- Compliance With Multiple-Dose Vaccine Schedules Among Older Children, Adolescents, and Adults: Results From a Vaccine Safety Dat
- Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine
- Surveillance for Viral Hepatitis – United States, 2015
- Hepatitis B FAQs for the Public
- Hepatitis B FAQs for Health Professionals
- Diabetes and Hepatitis B Vaccination
- Dynavax Announces FDA Approval of HEPLISAV-B(TM) for Prevention of Hepatitis B in Adults