Johnson & Johnson has announced that Janssen Vaccines & Prevention B.V., one of its Janssen Pharmaceutical Companies, will further advance its investigational Ebola vaccine regimen with a new award from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services.

The collaborative partnership with BARDA will support the company’s ongoing commitment to develop a novel prime-boost vaccine regimen to help prevent the spread of Ebola.

“Developing effective Ebola vaccines will be critical if we are to combat potential future outbreaks and protect frontline healthcare workers as well as the families and friends of Ebola victims,” said Paul Stoffels, M.D., Chief Scientific Officer of Johnson & Johnson.

“This award underscores the importance of public-private partnerships in tackling global health challenges. Our effort to accelerate the development of Janssen’s Ebola vaccine candidate to date would not have been possible without support from a wide range of global funders, including the National Institutes of Health (NIH), Europe’s Innovative Medicines Initiative (IMI), and the U.S. Department of Defense (DoD).”

Under the agreement, BARDA will provide funding of US$44.5 million, with options for additional funding, over five years to help support the development and potential licensure of the vaccine candidate.

The novel regimen involves an initial dose that primes the immune system to develop disease-specific immune responses, followed by a booster dose with the goal of potentially strengthening and optimizing the duration of the response.

The regimen uses a combination of two components based on AdVac® technology from Janssen Vaccines & Prevention B.V., and MVA-BN® technology from Bavarian Nordic.

Janssen first began work on Ebola vaccine development in collaboration with the NIH. Then during the 2014-2016 Ebola outbreak in West Africa, Johnson & Johnson accelerated Janssen’s vaccine program with a company commitment in excess of US$200M, and additional grants totaling more than €100M in funding from IMI/European Commission to support multiple clinical trials.

BARDA previously awarded funding in 2015 and 2016 that focuses on optimizing manufacturing processes for the vaccine, and the new agreement will strengthen support for the program.

“Never before has Johnson & Johnson mobilized resources so rapidly to accelerate a vaccine candidate – supporting the initiation of multiple clinical trials across three continents in just one year,” said Johan Van Hoof, M.D., Global Head of Infectious Diseases & Vaccines, Janssen.

“Thankfully, the Ebola crisis in West Africa is over, but we and other vaccine manufacturers remain determined to ensure that Ebola vaccines are successfully developed and made available to the world.”

A total of 11 Janssen-sponsored phase 1, 2 and 3 clinical studies of the Ebola vaccine regimen are being conducted across Europe, the United States and Africa.

Final clinical data from a Phase 1 study conducted in the UK were published in March 2017 in JAMA: The Journal of the American Medical Association, following publication of preliminary results in the Journal in April 2016.

In this study, 100 percent of healthy volunteers receiving the vaccine regimen generated an Ebola virus-specific antibody response that was sustained to at least 1 year following vaccination.

In September 2016, based in part on these data, the company filed for Emergency Use and Assessment Listing (EUAL) for the vaccine regimen with the World Health Organization, which is under review.

The 2014-2016 Ebola virus outbreak in West Africa was the largest outbreak since the virus was discovered 40 years ago.

The outbreak caused over 11,000 deaths, including more than 500 health care workers.

“History teaches us that Ebola will return-as we recently saw in the Democratic Republic of Congo,” said Professor Peter Piot, Director of the London School of Hygiene & Tropical Medicine (LSHTM) and part of the team that first isolated Ebola virus.

“These ongoing outbreaks demonstrate the importance of disease surveillance and management, the value of strong health systems, and the need to finish the job of developing safe and effective vaccines to help protect communities and prevent a resurgence of the virus. It is within our power, working in partnership, to prevent a future pandemic.” LSHTM is one of Janssen’s partners in the Ebola vaccine clinical research program.

The BARDA agreement is the latest collaboration that the Johnson & Johnson Family of Companies has engaged in to combat a wide range of infectious diseases with pandemic potential, including Zika, Influenza, HIV and TB.

Janssen’s investigational Ebola vaccine regimen was developed in a collaborative research program with the National Institutes of Health (NIH) and received direct funding and preclinical services from the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, under Contract Numbers HHSN272200800056C, and HHSN272201000006I and HHSN272201200003I, respectively.

BARDA previously awarded Janssen a total of US$44.6 million in 2015 and 2016 under contract HHSO100201500008C to help optimize manufacturing systems and capacity for the vaccine regimen, including heat-stability studies to verify that the regimen was optimized for use in African countries, and final product manufacturing and quality control activities.