Hepatitis Vaccines 2024
The U.S. Centers for Disease Control and Prevention (CDC) says most hepatitis viruses can be prevented by vaccination. The five hepatitis viruses – hepatitis A, hepatitis B, hepatitis C, hepatitis D, and hepatitis E are distinct viruses and require specific vaccines. The CDC released updated hepatitis vaccination schedules for children, adolescents, and adults in 2023. The World Health Organization (WHO) published the Guidelines Development Group for key updates of the 2015 WHO Guidelines for treating persons diagnosed with chronic hepatitis B virus infection and the 2017 WHO Guidelines on hepatitis B and C testing.
Hepatitis A Vaccines
The CDC published a Morbidity and Mortality Weekly Report in October 2023, from August 2016 to October 2022, 27 U.S. states reported 315 hepatitis A outbreak–related deaths, which peaked in 2019 and then decreased annually through 2022. Overall, 63% of decedents had at least one documented preexisting indication for hepatitis A vaccination. The WHO published an updated position paper on hepatitis A vaccines in October 2022, reviewing the longer-term (3–7 years) and more than seven years) follow-up studies, including data on efficacy, effectiveness, and safety of multidose and single-dose regimens of inactivated and live attenuated hepatitis A vaccines in children and adults.
Healive® is the first and only WHO-prequalified inactivated hepatitis A vaccine from China, it has been registered in more than 20 countries and organizations, with additional market approvals in Lebanon, Kyrgyzstan, Egypt, India, and Pakistan in 2023.
Havisure is India's initial indigenously developed two-dose Hepatitis A vaccine produced by Indian Immunologicals Ltd., a wholly-owned subsidiary of the National Dairy Development Board. Havisure is priced at Rs 2,150 per dose.
Hepatitis B Vaccinations
The CDC's Advisory Committee on Immunization Practices (ACIP) published 'Universal Hepatitis B Virus (HBV) Vaccination in Adults Aged 19–59 Years: Updated Recommendations of the Advisory Committee on Immunization Practices; the United States, 202022' on April 1, 2022. Previously, on February 23, 2022, the CDC's Hepatitis Vaccines Work Group presented an HBV update, and the ACIP voted in favor of it
On March 10, 2023, the CDC published Recommendations for Screening and Testing for Hepatitis B Virus Infection. New recommendations include hepatitis B screening for adults at least once a lifetime. The CDC report also expands risk-based testing recommendations. Of an estimated 580,000 to 2.4 million persons living with HBV infection in the United States, two-thirds may be unaware of their HBV infection.
Hepatitis C Vaccine
As of 2023, no U.S. FDA-approved vaccines target hepatitis C.
Hepatitis D Vaccine
As of 2023, no approved vaccines target the Hepatitis D virus (HDV). However, Gilead Sciences, Inc. announced on May 4, 2023, that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion for Hepcludex® (bulevirtide) for the treatment of adults with chronic HDV and compensated liver disease. Assembly Biosciences, Inc. announced in October 2023 the selection of development candidate ABI-6250, an orally bioavailable small molecule entry inhibitor, which is the first development candidate nominated by the company for the treatment of chronic hepatitis D virus (HDV) infection to progress to IND-enabling studies.
Hepatitis Vaccines Authorized
Engerix-B is a Hepatitis B Vaccine that is a noninfectious recombinant DNA hepatitis B vaccine.
Havrix Hepatitis A Vaccine is indicated for active immunization against disease caused by the hepatitis A virus.
Hecolin is a recombinant vaccine that contains the hepatitis E virus (HEV)-like particles prepared using a recombinant Escherichia coli expression system.
Heplisav-B® vaccine combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR), nine agonists, to enhance the immune response.
Recombivax HB is a recombinant vaccine that contains synthetic Hepatitis B surface antigens (HBsAg).
Twinrix Hepatitis Vaccine is indicated for active immunization against disease caused by the hepatitis A virus and infection by all known subtypes of the hepatitis B virus.
PreHevbrio® (Sci-B-Vac®) is a third-generation hepatitis B trivalent vaccine that mimics all three surface antigens, pre-S1, pre-S2, and S, of the hepatitis B virus; approved in Israel, the U.K, Canada, and the U.S.
