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Johnson & Johnson (J&J) committed up to $200 million to accelerate and significantly expand the production of an Ebola vaccine program in development at its Janssen Pharmaceutical Companies. The company is closely collaborating with the World Health Organization (WHO), the National Institute of Allergy and Infectious Diseases (NIAID), and other key stakeholders, governments, and public health authorities on the clinical testing, development, production, and distribution of the vaccine regimen.
The vaccine regimen, which was discovered in a collaborative research program with the National Institutes of Health (NIH), combines a Janssen preventative vaccine with a vaccine from Bavarian Nordic, a biotechnology company based in Denmark. This combination vaccine regimen has shown promising results in preclinical studies and is now planned to be tested for safety and immunogenicity in healthy volunteers in Europe, the US, and Africa starting in early January. Janssen is targeting production of more than one million doses of the vaccine regimen in 2015. Of these, 250,000 doses are expected to be released for broad application in clinical trials by May 2015.
The regimen consists of two vaccine components that are based on AdVac technology from Crucell Holland B.V., which is part of the Janssen Pharmaceutical Companies, and the MVA-BN technology from Bavarian Nordic. The research collaboration for a monovalent vaccine targeting the Zaire strain of the Ebola virus is part of an ongoing development program for a multivalent vaccine against other virus strains that cause disease in humans, including Ebola and Marburg viruses.
As part of an overall commitment to advance innovations that address unmet medical needs worldwide, a team of dedicated experts has been assigned to focus on bringing this preventative vaccine to people in need. The commitment by J&J includes an equity investment in Bavarian Nordic to provide capital for the development, testing, and production of Bavarian Nordic’s vaccine. Janssen will take the lead in funding and developing both components of the combination vaccine regimen.
“Our goal to produce more than a million vaccines in the next few months is within reach,” says Paul Stoffels, MD, chief scientific officer of J&J and worldwide chairman, Pharmaceuticals. “Ebola is a significant and growing threat to the people of West Africa and it has the potential to impact people around the world. We are committed to bringing our science, technology, innovation, and resources to help prevent and treat this deadly disease.”
“In preclinical testing conducted in partnership with the National Institutes of Health, the combination vaccine regimen has shown complete protection against Ebola,” said Johan Van Hoof, MD, global head, Infectious Diseases and Vaccines, Janssen. “Using our PER.C6 high density cell production technology, we have been able to produce large quantities of the Janssen component of the vaccine regimen in testing batches, and we have already started production toward our goal to have these vaccines available for clinical testing in the next several months.”
In September, J&J and Bavarian Nordic first announced they would fast-track the development and clinical testing of the vaccine program, which features a prime-boost regimen in which one vector is used to prime and the other to boost the immune response.
The program has received direct funding from, and is also using, preclinical services from NIAID. Preclinical experiments conducted at NIH of the combination vaccine regimen demonstrated that when both vaccines were administered two months apart, complete protection was achieved against the Kikwit Zaire strain of Ebola, which is highly similar to the virus that is the cause of the current outbreak in Western Africa.
The emergence of Ebola in West Africa has strained the health care systems of Liberia, Sierra Leone, and Guinea. The company’s long tradition of disaster response has prompted support of Direct Relief International’s efforts in this area as well as the efforts of other relief organizations. J&J is also participating in the ongoing efforts by public health authorities, including the Centers for Disease Control and Prevention and WHO, to mount a coordinated world response to address the immediate needs raised by the Ebola outbreak. The company is also seeking to secure additional partners and resources to assist in its efforts to increase vaccine production and further speed up the clinical trial program.
Source: Johnson & Johnson
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