The CDC’s Advisory Committee on Immunization Practices voted unanimously today to recommend the HEPLISAV-B recombinant vaccine to prevent hepatitis B virus infection.
In November 2017, the FDA approved the recombinant, adjuvanted vaccine, marketed by Dynavax, for active immunization against all known HBV subtypes in people aged 18 years or older. It is administered in two doses spaced 1 month apart.
Sarah Schillie, MD, MPH, MBA, a medical epidemiologist with the CDC’s Division of Viral Hepatitis, Vaccine Research and Policy Unit, presented data on HEPLISAV-B’s efficacy before the vote at the ACIP’s meeting in Atlanta.
“HEPLISAV-B is likely to improve hepatitis B vaccine series completion and result in earlier protection due to the administration schedule of doses over 1 month,” Schillie said. “The schedule may be especially beneficial for persons with anticipated low adherence, such as injection drug users.”
ACIP now recommends the HEPLISAV-B recombinant vaccine for HBV prevention.
The ACIP vote means that HEPLISAV-B is now among the HBV vaccines the group recommends for use, but it is not preferred over others, William Schaffner, MD, an Infectious Disease News Editorial Board member and professor of preventive medicine at Vanderbilt University Medical Center, said in an interview. He noted that the recommendation adds another weapon to the fight against HBV infection.
“I’m happy that HEPLISAV-B was recommended because the data showed that the vaccine is very strong, and only two doses are needed,” Schaffner said. “And the older people and others who don’t respond well, like people with diabetes and kidney disease, all responded exceeding well to HEPLISAV-B.”
Schillie reviewed data from studies assessing HEPLISAV-B’s efficacy in both healthy people and those with certain serious illnesses.
In those studies, 90% to 100% of participants who received HEPLISAV-B achieved seroprotection, compared with 70.5% to 90.2% of those who received a comparator vaccine, Engerix-B, marketed by GlaxoSmithKline.
Among participants with type 2 diabetes, 90% of those who received HEPLISAV-B were protected, compared with 65.1% of those receiving Engerix-B. Of those with chronic kidney disease, 89.9% of participants who received three doses of HEPLISAV-B were protected, compared with 81.1% of those who received four double doses of Engerix-B.
In addition, 45.6% of participants receiving HEPLISAV-B experienced mild adverse events, compared with 45.7% of those with Engerix-B. The groups also had similar rates of serious adverse events, which were experienced by 5.4% of participants in the HEPLISAV-B group and 6.3% of those receiving Engerix-B. Schillie said HEPLISAV-B’s safety will be assessed further in post-marketing studies.
The CDC recommends HBV vaccination for adults who are at risk for infection like:
- sex partners of people with the virus, those with multiple partners and men who have sex with men;
- those at risk for infection through blood exposure such as people who inject drugs, household contacts of people with HBV, health care workers and emergency responders;
- those who travel to regions where the virus is endemic;
- those with hepatitis C virus infection and chronic liver disease;
- those with HIV; and
- people who are incarcerated.
Universal HBV vaccination is recommended for all infants aged older than 1 day and anyone under the age of 19 years. – by Joe Green
Disclosure: Schillie reports no relevant financial disclosures. Schaffner reports being a consultant for Dynavax and Seqirus.