Xiamen Innovax launched the hepatitis E vaccine Hecolin® in October 2012. The vaccine was approved by China's State Food and Drug Administration based on the phase III trial (NCT02189603). In addition, the US NIH notified Xiamen that its Investigational New Drug application of Hecolin (HEV-239) at the FDA became effective on January 12, 2019.
Sinovac Biotech Ltd. Healive is the only WHO-prequalified hepatitis A vaccine from China. Since 2002, Healive has been registered in 21 countries and organizations worldwide and is authorized to be administered in 33 countries and regions to susceptible individuals over 12 months old.
Hepatitis Vaccine Candidates
HBAI20 vaccine candidate consists of a standard HBV vaccine to which the AI20 adjuvant is added.
VBI-2601 (BRII-179) is a novel recombinant, protein-based HBV immunotherapeutic candidate that builds upon the 3-antigen conformation of VBI's prophylactic 3-antigen HBV vaccine candidate and is combined with BRII-835, to enhanced B-cell and T-cell immunity. Initial data announced on February 15, 2023, suggest that the VBI-2601 and BRII-835 combination induce more robust anti-hepatitis B surface antigen-specific T-cell and antibody responses than BRII-835 alone.
VTP-300 vaccine candidate utilizes Vaccitech's ChAdOx1-MVA prime-boost combination to elicit an immune response against HBV. VTP-300 is the first antigen-specific immunotherapy shown to induce sustained reductions in Hepatitis B surface antigen. Topline final data from the Phase 1b/2a clinical trial of VTP-300 in people with chronic HBV infection were posted on March 28, 2023.
VIR-2218 and VIR-3434 combination - VIR-2218 is an investigational small interfering ribonucleic acid (siRNA) designed to inhibit the production of all HBV proteins (X, polymerase, S, and core), which may be acting as immune tolerogens. On Nov. 6, 2022, VIR announced results from Part A of the Phase 2 MARCH trial, including all three cohorts, demonstrating a mean HBsAg reduction of >2.5 log10 I.U./mL. These data showed that VIR-2218 and VIR-3434, an investigational HBsAg-targeting monoclonal antibody engineered to act as a therapeutic vaccine potentially, are additive in reducing HBsAg. In addition, the combination of VIR-2218 and VIR-3434 through up to 20 weeks of treatment in Part A was generally well tolerated. Combining the learnings from the VIR-2218 plus PEG-IFN-α trial with these encouraging new results has led to additional cohorts evaluating the triple combination of VIR-2218, VIR-3434, and PEG-IFN-α being added to Part B of the MARCH trial. Initial data from Part B are expected in the second half of 2023.
Antios Therapeutics' lead once-daily oral drug candidate for treating HBV ATI-2173 is an investigational phosphoramidate prodrug of clevudine monophosphate. ATI-2173 is the only Active Site Polymerase Inhibitor Nucleotide for HBV in clinical development.
Hepatitis Vaccine News 2023
April 24, 2023 - Belarus, Kyrgyzstan, Turkmenistan, and Uzbekistan have reached regional hepatitis B control targets set by the Action Plan for the Health Sector Response to Viral Hepatitis in the WHO European Region.
February 15, 2023 - VBI Vaccines Inc. announced interim data from the Phase 2 study evaluating the combination of VBI-2601 and BRII-835 in chronically infected HBV patients.
January 9, 2023 - Researchers are investigating TherVacB, a novel heterologous prime-boost therapeutic hepatitis B vaccine. In TherVacB, proteins prime the immune response, while for boost vaccination, a viral vector delivers the antigens. The benefit of heterologous prime-boost vaccination is more robust and longer-lasting immunity.
December 8, 2022 - Health Canada approved PreHevbrio™ for active immunization against infection caused by all known subtypes of hepatitis B virus in adults.
October 31, 2022 - Vaccitech plc announced the dosing of the first patients in HBV003, a Phase 2b clinical trial designed to evaluate the safety and efficacy of VTP-300 further when combined with a low-dose anti-PD-1 antibody in patients with chronic hepatitis B infection.
Acute Hepatitis in Children
The WHO, U.K., Europe, Canada, and the CDC have reported acute liver inflammation infections of unknown etiology among children since October 2021. As of February 2023, new reports are posted on this weblink.
