The development of a medication to treat Ebola will be accelerated under a contract awarded by the Office of the Assistant Secretary for Preparedness and Response www.phe.gov/about/aspr/pages/default.aspx (ASPR) within HHS. The contract supports the government-wide response to the Ebola outbreak in West Africa.
ASPR’s Biomedical Advanced Research and Development Authority at www.phe.gov/about/barda/pages/default.aspx (BARDA) will provide the funding as well as access to subject matter expertise and technical support for manufacturing, regulatory, and nonclinical activities through a $24.9 million 18 month contract awarded to Mapp Biopharmaceutical Inc. www.mappbio.com located in San Diego. ASPR can also extend the contract up to $43.3 million.
Work under the contract supports the development and manufacturing of the medication ZMapp to treat Ebola. “While ZMapp has received a lot of attention, it is one of several treatments under development for Ebola, but we still have very limited data on its safety and efficacy”, explained Dr. Nicole Lurie, Assistant Secretary for Preparedness and Response.
Previously, the Defense Threat Reduction Agency www.dtra.mil (DTRA) within DOD and NIH’s National Institute of Allergy and Infectious Diseases www.niaid.nih.gov (NIAID) supported initial work on this product.
To speed the development of ZMapp, BARDA will work closely with DTRA and NIAID. BARDA will also work with Mapp Biopharmaceutical to optimize and accelerate the manufacturing of ZMapp so testing can be done as soon as possible.
BARDA is working with other agencies to accelerate the development of Ebola therapeutics and vaccines and to optimize and expand production. BARDA is exploring whether their Centers for Innovation in Advanced Development and Manufacturing www.medicalcountermeasures.gov/barda/core-services/ciadm.aspx has data on other measures to accelerate the manufacturing time.
In addition, BARDA is seeking additional proposals for the advanced development of antibody treatments, antiviral drugs, and vaccines against the Ebola and Marburg viruses, since both can cause viral hemorrhagic fever. Program requirements are included in BARDA’s Broad Agency Announcement (BARDA-BAA-13-100-SOL-00013) at https://www.fbo.gov.