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Ebanga™ Ebola Monoclonal Antibody Clinical Trials, Dosage, Indication, Side Effects

Ebanga™ (mAb114, Ansuvimab-zykl) is a Zaire ebolavirus glycoprotein (EBOV GP)-directed human monoclonal antibody (mAb) indicated for the treatment of infection in adults and children. Ebanga (mAb114) is available in a lyophilized form and is a single monoclonal antibody (mAb) that binds to the core receptor binding domain of the Zaire ebolavirus surface protein, preventing the virus from infecting human cells. It was isolated from the blood of a survivor of the 1995 Ebola virus disease (EVD) outbreak in the Democratic Republic of Congo (DRC). mAbs are proteins produced in a lab or other manufacturing facility that act like natural antibodies to stop a germ, such as a virus, from replicating after it has infected a person. These particular mAb binds to a portion of the Ebola virus's surface called the glycoprotein, which prevents the virus from entering a person's cells. This area of the Ebola glycoprotein, the receptor binding domain (RBD), was previously thought to be unreachable by antibodies because it is well-hidden by other parts of the virus and only becomes exposed after it enters the cell.

The U.S. National Institute of Allergy and Infectious Diseases (NIAID) and researchers at Dartmouth College studied how Ebang neutralizes the EBOV and determined that it binds to the core of the Ebola glycoprotein, blocking its interaction with a receptor on human cells. The U.S. Vaccine Research Center developed Ebanga (mAb114) with support from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, and the Biomedical Advanced Research and Development Authority (BARDA). Ebanga was granted an FDA Orphan Drug and Breakthrough Therapy designation. The U.S. Food and Drug Administration (FDA) authorized Ebanga for intravenous injections on December 21, 2020.

On August 19, 2022, the World Health Organization (WHO) Guideline Development Group (GDG) made a Strong Recommendation for treatment with mAb114 for patients with real-time polymerase chain reaction (RT-PCR) confirmed EVD and for neonates of unconfirmed EVD status, seven days or younger, born to mothers with confirmed EVD. This new WHO living guideline is written to accompany the optimized supportive care (oSoC) for EVD standard operating procedures.

As of September 14, 2025, treatment courses of Mab114 have been dispatched to treatment centers in Bulape, DRC.

Emergent BioSolutions agreed with Ridgeback Biotherapeutics to expand the availability of Ebanga on July 7, 2022. Emergent is responsible for the manufacturing, sale, and distribution of Ebanga in the USA and Canada, and Ridgeback Bio serves as the global access partner for Ebanga. Ridgeback Biotherapeutics L.P. is located in Miami, FL. Ridgeback obtained a license for mAb114 from the U.S. NIH in 2018. DrugBank: DB16385; UNII: TG8IQ19NG2.

Ebanga Indication

Ebanga is indicated for treating infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection. Zaire ebolavirus is one of four Ebolavirus species that can cause a potentially fatal human disease. It is transmitted through blood, body fluids, tissues of infected people or wild animals, and surfaces and materials, such as bedding and clothing, contaminated with these fluids. The efficacy of Ebanga has not been established for other species of the Ebolavirus and Marburgvirus genera. Zaire ebolavirus can change over time, and factors such as the emergence of resistance or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating Zaire ebolavirus strains when deciding whether to use Ebanga.

Ebanga Dosage

Ebanga is administered by IV infusion at doses of 5, 25, and 50 mg. Ebanga is available in a lyophilized form. For injection: 400 mg lyophilized powder in a single-dose vial for reconstitution and further dilution.

Ebanga Side Effects and Interactions

Hypersensitivity reactions, including infusion-associated events, have been reported with Ebanga. These may include acute, life-threatening responses during and after the infusion. Discontinue the administration of EBANGA immediately and administer appropriate emergency care. No studies have been conducted on vaccine interactions. Ebanga may reduce the efficacy of the live vaccine. The interval between the administration of Ebanga therapy and live vaccination should be in accordance with current vaccination guidelines.

BARADA Agreements

BARDA is part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). On September 12, 2024, Emergent announced that it had been awarded a contract modification valued at $41.9 million for drug substance engineering and scale-up process validation, as well as long-term stability and commercial readiness, to support its ongoing scale-up program for Ebanga. On July 31, 2023, Emergent announced that BARDA had awarded it a 10-year contract, valued at up to a maximum of $704 million, under contract number 75A50123C00037, for the advanced development, manufacturing scale-up, and procurement of Ebanga™. On January 13, 2025, the company executed a contract modification for the second option period, valued at approximately $16.7 million, for drug product process and analytical testing validation, as well as long-term stability, for Ebanga™.

