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Under Project BioShield, the agency could provide more than $170 million in funding to purchase and support late-stage development of Ebola vaccines and therapeutic drugs.
The US Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA) will use Project BioShield funding to purchase up to approximately $170.2 million in vaccines and therapeutic drugs to treat Ebola infections, HHS announced on Sep. 29, 2017.
Under terms of the agreements, BARDA will provide Project BioShield funding for each company developing the Ebola vaccines and therapeutic drugs, to help them validate manufacturing processes and undertake final preparations for applying for approval with FDA. While regulatory filing and review processes move forward, the agreement would also allow BARDA to purchase the vaccines and drugs outright, so that they could be used in the event of a public health emergency.
The agency could purchase up to 1.13 million regimens of vaccine, including a single-dose vaccine from Merck & Co., as well as a two-dose vaccine from Janssen Vaccines and Prevention B.V., a Johnson & Johnson company. BARDA will also purchase a therapeutic drug from Mapp Biopharmaceutical, based in San Diego, CA, and a therapeutic drug from Regeneron Pharmaceuticals, based in Tarrytown, NY.
BARDA will provide $39.2 million for late-stage development and purchase of Merck’s single-dose vaccine, which showed potential efficacy during clinical testing in Guinea, West Africa, using a ring-vaccination protocol. The vaccine would be used for people at high risk of exposure to Ebola. The vaccine’s discovery was supported by the Public Health Agency of Canada, which partnered with the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, and the US Department of Defense (DoD) to fund early development.
Continued development of the vaccine was carried out by BioProtection Systems, a biotechnology subsidiary of NewLink Genetics, a US-based biopharmaceutical company. The vaccine’s continued development is supported by NIAID, BARDA, DoD, and international partners. Merck is expected to apply for licensure of the vaccine through FDA.
BARDA will also provide $44.7 million for late-stage development and purchase of Janssen’s two-dose vaccine, which would be used prophylactically by people who have not yet been exposed to Ebola but who could be, such as health care workers and the general public. This regimen requires an initial vaccination to protect against Ebola, followed by a second dose using different technology to boost the body’s immune response. This two-dose approach is currently in multiple Phase III studies. Janssen also received early funding from NIAID to conduct clinical studies of its two-dose vaccine in Guinea and Liberia in West Africa. It has since transitioned to BARDA’s advanced research and development program.
Under an agreement with Mapp Biopharmaceutical, BARDA will initially provide $45.9 million for late-stage development and initial purchase of ZMapp, a therapeutic drug that combines three monoclonal antibodies (mAbs) to bind certain proteins in the virus cell to neutralize it, decreasing the amount of virus in the body.
The drug was manufactured for a Phase I/II clinical trial during the 2014-2016 Ebola epidemic. It remains available and, through an expanded access protocol in the US and West Africa, the company can collect clinical data when it is used. Initial development of the drug was supported by NIAID and the Defense Threat Reduction Agency within DoD. BARDA facilitated the drug’s development, working in conjunction with those agencies and separately with the company to optimize and accelerate manufacturing.
Under the Regeneron agreement, BARDA will initially provide $40.4 million for late-stage development, and also buy a mAb manufactured from specialized Chinese hamster ovary cells. Regeneron used its proprietary technology to accelerate the drug’s development timeline and would be able to produce it in large volumes in the event of an emergency.
Ebola is considered a potential bioterrorism threat by the US Department of Homeland Security as well as a naturally occurring public health threat. Natural Ebola outbreaks occur most often in African countries, the most recent of which took place beween 2014 and 2016, according to HHS.