From Merck:

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

Wednesday, December 23, 2015 8:30 am EST

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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: http://www.who.int/en/.

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, visit www.merck.com and connect with us on Twitter, Facebook, YouTube and LinkedIn.

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