Vaccine Info

Ebola Vaccine Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo)

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December 1, 2023
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Ebola Vaccine Zabdeno® and Mvabea®

The Johnson & Johnson (J&J) Janssen Ebola prevention vaccine therapy consists of two components, Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo). Zabdeno is given first, and Mvabea is administered approximately eight weeks later as a vaccine booster. This prime-boost vaccination method is an established approach for preventing infectious diseases during Ebola outbreaks for individuals at risk of exposure and preventively before episodes, says J&J.

J&J's Janssen division developed Zabdeno, a monovalent vaccine designed to provide active, specific, acquired immunity to the Ebola virus. The vaccine is based on an adenovirus type 26 (Ad26) vector expressing the glycoprotein of the Ebola virus Mayinga variant. Janssen has rapidly advanced the vaccine's development with multiple clinical Phase 1, 2, and 3 trials in parallel in healthy adults, children, elderly, and immunocompromised populations across Europe, the U.S., and Africa.

Bavarian Nordic's Mvabea (MVA-BN-Filo) is a multivalent vaccine preparation designed to provide active acquired immunity to Sudan, Ebola, Marburg, and Tai Forest (formerly Côte d'Ivoire ebolavirus). 

Zabdeno and Mvabea combination was evaluated under the European Medicines Agency (EMA) (EMEA/H/C/005337) accelerated assessment. However, as a precautionary measure, a Zabdeno booster vaccination should be considered for individuals at imminent risk of exposure to the Ebola virus, for example, healthcare professionals and those living in or visiting areas with an ongoing Ebola virus outbreak who completed the Zabdeno, Mvabea 2-dose primary vaccination regimen.

On June 4, 2021, J&J welcomed a new recommendation by the WHO's Strategic Advisory Group of Experts on Immunization (SAGE)  that supports the use of the Ebola vaccine regimen both during outbreaks for individuals at risk of Ebola exposure and preventively in the absence of an outbreak, as protection against Ebola virus disease (EVD) is considered a significant public health interest. Accordingly, African countries began evaluating a single dose of Bavarian Nordic's Mvabea (MVA-BN-Filo) to treat the Marburg virus disease in August 2021. 

The Lancet published a study on September 13, 2021, concluding, 'The Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimens were well tolerated, with no safety concerns in children aged 1–17. They induced robust humoral immune responses, suggesting the suitability of this regimen for Ebola virus disease prevention in children.' ClinicalTrials.gov: NCT02509494. Data from two papers published in The Lancet Infectious Diseases demonstrated that Zabdno and Mvabea generated robust humoral immune responses in adults and children, with the immune responses persisting in adults for at least two years. The data also showed that booster vaccination with Ad26.ZEBOV, administered to adults two years after the initial immunization, induced a robust anamnestic response within seven days. On December 14, 2022, a study published by the New England Journal of Medicine concurred with The Lancet's findings. In addition, the JAMA Network published Ebola Vaccines Safe and Immunogenic in Clinical Trials on January 24, 2023.

Janssen is now Johnson & Johnson Innovative Medicine.

Zabdeno and Mvabea Vaccine History

The U.S. NIAID, BARDA, and other funding partners supported the development, preclinical, and clinical testing of this investigational vaccine regimen designed to protect against the virus responsible for the 2014-2016 Ebola outbreak in West Africa. As of June 4, 2021, J&J confirmed that more than 235,000 people had received at least the first dose of the Ebola vaccine, including 190,000 fully vaccinated with both doses.

On May 29, 2020, the EMA human medicines committee recommended granting Zabdeno and Mvabea a positive opinion for marketing authorizations under exceptional circumstances because the applicant was able to demonstrate that it is not possible to conduct a randomized controlled study that might generate comprehensive clinical data on the efficacy of the latest Ebola vaccine even after authorization. The EMA has approved its use in individuals aged one year or older.

The U.S. National Institutes of Health sponsored the initial development of the Mvabea (MVA-BN-Filo) vaccine, which is now managed by Janssen, a Johnson & Johnson company licensed MVA-BN Filo for use from Bavarian Nordic in a prime-boost vaccine regimen together with their adenovirus-based vaccine candidate, Ad26.ZEBOV. Both vaccines use a viral vector approach, where a virus is genetically modified not to replicate but is used to express the target virus's essential proteins safely; in this case, the Ebola virus. Global partners in the vaccine program include the Biomedical Advanced Research and Development Authority and the National Institutes of Health.