Ebanga (mAb114) News

September 14, 2025 - The WHO reported that treatment courses of the monoclonal antibody therapy (Mab114) drug have also been sent to treatment centers in Bulape, an area in the DRC, for clinical care during the 17th Ebola outbreak.

January 13, 2025 - Simon Lowry, M.D., chief medical officer, head of research and development, Emergent, commented, "Ebola is a devastating infectious illness with limited treatment options. This important work reinforces Emergent's leadership in developing solutions to address priority public health threats."

September 12, 2024 - Paul Williams, senior vice president of products business, Emergent, stated, "We look forward to progressing the program to supply treatment courses to enable preparedness against the Ebola virus. This important work demonstrates our leadership position in providing critical medical countermeasures."

July 31, 2023: Dr. Kelly Warfield, senior vice president of science and development at Emergent, stated in a press release, "The Ebola virus can emerge unexpectedly, posing a risk to global health. Its elusive nature makes it difficult to predict when and where an outbreak may occur, underscoring the importance of preparedness efforts against this public health threat."

March 8, 2023: The journal Frontiers published an article titled "Ebanga™: The most recent FDA-approved drug for treating Ebola."

September 30, 2022 - AllAfrica published Ebola - What Are the Symptoms, How Does It Spread, and Where Did It Come From?

August 19, 2022: The WHO published its first guideline for Ebola virus disease therapeutics, with strong new recommendations for monoclonal antibodies. The WHO calls on the global community to increase access to these medicines.

July 7, 2022 - Emergent BioSolutions Inc. confirmed an agreement with Ridgeback Biotherapeutics to expand the availability of Ebanga. 

April 1, 2021 - The NEJM Journal reported that during the 2018–2020 Ebola virus disease (EVD) outbreak in North Kivu province in the Democratic Republic of Congo, EVD was diagnosed in a patient who had received the recombinant vesicular stomatitis virus-based vaccine expressing a ZEBOV glycoprotein (rVSV-ZEBOV) (Merck). His treatment included an Ebola virus (EBOV) -specific monoclonal antibody (mAb114), and he recovered within 14 days. However, six months later, he presented again with severe EVD-like illness and EBOV viremia and died. Epidemiologic and genomic investigations showed that the patient relapsed into acute EVD, leading to a transmission chain resulting in 91 cases across six health zones over four months.

February 2, 2021—The antibody mAb114, or ansuvimab, is marketed as Ebanga by Ridgeback Therapeutics L.P. of Miami. The company licensed the antibody and manufacturing processes from NIAIOverhan. In 2018, the Frederick National Laboratory's Vaccine Clinical Materials Program manufactured 10,000 drug product vials for use in clinical trials in the Democratic Republic of the Congo.

December 22, 2020 - Ridgeback Biotherapeutics L.P. announced today that the U.S. Food and Drug Administration approved Ebanga to treat Ebola. Ebanga is now approved to treat infections caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to mothers who are RT-PCR positive for Zaire ebolavirus infection. The efforts of the Pamoja Tulinde Maisha (PALM ["Together Save Lives" in the Kiswahili language]) study team conclusively demonstrated Ebanga's safety and efficacy in a randomized controlled trial conducted during the 2nd largest and longest outbreak in DRC history. The PALM study team's efforts represent a landmark achievement in developing medical countermeasures for emerging infectious diseases.

December 21, 2020 - The U.S. Food and Drug Administration approved Ebanga (Ansuvimab-zykl), a human monoclonal antibody, for the treatment of Ebolavirus infection in adults and children. Ebanga blocks the binding of the virus to the cell receptor, preventing its entry into the cell.

August 28, 2020—Ridgeback Biotherapeutics LP. announced the implementation of an expanded access protocol to ensure rapid access to its promising Ebola treatment, ansuvimab, in the Democratic Republic of the Congo (DRC). The Institut National de Recherche Biomédicale of the DRC is conducting an open-label, expanded-access clinical trial, initiated earlier this month. Ridgeback is providing study drug and operational support for this trial.

