Johnson & Johnson Announces European Commission Approval of Two-Dose Ebola Vaccine Regimen Zabdeno® and Mvabea®
Janssen Pharmaceuticals
Pharmaceutical R&D Developer
Johnson & Johnson
Healthcare Product Manufacturers, Health Service Providers
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
Compiled by Keke
On July 1 local time, Johnson & Johnson announced that its Janssen Pharmaceuticals’ two-dose Ebola vaccine regimen, Zabdeno®(Ad26.ZEBOV) and Mvabea®(MVA-BN-Filo) has received marketing authorization from the European Commission (EC) for active immunization to prevent Ebola virus disease caused by the Zaire ebolavirus species in individuals aged 1 year and older.
The most severe Ebola outbreak to date occurred in West Africa, causing nearly 30,000 infections and more than 11,000 deaths between 2014 and 2016. The second-largest Ebola outbreak on record erupted in the Democratic Republic of the Congo in 2018, resulting in over 3,000 cases and more than 2,000 deaths, with a case fatality rate of 65%.
Dr. Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson, stated: “The European approval of Janssen’s Ebola vaccine regimen marks a milestone moment, both for our company and in the global fight against the deadly Ebola virus.”
Dr. Mathai Mammen, Global Head of Janssen Research & Development, stated: “The approved Ebola vaccine is the first vaccine to emerge from our vaccine portfolio and the first approved vaccine developed using Janssen’s AdVac® technology. The same technology is currently being used to develop vaccine candidates for the prevention of SARS-CoV-2, Zika virus, respiratory syncytial virus (RSV), and human immunodeficiency virus (HIV).”
Janssen’s Ebola vaccine regimen comprises two doses, one of which is based on AdVac®The first dose of Ad26.ZEBOV developed using viral vector technology; and the second dose of MVA-BN-Filo administered approximately 8 weeks later, based on Bavarian Nordic’s MVA-BN platform.®Technical Research and Development.
AdVac®The technology uses an adenovirus vector to carry the genetic codes for several Ebola virus proteins, mimicking pathogen components to trigger an immune response. The antigens are produced to simulate the pathogen without causing severe disease. Upon exposure to these antigens, the body generates a durable humoral and cellular immune response by producing immune cells and antibodies. In the future, if the human body encounters the actual pathogen, it will be able to respond more rapidly and effectively, thereby preventing the pathogen from inducing disease. MVA-BN®The technology utilizes a further attenuated version of the modified vaccinia Ankara (MVA) virus, which is replication-deficient in vaccinated individuals, meaning it cannot spread among them. Meanwhile, it can induce robust cellular (CTL) and humoral (antibody) immune responses, and also stimulate responses in individuals with pre-existing vaccine-induced immunity.
This regimen is specifically designed to induce long-term immunity against the Ebola virus in adults and children aged one year and older. Therefore, it will be used for preventive vaccination in countries with the highest likelihood of outbreaks, as well as for providing preventive vaccination to other high-risk populations.
Janssen has published the Phase 1 clinical study results of its preventive Ebola vaccine regimen in The New England Journal of Medicine and The Journal of Infectious Diseases; at the 2019 European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), pooled results from a total of 11 clinical studies involving Phases 1, 2, and 3 were presented. These studies evaluated the safety and immunogenicity of the vaccine regimen in more than 6,500 children aged one year and older and adults across the United States, Europe, and Africa, comparing the outcomes of clinical and preclinical efficacy studies through immunobridging analyses.
These study data collectively demonstrate that the vaccine regimen is well-tolerated and can induce robust and durable immune responses against the Zaire ebolavirus species. The protective efficacy of this vaccine regimen was established by integrating clinical immunogenicity results with efficacy and immunogenicity data obtained from non-human primate studies.
In May 2019, the WHO Strategic Advisory Group of Experts on Immunization (SAGE) recommended the use of this Ebola vaccine regimen to contain the Ebola virus outbreak in the Democratic Republic of the Congo, and as a measure to prevent the spread of the Ebola virus to areas outside the epidemic zones. To date, more than 50,000 people in the Democratic Republic of the Congo and Rwanda have been vaccinated. Including clinical trials, approximately 60,000 individuals have received the vaccine. Currently, Janssen is actively preparing to submit a marketing application to the U.S. Food and Drug Administration (FDA).
Reference Source: Johnson & Johnson Announces European Commission Approval for Janssen’s Preventive Ebola Vaccine
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.