FDA/CDC

ACIP unanimously recommends HEPLISAV-B


 

REPORTING FROM AN ACIP MEETING

At a meeting of the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices, members unanimously voted to include HEPLISAV-B on the ACIP list of recommended products to vaccinate adults against hepatitis B.

“I think this is a huge advance, and a step forward “ said David S. Stephens, MD, of Emory University, Atlanta, who is a voting member of ACIP.

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HEPLISAV-B was approved by the Food and Drug Administration in November 2017, but this recommendation by the ACIP reinforces its usefulness as a vaccine against hepatitis B virus (HBV) in adults. It is a two-dose vaccine intended for administration over the course of a month. This stands in contrast to prior HBV vaccines, which use a three-dose approach. One of the factors that may make HEPLISAV-B effective after two doses is the use of the 1018 adjuvant, which binds Toll-like receptor 9 to stimulate a directed immune response to hepatitis B surface antigen.

According to Sarah Schillie, MD, of ACIP’s Hepatitis Work Group, the reduction from three doses to two also will improve vaccine series completion rates, providing more effective protection. This could be very important for health care professionals, with only about 60% of treated individuals fulfilling the three doses necessary for complete HBV protection.

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