Johnson & Johnson has made a commitment of 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), as well as 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 United States, and Africa starting in early January. Janssen is targeting production of more than one million doses of the vaccine regimen in 2015, 250,000 of which 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.

The commitment by Johnson & Johnson 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.In September, Johnson & Johnson 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 the NIAID, part of the NIH. Preclinical experiments conducted at the 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.

Johnson is also participating in the ongoing efforts by public health authorities, including the Centers for Disease Control and Prevention and the 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.

See related story, “Pharma Companies Seek to Ramp up Production for Experimental Ebola Treatments”

Source: Johnson & Johnson