September 6, 2019: Ridgeback Biotherapeutics L.P. announced that the Food and Drug Administration has recently granted mAb114, an experimental treatment for Ebola, Breakthrough Therapy designation. 

August 13, 2019: The first-ever multi-drug randomized controlled trial to evaluate the safety and efficacy of Ebola Zaire therapeutic medications reported two experimental products that would continue to be studied. The investigational agents in the Pamoja Tulinde Maisha study were ZMapp, remdesivir, mAb114, and REGN-EB3. Additionally, this DSMD said, 'all future study participants should be randomized to receive either the REGN-EB3 or mAb114 medications.'

December 13, 2018 - Ridgeback Biotherapeutics L.P. announced that it has entered into a patent license agreement with the NIH for intellectual property related to the mAbs mAb114, an experimental treatment for Ebola.

Ebanga (mAb114) Antibody Clinical Trials

The Pamoja Tulinde Maisha (PALM [together save lives]) study was a randomized, controlled trial of four investigational agents (ZMapp, remdesivir, mAb114, and REGN-EB3) for the treatment of patients with Ebola virus disease. The study began on November 20, 2018, in the Democratic Republic of the Congo (DRC) as part of the emergency response to an ongoing Ebola outbreak in the North Kivu and Ituri Provinces. EBANGA lowered the risk of dying from the infection.

IXIARO® JESPECT® Japanese Encephalitis Vaccine Clinical Trials, Dosage, Indication, Side Effects

Valneva SE's IXIARO® (JESPECT® in Australia and New Zealand) is an inactivated, adsorbed Vero cell culture-derived vaccine targeting the Japanese encephalitis virus (JEV). It is prepared by propagating the JEV strain SA14-14-2 in Vero cells. Multiple viral harvests are pooled, clarified, and concentrated. The virus suspension is treated with protamine sulfate to remove contaminating DNA and proteins. The partially purified virus is processed and fractionated through sucrose density gradient centrifugation. Each fraction is analyzed for the presence of the virus, and fractions with the highest virus activity are pooled to give a purified virus suspension. The purified virus is then inactivated by formaldehyde treatment. IXIARO's final preparation is adjusted to a specified protein concentration and formulated by adding aluminum hydroxide.

The IXIARO JEV was developed through a cooperative research and development agreement with the Walter Reed Army Institute of Research. In 2018, the U.S. Food and Drug Administration (FDA) issued STN: BL 125280, which included a statistical review, Clinical Review, and toxicology review. An approval letter was issued on October 4, 2018. 

The U.S. Department of Defense (DoD) has relied on IXIARO since 2010 to help protect personnel deployed to JE-endemic areas for whom JE vaccination is recommended. Under a new one-year contract announced on September 25, 2023, the DoD will purchase a minimum of $32 million in IXIARO® vaccines and may buy additional doses over the next 12 months. Vaccine deliveries will commence in 2023. On January 30, 2025, Valneva announced a new one-year contract under which the DoD will purchase a minimum of $32.8 million worth of IXIARO and may purchase additional doses over the following 12 months.

A study estimated that between 2000 and 2015, 307,774 JE cases (95% CI: 167,442–509,583) were averted globally due to vaccination. The UK Health Security Agency published new guidance on JE vaccination in the 'Green Book' (Chapter 20) in February 2024. On September 5, 2024, the U.S. CDC published the Japanese Encephalitis Vaccine Evidence-to-Recommendations Framework, and in April 2025, it updated the JE Yellow Book 2026.

France-based Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) is a specialty vaccine company focused on developing vaccines for diseases with significant unmet needs. For more information, visit www.valneva.com. Valneva USA, Inc. is located at 910 Clopper Road, Suite 160S, Gaithersburg, MD 20878, USA. 

IXIARO Vaccine Availability 2025

As of 2025, IXIARO is the only Japanese encephalitis vaccine approved by the U.S. FDA, which is commercially available at various travel vaccine retailers. IXIARO/JESPECT is licensed for adults in the United States, Australia, New Zealand, Europe, Canada, Germany, Switzerland, Hong Kong, Singapore, Israel, Norway, Liechtenstein, Iceland, Japan, the United Kingdom, and the Republic of Korea. In all other licensed territories, IXIARO®/JESPECT® is indicated for use by adults. In Germany, CSL Seqirus will distribute IXIARO®.

