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Hepatitis Vaccines 2022

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Last reviewed
May 13, 2022
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Hepatitis Vaccines For 2022

The vision of the U.S. CDC is to eliminate viral hepatitis globally. The five hepatitis viruses – hepatitis A, hepatitis B, hepatitis C, hepatitis D, and hepatitis E – are distinct and can spread in different ways, affect diverse populations, and result in various health outcomes.

One dose of single-antigen hepatitis A vaccine has been shown to control outbreaks of hepatitis A successfully, says the CDC. And the CDC's Advisory Committee on Immunization Practices (ACIP) recommends various people receive hepatitis B vaccination.

In addition to groups for whom HepB vaccination is already recommended, the ACIP recommended on April 1, 2022, that all adults aged 19–59 years should receive HepB vaccines.

Hepatitis Vaccine Schedules For 2022

The U.S. CDC released updated hepatitis vaccination schedules for children, adolescents, and adults on Feb. 17, 2022.

Hepatitis B Vaccine Schedule For 2022

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 April 1, 2022. Previously, on Feb. 23, 2022, the CDC's Hepatitis Vaccines Work Group presented an update, and the ACIP voted in the affirmative.

Hepatitis A Outbreaks In 2022

As of May 6, 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 44,241 cases, hospitalizations (61%), and 420 related fatalities.

Adenovirus Linked Acute Hepatitis in Children Outbreaks In 2022

Various adenovirus 41f linked - acute hepatitis outbreaks have occurred worldwide. On May 3, 2022, the WHO published an acute severe hepatitis in children FAQ. Visit this webpage to review the latest news.

Hepatitis Vaccines - U.S. FDA Authorized For 2022

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 Globally

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 For 2022

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.

Hepatitis Vaccine News For 2020 - 2022

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 recommending universal hepatitis C virus (HCV) screening of 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).

December 11, 2021 - Wylie Online Libray published a BRIEF DEFINITIVE REPORT - Progress towards achieving viral hepatitis B and C elimination in the Asia and Pacific region: Between 2015 and 2020, chronic HBV prevalence declined from 4.69% to 4.30%, and HCV prevalence declined from 0.64% to 0.58%. 

December 9, 2021 - Vir Biotechnology, Inc. announced that the first patient has been dosed in a Phase 2 clinical trial evaluating novel therapeutic combinations for the treatment of chronic hepatitis B virus (HBV) infection. The multi-arm trial, which is being conducted in collaboration with Gilead Sciences, Inc., is assessing various combinations of VIR-2218, Vir's investigational small interfering ribonucleic acid that mediates RNA interference; selgantolimod (GS-9688), Gilead Sciences' investigational TLR-8 agonist; and nivolumab, an approved PD-1 inhibitor, in both nucleos(t)ide-suppressed patients and viremic patients. Patients with HBV treatment experience also may receive tenofovir alafenamide fumarate.

November 17, 2021 - The New York State Department of Health released the New York State Hepatitis C Elimination Plan.

November 17, 2021 - The Camden County NJ Health Department was notified by a health care provider that a food handler employed at a Starbucks at 1490 Blackwood Clementon Road in Gloucester Township tested positive for hepatitis A and worked through the infectious period.

October 14, 2021 - VBI Vaccines Inc. announced that results from the pivotal Phase 3 study, CONSTANT, of VBI's prophylactic 3-antigen hepatitis B vaccine candidate in adults age 18-45. VBI's vaccine candidate demonstrated robust and consistent immune responses across all three lots after two and three doses, with higher seroprotection rates and antibody geometric mean concentration compared to Engerix-B® No safety signals were observed. Together with results from the first pivotal Phase 3 study, PROTECT, these results formed the basis for the regulatory submissions of VBI's 3-antigen HBV vaccine candidate in the U.S., Europe, and Canada.

September 29, 2021 - The U.S. CDC Advisory Committee on Immunization Practices working group recommends that all adults unvaccinated against hepatitis B get vaccinated.

August 25, 2021 - An increase in hepatitis E and acute watery diarrhea cases has been seen in the camp for internally displaced persons in Bentiu, South Sudan. While we were treating an average of 230 patients per month throughout the year, we saw 1,454 in July - a 50% rise in the number of patients seen in June. The most affected are children aged under five years. The most affected are children aged under five years. No U.S. FDA-Approved vaccine for hepatitis E is currently available in the USA. However, in 2012, the Hecolin® recombinant vaccine from Xiamen Innovax was approved for use in China.

August 23, 2021 - The JAMA Network published an Original Investigation Comparative Efficacy of a High-Dose vs. Standard-Dose Hepatitis B Revaccination Schedule Among Patients With HIVA Randomized Clinical Trial. In this clinical trial, including 107 adults at a single HIV and hepatology clinic in Chile, 72% of patients receiving a high dose of HBV vaccine achieved serological response compared with 51% in the standard-dose group. In addition, more elevated and longer-lasting hepatitis B surface antibody titers were also seen in the high-dose group.

