unapproved medical products or unapproved uses of approved medical
products to be used in Ebola R& D between 2014 and 2016.119 The FDA is
also co-sponsoring post-outbreak Ebola R& D. In May 2016, the agency
issued a $3.6 million contract to Stanford University to conduct studies on
survivors of the outbreak.120 But even with added institutional support arising
from biosecurity concerns—which Zika lacked—by the time Ebola vaccine
trials began, the number of reported cases had already began declining121 and,
as of early 2017, there is no approved vaccine.122
While the real question is whether the voucher program will be able to
incentivize future innovation on Ebola, Zika, and similar diseases, it bears
noting that the partnerships to speed up R& D on Ebola and Zika formed
before the inclusion of these viruses on the voucher-eligible list. A simple
look at the chronology of the response to Ebola puts the significance of
expanding the program to cover Ebola into perspective. The West Africa
outbreak began in March 2014, but the WHO did not declare it an emergency
until mid-August.123 Congress added Ebola to the voucher program in
December 2014.124 Meanwhile, the aforementioned recombinant vaccine
(rVSV) was licensed to an American pharmaceutical company in 2010,
received funding by BARDA in 2014-2015, and underwent phase I clinical
trials from late 2014 to early 2015.125 A bivalent vaccine (cAd3-EBO-Z) was
developed with partial funding from NIH and the NIAID and entered clinical
trials in 2014.126 Several other vaccine candidates followed similar
119. U.S. FOOD & DRUG ADMIN., EMERGENCY USE AU THORIZATIONS: 2014 EBOLA VIRUS
EMERGENCY USE AUTHORIZATION,
http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm#ebola
(last updated Mar. 7, 2017).
120. U.S. FOOD & DRUG ADMIN, SURVIVOR STUDIES: BETTER UNDERSTANDING EBOLA’S
AFTER-EFFECTS TO HELP FIND NEW TREATMENTS,
http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/M
CMRegulatoryScience/ ucm500274.htm (last updated Jan. 31, 2017).
121. See Kai Kupferschmidt, Second Ebola Vaccine Trial May Be Too Little, Too Late,
SCI. MAG. (Apr. 14, 2015), http://www.sciencemag.org/news/2015/04/second-ebola-vaccine-
trial-may-be-too-little-too-late.
122. There is however hope that a vaccine might soon reach the market. See Final Trial
Results Confirm Ebola Vaccine Provides High Protection Against Disease, WORLD HEALTH
ORG., (Dec. 23, 2016), http://www.who.int/mediacentre/news/releases/2016/ebola-vaccine-
results/en/.
123. Media Centre Statement, World Health Org., Statement on the 1st meeting of the
IHR Emergency Committee on the 2014 Ebola Outbreak in West Africa (Aug. 8, 2014),
http://www.who.int/mediacentre/news/statements/2014/ebola-20140808/en/.
124. See S.2917 - Adding Ebola to the FDA Priority Review Voucher Program Act; X
see also Public Law No: 113-233, Dec. 16, 2014.
125. J. A. Regules et al.,
A Recombinant Vesicular Stomatitis Virus Ebola Vaccine, NEW
ENG. J. MED. 330, 331 (Jan. 26, 2017),
http://www.nejm.org/doi/full/10.1056/NEJMoa1414216#t=article.
