The European Medicines Agency, or EMA, has announced its conditional marketing authorization of a vaccine used to prevent the spread of the Ebola virus. UF 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 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 World Health Organization 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 Ira Longini, Ph.D., a professor in the department of biostatistics at the College of Public Health and Health Professions and the College of Medicine, and a key figure in the design of the Ebola vaccine trial and the analysis of its statistical data. “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. Longini collaborated with Natalie Dean, Ph.D., a UF assistant professor of biostatistics, and an international team working with the WHO to use a ring vaccination approach to test the new vaccine.
With ring vaccination, people in contact with those who have contracted a virus — including family members, neighbors and co-workers — receive the vaccination. It is the same approach used in the consolidation phase in the eradication of smallpox.
In findings published in the journal Lancet in 2016, the researchers reported that the vaccine is nearly 100% effective at preventing Ebola when given 10 or more days before exposure.
The strategy is being used in the current Ebola outbreak in the Democratic Republic of the Congo. More than 236,000 people have been vaccinated, including more than 60,000 health and frontline workers in the country and neighboring countries of Uganda, South Sudan, Rwanda and Burundi.