OR WAIT null SECS
As part of the international effort to develop vaccines that protect against Ebola and similar viruses, the advanced development of an experimental vaccine regimen will take new steps with support from a four-year, $28.5 million agreement between the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR) and Crucell Holland, B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, in the Netherlands.
“History has shown that Ebola doesn’t really disappear – there have been roughly 35 outbreaks in the past forty years – so we need to be fully prepared for the future with licensed vaccines and therapies for this disease,” explains Robin Robinson, PhD, director of ASPR’s Biomedical Advanced Research and Development Authority (BARDA), the office that will manage the project. “By pursuing multiple Ebola vaccines and leveraging innovative technology, we can address biodefense needs here in the United States while spurring affordable options for global use.”
The experimental Ebola vaccine regimen being developed has two components, a prime and a boost. The prime, Ad26.ZEBOV, is made by Crucell Holland, B.V., and the boost, MVA-BN-Filo, is made by Bavarian Nordic A/S of Kvistgaard, Denmark.
The first clinical studies of the Ebola prime-boost vaccine regimen began in the United States and the United Kingdom in January and a phase 2 study followed in July. While studies continue, BARDA will focus on supporting manufacturing development of the prime and boost vaccines.
Today’s agreement includes process optimization, characterization and validation of manufacturing processes; stability studies; fill-finish manufacturing; technology transfer between the two companies, and related activities. This work is critical to making these vaccines available and is necessary for each company to apply for licensure through the U.S. Food and Drug Administration. The agreement can be extended for up to a total of seven years and approximately $69 million.
In addition, BARDA has the option to use clinical grade material developed through this project to provide vaccine for clinical studies comparing the safety and immunogenicity of different formulations of the boost vaccine when given in combination with Crucell Holland, B.V.’s, Ad26.ZEBOV prime vaccine.
BARDA supported the late stage development of the technology used to produce MVA-BN-Filo as part of a smallpox vaccine development project. BARDA later purchased that smallpox vaccine for the Strategic National Stockpile.
HHS enhances and protects the health and well-being of all Americans by providing for effective health and human services and fostering advances in medicine, public health, and social services.
ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. To learn more about preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, www.phe.gov.
Within ASPR, BARDA develops and procures medical countermeasures – vaccines, medicines, diagnostics and medical equipment – that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.