Hepatitis Vaccines For 2023
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 various vaccines.
The CDC released updated hepatitis vaccination schedules for children, adolescents, and adults on Feb. 17, 2022.
Hepatitis A Vaccines
The World Health Organization (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 vaccinated during childhood.
Hepatitis B Vaccinations
And the CDC's Advisory Committee on Immunization Practices (ACIP) published 'Universal Hepatitis B Vaccination in Adults Aged 19–59 Years: Updated Recommendations of the Advisory Committee on Immunization Practices; the United States, 2022, April 1, 2022. Previously, on February 23, 2022, the CDC's Hepatitis Vaccines Work Group presented an update, and the ACIP voted in the affirmative.
Hepatitis C Vaccine
As of January 2023, there are no U.S. Food and Drug Administration (FD) approved vaccines targeting hepatitis C.
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 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.
Hepatitis Vaccines Globally Authorized
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®, the only WHO-prequalified hepatitis A vaccine from China. Since 2002, Healive has been registered in 21 countries and organizations around the world 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 designed to target enhanced B-cell and T-cell immunity.
VTP-300 vaccine candidate utilizes Vaccitech's ChAdOx1-MVA prime-boost combination to elicit an immune response against HBV. Vaccitech's updated interim analysis includes data from the fully-enrolled phase 1/2 clinical trial of 55 patients with chronic HBV)with at least three months of follow-up. It shows that VTP-300 induced meaningful sustained reductions of HBV surface antigen (HBsAg) in people with chronic HBV. Declines were most prominent in patients with lower baseline HBsAg. HBsAg is a hallmark of chronic HBV infection. Unfortunately, fewer than 10% of patients on current standard-of-care HBV therapies achieve sustained HBsAg decrease or loss, a state associated with a functional cure of the disease.
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.
Acute Hepatitis Cases in Children
The WHO, U.K., Europe, Canada, and the CDC have reported acute liver inflammation infections of unknown etiology among children since Oct. 2021. As of September 2022, acute hepatitis in children breaking news is posted on this weblink.
Hepatitis Vaccine Price
Hepatitis vaccine prices are posted by the U.S. CDC Price List, which was last updated in September 2022. Vaccine prices range from $74 to $134. In addition, minors who meet at least one of the following criteria are eligible to receive the CDC's Vaccines for Children. Additional hepatitis vaccine prices and discount information are posted at InstantRx™.
Hepatitis Vaccine News 2022-2023
January 9, 2023 - Researchers are investigating TherVacB, a novel heterologous prime-boost therapeutic hepatitis B vaccine. In TherVacB, proteins are used to prime the immune response, while for boost vaccination, the antigens are delivered by a viral vector. The benefit of heterologous prime-boost vaccination is stronger 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.
October 20, 2022 - The AIDS Clinical Trials Group presented a session demonstrating that a three-dose regimen of the HEPLISAV-B vaccine fully protected people living with HIV.
September 30, 2022 - The U.S. CDC MMWR - Widespread Hepatitis A Outbreaks Associated with Person-to-Person Transmission, U.S. 2016–2020. Increased hepatitis A vaccination coverage, through the implementation of nontraditional vaccination strategies to reach disproportionately affected populations, along with improved universal and catch-up childhood vaccination, will be necessary to respond to the current hepatitis A outbreaks and prevent similar outbreaks in the future.
September 13, 2022 - The Lancet published: Safety and efficacy of bulevirtide in combination with tenofovir disoproxil fumarate in patients with hepatitis B virus and hepatitis D virus coinfection (MYR202): a multicentre, randomized, parallel-group, open-label, phase 2 trial. Interpretation: Bulevirtide significantly declined hepatitis D virus RNA over 24 weeks. After cessation of bulevirtide, hepatitis D virus RNA concentrations rebounded. Longer treatment durations and combination therapies should be investigated.
September 22, 2022 - Vir Biotechnology, Inc. announced that the first patient had been dosed in the Phase 2 SOLSTICE clinical trial evaluating VIR-2218 and VIR-3434 as monotherapy and in combination for the treatment of people living with chronic hepatitis D virus.
September 8, 2022 - France-based Valneva SE and VBI Vaccines Inc. established a partnership in European markets for the marketing and distribution of PreHevbri®, the only 3-antigen hepatitis B vaccine approved in Europe.
August 17, 2022 - BMJ Hepatology published Original research: Novel prime-boost immune-based therapy inhibiting both hepatitis B and D virus infections. Conclusion: The herein-described preS1-HDAg immunotherapy is shown to be immunogenic, and vaccine-induced antibodies are highly effective at preventing HBV and HDV (super)infection both in vitro and in vivo. The vaccine could complement current and future therapies for controlling chronic HBV and HDV infection.
July 28, 2022 - The WHO observes World Hepatitis Day each year to raise awareness of viral hepatitis, which causes inflammation of the liver that leads to severe disease and liver cancer.
