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Johnson and Johnson announced that it would submit its Ebola vaccine research program to the European Medicines Agency (EMA) for a listing permit.
The company's Jeansan division is seeking permission to prevent Ebola virus disease (EVD), a species of Ebola virus in Zaire.
The company confirmed that the two-dose program (Ad26.ZEBOV, MVA-BN-Filo) was submitted simultaneously to support each vaccine on the basis of the decision of the European Medicines Agency's Human Medicines Commission (CHMP) to approve an accelerated evaluation of these applications in September.
"Given that the world's largest Ebola outbreak occurred only six years ago, and the latest outbreak is currently occurring in the Democratic Republic of the Congo, it is critical that we ensure that the world is prepared for Ebola," said Paul Stoffel, chief scientific officer at Johnson and Johnson.
"Based on the understanding that vaccines play an important role in responding to the threat of the epidemic, we look forward to the European Medicines Agency reviewing our licensing applications," he added.First, second and third phase clinical study data assessing the safety and immunogenicity of adult and child vaccine programmes, as well as data from more than 6,500 volunteers from more than 10 clinical studies in the United States, Europe and Africa, supported the application for a listing permit.Currently, the company is also in discussions with the U.S. Food and Drug Administration (FDA) to determine the data set required to submit the Ebola vaccine program under fdatic licensing under the U.S. Food and Drug Administration's animal regulations. (cyy123.com)