On November 17, 2020, The Lancet published a study, Safety and immunogenicity of a two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in European adults (EBOVAC2): a randomized, observer-blind, participant-blind, placebo-controlled, phase 2 trial. This study concluded with the 'two-dose heterologous regimen with Ad26.ZEBOV and MVA-BN-Filo were safe, well-tolerated, and immunogenic, with humoral and cellular immune responses persisting for one year after vaccination. These data support the intended prophylactic indication for the vaccine regimen.'

Johnson & Johnson - Janssen has assembled a stockpile of 1.5 million vaccine regimens for potential use in public health emergencies. The applicant for both Zabdeno and Mvabea is Janssen-Cilag International N.V.

Zabdeno and Mvabea Indication

The Ad26.ZEBOV / MVA-BN-Filo combination is indicated to provide an active acquired immunity to the Ebola virus. Clinical results suggest that Ad26.ZEBOV prime immunization readily induces an immune response enhanced by MVA-BN-Filo boosting, inducing a durable immunity to Ebola Zaire. Both the prime and boost are well tolerated with a good safety profile. Janssen's Ebola vaccine regimen is specifically designed to support preventive vaccination in countries that are at risk of Ebola outbreaks, as well as for other at-risk groups such as healthcare workers, Biosafety Level 4 (BSL-4) lab workers, the military deployed from other countries, airport staff and visitors to high-risk countries. Therefore, this prophylactic 2-dose regimen is unsuitable for an outbreak response where immediate protection is necessary.

Zabdeno and Mvabea Dosage

Heterologous 2-dose vaccination with Ad26.ZEBOV and MVA-BN-Filo against the Ebola virus were well tolerated and immunogenic in healthy volunteers. The vaccine is administered as an intramuscular injection. A study published in 2020 found 'the two-dose heterologous regimen with Ad26.ZEBOV and MVA-BN-Filo were safe, well-tolerated, and immunogenic, with humoral and cellular immune responses persisting for one year after vaccination.

The EMA recommends a Zabdeno booster for individuals at high risk of Ebola virus exposure if their 2-dose vaccine regimen was completed more than four months ago. And, if four weeks have passed, the Johnson & Johnson Ebola vaccine combination can be administered with other vaccines.

Zabdeno and Mvabea Side Effects

The most common side effects found in participants in the clinical trials were injection-site reactions (pain, warmth, and swelling), fatigue, headache, myalgia, arthralgia, and chills reported by the EMA. In a phase 1 study, the reporting of A.E.s was identical to that described for the VAC52150EBL1003 trial. Briefly, solicited A.E.s were recorded in a diary by participants for seven days following each vaccination, and unsolicited A.E.s were collected at all visits until 21 days after dose 2. 

Zabdeno and Mvabea Safety

In November 2023, The Lancet Global Health published: Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in infants: a phase 2, randomized, double-blind, active-controlled trial in Guinea and Sierra Leone. This analysis concluded Ad26.ZEBOV and MVA-BN-Filo were well tolerated and induced strong humoral responses in infants younger than one year. There were no safety concerns related to vaccination.

Zabdeno and Mvabea News

January 31, 2023 - The JAMA Network published a review of three vaccine regimens against Zaire Ebola virus disease that safely produced immune responses for up to 12 months, according to two clinical trials of adults and children reported in the New England Journal of Medicine.

December 9, 2021 - The peer-reviewed journal PLOS Pathogens published: Current state of Ebola virus vaccines: A snapshot.

October 4, 2021 - The journal PLOS Medicine published a RESEARCH ARTICLE: Safety and immunogenicity of 2-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccination in healthy and HIV-infected adults: A randomized, placebo-controlled Phase II clinical trial in Africa. Conclusions - Ad26.ZEBOV, MVA-BN-Filo vaccination was well tolerated and immunogenic in healthy and HIV-infected African adults. Increasing the interval between vaccinations from 28 to 56 days improved the magnitude of humoral immune response; however, antibody body levels persisted for at least one year and Ad26. In addition, ZEBOV booster vaccination demonstrated the presence of vaccination-induced immune memory. These data supported the approval by the European Union for prophylaxis against EBOV disease in adults and children ≥1 year of age.

September 13, 2021 - A new study published by the journal The Lancet assessed the Safety and immunogenicity of a two-dose heterologous vaccine regimen comprising the adenovirus type 26 vector-based vaccine encoding the Ebola virus glycoprotein (Ad26.ZEBOV) and the modified vaccinia Ankara vector-based vaccine, encoding glycoproteins from the Ebola virus, Sudan virus, and Marburg virus, and the nucleoprotein from the Tai Forest virus (MVA-BN-Filo), in a pediatric population in Sierra Leone, Africa. Ebola virus glycoprotein-specific binding antibody responses at 21 days after the second dose of the Ebola virus vaccine were observed in about 97% of the children. And there were no treatment-related deaths.

