Heplisav-B® Vaccine 2023
The Heplisav-B® two-dose vaccine combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR), nine agonists, to enhance the immune response. Dynavax's HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] is an adult hepatitis B vaccine indicated to prevent infection caused by all known subtypes of hepatitis B virus adults age 18 years and older.
TLRs are expressed on dendritic cells and other innate immune cells and are among the most important receptors for eliciting a response to the presence of invading pathogens. Humans have ten types of TLRs that are similar in structure but recognize different viruses or bacteria. Thus, activating specific TLRs can stimulate and control particular types of innate immune responses that can be harnessed to enhance adaptive responses and potentially improve vaccines and cancer-killing activities. Research at Dynavax has identified proprietary, synthetic oligonucleotides (short segments of DNA) that selectively and optimally activate these receptors.
In 2017, HEPLISAV B was U.S. Food and Drug Administration (FDA) (BLA 125428) and European Commission-approved hepatitis B vaccine for adults with a two-dose regimen completed in one month. On February 28, 2023, the United Kingdom Medicines and Healthcare products Regulatory Agency granted Marketing Authorization in Great Britain to Dynavax GmbH for HEPLISAV B, indicated for active immunization against HBV caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.
Emeryville, California-based Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines. Dynavax has worldwide commercial rights to HEPLISAV-B.
The retail price ranges from $131 to $160. Most insurance plans will cover this vaccine; however, there are discounts that can be found to reduce the cost of the vaccine.
In 2022, the U.S. CDC issued a universal recommendation that adults aged 19-59 receive hepatitis B vaccination. The Heplisav-B vaccine is indicated for preventing infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. Hepatitis B is a viral liver disease that can become chronic and lead to cirrhosis, liver cancer, and death. There is no cure for hepatitis B, but effective vaccination can prevent it. In adults, hepatitis B is spread through infected blood and unprotected sex with an infected person.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following the administration of HEPLISAV-B. In addition, immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.
On December 15, 2020, the U.S. Preventive Services Task Force published a final recommendation on screening for hepatitis B virus infection in adolescents and adults. Based on its review of the evidence, the Task Force recommends that clinicians screen teens and adults at increased risk of hepatitis B infection to help prevent serious health problems.
Heplisav-B and HIV
With rising transmission, the hepatitis B virus is 50 to 100 times more infectious than HIV. The NIH phase 3 study, "High HBsAb seroprotection achieved four weeks after three doses of HepB-CpG vaccine in people living with HIV (PLWH) without prior HBV vaccination. According to the findings, all participants achieved seroprotection, with 88% of participants achieving HbsAb levels greater than 1000 mIU/mL. High antibody levels are thought to be associated with long-term vaccine durability. Eight weeks after the second dose, 94.4% of participants achieved seroprotection; this percentage increased to 98.5% by week 24 before the third dose. The most common side effects of vaccination were injection site pain, malaise, fatigue, muscle aches, and headaches.
Heplisav-B Vaccine Dosage
The Heplisav-B vaccine is administered by intramuscular injection in the deltoid region. It is a 2-dose series given one month apart. Heplisav-B may not prevent hepatitis B infection in individuals with an unrecognized hepatitis B infection at the time of vaccine administration. For the complete U.S. Prescribing Information for HEPLISAV-B, click here.
Heplisav-B Vaccine Side Effects
The most common patient-reported adverse reactions reported within seven days of vaccination were injection site pain (23%-39%), fatigue (11%-17%), and headache (8%-17%). Therefore, do not administer HEPLISAV-B to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. In addition, appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following the administration of HEPLISAV-B.
Heplisav-B Vaccine Revenues
On August 4, 2022, the Company announced for Q2 2022 the HEPLISAV-B® vaccine net product revenue of $32.7 million, up 139% from $13.7 million for Q2 2021.
Heplisav-B Vaccine News 2023
February 28, 2023 - Ryan Spencer, Chief Executive Officer of Dynavax, stated in a press release, "We are very pleased that HEPLISAV B has received this latest approval and look forward to continuing ongoing discussions with potential commercial partners for Great Britain. This approval highlights the capabilities and continued successful execution of the organization."
October 20, 2022 - The U.S. NIH published: Three-dose hepatitis B vaccine regimen protects people with HIV.
August 4, 2022 - "During the second quarter, we continued to successfully execute on our key priorities and are on track for another profitable year with record revenues for both HEPLISAV-B and CpG 1018 adjuvant," commented Ryan Spencer, Chief Executive Officer of Dynavax.
March 25, 2022 - An Original Investigation published by the JAMA Network: Association Between 2-Dose vs. 3-Dose Hepatitis B Vaccine and Acute Myocardial Infarction. In this prospective cohort noninferiority study of 31,183 recipients of the HepB-CpG vaccine and 38,442 recipients of the HepB-alum vaccine, rates of acute MI per 1000 person-years were 1.67 and 1.86, respectively. The upper confidence limit for the adjusted hazard ratio was 1.32, less than the noninferiority margin of 2. This means the receipt of HepB-CpG compared with HepB-alum was not significantly associated with an increased risk of acute myocardial infarction.
