Merck’s Ebola Vaccine Receives Breakthrough Therapy Designation from FDA and PRIME Status from EMA
Merck achieved big milestone by receiving the Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) and PRIME (PRIority MEdicines) status from the European medicines Agency (EMA) for its investigational vaccine for Ebola Zaire, V920 (rVSV-ZEBOV, live attenuated).
Merck handles research, development, manufacture and regulation of V920. It was first engineered by scientists from the Public Health Agency of Canada’s National Microbiology Laboratory which was later licensed to a subsidiary of NewLink Genetics Corporation.
Ebola hit its peak, with the disease spreading all over Africa, in 2014. It was then Merck licensed V920 from NewLink Genetics. The company aimed to bolster the development, licensure and availability of the vaccine.
Merck and NewLink Genetics have since worked together on a broad clinical development program, funded by the U.S. Government including the Department of Health and Human Service’s Biomedical Advanced Research Development Authority (BARDA) and the Department of Defense’s Defense Threat Reduction Program/Joint Vaccination Acquisition Program (DTRA/JVAP) among others.
The international organization, Gavi (global alliance for vaccines and immunizations) had signed a historic $5 million deal with Merck in advance before the licensing of the drug. It was an advance commitment to purchase the vaccines being developed by the Merck as a measure to keep the supply of vaccine available for potential outbreaks of deadly Ebola virus in Gavi-eligible countries.
The V920 had shown excellent results in its late-stage clinical trials and it is expected that Merck will submit the vaccine for regulatory approval by 2017.
Ebola virus disease is a fatal viral fever caused in humans due to ebola viruses. EBOV virus formerly known as Zaire ebolavirus is one of the most deadly virus which causes ebola virus fever. It can spread by direct contact of body fluids, The infected person has 50% chance of death.
“The granting of Breakthrough Therapy Designation by the FDA and PRIME status by the EMA will enable us to continue to accelerate development of V920, and we greatly appreciate the collaboration of these agencies in moving this vaccine candidate forward in potentially meeting this public health need,”-Paula Annuziato, M.D., vice president for clinical research, Merck Research Laboratories.
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