J&J Gets Federal Mfg Grant for Ebola Vaccine

Crucell Holland B.V., one of its Janssen Pharmaceutical Companies of Johnson & Johnson, has been awarded $28.5 million from The Biomedical Advanced Research and Development Authority (BARDA), part of the US. Department of Health and Human Services, to help accelerate the development of its investigational Ebola prime-boost vaccine regimen. The regimen, which is currently being tested in clinical studies, uses a combination of two components based on AdVac technology from Crucell Holland B.V. and MVA-BN technology from Bavarian Nordic, a Danish biotechnology company

The agreement involves a five-year commitment, with options for an additional $40.5 million funding, to optimize manufacturing systems and capacity for the vaccine regimen, including technology transfers to large-scale production facilities, heat-stability studies to verify that the regimen is optimized for use in African countries, and final product manufacturing and quality control activities.

Phase I clinical studies of the prime-boost vaccine regimen began in the United Kingdom and United States in December 2014, followed by several sites in Africa. A Phase II study, to be carried out in the UK and France, started in July 2015, and plans are advanced for beginning a safety and immunogenicity study in Sierra Leone and additional Phase II studies outside the outbreak area in Africa. While clinical studies continue, BARDA will focus on supporting manufacturing development of the regimen's prime and boost components.

Prime-boost vaccine regimens involve an initial dose that primes the immune system to develop disease-specific antibodies, followed by a booster dose at a later date that can strengthen and optimize the duration of the immune response. A number of widely used vaccines use a multi-dose approach to create stronger and longer-lasting immunity, including some for polio, rotavirus and HPV.

Janssen, in partnership with Bavarian Nordic, has produced drug supply for more than 800,000 regimens and is set-up to be able to produce a total of 2 million regimens of the Ebola vaccine regimen during the course of 2015.

Janssen's investigational Ebola vaccine regimen was discovered in a collaborative research program with the National Institutes of Health (NIH), and uses a prime-boost combination of two components that are based on AdVac technology from Crucell Holland and the MVA-BN technology from Bavarian Nordic. This program received direct funding and preclinical services from the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH. In October 2014, Johnson & Johnson announced a commitment to accelerate and significantly expand production of an Ebola vaccine program in development at its Janssen Pharmaceutical Companies. In January 2015, the Innovative Medicines Initiative (IMI) awarded a consortia of leading global research institutions and non-government organizations working in conjunction with the Janssen Pharmaceutical Companies grants totaling more than EUR 100 million ($111 million) from the Ebola+ program to support the development, manufacturing, and deployment of the vaccine regimen. 

Source: Johnson & Johnson

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