July 25, 2022 - Concurrent testing for chronic hepatitis B and tuberculosis (T.B.) occurs in the minority (1/3) of patients who test positive for either condition, despite similar risk profiles and, for some, risk of T.B. therapy-induced liver damage, according to a new Quest Diagnostics Health Trends® study published in the Journal of Public Health Management & Practice.
July 11, 2022 - Singapore-based SCG Cell Therapy Pte Ltd announced that U.S. FDA had cleared the Investigational New Drug application for SCG101, an investigational T-cell receptor (TCR) T cell therapy for patients with hepatitis B virus (HBV) related liver cancer. This clearance initiates the advancement of SCG101 Phase 1/2 clinical trials globally. SCG101 is an autologous TCR T cell therapy that can recognize HBV-derived T cell epitope presented on the cell surface by specific major histocompatibility complex class I molecules. With the specific HLA typing, SCG101 can redirect T cells specifically against the HBV antigen not only to target and eliminate HBsAg-positive HCC cells but also to eradicate HBV cccDNA (covalently closed circular DNA).
July 7, 2022 - The journal PNAS published a study by UNC School of Medicine scientists who discovered that replication requires specific interactions between the human protein ZCCHC14 and a group of enzymes called TENT4 poly(A) polymerases. They also found that the oral compound RG7834 stopped replication at a key step, making it impossible for the virus to infect liver cells.
June 28, 2022 - VBI Vaccines Inc. announced new data from a follow-up analysis from the pivotal Phase 3 study of the 3-antigen prophylactic HBV vaccine known as PreHevbrio™, PreHevbri™, and Sci-B-Vac®.
June 25, 2022 - Vir Biotechnology, Inc. announced new data presented at ILC demonstrated that a six-dose regimen of VIR-2218 provided more significant and more durable reductions in hepatitis B surface antigen (HBsAg) than a two-dose regimen, with all participants achieving a >1 log10 I.U./mL reduction during the trial. Phase 1 results evaluating VIR-3434 showed that a single dose (6 mg, 18 mg, 75 mg, or 300 mg) resulted in a rapid reduction of HBsAg, with the most significant and most durable response noted with the 300 mg dose. Finally, preclinical in vivo data demonstrated that combining both investigational compounds resulted in more significant HBsAg reductions than either compound alone.
June 25, 2022 - GSK plc announced interim results from the B-Clear phase IIb trial showing that bepirovirsen (GSK3228836), an investigational antisense oligonucleotide treatment for hepatitis B, reduced levels of hepatitis B surface antigen and HBV DNA after 24 weeks' treatment in people with chronic hepatitis B.
June 25, 2022 - Antios Therapeutics, Inc. announced following 90 days of dosing, ATI-2173, in combination with tenofovir disoproxil fumarate, was generally well-tolerated with alanine aminotransferase (ALT) normalization and no ALT flares off-treatment. And Antios' capsid assembly modulators ATI-1428 and ATI-1645 show safe and potent in vitro and in vivo activity and excellent pharmacokinetic profiles.
June 20, 2022 - The peer-review journal The Lancet published - Global, regional, and national burden of hepatitis B, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. The prevalence of chronic HBV infection declined over time, particularly in children younger than five years, since the introduction of the hepatitis B vaccination. HBV-related death rates also decreased.
June 7, 2022 - World Hepatitis Summit 2022 urges action to eliminate viral hepatitis - "Women's and children's health needs to be a top priority if we are to achieve hepatitis elimination by 2030. Hepatitis B is a major public health threat requiring collective efforts to advance universal vaccination of newborns against Hepatitis B and prevent mother-to-child transmission," commented Right Honourable Helen Clark, Former Prime Minister of New Zealand and Board Chair of the Partnership on Maternal, Newborn and Child Health.
June 1, 2022 - VBI Vaccines Inc. announced that the U.K. Medicines and Healthcare Products Regulatory Agency had granted marketing authorization for PreHevbri™ for active immunization against infection caused by all known subtypes of HBV in adults.
May 20, 2022 - The UK Heath Security Agency published its third detailed technical briefing on the UK-wide investigations into a rise in cases of sudden onset hepatitis in children.
May 5, 2022 - eClinicalMedicine published results from a study focused on hepatitis B virus reactivation (HBVr) in patients treated with abatacept. Interpretation: We identified a positive signal between abatacept exposure and HBVr. Future prospective studies should further confirm the relationship and provide evidence to develop strategies involving pre-treatment screening, monitoring, and utilization of antiviral prophylaxis when using abatacept in patients with rheumatic diseases. Abatacept is a selective T-cell costimulation modulator approved for treating rheumatoid arthritis, juvenile idiopathic arthritis, and psoriatic arthritis.
May 2, 2022 - VBI Vaccines Inc. announced that the European Commission granted Marketing Authorisation for PreHevbri.
April 26, 2022 – Antios Therapeutics, Inc. announced that the USPTO had issued a Notice of Allowance for U.S. Patent Application No. 16/312,756, titled: "Phosphoramidates for the Treatment of Hepatitis B Virus," covering compositions containing Antios' novel Active Site Polymerase Inhibitor Nucleotide, ATI-2173, in combination with other therapies and mechanisms of action.
