NVHR Welcomes FDA Approval of New Hepatitis B Vaccine

The NVHR today welcomed the FDA approval of HEPLISAV-B for prevention of hepatitis B virus infection in adults ages 18 and older.

FDA Approved HEPLISAV-B, the First Hepatitis B Vaccine Approved in the U.S. in Over 25 Years; New Tool Can Help the U.S. Eliminate the Virus & Address the Opioid Epidemic

SAN FRANCISCO, CA (Nov. 10, 2017) – The National Viral Hepatitis Roundtable (NVHR) today welcomed the U.S. Food and Drug Administration’s (FDA) approval of HEPLISAV-B for prevention of hepatitis B virus infection in adults ages 18 and older. HEPLISAV-B is the first new hepatitis B vaccine approved in the United States in more than 25 years and the only two-dose hepatitis B vaccine for adults.

“The approval of HEPLISAV-B provides an important new tool for reversing the unfortunate trend of increased acute hepatitis B infections in the U.S.,” said Ryan Clary, NVHR executive director. “NVHR will work with our advocacy partners to ensure everyone has access to this vaccine, particularly high-risk populations for hepatitis B infection, such as people who inject drugs.”

Hepatitis B is an extremely infectious and potentially deadly virus affecting up to 2 million people in the United States. Asian Americans and Pacific Islanders are disproportionately impacted, accounting for more than 50% of people living with chronic hepatitis B in the country. While there is effective treatment for hepatitis B, there is no cure and infections are on the rise. In 2015, new cases of acute hepatitis B increased by more than 20 percent, largely as a result of the nation’s opioid crisis.

In March 2017, the National Academies of Sciences, Medicine and Engineering released A National Strategy for the Elimination of Hepatitis B and C. The National Academies noted that only a quarter of adults over the age of 19 have been fully immunized against hepatitis B and called for expanded access to vaccination as part of the overall strategy to eliminate the public health threat of hepatitis B in the United States by 2030. Current hepatitis B vaccines require three shots over a six-month period for full protection; however, almost half of adults fail to complete the series within one year. HEPLISAV-B is a two-dose vaccination taken over a one-month period, increasing the likelihood of successful completion.

“Not only is the approval of HEPLISAV-B a significant step towards achieving hepatitis B elimination, but it presents a new opportunity to help end the rapid spread of the virus among people who inject drugs,” added Clary. “The federal government should eliminate barriers for all Americans who inject drugs to get vaccinated for hepatitis B as part of its overall effort to address the nation’s opioid emergency.”

About the National Viral Hepatitis Roundtable (NVHR)
The National Viral Hepatitis Roundtable is a broad coalition working to fight, and ultimately end, the hepatitis B and hepatitis C epidemics. We seek an aggressive response from policymakers, public health officials, medical and health care providers, the media, and the general public through our advocacy, education, and technical assistance. NVHR believes an end to the hepatitis B and C epidemics is within our reach and can be achieved through addressing stigma and health disparities, removing barriers to prevention, care and treatment, and ensuring respect and compassion for all affected communities. For more information, visit www.nvhr.org.

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