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Janssen to produce more than one million doses of the investigational vaccine regimen in 2015
October 22, 2014
By: Kristin Brooks
Johnson & Johnson has made a commitment of as much as $200 million to accelerate and significantly expand the production of an Ebola vaccine program in development at its Janssen Pharmaceutical Companies. The company is 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 combines a Janssen preventative vaccine with a vaccine from Bavarian Nordic, a biotechnology company based in Denmark, which has shown promising results in preclinical studies. It will be tested for safety and immunogenicity in healthy volunteers in Europe, the U.S. and Africa in early January. Janssen is targeting production of more than one million doses of the vaccine regimen in 2015, 250,000 of which may be released for broad application in clinical trials by May 2015. 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. In September, J&J and Bavarian Nordic fast-tracked 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. “We are urgently working to provide our vaccine expertise, production capabilities, our people and resources to address the Ebola crisis,” said Alex Gorsky, chairman and chief executive officer, Johnson & Johnson. “Our innovation model enables us to quickly mobilize our extensive resources to collaborate with health authorities and governments and other experts to help contain this disease, save lives, and protect the health and lives of those at risk. We have an important responsibility as a leading global healthcare company to do all we can to address this urgent unmet medical need.” “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, M.D., 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.”
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