Johnson & Johnson’s Response to the Deadly Ebola Virus
Ebola is a deadly disease that threatens African countries and can cross international borders if it isn’t contained. The 2014-2016 West Africa Ebola Outbreak, responsible for infecting more than 28,000 people and claiming more than 11,000 lives, was a global crisis that spurred the world into action. In response, scientists at Janssen quickly accelerated work on a vaccine, forged new partnerships and mobilized to conduct multiple studies across three continents.
In July 2020, the European Commission (EC) approved Johnson & Johnson’s Ebola vaccine regimen for the prevention of Ebola Virus Disease, completing the journey from the first clinical studies to approval by a stringent regulatory authority in just six years and marking the first major regulatory approval of a vaccine developed by Janssen. In April 2021, the World Health Organization (WHO) granted Prequalification status to the regimen, an important stepping stone to registration in African countries at risk of outbreaks and broader access to those most in need.
From August 2018 to June 2020, the Democratic Republic of the Congo (DRC) faced the world’s second-largest Ebola outbreak on record. The DRC and its partners deployed Johnson & Johnson's Ebola vaccine regimen alongside other tools as part of an expansive public health effort that helped end the outbreak. To date, more than 225,000 people worldwide have received the first dose of Johnson & Johnson’s Ebola vaccine regimen. In February 2021, new Ebola outbreaks were declared in the DRC and across the continent in Guinea, emphasizing more than ever the need for preventive vaccines.
We have a responsibility as a leading global healthcare company to do all we can to address this urgent unmet medical need.
The European approval of Johnson & Johnson’s Ebola vaccine regimen is a landmark moment—both for our Company and in the world’s battle against the deadly Ebola virus.
In less than six years, with the strength of global public-private collaborations, we have an approved Ebola vaccine which could help those most in need, with the ultimate goal of preventing outbreaks before they start.
The preventive Ebola vaccine regimen developed by the Janssen Pharmaceutical Companies of Johnson & Johnson:
• Consists of a two-dose regimen leveraging different vaccines Ad26.ZEBOV and MVA-BN-Filo
• Is well tolerated and induces robust and durable immune responses to the Zaire ebolavirus species—the cause of both of the deadly outbreaks in the last six years.
The Rwanda Ministry of Health’s UMURINIZI campaign is the first large-scale use of the Johnson & Johnson Vaccine Monitoring Platform, a digital tool that integrates innovative technologies to implement vaccination campaigns effectively and efficiently.
• Biometric iris scanning identification tracks each patient’s unique identification
• Management reporting dashboard tracks progress in near-real time
• Mobile phone messaging drives adherence and strong follow up with participant
· Janssen begins vaccine research, with support from the National Institutes of Health, against filoviruses, which include Ebolavirus
· WHO declared a Public Health Emergency of International Concern (PHEIC) for Ebola outbreak in West Africa
· J&J commits to accelerate development and expand production of Ebola vaccine regiment; first-in-human study began in UK
· Announcement of IMI-supported consortia, including financial support from the Biomedical Advanced Research and Development Authority (BARDA)
· ‘EBOVAC-Salone’ study begins in Sierra Leone
· First clinical data for Ebola vaccine regimen published in JAMA
· Johnson & Johnson completes submission to WHO for Emergency Use Assessment and Listing (EUAL)
· Second-largest Ebola outbreak begins in North Kivu, DRC
· WHO declares the DRC epidemic a Public Health Emergency of International Concern (PHEIC)
· WHO’s SAGE committee recommends evaluation of Johnson & Johnson vaccine regimen in DRC
· Johnson & Johnson files for EU approval of vaccine regimen
· Conditional approval under exceptional emergency granted by the Rwanda Food and Drug Administration
· European Commission announces approval of Johnson & Johnson’s Ebola vaccine regimen
· Second-largest Ebola outbreak in North Kivu, DRC declared over
· New outbreaks begin in Guinea and DRC
· More than 225,000 people have started regimen to date
· J&J announces it will provide up to 200,000 Ebola vaccine regimens to support a WHO early access clinical program launched in response to the West Africa outbreak
· Johnson & Johnson Ebola vaccine regimen receives Prequalification from the World Health Organization
· The WHO’s SAGE Committee recommends use of the J&J Ebola vaccine regimen both during outbreaks for individuals at some risk of Ebola exposure, and preventively for national and international first responders.
Johnson & Johnson made a significant investment in the Janssen Ebola vaccine development program. We also forged strategic partnerships with a wide range of the world’s leading scientific and medical research organizations to accelerate our progress.