Johnson & Johnson Ebola Vaccine Development

Partnership objectives

To accelerate the development of investigational “prime-boost” vaccine regimens to protect against filoviruses including the Ebola virus, with the ultimate goal of ensuring the world is prepared for future outbreaks. 

The collaboration between Janssen and Bavarian Nordic potentially allows for a faster and significant production of the doses required to ultimately halt the spread of Ebola. The collaboration between Janssen and Bavarian Nordic potentially allows for a faster and significant production of the doses required to ultimately halt the spread of Ebola. Copyright Bavarian Nordic

What are the health needs and challenges?

The 2014-2016 Ebola outbreak in West Africa was the biggest filovirus outbreak the world has ever seen. More than 28,600 individuals were infected with the virus across Guinea, Sierra Leone and Liberia and more than 11,300 people died – including more than 500 healthcare workers. Experts agree that future outbreaks are highly likely. Additionally, the documented persistence of the virus in Ebola survivors adds to the urgency of finding a robust and durable vaccine that produces sustained immunity. Vaccine regimens in development could be vital prevention tools for outbreak response and preparedness, particularly for health workers and other vulnerable populations on the frontlines.

No licensed vaccine to prevent Ebola virus disease currently exists.  

Description of partnership activities and how they address needs and challenges

Since 2014, Johnson & Johnson has mobilized significant resources to accelerate the development of heterologous prime-boost Ebola vaccine regimens, including monovalent and multivalent regimens. Heterologous prime-boost vaccine regimens aim to create longer-lasting immunity through the administration of multiple vaccine doses of different kinds over time.

The monovalent program, designed to address the Ebola virus, features a prime-boost vaccine regimen of two vaccine components that are based on AdVac® technology from Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, and MVA-BN® technology from Bavarian Nordic. Janssen launched 10 Phase 1, 2 and 3 studies in rapid succession across three continents to evaluate this vaccine regimen, and secured funding from leading sponsors of research in Europe (the Innovative Medicines Initiative) and the US (the National Institutes of Health, and the Biomedical Advanced Research and Development Authority) to support this program.

Johnson & Johnson is also developing a second-generation, multivalent version of the AdVac/MVA-BN vaccine regimen. The multivalent prime-boost regimen is intended to protect against multiple filoviruses that cause disease in humans, including the Ebola, Sudan and Marburg viruses.

Janssen’s investigational Ebola vaccine regimens originate from a collaborative research program with the US National Institutes of Health that began in 2008.

Lessons learned

To be fully prepared for the next major Ebola outbreak, the world will likely need several Ebola vaccines. Different vaccines may offer different advantages. For example, some may be optimized for rapid administration during an emerging outbreak and others for long-term prevention and protection of vulnerable populations such as health workers. Additionally, it will be important to have more than one proven and approved vaccine available to ensure uninterrupted supply and overcome potential manufacturing constraints associated with a specific product.

Many challenges face the successful development and deployment of an Ebola vaccine, especially in resource-limited countries. Johnson & Johnson is collaborating with partners to promote awareness, understanding and uptake of new Ebola vaccines in clinical trial settings through communications and community engagement strategies.

Summary of impact and forward looking information

Final Phase 1 results from a UK study of the investigational monovalent vaccine regimen were published in March 2017 in JAMA: The Journal of the American Medical Association. The study in healthy volunteers found that the regimen was well-tolerated, and produced an immune response among 100 percent of participants that was sustained 1 year following vaccination. Preliminary data from Phase 1 trials in Africa also suggest that the vaccine regimen elicits a persistent immune response.

In partnership with Bavarian Nordic, Janssen has rapidly scaled up production of the vaccine regimen and currently has approximately 1,800,000 regimens available, with the capacity to produce several million regimens if needed.

In September 2016, Johnson & Johnson completed a submission to the World Health Organization (WHO) for Emergency Use Assessment and Listing (EUAL) for the monovalent prime-boost vaccine regimen. The EUAL is a special procedure that can be implemented where there is an outbreak of a disease with high rates of morbidity or mortality and a lack of approved treatment or prevention options. If the WHO grants EUAL, this will accelerate the availability of Janssen’s investigational vaccine regimen to the international community in the event another Ebola crisis occurs.

Also in September 2016, Janssen began a first-in-human Phase 1 clinical study of its second-generation multivalent vaccine regimen for the Ebola, Sudan and Marburg viruses. The National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health, is funding the US study to test the safety, tolerability and immunogenicity of the multivalent Ebola vaccine regimen.

Videos

Johnson & Johnson boosts Ebola vaccine efforts

IFPMA 2014 Interview Series with Dr. Olga Popova

Ebola: Johnson & Johnson Racing to Develop a Vaccine

Partnership information

Company(ies) Johnson & Johnson

Partner(s) Bavarian Nordic, Biomedical Advanced Research and Development Authority (BARDA), Centre Muraz, Grameen Foundation, Innovative Medicines Initiative (IMI), INSERM / INTS (Institut National de la Transfusion Sanguine), London School of Hygiene and Tropical Medicine, University of Oxford, US National Institutes of Health (NIH), Vibalogics, World Vision

Type of Partner(s) Academia / Hospitals, Generic Manufacturers, Government, NGOs, Other Business

Therapeutic Focus Neglected Tropical Diseases

Disease(s) Ebola

Program Type(s) Prevention Programs - Vaccines, Research & Development - Development of Treatments

Targeted Population(s) Health professionals, Patients in needs of treatment

Region(s) Europe & Central Asia, North America, Sub-Saharan Africa

Number of Countries 14

Country(ies) Burkina Faso, Côte d'Ivoire, Denmark, France, Germany, Guinea, Kenya, Liberia, Netherlands, Sierra Leone, Switzerland, Uganda, United Kingdom, United States of America

Start Date 2014

More information J&J Ebola Vaccine Development

Anticipated completion date Ongoing

« With a strong heritage in collaborative partnerships, we aim to ultimately eradicate deadly diseases like Ebola and save lives. »

Paul Stoffels, M.D., Chief Scientific Officer of Johnson & Johnson