Johnson & Johnson has formed a consortia with leading global research institutions and non-government organizations to work in conjunction with Janssen Pharmaceutical to accelerate the development of its Ebola vaccine regimen. The Innovative Medicines Initiative (IMI) plans to award these consortia grants totaling more than $116 million from the Ebola+ program to support the development, manufacturing and patient education for the vaccine regimen.
The IMI is Europe's largest public-private initiative aiming to speed up the development of better and safer medicines for patients. Funding for the IMI Ebola+ program comes in part from Horizon 2020, the European Union's research and innovation program, and in part in the form of in-kind contributions from the European Federation of Pharmaceutical Industries and Associations (EFPIA) partners in the projects.
"In the face of the global challenge of Ebola, bringing together the expertise and capabilities of the pharmaceutical industry, academic centers and NGOs will be critical to help solve this crisis," said Paul Stoffels, M.D., chief scientific officer and worldwide chairman, pharmaceuticals, Johnson & Johnson. "The European Commission's support through IMI bolsters collaboration that should significantly accelerate efforts to help address this humanitarian crisis."
"It is great to see the multiple partners come together to accelerate the development of an effective vaccine both for the current epidemic and future outbreaks," said professor Peter Piot, M.D., director of the London School of Hygiene & Tropical Medicine, one of the consortia partners. "This is an opportunity to make sure that this is the last Ebola epidemic in which our only tools to control it are isolation and quarantine."
The funds were announced to support several consortia working together on a total of four projects. Three of the projects are designed to address the need to accelerate phase I, II and III trials and scale up production of the prime-boost vaccine regimen. A phase I trial led by Oxford Vaccines Group currently is underway with trials in Africa being planned. The phase II and III trials in Europe and Africa, subject to review of the preliminary phase I data, will be carried out in parallel. A fourth project will investigate innovative ways and technology to raise awareness and acceptance of vaccination campaigns. A total of eight projects are being funded under this round of the IMI's Ebola+ program.
"With people still contracting this disease, there is still a risk that Ebola will continue to spread and that we could have another major outbreak in the future," said Johan Van Hoof, M.D., global head of infectious diseases and vaccines, Janssen.
Professor Andrew Pollard and Dr. Matthew Snape, who are leading the phase I and II Ebola vaccine trials at the University of Oxford for IMI, said, "The initial testing of vaccines for Ebola already is underway at the university with an astonishing response from the public to volunteer for the trials, to provide the earliest possible information to guide further studies of a prime boost vaccine, that if approved, may help control the Ebola outbreak in West Africa."
Organizations joining Janssen include the London School of Hygiene & Tropical Medicine, University of Oxford, Institut National de la Sante et de la Recherche Medicale (INSERM), La Centre Muraz, Bavarian Nordic, Vibalogics, Grameen Foundation and World Vision of Ireland.
On Jan. 6, Johnson & Johnson announced the start of a phase I, first-in-human clinical trial of a preventive Ebola vaccine in development at Janssen Pharmaceutical. The trial is being led by the Oxford Vaccine Group, part of the University of Oxford department of pediatrics.
J&J also announced Janssen, in partnership with Bavarian Nordic, has produced more than 400,000 regimens of the prime-boost vaccine for use in large-scale clinical trials by April 2015. A total of two million regimens is projected to be available through the course of 2015, with the ability to quickly scale up to a projected five million regimens, if required, over a 12- to 18-month period.
In October, J&J announced a commitment of up to $200 million to accelerate and significantly expand production of an Ebola vaccine program in development at Janssen Pharmaceutical. The company has been seeking to share the financial risk of these vaccine and development clinical trial costs by pursuing governmental and non-governmental funding sources.