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.
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 HEPLASIV-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 antigens.
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 60 percent of treated individuals fulfilling the three doses necessary for complete HBV protection.
Although fewer doses are needed with HEPLISAV-B, it displays similar immunogenicity to similar vaccines (90.0 percent-100 percent vs. 70.5 percent-90.2 percent). It is also more effective, compared with similar vaccines in those with type II diabetes (90 percent vs. 65.1 percent) and chronic kidney disease (89.9 percent vs. 81.1 percent).
HEPLISAV-B uses an adjuvant, but it appears to be safe and well tolerated. The rate of mild (45.6 percent vs. 45.7 percent) and serious (5.4 percent vs. 6.3 percent) reactions were similar among HEPLISAV-B and comparable vaccines, although cardiovascular events WERE more common with this vaccine than with others (0.27 percent vs. 0.14 percent).
Researchers supported the recommendations of HEPLISAV-B and voiced reservations about these findings. “I am concerned about the myocardial infarction signal and the use of this new adjuvant and certainly urge us to look at the postmarketing data carefully.”
While the reported incidence rate of acute HBV cases consistently fell during 2000-2015, it began to rise again at the end of 2015. This is linked with concomitants rise in injection drug use, which also is a risk factor in transmitting HBV. Over the same period, the incidence of HBV was highest in people aged 30-49 years. With these factors to consider, the vote by ACIP for HEPLISAV-B as a recommended vaccine is timely and may help reduce HBV infections in adults.