July 28, 2021 - World Hepatitis Day is commemorated yearly to increase awareness and understanding of viral hepatitis as a global priority. World Hepatitis Day has been observed annually since 2011, the birthday of Nobel-prize-winning scientist Dr. Baruch Blumberg, who discovered the Hepatitis B virus in 1967.

July 15, 2021 - Vir Biotechnology, Inc. announced that the first patient had been dosed in the Phase 2 MARCH trial evaluating VIR-2218 and VIR-3434 to treat patients with chronic hepatitis B virus infection – a combination designed to achieve a functional cure.

July 15, 2021 - New guidelines from the WHO strongly recommend offering self-testing for hepatitis C virus (HCV) as a different approach to HCV testing services. 

July 11, 2021 - A vaccine to protect against infection with hepatitis C could be in use within five years, says Professor Sir Michael Houghton.

July 9, 2021 - CDC MMWR: Unexpected Hepatitis B Virus Infection After Liver Transplantation — the United States, 2014–2019. 'During 2019, the Organ Procurement and Transplantation Network and CDC received an increased number of reports of HBV infection among liver recipients from HBV-negative donors; 12 of 14 implicated donors had evidence of recent injection drug use, and 13 donors were hepatitis C virus –seropositive.'

June 25, 2021 - Vir Biotechnology, Inc. announced new data from its ongoing Phase 2 clinical trials of VIR-2218 and ongoing Phase 1 studies of VIR-3434 in patients with chronic hepatitis B virus infection. The results demonstrate positive safety findings plus a reduction in hepatitis B surface antigen (HBsAg) for both compounds. In summary, data presented this week demonstrate the promising safety profile and the potential durable response of VIR-2218, an investigational small interfering ribonucleic acid (siRNA) that mediates RNA interference (RNAi), through 48 weeks. In a separate analysis evaluating VIR-2218 in combination with pegylated interferon alfa (PEG-IFN-α) for 12 weeks, a more rapid and substantial HBsAg decline was observed co-administration cohort compared to VIR-2218 alone. The treatment regimen resulted in no new safety signals.

June 24, 2021 - People living with the human immunodeficiency virus (HIV) are potentially at high risk of being infected with the hepatitis B virus (HBV), as both viruses share transmission routes. HIV/HBV coinfection has been associated with increased HBV DNA levels, accelerated liver disease progression, and increased all-cause and liver-related mortality. The prevalence of HIV/HBV coinfection in Spain at the end of 2018 was 3.2%, which does not differ significantly from percentages reported in studies performed over the past 15 years. All HIV/HBV-coinfected patients were on anti-HBV drugs and most of which HBV DNA was fully suppressed. Liver cirrhosis and HDV infection were identified as common problems among HIV/HBV-coinfected patients.

June 23, 2021 - Brii Biosciences and VBI Vaccines Inc. announced final results from a Phase 1b/2a study on BRII-179 (VBI-2601), a novel recombinant, protein-based immunotherapeutic candidate, in patients with chronic hepatitis B virus infection.

June 9, 2021 - Brii Biosciences announced that it would present the complete dataset from its Phase 1b/2a study evaluating BRII-179 (VBI-2601) as a treatment for chronic hepatitis B virus at the European Association for the Study of the Liver's International Liver Congress on June 23, 2021.

May 19, 2021 - The 2019 Viral Hepatitis Surveillance Report is published by the Division of Viral Hepatitis, Centers for Disease Control and Prevention. Data are presented for the cases of viral hepatitis infection from January 2019 through December 31 2019.

May 11, 2021 - The Lancet published a study: Immunogenicity and safety of a tri-antigenic versus a mono-antigenic hepatitis B vaccine in adults (PROTECT): a randomized, double-blind, phase 3 trial. Interpretation - The safety and efficacy of the tri-antigenic hepatitis B vaccine show its usefulness for preventing HBV infection in adults, including those with stable and controlled chronic conditions. Funding - VBI Vaccines.

April 21, 2021 - Brii Biosciences, Vir Biotechnology, Inc., and VBI Vaccines Inc. announced that the first patient had been dosed in Phase 2 clinical trial evaluating BRII-835 (VIR-2218), an investigational small interfering ribonucleic acid-targeting hepatitis B virus (HBV), in combination with BRII-179 (VBI-2601), an investigational HBV immunotherapeutic, for the treatment of chronic HBV infection. This is the first clinical trial in the field to evaluate the combination of these two HBV mechanisms of action.

April 12, 2021 - VBI Vaccines Inc. announced data and next steps from the high-dose cohort of its Phase 1b/2a clinical study of VBI-2601 (BRII-179), the company's hepatitis B immunotherapeutic candidate, in chronically infected hepatitis B patients. VBI-2601 (BRII-179) is being developed in collaboration with Brii Biosciences as part of a potential functional cure for chronic hepatitis B virus infection.

