With new collaboration, investigational Ebola vaccine regimen advances

Ebola virus disease (EVD), formerly known as Ebola haemorrhagic fever, is a severe, often fatal illness in humans. The virus is transmitted to people from wild animals and spreads in the human population through human-to-human transmission. The average EVD case fatality rate is around 50%. Case fatality rates have varied from 25% to 90% in past outbreaks. The first EVD outbreaks occurred in remote villages in Central Africa, near tropical rainforests. The 2014–2016 outbreak in West Africa involved major urban areas as well as rural ones.

Johnson & Johnson recently revealed that 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.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, they are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease. They bring together the best minds and pursue the most promising science.

The collaborative partnership with BARDA is believed will assist the company’s ongoing dedication to build up a novel prime-boost vaccine regimen to aid in thwarting the increase of Ebola. The financial support symbolizes one of the first of BARDA’s Project BioShield awards for investigational Ebola vaccines and drugs.

The BARDA agreement is the newest partnership that the Johnson & Johnson Family of Companies has engaged in to fight an extensive range of transmittable diseases with epidemic tendencies, including Zika, Influenza, HIV and TB.

“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$44.7 million, with alternatives for added financial support, over five years to help assist the development and potential licensure of the vaccine candidate. The routine includes a preliminary dose that primes the immune system to build up 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.”

KEMI AJUMOBI