Johnson & Johnson (NYSE: JNJ) today announced that its Janssen Pharmaceutical Companies will provide up to 200,000 Ebola vaccine regimens to the Republic of Rwanda. This commitment will support a new immunization program led by the Rwanda Government that aims to help protect the country’s citizens from the Ebola outbreak in neighboring Democratic Republic of the Congo (DRC). The first batches of Janssen vaccine have been delivered to the country, and further shipments are being organized.
On July 17, 2019, the World Health Organization (WHO) declared the DRC Ebola outbreak a Public Health Emergency of International Concern (PHEIC). More than 3,300 cases, including more than 2,200 deaths, have been reported to date, making the outbreak second only to the 2014-2016 West Africa epidemic, and raising concerns about its potential to cross international borders. In October, the Johnson & Johnson announced that the DRC would begin using the Janssen investigational vaccine as part of an expanded response to the outbreak.
“Johnson & Johnson recognizes the Rwandan Government’s decision to proactively deploy Janssen’s investigational Ebola vaccine to help prevent the spread of the disease into the country,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson. “We stand ready to support Rwanda’s initiative on epidemic preparedness.”
WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization recommended in May 2019 that Janssen’s investigational Ebola vaccine regimen be evaluated as part of expanded efforts to contain the DRC outbreak. Additionally, WHO’s Emergency Committee stated, “At-risk countries should put in place approvals for investigational medicines and vaccines as an immediate priority for preparedness.”
Dr. Diane Gashumba, Rwanda Minister of Health, said, “Following various trials of the Ebola vaccine in different countries, and the World Health Organization’s Strategic Advisory Group of Experts’ recommendations, the Rwanda Food and Drug Authority have reviewed the trials made about this vaccine around the world and it has been approved that the Janssen vaccine is safe and that it can be given as a preventive measure. Therefore, Rwanda FDA granted conditional approval under exceptional emergency for Janssen’s Ebola vaccine regimen.”
Dr. Gashumba continued, “We are thankful to Johnson & Johnson who demonstrated commitment as a global partner to improve the health of our people by providing the Ebola vaccine that we are going to use during this voluntary Ebola vaccination campaign, and we acknowledge Wellcome Trust and the UK Department for International Development (DFID) for participating in the funding of the Umurinzi Program.”
To date, nearly 8,000 volunteers across the U.S., Europe and Africa have participated in multiple clinical studies of the Janssen vaccine. This includes approximately 1,300 individuals who have received the Janssen vaccine in the DRC according to the country’s Ebola response committee. The two-dose regimen includes Ad26.ZEBOV as the first dose, which is based on Janssen’s AdVac® technology, and MVA-BN-Filo as the second dose, which is based on Bavarian Nordic’s MVA-BN® technology and is administered approximately eight weeks later. Study results indicate that the vaccine is well tolerated and induces robust and durable immune responses to the Ebola virus Zaire strain – the cause of the DRC outbreak.
Johnson & Johnson has made a significant investment in Janssen’s Ebola vaccine regimen since its decision to accelerate the development program in 2014 in response to the widespread outbreak that occurred in West Africa that year. The vaccine regimen was developed in collaboration with global partners, including Bavarian Nordic A/S, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), the Innovative Medicines Initiative (IMI) funded through the EU Horizon 2020 programme, and the National Institutes of Health (NIH) at HHS.-Bio Space