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Gates Package, p.55 · gates:exh:00029
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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.
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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,
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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.