September 28th, 2019

Janssen Testing Vaccine for Ebola and Marburg Virus

Janssen Vaccines working on a second-generation vaccine for the Ebola Zaire, Ebola Sudan, and Marburg virus

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Johnson & Johnson (J&J) announced today that Janssen Vaccines & Prevention B.V. 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.

There are currently no licensed Ebola vaccines on the market.

Janssen Vaccines and Prevention BV, are working on a second-generation vaccine product, which would provide protection against three killer viruses, which are Ebola Zaire, Ebola Sudan, and the related Marburg virus.

The start of the so-called Phase 1 trial, is the first stage of clinical testing in people.

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.

"Over the past four decades, we have seen 25 Ebola outbreaks, with the most recent in West Africa killing seven times more people than all previous outbreaks combined," said Paul Stoffels, M.D., Chief Scientific Officer, Johnson & Johnson.

"We must take action now so that a tragedy on the scale of West Africa never happens again. Having an Ebola vaccine available is critical for global preparedness.”

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“If the WHO grants an emergency use listing, this will accelerate the availability of Janssen's investigational vaccine regimen to the international community in the event another Ebola crisis occurs."

While EUAL potentially allows for deployment of a vaccine in an emergency, the vaccine remains investigational pending formal regulatory agency review and approval.

The first outbreak of the Ebola disease was reported exactly 40 years ago, in Zaire (now the Democratic Republic of the Congo).

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 study found that 100 percent of study participants achieved an initial antibody response to Ebola, and that this was sustained eight months following vaccination among all volunteers.

Janssen has made a substantial investment to support the development of its investigational monovalent Ebola vaccine regimen and multivalent Ebola, Sudanand Marburg vaccine regimen. For 130 years, Johnson & Johnson has been committed to improving the health of individuals, families and communities around the world, including the most vulnerable populations.