500,000 Ebola Vaccines Donated to the DRC
Janssen Ebola Zaire vaccine regimen consists of 2 doses leveraging Ad26.ZEBOV and MVA-BN-Filo vaccines
New Jersey-based Janssen Pharmaceutical Companies of Johnson & Johnson announced it is donating up to 500,000 Ebola Zaire vaccine regimens in support of a new clinical study in the Democratic Republic of Congo (DRC).
The 1st batches of the Janssen Ebola vaccine regimen have been shipped to the country.
The Janssen vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo) consists of two doses leveraging different vaccines. The goal of this approach is to induce robust and long-lasting immunity.
The 2-dose vaccination regimen includes Ad26.ZEBOV as the 1st dose, which is based on Janssen's AdVac® technology, and MVA-BN-Filo as the 2nd dose, which is based on Bavarian Nordic's MVA-BN® technology and is administered approximately 8 weeks later.
This vaccination regimen utilizes a viral vector strategy in which viruses – in this case, adenovirus serotype 26 (Ad26) and Modified Vaccinia Ankara (MVA) – are genetically modified so that they cannot replicate in human cells, while safely inducing the production of Ebola virus proteins in order to trigger an immune response.
This is good news, since on July 17, 2019, the World Health Organization (WHO) declared the Ebola outbreak in DRC a Public Health Emergency of International Concern (PHEIC), stating that "optimal vaccine strategies that have maximum impact on curtailing the outbreak, as recommended by WHO's Strategic Advisory Group of Experts (SAGE), should be implemented rapidly."
Furthermore, as of October 29, 2019, the WHO reported there have been 3,268 Ebola Zaire cases confirmed in central African countries, with a case fatality ratio of 67 percent, since the current Ebola outbreak began in August 2018.
Alex Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson, said in a related press release, "The fact that we're in a position to help the people of the DRC protect their communities from such a serious threat—just a few years after we pledged to accelerate vaccine development efforts—is a testament to both the ingenuity of Janssen's scientists, and the power of close collaboration between partners committed to working for the greater good of all."
In line with recent recommendations from SAGE, the new vaccination initiative in the DRC will offer the Janssen investigational vaccine regimen to individuals at some risk of Ebola infection who live in areas close to the current outbreak zone, with the goal of preventing the further geographic spread of the virus.
As part of the DRC's expanded public health response, a new clinical study of the vaccine regimen will be implemented by the Institut National de Recherche Biomédicale (INRB) and the DRC Ministry of Health, supported by Médecins Sans Frontières (MSF), Epicentre and the London School of Hygiene & Tropical Medicine (LSHTM), under the leadership of the Principal Investigator Professor Jean-Jacques Muyembe, INRB Director and head of the DRC multisector Ebola response committee.
This new clinical trial will be sponsored by LSHTM and funded by the Coalition for Epidemic Preparedness Innovations (CEPI), the European Union, the UK Department for International Development (DFID), Wellcome and the Paul G. Allen Family Foundation. Janssen is donating supplies of its investigational vaccine regimen for the study.
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