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Hepatitis B Foundation Applauds FDA Approval of New Hepatitis B Vaccine

FDA Approved HEPLISAV-B, the First New Hepatitis B Vaccine in More than 25 Years

DOYLESTOWN, PA (November 10, 2017): Today on World Immunization Day, the Hepatitis B Foundation applauded the U.S. Food and Drug Administration’s (FDA) approval of HEPLISAV-B™, the first new hepatitis B vaccine in more than 25 years and the only two-dose schedule for the prevention of infection in adults.

Hepatitis B (HBV) is an extremely infectious virus (100 times more infectious than HIV/AIDS), and it is the most common serious liver infection in the world. More than 257 million people worldwide and up to 2.2 million in the United States are chronically infected with hepatitis B. Each year up to 1 million people die from HBV despite the fact that it is preventable and treatable.

“The new two-dose vaccine is a game changer,” said Timothy Block, PhD, president of the Hepatitis B Foundation. “Current vaccines require three doses over 6 months, which makes it hard for some people to get all doses. With the new vaccine, people can be fully protected with two doses, in just one month. As we work towards finding a cure and eliminating hepatitis B in the U.S. and globally, having this new tool in our arsenal will play a critical role in preventing infections.”

Hepatitis B is associated with significant health disparities in the U.S., disproportionately affecting Asian American, Pacific Islander, and African communities. Asian Americans and Pacific Islanders make up 50% of the HBV infection burden in the U.S., and have liver cancer rates that are up to 13 times higher than Caucasian populations.

In addition, for the first time since 2006, the number of reported cases of acute HBV infection across the country is rising, and increased by 20.7% in 2015 alone. Parts of the country that are hardest hit by the opioid epidemic are now facing a rise in acute HBV infection associated with injection drug use.

While the current three-dose HBV vaccine series offers lifelong protection from HBV infection, data from 2013 indicated that only 32.6% of adults aged 19 to 49 years were covered by the vaccine. Coverage is estimated to be even lower among injection drug users. Moving from a three-dose vaccine to a two-dose vaccine can help overcome challenges to vaccine completion, and lead to higher coverage and protection rates, especially for high-risk communities.

“It is critical to increase HBV vaccination coverage, particularly among high-risk populations and young adults born prior to 1991, when HBV vaccination for infants became routine,” said Chari Cohen, DrPH, MPH, vice president for public health and programs at the Hepatitis B Foundation and co-chair of the Hep B United coalition. “We are very excited about the new two-dose vaccine and look forward to working with our partners to ensure all communities have access to this life-long protection from hepatitis B and liver cancer.”

About the Hepatitis B Foundation
The Hepatitis B Foundation is the nation’s leading nonprofit organization solely dedicated to finding a cure for hepatitis B and improving the quality of life for those affected worldwide through research, education and patient advocacy. To learn more, go to, read our blog at, follow us on Twitter @HepBFoundation, find us on Facebook at or call 215-489-4900.

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