COVID-19 Records

Attachment

Gates Package, p.55 · gates:exh:00029

Page text: p.55 · original PDF

Date
(unknown precision)
Type
attachment · document
Topics
VaccinesTherapeutics and treatmentsTesting and surveillanceIntelligence community assessments
exchange information about investigational products for Ebola in support of international response efforts, FDA is also providing technical support and scientific advice to WHO on the potential for the development and use of convalescent plasma in affected countries. © Issuing an Emergency Use Authorization for use of a diagnostic test--developed by DoD-- to detect the Ebola virus in laboratories designated by DoD. This test has been made available to 14 laboratories within the United States that are located close to ports-of-entry where travelers from West Africa frequently arrive in the United States, which will support the rapid diagnosis of any suspected cases of Ebola. © Monitoring for fraudulent products that claim to prevent or treat Ebola infection and taking actions, as warranted, to protect public health, For example, FDA recently issued warning letters to three firms marketing products that claim to prevent, treat, or cure infection with the Ebola virus. National Institutes of Health H): 'The NIH's National Institute of Allergy and Infectious Diseases (NIAID) is accelerating ongoing research efforts and partnering with governments and private companies throughout the world to speed the development of medical countermeasures that could help control the current Ebola epidemic and future outbreaks, NIAID research is focusing on understanding how Ebola causes and in people, and researchers are also working on the development of Ebola c tools, vaccines, and therapeutics, Specific activities include: * Providing support to and collaborating with Mapp Biopharmaceutical, Inc., to develop MB003--a combination of three antibodies that prevents Ebola in monkeys when administered as late as 48 hours after exposure, NIAID is also evaluating therapeutics licensed or in development for the treatment of other diseases for their potential activity against Ebola. * Advancing development of novel diagnostic tools that are capable of detecting Ebola and other viruses or antiviral antibodies, * Providing technical diagnostic support on-the-ground in Liberia, © Testing Ebola vaccine candidates, The NIAID Vaccine Research Center has a robust viral hemorrhagic fever vaccine development program, Two Ebola vaccine candidates are undergoing Phase 1 clinical testing this fall, NIAID will play a critical role in advancing these Ebola vaccine candidates. 'The results of these Phase I studies will inform essential discussions about whether and how such vaccines could be of use in the current epidemic or future Ebola outbreaks. Office of the Assistant Secretary for Preparedness and Response (ASPR)/ Biomedical Advanced Research and Development Authority (BARDA) ASPR/BARDA is supporting large-scale production of medical countermeasure: measure to the Ebola epidemic, Specific activities include: a response © Providing funding and technical assistance for the development and scaled-up manufacturing of the ZMapp monoclonal antibody therapeutic. © Working with DoD/DTRA and industry partners to scale up the manufacturing of one of several promising investigational Ebola vaccine candidates to commercial scale, 'Commented [DES/IMAC3]: Note to HHS: ASPR has their own Congressional open regarding their role in the response; will be Important to make sure the two responses are consistent.