The European Medicines Agency, or EMA, has announced its conditional marketing authorization of a vaccine used to prevent the spread of the Ebola virus. University of Florida researchers played an integral role in the design and analysis of trials testing the effectiveness of the vaccine, manufactured by Merck.
Conditional authorization brings the vaccine a major step closer to licensing, which will eventually make the vaccine more widely available to protect people who are at risk of contracting Ebola.
The announcement by the European Medicines Agency (EMA), the European agency responsible for the scientific evaluation of medicines developed by pharmaceutical companies, is the preliminary step before the European Commission, the executive branch of the European Union, decides on licensing. At the same time, the WHO will move toward prequalification of the vaccine.
“My hope is that we can now integrate the vaccine and ring vaccination strategy in a seamless manner with an approved product,” said Dr. Ira Longini, a professor in the department of biostatistics at the University of Florida College of Public Health and Health Professions and the College of Medicine, and a key figure in the design and analysis of the Ebola vaccine trial. “This should make Ebola prevention and control even more effective than it is now and save even more lives.”
A randomized trial for the vaccine, known as rVSV-ZEBOV-GP, began during the Guinea outbreak in 2015. Dr. Longini collaborated with Dr. Natalie Dean, a UF assistant professor of biostatistics, and an international team working with the WHO to use a ring vaccination approach.
In findings published in The Lancet, the researchers reported that the vaccine is nearly 100 percent effective at preventing Ebola when given 10 or more days before exposure.Friday Letter Submission, Publish on October 25