Visit PreventJE.com, a website for travel health professionals and their patients focusing on the risk and prevention of Japanese encephalitis in travelers to Asia. In Australia, information on eligibility for the free JE vaccine is available on the NSW Health website.

IXIARO Vaccine Approvals

In March 2009, the U.S. Food and Drug Administration (FDA) approved JE-VC for adults aged 17 years and older. In June 2009, the CDC's Advisory Committee on Immunization Practices (ACIP) approved recommendations for the use of JE-VC in adults. In September 2010, the FDA approved a JE-VC booster dose for adults. In May 2013, FDA approval for JE-VC was extended to include children aged two months through 16 years. ACIP recommendations for the pediatric use of JE-VC were approved in June 2013. In April 2018, the FDA approved a booster dose for the pediatric age group. On March 8, 2020, Valneva announced that the FDA approved an extension of the shelf life of IXIARO from 24 months to 36 months.

IXIARO Indication

IXIARO is indicated for active immunization to prevent disease caused by the JEV, the leading cause of vaccine-preventable encephalitis, and is approved by the U.S. CDC for use in individuals two months of age and older. The CDC says travelers to areas at risk for Japanese encephalitis should discuss the need for vaccination with their healthcare provider. JE is a deadly infectious disease occurring throughout most of Asia and parts of the western Pacific, spread by mosquitoes, pigs, and sheep. JE is fatal in approximately 30% of those who show symptoms, leaving half of the survivors with permanent brain damage.

IXIARO Side Effects

IXIARO contains protamine sulfate, a compound known to cause hypersensitivity reactions in some individuals. Therefore, severe allergic reaction (e.g., anaphylaxis) after a previous dose of IXIARO®, any other Japanese encephalitis vaccine, or any component of IXIARO®, including protamine sulfate ─ a compound known to cause hypersensitivity reactions in some individuals ─ is a contraindication to the administration of IXIARO®. Individuals with a history of severe allergic reaction to another Japanese encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO is considered. The most common ( > 10%) adverse reactions were fever, irritability, diarrhea, and injection site redness in infants two months to < 1 year of age; fever in children 1 to < 12 years of age; pain and tenderness in adolescents 12 to < 18 years of age; and, headache, myalgia, and injection site pain and tenderness in adults.

IXIARO Dosage

IXIARO is administered by intramuscular injection and is approved for use in individuals 2 months of age and older. In 2019, the U.S. CDC's ACIP committee strengthened its language on booster doses, stating that they should be given at least 1 year after the primary series if the person has ongoing or re-exposure to the JE virus.   

Primary Series: Children 2 months to <3 Years of age: Primary immunization with IXIARO consists of two (2) 0.25 mL doses, administered 28 days apart; Individuals 3 years of age and older: Primary immunization with IXIARO consists of two (2) 0.5 mL doses, administered 28 days apart; Complete the primary immunization series at least one week before potential exposure to JEV.

Booster Dose: Individuals 17 years of age and older: If the primary series of two doses was completed more than one year previously, a booster dose might be given if ongoing exposure or re-exposure to JEV is expected; Infants, children, and adolescents two months to <17 years of age: The safety and immunogenicity of a booster dose have not been evaluated.

Immunocompromised individuals may have a diminished immune response to IXIARO.

U.S. CDC Japanese Encephalitis Vaccine Recommendations

The U.S. CDC developed Japanese Encephalitis vaccine recommendations using an explicit evidence-based method based on the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach.

Japanese Encephalitis Outbreaks

The World Health Organization (WHO) states that JE outbreaks intensify during the rainy (monsoon) season in Asia (India, Nepal) and the Pacific (Australia), when vector populations increase.

IXIARO Vaccine Sales

In the first half of 2025, IXIARO® /JESPECT® sales increased by 30.6% to €54.7 million compared to €41.9 million in the first half of 2024. Sales to both travelers and the DoD grew in double digits compared to the first half of 2024, when IXIARO® supply constraints impacted sales.

In 2024, IXIARO/JESPECT sales increased by 28% to €94.1 million, demonstrating double-digit growth among travelers and the U.S. Department of Defense compared to 2023. Valneva has been supplying additional doses of IXIARO® to the U.S. DoD under the current contract, signed in September 2023.

