In contrast to 2014, news on the Ebola virus today is relatively minimal. However, Ebola outbreaks are still occurring, most recently in the Democratic Republic of Congo. This article reviews the response of the U.S. FDA to the Ebola virus and programs that have encouraged the availability of investigational medical countermeasures, including vaccines and diagnostic tests...

1. FDA’s Efforts to Respond to the Ebola Virus
By: Song Seto, Ph.D.
In contrast to 2014, news on the Ebola virus today is relatively minimal. However, Ebola
outbreaks are still occurring, most recently in the Democratic Republic of Congo. This article
reviews the response of the U.S. FDA to the Ebola virus and programs that have encouraged the
availability of investigational medical countermeasures, including vaccines and diagnostic tests.
During 2014-2015, more than 28,000 Ebola virus cases were reported in Guinea, Liberia, and
Sierra Leone. The virus, which can spread rapidly through bodily fluids of infected animals or
humans, caused 11,310 deaths. On August 5, 2014, the U.S. FDA authorized the use of a
diagnostic test developed by the U.S. Department of Defense to detect the Ebola Zaire virus via
RT-PCR. The authorization was granted through an Emergency Use Authorization (EUA),
which allows FDA to facilitate the availability and unapproved uses of medical countermeasures
(MCMs) needed to prepare for and respond to chemical, biological, radiological, and nuclear
(CBRN) emergencies. Besides meeting the requisite determination to justify the authorization,
the unapproved medical product must meet the following criteria:
- Addresses a serious or life-threatening disease or condition
- Has evidence of effectiveness
- Has undergone a risk-benefit analysis; and
- There are no alternatives to the candidate product
Due to the continual outbreaks of Ebola, FDA has reissued EUAs to authorize new diagnostic
tests for the detection of the Ebola virus. To date, there are 9 nucleic acid tests and 2 rapid
diagnostic tests that have received Ebola virus EUAs. The most recent was issued on November
9, 2018 and detects antigens with a battery-operated reader, allowing for screening outside of a
laboratory.
On May 8, 2018 an Ebola outbreak was announced in the Democratic Republic of Congo. In
August 2018, the outbreak was reported for the North Kivu Province, resulting in 357 deaths.
Unlike the situation in 2014, there are experimental Ebola vaccines currently being deployed to
at-risk populations. One vaccine, developed by Merck, V920 (rVSV∆G-ZEBOV-GP, live
attenuated), received the Breakthrough Therapy Designation from FDA in July 2016. The
Breakthrough Therapy Designation is intended to expedite the development and review of a
candidate drug that is planned for use, alone or in combination, to treat a serious or life-
threatening disease or condition when preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement over existing therapies on one or more clinically

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significant endpoints. On November 13, 2018, Merck initiated the submission of a rolling
Biologics License Application (BLA) to FDA for V920.
In recent years, FDA has had more authority and resources to advance the development of
countermeasures to address emerging threats. While the EUA process can still be lengthy, FDA
states that they are continually balancing the risk and benefits to ensure that investigational
products can provide benefits to patients. Coupled with initiatives such as the Breakthrough
Therapy Designation and the Breakthrough Device Designation, FDA is opening channels to
collaborate on promising new treatments.
Do you want to know more about the regulatory pathway for your medical device? Please
contact us at (248) 987-4497 or info@emmainternational.com.