The World Health Organization (WHO) intends to evaluate the Emergency Use Assessment and Listing (EUAL) application for an investigational Ebola vaccine that has been developed by Merck.
The Ebola Zaire vaccine, called V920, needs the EUAL to accelerate its production and availability. The vaccine must be ready to prevent further public health emergencies, such as another Ebola outbreak.
This process is designed to ensure that procurement agencies with the United Nations and member states are able to use the vaccine in the case of emergencies.
The WHO wishes to clarify that EUAL designation does not prequalify the vaccine. Instead, it is a procedure for a special purpose, such as in the case of a disease outbreak that causes high mortality and/or morbidity rates when there are few available treatments or prevention strategies. In this case, the vaccine may be recommended for only a short time while researchers collect clinical trial data to conduct formal regulatory processes.
“This application to the WHO is an important step toward enabling V920 to be used if a public health emergency of international concern were to be declared for the Ebola Zaire species prior to licensure of the vaccine candidate,” Dr. Paula Annunziato, Merck’s vice president for clinical research, said.