IXIARO Vaccine News

August 12, 2025 - Peter Bühler, Valneva's Chief Financial Officer, commented, "We also substantially reduced our spending and successfully leveraged our ATM program to welcome two new leading healthcare investors among our main shareholders, strengthening our financial position ahead of this important clinical catalyst."

January 30, 2025 - Dipal Patel, Chief Commercial Officer of Valneva, commented, "We are honored to continue our long-term relationship with the DoD. The U.S. military has trusted IXIARO® for over ten years to help protect military personnel, their families, civilian government service personnel, and government contractors from this potentially deadly disease."

November 7, 2024 - Valneva anticipates receiving new vaccine orders in 2025.

October 31, 2024 - Victoria's Minister for Health, Mary-Anne Thomas, stated, "Following expert advice from the Chief Health Officer, we're expanding this important program to ensure more Victorians can access the free JEV vaccine and protect themselves and their loved ones this summer."

May 15, 2024 - The U.S. CDC published Japanese Encephalitis Vaccine Information for Healthcare Providers.

September 25, 2023 - Dipal Patel, Chief Commercial Officer of Valneva SE, commented, "We are excited to continue our long-term relationship with the DoD. The U.S. military has trusted IXIARO® for over ten years to help protect military personnel, their families, civilian government service personnel, and government contractors from this potentially deadly disease."

September 21, 2023 - Valneva SE confirmed it distributes IXIARO® directly to the U.S. DoD.

July 11, 2022 - A non-peer-reviewed study: Safety and immunogenicity following co-administration of Yellow fever vaccine with Tickborne encephalitis or Japanese encephalitis vaccines concluded: Inactivated TBEV or JEV vaccines can be co-administered with the live attenuated YFV vaccine without an increased risk of adverse events and reduced development of nAbs to the respective viruses.

September 3, 2021 - Valneva SE announced that the U.S. Department of Defense had exercised the first option of the contract signed in September 2020 to purchase a further supply of its Japanese encephalitis vaccine, IXIARO®.

July 19, 2019 - The CDC's Advisory Committee on Immunization Practices (ACIP) Recommendations for Japanese Encephalitis Vaccine were updated.

June 5, 2019: The European Medicines Agency approved the extension of the shelf life of the Japanese encephalitis vaccine IXIARO from 24 months to 36 months.

March 1, 2019 – At its meeting on February 27, 2019, the U.S. CDC's ACIP voted unanimously to expand the JEV vaccination recommendations. 

Ixiaro Clinical Trials

Ixiaro, the Japanese Encephalitis vaccine, has been involved in over 60 clinical trials.  

Infanrix® Pediarix™ Combination Vaccine

Infanrix® (STN: BL 103647) is a vaccine combination indicated for active immunization against diphtheria, tetanus, and pertussis, approved in 1997. Infanrix active ingredients are non-infectious substances from tetanus, diphtheria bacteria, and purified proteins of pertussis bacteria. Pediarix™ [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine], Suspension for Intramuscular Injection Initial U.S. Approval: 2002.

In Europe, Infanrix hexa is a vaccine used to protect babies and toddlers against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio), and diseases such as bacterial meningitis caused by the bacterium Haemophilus influenzae type b (Hib). And in New Zealand, INFANRIX-IPV Combined diphtheria-tetanus-acellular pertussis (DTPa) and enhanced inactivated polio suspension for injection.

Infanrix Vaccine Indication

Infanrix is a vaccine indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children six weeks to 7 years of age (before the seventh birthday).

Infanrix Vaccine Dosage

Infanrix is approved for intramuscular administration in infants and children six weeks to 7 years of age (before the seventh birthday) as a 5-dose series. A primary immunization course of 3 doses is administered at 2, 4, and 6 months of age (at intervals of 4 to 8 weeks). The first dose may be given as early as six weeks of age. Followed by two booster doses, administered at 15 to 20 months and 4 to 6 years of age. Preferred administration site: Anterolateral aspect of the thigh for most infants younger than 12 months. Deltoid muscle of the upper arm for most children 12 months of age to 7 years of age. Each 0.5 mL dose contains 30 IU (25 Lf U) of diphtheria toxoid.

Infanrix Vaccine News

February 21, 2022 - The UK Health Agency published the 2022 routine immunization schedule. This publication included immunization programs as well as additional vaccines for individuals with underlying medical conditions.

