World Health Organization to Review Merck’s Investigational Ebola Vaccine for Emergency Use Assessment and Listing


December 23, 2015 8:30 am ET

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada,
announced today that the application for Emergency Use Assessment and
Listing (EUAL) for the company’s investigational Ebola Zaire vaccine,
V920 (rVSV∆G-ZEBOV-GP, live attenuated), has been accepted for review by
the World Health Organization (WHO).

According to the WHO, the EUAL process is designed to expedite the
availability of vaccines needed for public health emergencies such as
another outbreak of Ebola. The procedure is intended to assist United
Nations’ procurement agencies and Member States on the acceptability of
using a vaccine candidate in an emergency-use setting. EUAL designation
is not prequalification by WHO, but rather is a special procedure
implemented when there is an outbreak of a disease with high rates of
morbidity and/or mortality and a lack of treatment and/or prevention
options. In such instances, WHO may recommend making a vaccine available
for a limited time, while further clinical trial data are being gathered
for formal regulatory agency review by a national regulatory authority.

“This application to the WHO is an important step toward enabling V920
to be used if a public health emergency of international concern were to
be declared for the Ebola Zaire species prior to licensure of the
vaccine candidate,” said Paula Annunziato, M.D., vice president for
clinical research, Merck Research Laboratories.

The decision to grant V920 EUAL status will be based on data regarding
quality, safety, and efficacy/effectiveness; as well as a risk/benefit
analysis for emergency use. While EUAL designation allows for emergency
use, the vaccine remains investigational and has not yet been licensed
for commercial distribution.

For more information on the WHO’s EUAL process please visit:

V920 was initially engineered by scientists from the Public Health
Agency of Canada and was licensed to a subsidiary of NewLink Genetics
Corporation. In late 2014, when the current Ebola outbreak was at its
worst, Merck licensed V920 from NewLink Genetics, with the goal of
accelerating the assessment of this candidate vaccine. Since that time,
Merck has helped to enable a broad development program working with a
number of external collaborators. Research evaluating V920 is ongoing in
Phase 1, 2 and 3 clinical trials at sites in Africa, the United States,
Canada, and the European Union.

Merck is now responsible for research, development and manufacturing
efforts in support of V920. Merck has committed to work closely with
other stakeholders to accelerate the continued development, production
and, if licensed, distribution of the vaccine.

About Merck

Today’s Merck is a global health care leader working to help the world
be well. Merck is known as MSD outside the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies and
animal health products, we work with customers and operate in more than
140 countries to deliver innovative health solutions. We also
demonstrate our commitment to increasing access to health care through
far-reaching policies, programs and partnerships. For more information,
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Pamela Eisele, 267-305-3558
Skip Irvine, 215-652-6059
Teri Loxam, 908-740-1986
Justin Holko, 908-423-5088

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