NEW BRUNSWICK, NJ—Johnson & Johnson (J&J) on January 16 announced it is forming a cooperative with leading global research institutions and non-government organizations to work together to speed up development of its Ebola vaccine regimen.
The Innovative Medicines Initiative (IMI), Europe’s largest public-private partnership will provide funding grants totaling more than 100 million euros ($115 million) from the Ebola+ program to support the development, manufacturing and patient education for the vaccine regimen.
Funding for the IMI Ebola+ program comes from Horizon 2020, the European Union’s research and innovation program, and from in-kind contributions made by the European Federation of Pharmaceutical Industries and Associations (EFPIA) partners in the projects, said the company.
The cooperative is also supported by the European Commission.
“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 Dr. Paul Stoffels, Chief Scientific Officer and Worldwide Chairman of Pharmaceuticals at J&J.
“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 Dr. Peter Piot, 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 will support several groups which are working together on a total of four projects.
While three of the projects will address the need to speed up 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 is currently planning trials in Africa.
The Phase II and III trials in Europe and Africa, subject to review of the preliminary Phase I data, will take place at the same time.
A fourth project will study innovative ways to raise awareness and acceptance of vaccination campaigns.
In all, eight projects are being paid for 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 Dr. Johan Van Hoof, Global Head of Infectious Diseases and Vaccines, Janssen.
“We highly appreciate the European Commission’s support and are pleased to be joined by them and our distinguished partners in further accelerating our goal of bringing this vaccine, if approved, to families and frontline health care professionals as fast as possible.”
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 is already underway there, describing “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.”
The organizations joining J&J’s Janssen Pharmacueticals division in the effort 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 A/S, Vibalogics, and Grameen Foundation and World Vision of Ireland.
As we reported, J&J announced on January 6 the start of a Phase I, first-in-human clinical trial of a preventive Ebola vaccine in development at Janssen. The trial is being led by the Oxford Vaccine Group, part of the University of Oxford Department of Paediatrics.
J&J also announced that Janssen, in partnership with Bavarian Nordic A/S, has already produced more than 400,000 regimens of the prime-boost vaccine for use in large-scale clinical trials by April 2015.
A total of 2 million regimens are projected to be available this year, with the ability to quickly scale up to a projected 5 million regimens, if required, over a period of 12 to 18 months.
Last October, J&J announced a commitment of up to $200 million to accelerate and significantly expand production of an Ebola vaccine program. 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.
“The Grant Agreements for all IMI projects involving Janssen under the first call of the Ebola+ program are still being finalized. Final information on all selected projects, including full budget details, will be published once, and if, the Grant Agreements have been signed,” reads a note from J&J.
In December, the GAVI Vaccine Alliance, a leading public-private partnership organization, gave the three drug makers independently working on a vaccine more motivation to get the vaccines ready quickly.
Gavi said it would guarentee $300 million to procure a safe and effective vaccine once it could be recommended for use by the World Health Organization (WHO).
“The Ebola outbreak, and its tragic effect on countries where we have been working for years, has tested Gavi’s ability to respond quickly to an urgent need and I am proud of the decision taken by the Board today,” said Gavi CEO, Dr. Seth Berkley.
“The Ebola outbreak reminds us of the critical importance of vaccines in fighting infectious diseases. The Board’s decision underlines Gavi’s commitment to support the people of the Ebola-affected countries by ensuring that they will have access to a WHO-recommended vaccine as soon as one is approved and available from manufacturers,” said Berkley.
“We are making determined efforts to ensure that people living in Ebola-affected countries are protected as soon as possible and do not have to face another terrible outbreak in the future.”
In a newspaper report on this topic, one reader commented, “The Scripps Research Institute’s Ollmann Saphire laboratory has started a project to find a vaccine for Ebola using resources of the World Community Grid and BOINC. They are using the AutoDock and AutoDock VINA software… I wonder if J&J would consider collaborating with this project.”