February 9, 2022 - GSK reported sales of DTPa-containing vaccines (Infanrix, Pediarix, and Boostrix) decreased 4% AER but grew 1% CER. Infanrix/Pediarix sales decreased 14% AER and 9% CER to £543 million, reflecting lower tender volume in Europe and internationally and a change in recommendation for the dosing schedule in Germany, partly offset by increased demand in the US. Boostrix sales grew 9% AER and 14% CER to £521 million, primarily driven by demand recovery and tender volumes in International, as well as higher demand and share in the US.

October 31, 2019 - GSK Korea announced its newly launched Infanrix IPV-Hib, a quintuplet vaccine that covers diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae type b (Hib). The company hopes that by adding efficiency to the excellence of the existing Infanrix brand, it can become a vaccine that leads to disease prevention for infants and toddlers, said Professor Lee Jin of the Department of Pediatrics at Hanil Hospital.

Infanrix Vaccine Clinical Trials

Infanrix has been tested in over 140 clinical trials. They can be found at this link.

Heplisav-B® Vaccine Clinical Trials, Dosage, Indication, Side Effects

The Heplisav-B® two-dose vaccine enhances the immune response by combining hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) and nine agonists. 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 the hepatitis B virus in adults 18 years and older. HEPLISAV-B vaccine is the first and only adult hepatitis B vaccine approved in the U.S., the European Union, and Great Britain.

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 became a 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. 

Dynavax announced on May 14, 2024, a regulatory update for the Company's supplemental Biologics License Application (sBLA) to include a four-dose HEPLISAV-B® vaccine regimen for adults on hemodialysis. The FDA has issued a Complete Response Letter (CRL) in response to the sBLA, stating that the application did not provide sufficient data to support the full evaluation of the effectiveness or safety of a four-dose regimen of HEPLISAV-B. The CRL has no impact on the approved indication for HEPLISAV-B in the U.S., the European Union, and Great Britain, which prevents infection caused by all known subtypes of hepatitis B virus in adults. The CRL also does not affect the approval decision received from the European Commission in October 2023 for the four-dose HEPLISAV-B regimen for the adult hemodialysis population.

On February 20, 2025, the Company announced HEPLISAV-B® 2024 net product revenue grew 26% year-over-year to $268 million; net product revenue is expected to be $305 to $325 million in 2025.

Emeryville, California-based Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines. Dynavax has worldwide commercial rights to HEPLISAV-B. On May 9, 2024, the Company announced HEPLISAV-B® vaccine net product revenue grew 10% year-over-year to approximately $48 million in the first quarter of 2024. It also reaffirmed the full-year 2024 HEPLISAV-B net product revenue guidance of $265 - $280 million. HEPLISAV-B's total market share in the U.S. increased to approximately 44%, compared to about 35% at the end of 2022.

Heplisav-B Pricing

The retail price ranges from $131 to $160. Most insurance plans will cover this vaccine; however, some discounts can be found to reduce the cost of the vaccine.

Heplisav-B Indication

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% 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 News

February 20, 2025 - Ryan Spencer, Chief Executive Officer of Dynavax commented, "Looking ahead to 2025, we plan to drive significant top-line growth as we continue to establish HEPLISAV-B as the market share leader in the expanding hepatitis B vaccine market in the U.S.

January 8, 2024 - Ryan Spencer, Chief Executive Officer of Dynavax, stated, "Turning to this year, we believe HEPLISAV-B is well-positioned entering 2024, supported by significant market share gains in the total market and key market segments. We remain extremely confident in the long-term growth of the hepatitis B market, with HEPLISAV-B expected to achieve a majority market share in the U.S."

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 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: A three-dose hepatitis B vaccine regimen protects people with HIV.

August 4, 2022 - "During the second quarter, we continued to execute on our key priorities successfully 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 applauds yesterday's vote by the U.S. U.S. 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's vaccine committee presented Universal Adult Hepatitis B Vaccination: Introduction.

September 29, 2021 - The U.S. CDC's 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 vaccine company that develops, manufactures, and commercializes 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 compared to Engerix-B.

February 19, 2021 - Dynavax Technologies Corporation announced that the European Commission had granted Marketing Authorization for HEPLISAV B.

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. 

December 10, 2020 - Dynavax Technologies Corporation announced that the European Medicines Agency Committee for Medicinal Products for Human Use 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. 

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.