February 24, 2021 - San Diego-based VLP BioTech, Inc. announced developing a more practical vaccine-based viral entry inhibitor to block HBV/HDV liver invasion. The company is seeking potential partners or licensees interested in this technology or combination therapies' clinical development.

February 19, 2021 -  Dynavax Technologies Corporation announced that the European Commission had granted Marketing Authorization for HEPLISAV B (Hepatitis B Vaccine (Recombinant), Adjuvanted) for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.

February 2, 2021 - VBI Vaccines Inc. announced that the U.S. Food and Drug Administration had accepted its filing of the Biologics License Application for the Company's 3-antigen prophylactic hepatitis B vaccine candidate to prevent infection caused by all known subtypes of the hepatitis B virus in adults.

February 1, 2021 - Vaccitech Ltd. announced the dosing of the first patient in HBV002. HBV002 is a Phase 1b/2a clinical trial designed to evaluate the safety and preliminary efficacy of VTP-300 both with and without a low-dose anti-PD-1 antibody in patients with chronic hepatitis B infection. The study plans to enroll 64 patients in South Korea, Taiwan, and the UK.

January 25, 2021 - Atlanta-based Antios Therapeutics, Inc. announced that it had completed the Phase 1b clinical trial of ATI-2173, an Active Site Polymerase Inhibitor Nucleotide (ASPIN), in patients with chronic hepatitis B virus infection. ATI-2173 is a novel, orally-administered, liver-targeted Active Site Polymerase Inhibitor Nucleotide (ASPIN) molecule designed to deliver the 5’-monophosphate of clevudine to the liver. This L-nucleoside's active 5’-triphosphate has unique antiviral properties as a non-competitive, non-chain terminating HBV polymerase inhibitor that distorts HBV polymerase's active site, resulting in potent HBV antiviral activity and extended off-treatment suppression of HBV DNA. In addition, ATI-2173 targets the liver, delivering high levels of the unique 5'- triphosphate while limiting systemic exposure to the parent L-nucleoside. Thus, ATI-2173 has the potential to become an integral part of a curative combination regimen for chronic hepatitis B.

January 15, 2021 - VBI Vaccines Inc. announced that results from a Phase 4 study of VBI's prophylactic 3-antigen Hepatitis B virus (HBV) vaccine in younger adults were published in vaccine, a journal publication from Elsevier. The study was designed to evaluate VBI's 3-antigen HBV vaccine's immunogenicity in support of that batch's qualification as a new reference standard for vaccine release to the Israeli market, where VBI's vaccine is available as Sci-B-Vac®.

January 12, 2021 - Gilead Sciences and Vir Biotechnology, Inc. announced that the companies have entered into a clinical collaboration to evaluate novel therapeutic combination strategies to develop a functional cure for the chronic hepatitis B virus. Anuj Gaggar, VP, Clinical Research, Virology at Gilead, stated, "We believe that selgantolimod and VIR-2218 have the potential to be best-in-class therapeutics and could provide a compelling new combination approach to a functional cure for HBV."

January 7, 2021 - The U.S. Department of Health and Human Services released a national plan to address the serious, preventable public health threat caused by viral hepatitis in the United States. The Viral Hepatitis National Strategic Plan for the United States: A Roadmap to Elimination 2021–2025 sets national goals, objectives, and strategies to respond to viral hepatitis epidemics. Building on three prior National Viral Hepatitis Action Plans over the last 10 years, the Viral Hepatitis National Strategic Plan is the first to eliminate viral hepatitis as a public health threat in the United States 2030. 

December 30, 2020 - A Maryland-based biopharmaceutical company announced that it had enrolled the first patient in its multinational Phase 2 clinical trial of HepTcell, a novel peptide-based immunotherapeutic under development to treat chronic hepatitis B.

December 15, 2020 - The U.S. Preventive Services Task Force published a final recommendation statement 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. "Screening teens and adults who are at increased risk for hepatitis B infection can help detect the virus and enable treatment to prevent serious health effects," says Task Force member Chyke Doubeni, M.D., M.P.H. "Evidence consistently shows that screening and early treatment leads to better health outcomes."

July 18, 2020 - The USA has been experiencing person-to-person outbreaks of hepatitis A in unprecedented numbers during the vaccine era. As of May 2020, 33 states had reported hepatitis A outbreaks involving approximately 32,500 cases reported by the Centers for Disease Control and Prevention.

February 3, 2020 - The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices published the revised Recommended Adult Immunization Schedule for 2020 in the Annals of Internal Medicine.

Note: This content has been reviewed by healthcare professions, such as Dr. Robert Carlson.

Clinical Trials

No clinical trials found