November 4, 2021 - The Hepatitis B Foundation applaud yesterday's vote by the U.S.CDC'ss Advisory Committee on Immunization Practices to recommend universal hepatitis B vaccination for all adults ages 19 to 59 in the U.S. Adults 60 and older are advised to follow risk-based guidelines to determine if they should receive the vaccine.
November 3, 2021 - The U.S.CDC'ss vaccine committee presented: Universal Adult Hepatitis B Vaccination: Introduction.
September 29, 2021 - The U.S.CDC'ss vaccine committee presented: Evidence to Recommendations Framework: Should all HepB-unvaccinated adults receive hepatitis B vaccination?
May 27, 2021 - Dynavax Technologies announced it has entered into a commercialization agreement with Bavarian Nordic to market and distribute the HEPLISAV B Vaccine in Germany, with an expected launch in the fourth quarter of 2021. Bavarian Nordic is a fully integrated vaccines company focused on developing, manufacturing, and commercializing life-saving vaccines.
April 27, 2021 - Dynavax Technologies Corporation announced the post-marketing study results assessing the rates of occurrence of acute myocardial infarction (AMI) in persons receiving HEPLISAV-B compared with Engerix-B. The AMI rate per 1,000 person-years was 1.67 for HEPLISAV-B and 1.86 for Engerix-B. The hazard ratio comparing the rate of AMI in the HEPLISAV-B group with the Engerix-B group was 0.92 with a 95% confidence interval of 0.63 to 1.32. The upper bound of the 95% confidence interval of the hazard ratio comparing the rate of AMI in the HEPLISAV-B group to the Engerix-B group was less than 2.0, meeting the primary endpoint. Thus, these results show no increased risk of AMI associated with vaccination with HEPLISAV-B than Engerix-B.
February 19, 2021 - Dynavax Technologies Corporation announced that the European Commission had granted Marketing Authorization for HEPLISAV B for the active immunization against hepatitis B virus infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The approval was issued following the European Medicines Agency Committee for Medicinal Products for Human Use's positive opinion on its marketing authorization application.
January 7, 2021 - Dynavax Technologies Corporation announced the final immunogenicity and interim safety results of the ongoing clinical trial evaluating HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] in patients undergoing hemodialysis. In this clinical trial, final immunogenicity data in 119 patients evaluating a 4-dose regimen of HEPLISAV-B in adults with end-stage renal disease undergoing hemodialysis demonstrated a seroprotection rate of 89.3% with high levels of anti-HBs antibodies, which are critical to maintaining protection in patients undergoing hemodialysis. In addition, interim safety data showed HEPLISAV-B is well tolerated, and no safety concerns were observed. Full safety data are expected by the end of 2021.
December 15, 2020 - The U.S. Preventive Services Task Force member Chyke Doubeni, M.D., M.P.H, stated," Evidence consistently shows that screening and early treatment leads to better health outcomes" The task force's final recommendation statement and corresponding evidence summary have been published online in the Journal of the American Medical Association and on the Task Force website at http://uspreventiveservicestaskforce.org.
December 10, 2020 - Dynavax Technologies Corporation announced that the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion on the Company's Marketing Authorization Application, recommending the granting of marketing authorization for HEPLISAV-B for the active immunization against hepatitis B virus infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The CHMP recommendation was based on the assessment of HEPLISAV-B demonstrated by the safety and immunogenicity results from three Phase 3 clinical trials and post-marketing safety results.
April 28, 2020 - Dynavax Technologies Corporation reported immunogenicity and safety data from an interim analysis of the ongoing clinical trial evaluating HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] in patients undergoing hemodialysis. Interim analysis of safety data in 70 patients in this clinical trial evaluating a 4-dose regimen of HEPLISAV-B in adults with end-stage renal disease who are initiating or undergoing hemodialysis showed HEPLISAV-B has well tolerated a seroprotection rate of 86.4% in 44 patients.
Heplisav-B Clinical Trials
Heplisav-B has been involved in 11 clinical trials to test the vaccine's safety and efficacy.
This phase III/IV study will evaluate the response to and safety of the HBV vaccine HEPLISAV-B in two study populations living with HIV: prior HBV vaccine recipients who are deemed non-responders (Group A) and individuals who are naïve to HBV vaccination (Group B).
Clinical Trial NCT04199715: Phase 1 Safety and Efficacy of a Hepatitis B Vaccine in Immunosuppressed Patients.
Clinical Trial NCT04385524: Use of Dynavax Heplisav B in Healthcare Workers Previously Vaccinated With 3-dose Vaccine Who Failed to Demonstrate Seroprotection. Last Update Posted: May 13, 2020.