August 23, 2021 - The WHO Africa announced that frontline health workers, practitioners of traditional medicines or traditional healers, and commercial motorbike riders in Sierra Leone who received the first dose are given their second jab to maximize their protection against the disease. There were 8,583 people vaccinated with the first dose who would receive their second dose of the vaccine as the entire regimen. In addition, health workers who had not been vaccinated with the first dose of the Ebola vaccine because of difficulty exigency for their second COVID-19 vaccine dose will now have the chance to be vaccinated with the first dose of the Ebola vaccine and then wait for their second dose six weeks later.

August 17, 2021 - The World Health Organization Africa confirmed it helped the vaccine deployment from Guinea to Cote d'Ivoire of about 3,000 vaccine doses manufactured by Johnson & Johnson, which will be used to boost the vaccination in areas not experiencing active Ebola transmission.

June 4, 2021 - Johnson & Johnson announced it 'welcomes the recommendation by the Strategic Advisory Group of Experts on Immunization for the World Health Organization.

May 13, 2021 - Johnson & Johnson announced the World Health Organization and the government of Sierra Leone have begun administering the Company's Ebola vaccine regimen.

May 11, 2021 - Vaccinations were launched in Kambia District, a primary international entry point by road crossing and significant economic and commercial importance for Guinea and Sierra Leone. About 16,000 people have been targeted for vaccination in the selected border districts, and individuals will receive two doses of the vaccine given approximately eight weeks apart.

April 10, 2021 - The government of Sierra Leone and the World Health Organisation announced Johnson & Johnson; Janssen has donated about 4,500 Ebola vaccines to prevent Ebola in the country.

April 6, 2021 - Denmark-based Bavarian Nordic A/S announced the Company had received a new supply order from Janssen Pharmaceutica NV, part of the Janssen Pharmaceutical Companies of Johnson & Johnson, valued at approximately USD 28 million. Under the contract, Bavarian Nordic will manufacture and deliver bulk drug substances of the MVA-BN® Filo vaccine, licensed to Janssen as part of its Ebola vaccine regimen, Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN Filo), which the European Commission approved in 2020.

November 17, 2020 - Study published by The Lancet: Vaccine - Study Interpretation - The two-dose heterologous regimen with Ad26.ZEBOV and MVA-BN-Filo were safe, well-tolerated, and immunogenic, with humoral and cellular immune responses one year after vaccination. Together, these data support the intended prophylactic indication for the vaccine regimen.

July 1, 2020 - The European Commission adopted the decision granting marketing authorizations to Janssen, a Johnson & Johnson company, for a vaccine against Ebola.

June 12, 2020 - Bavarian Nordic A/S announced that the Company has entered into a new supply contract with Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson valued at USD 13.9 million. Under the agreement, Bavarian Nordic will manufacture and deliver bulk drug substances of its MVA-BN® Filo vaccine, which Janssen has licensed as part of its Ebola vaccine regimen.

October 31, 2019 - Bavarian Nordic A/S announced that its partner, J&J Janssen Pharmaceutical Companies of Johnson & Johnson, would donate up to 500,000 doses of its investigational Ebola vaccine regimen to support vaccination efforts in the Democratic Republic of the Congo.

April 19, 2019 - A phase 1 study of healthy volunteers, immunization with Ad26.ZEBOV or MVA-BN-Filo did not result in any vaccine-related serious adverse events.

March 14, 2017 - Immune Responses to Novel Adenovirus Type 26 and Modified Vaccinia Virus Ankara–Vectored Ebola Vaccines at 1 Year.

September 12, 2016 – Bavarian Nordic A/S announced that Janssen Vaccines & Prevention B.V. (Janssen) had completed a submission to the World Health Organization (WHO) for Emergency Use Assessment and Listing (EUAL) for its investigational preventive Ebola prime-boost vaccine regimen, which includes Bavarian Nordic's MVA-BN® Filo vaccine.

October 22, 2014 – Bavarian Nordic A/S announced a global license and supply agreement for its MVA-BN Filovirus (Ebola and Marburg) vaccine candidate with Crucell Holland B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson. 

Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo) Ebola Vaccine Clinical Trials

As a result of these collaborations, more than 6,500 individuals have now participated in clinical studies for the Ebola vaccine across the U.S., Europe, and Africa. So far, the data from these studies suggest that the vaccine stimulates a robust immune response and has a favorable safety profile.

ClinicalTrials.gov: NCT02509494 - Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo (EBOVAC-Salone). Last Update Posted: June 29, 2020.