Janssen applies for WHO EUAL status for new Ebola vaccine

Janssen has completed a submission to the World Health Organization (WHO) to secure emergency use assessment and listing (EUAL) status for its new Ebola vaccine.

If successful, the EUAL procedure would allow Janssen's investigational preventive Ebola prime-boost vaccine regimen to be used when there is an outbreak of the disease with high rates of morbidity or mortality, plus a lack of available treatment or prevention options.

The EUAL process helps UN member states and procurement agencies determine the acceptability for use of a specific vaccine in public health emergencies. The decision to grant this status to Janssen's new vaccine will be based on an evaluation of available data including quality, safety and immunogenicity, as well as a risk/benefit analysis.

Although this procedure would allow for the deployment of the vaccine in an emergency, it remains investigational until formal regulatory agency review and approval processes are completed.

Dr Johan Van Hoof, global therapeutic area head for infectious diseases and vaccines at Janssen Pharmaceutical Companies, said: "If listed for emergency use, the investigational Janssen vaccine regimen could be a vital prevention tool for rapid outbreak response, particularly for health workers and vulnerable communities on the frontlines."

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