April 15, 2022 - Science.org reported nine cases of acute hepatitis had been recorded in Alabama. Five of the nine patients tested positive for type 41 adenovirus. In Spain, three children ages 2 to 7 have also been diagnosed with acute hepatitis—with one child requiring a liver transplant.
April 14, 2022 - Review: Investigation into cases of hepatitis of unknown etiology among young children, Scotland, 1 January 2022 to 12 April 2022
April 8, 2022 - The EMA's vaccine committee concluded that available evidence does not support a causal link between mRNA COVID-19 vaccines Comirnaty and Spikevax and very rare cases of autoimmune hepatitis, a serious chronic inflammatory condition in which the immune system attacks and damages the liver.
March 31, 2022 - Brii Biosciences Limited presented new data from a Phase 2 trial of BRII-835 (VIR-2218) in patients with chronic HBV infection. The data demonstrate that BRII-835, an investigational small interfering ribonucleic acid that mediates RNA interference, results in a dose-dependent reduction in hepatitis B surface antigen.
March 30, 2022 - Antios Therapeutics, Inc. announced new data from the Phase 1b and 2a clinical trials of ATI-2173 that showed ATI-2173 alone, or in combination with tenofovir disoproxil fumarate (TDF), was generally well-tolerated among the cohorts, and ATI-2173 and TDF suppressed HBV DNA and induced declines in biomarkers of cccDNA activity.
March 29, 2022 - VBI Vaccines Inc. announced PreHevbrio™ [Hepatitis B Vaccine (Recombinant)] is now available in the United States for Wholesale Acquisition Cost set at $64.75/dose.
March 25, 2022 - A prospective study published by the JAMA Network found there was no higher risk of heart attack for recipients of the two-dose hepatitis B cytosine phosphoguanine adjuvant vaccine (Heplisav-B) compared to the three-dose hepatitis B vaccine with an aluminum hydroxide adjuvant (Engerix-B),
March 3, 2022 - The latest annual report from UKHSA shows the estimated prevalence of chronic hepatitis C in England has continued to decline to around 81,000 in 2020 (compared to 129,000 in 2015) – a 37% fall in the general population and 40% decline in people who inject drugs.
February 25, 2022 - Massachusetts-based VBI Vaccines Inc. announced that the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for VBI's 3-antigen hepatitis B (HBV) vaccine, under the brand name PreHevbri™ for active immunization against infection caused by all known subtypes of the hepatitis B virus in adults.
February 22, 2022 - To assess cost and changes in disease burden, three scenarios were tested: "Tx All," which consisted of screening and treating all hepatitis B surface antigen (HBsAg)-positive individuals by 2030; "Tx All $2000," which considered the effect of reducing annual treatment costs to $2,000 by 2025; and "Cost-Saving," which calculated what annual treatment cost would be necessary by 2025 to achieve cost savings by 2050. "The scenarios assume a simplification of the diagnosis," said lead author Devin Razavi-Shearer, the HBV/HDV project lead at the Center for Disease Analysis Foundation.
February 20, 2022 - A peer-reviewed study - The effectiveness of low dead space syringes for reducing the risk of hepatitis C virus acquisition among people who inject drugs - showed using fixed LDSS was associated with a 76% lower likelihood of recent hepatitis C virus infection compared to using any syringes with detachable needles.
February 16, 2022 - The American College of Obstetrics and Gynecology joined the U.S. CDC in recommending universal hepatitis C virus (HCV) screening for pregnant women. The positivity rate of HCV IgG was higher among those tested using risk-based vs. universal screening (5.4% vs. 2.3%).
February 12, 2022 - Olivier Segeral with the French National Agency for Research on AIDS confirmed a recent study in Cambodia showed Tenofovir prophylaxis for four weeks or more, along with early infant vaccination, helped stem hepatitis B virus mother-to-child transmission without the use of hepatitis B immunoglobulin.
January 5, 2022 - VBI Vaccines Inc. announced that the first patient had been dosed in a second Phase 2a/2b clinical study evaluating VBI-2601 (BRII-179).
Hepatitis A Outbreaks
On May 28, 2022, the FDA, along with the CDC, the Public Health Agency of Canada, and the Canadian Food Inspection Agency, state, and local partners are investigating a multistate outbreak of hepatitis A infections in the USA and Canada potentially linked to fresh organic strawberries branded as FreshKampo and HEB, purchased between March 5, 2022, and April 25, 2022.
As of May 20, 2022, the CDC confirmed that 37 U.S. states had reported hepatitis A cases, and 15 declared the end of their outbreaks. Since the outbreaks were first identified in 2016, 37 states reported 44,260 cases, hospitalizations (61%), and 420 related fatalities.
Acute Hepatitis in Children Outbreak
Various acute hepatitis outbreaks have occurred worldwide as of June 1, 2022. Visit this webpage to review the latest news.
Note: This content has been reviewed by healthcare professionals, such as Dr. Robert Carlson.