Bavarian Nordic has announced that Janssen Vaccines & Prevention has completed a submission to the World Health Organization (WHO) for Emergency Use Assessment and Listing (EUAL) for its investigational preventive Ebola prime-boost vaccine regimen, which includes Bavarian Nordic's MVA-BN Filo vaccine. The EUAL is a special procedure that can be implemented when there is an outbreak of a disease with high rates of morbidity or mortality and a lack of treatment or prevention options.
EUAL assists UN Member States and procurement agencies determine the acceptability for use of a specific vaccine in a public health emergency. The decision to grant EUAL to the investigational vaccine regimen will be based on an evaluation of available data including quality, safety, and immunogenicity, as well as a risk/benefit analysis. While EUAL potentially allows for deployment of a vaccine in an emergency, the vaccine remains investigational pending formal regulatory agency review and approval.
Paul Chaplin, president and chief executive officer of Bavarian Nordic, said, "We applaud Janssen's continued efforts to advance the development of the Ebola vaccine regimen. Although we are no longer in an outbreak situation, the scale and impact of the recent Ebola epidemic in West Africa has clearly demonstrated that the world needs to be prepared in case of future outbreaks."
The first clinical data for the investigational Janssen vaccine regimen among healthy volunteers were published in JAMA: The Journal of the American Medical Association in April 2016. The phase I results from a U.K. study suggested that the regimen was well-tolerated and immunogenic (produced an immune response). The study found that 100% of study participants achieved an initial antibody response to Ebola, and that this was sustained eight months following vaccination among all volunteers.
The U.K. study provided the first set of data from a total of 10 clinical studies that are being conducted on a parallel track across the U.S., Europe and Africa in support of potential full licensure for the Ebola vaccine regimen. The first study of the vaccine regimen in a West African country affected by the Ebola epidemic began in Sierra Leone in October 2015.
Janssen is also preparing to initiate a first-in-human phase I clinical study to test a second-generation, multivalent version of the AdVac/MVA-BN vaccine regimen. The multivalent heterologous prime-boost regimen is intended to protect against multiple filoviruses that cause disease in humans, including the Ebola, Sudan and Marburg viruses. The U.S. study will test the safety, tolerability and immunogenicity of this vaccine regimen in varying dosing schedules among healthy volunteers. The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, is funding this study.