WHO to review MSD’s Ebola vaccine for emergency use
pharmafile | December 24, 2015 | News story | Manufacturing and Production, Research and Development | Ebola vaccine, Ebola virus, MSD, WHO, Zebov
The World Health Organisation (WHO) has accepted MSD’s application for the company’s investigational Ebola vaccine, V920 (Zebov), to be reviewed as a drug for Emergency Use Assessment and Listing (EUAL).
WHO says the EUAL process is designed to expedite the availability of vaccines needed for public health emergencies, such as another outbreak of the Ebola virus. The procedure assists United Nations’ procurement agencies and Member States on which vaccine candidates to use in an emergency-use setting.
EUAL designation is a special procedure implemented when there is an outbreak of a disease with high rates of morbidity and/or mortality, when a lack of treatment and/or prevention options are available. In the event of a future Ebola outbreak, WHO may recommend making the vaccine available for a limited time, while further clinical trial data are being gathered for formal regulatory review.
Zebov 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 it from NewLink Genetics, with the goal of accelerating the assessment of this candidate vaccine. Research evaluating the vaccine is ongoing in Phase I, II and III clinical trials at sites in Africa, the United States, Canada, and the European Union.
The first trial results were published in July, which suggested the vaccine provides high protection against the disease as early as ten days after vaccination. WHO will use this data and data from the other ongoing trials in making its decision on whether or not to grant EUAL status.
“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,” says Paula Annunziato, vice president for clinical research, Merck Research Laboratories.
Joel Levy
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