Hepatitis Vaccines For 2022
The U.S. CDC says most hepatitis viruses can be prevented by vaccination. However, the five hepatitis viruses – hepatitis A, hepatitis B, hepatitis C, hepatitis D, and hepatitis E – are distinct and can spread differently. The CDC released updated hepatitis vaccination schedules for children, adolescents, and adults on Feb. 17, 2022.
And the CDC's Advisory Committee on Immunization Practices (ACIP) recommends various people receive hepatitis B vaccination. The U.S. CDC published 'Universal Hepatitis B Vaccination in Adults Aged 19–59 Years: Updated Recommendations of the Advisory Committee on Immunization Practices — the United States, 2022' on Apr. 1, 2022.
Previously, on Feb. 23, 2022, the CDC's Hepatitis Vaccines Work Group presented an update, and the ACIP voted in the affirmative. Therefore, the ACIP recommends that all adults aged 19–59 should receive HepB vaccination.
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 Jul. 21, 2022, acute hepatitis in children breaking news is posted on this weblink.
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 antigen (HBsAg).
Twinrix Hepatitis Vaccine is indicated for active immunization against disease caused by hepatitis A virus and infection by all known subtypes of 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 and the U.S.
Hepatitis Vaccines Global
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.
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. The HBV DNA sequence in the viral vectors is derived from a genotype C sequence, the most common genotype circulating worldwide.
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. VIR-3434 is an investigational HBV-neutralizing monoclonal antibody designed to block the entry of all ten genotypes of HBV into hepatocytes and reduce the level of virions and subviral particles in the blood. It has also been Fc engineered to include the XX2 "vaccinal mutation," allowing it to potentially function as a therapeutic T cell vaccine against HBV.
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.
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 (TB) occurs in a minority (1/3) of patients who test positive for either condition, despite similar risk profiles and, for some, risk of TB 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 greater and more durable reductions in hepatitis B surface antigen (HBsAg) than a two-dose regimen, with all participants achieving a >1 log10 IU/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 largest and most durable response noted with the 300 mg dose. Finally, preclinical in vivo data demonstrated that the combination of both investigational compounds resulted in greater 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 5 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 UK Medicines and Healthcare Products Regulatory Agency had granted marketing authorization for PreHevbri™ for active immunization against infection caused by all known subtypes of the 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 who were 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 the treatment of 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 as having 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 who were 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 has 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 have declared the end to 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 professions, such as Dr. Robert Carlson.