Statement on Data Published in PLOS Medicine on Tolerability and Immune Response of Johnson & Johnson Ebola Vaccine Regimen in Adults Living with HIV
NEW BRUNSWICK, N.J., October 29, 2021 – Data published in PLOS Medicine demonstrated that the Johnson & Johnson (the Company) Ebola vaccine regimen, Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo), was well tolerated and induced a robust immune response in both healthy adults and adults living with HIV. These findings, alongside Phase 3 data recently published in The Lancet Infectious Diseases, support the potential prophylactic use of the vaccine regimen to protect people at risk of acquiring Ebola. The regimen was granted Marketing Authorisation by the European Commission in July 2020 and Prequalification from the World Health Organization (WHO) in April 2021.
The data is from the Phase 2 EBL2002 study, which was conducted in Burkina Faso, Cote d’Ivoire, Kenya and Uganda and enrolled 668 healthy adults and 142 adults living with HIV. There were no safety signals of concern.
“These data add to the growing body of evidence supporting the prophylactic use of the Johnson & Johnson Ebola vaccine regimen to protect people at risk of Ebola. This is critical to our vision of protecting some of the world’s most vulnerable and underserved people – including people living with HIV – by preventing Ebola outbreaks before they start,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson. “The recent re-emergence of Ebola in the Democratic Republic of the Congo, which is the latest in a series of outbreaks in Africa in just the past year, reinforce the need for a proactive approach to address this persistent public health threat.”
More than 30 outbreaks have been declared since the Ebola virus was discovered in 1976, the worst of which have occurred in Africa in the past seven years. Johnson & Johnson accelerated the development of its Ebola vaccine at the outset of the 2014-2016 Ebola crisis, which caused more than 11,000 deaths.
The Company has responded to recent Ebola outbreaks by making available vaccine regimens to governments and the World Health Organization (WHO). Most recently in May 2021, Johnson & Johnson announced it would make available up to 200,000 Ebola vaccine regimens in support of a WHO early access clinical program launched in response to an outbreak in Guinea and aimed at preventing Ebola in West Africa. In addition to assisting with outbreak response, the Company is focused on efforts to ensure its Ebola vaccine regimen is more broadly accessible to the countries and communities in Africa who need it most.
About Johnson & Johnson’s Ebola Vaccine
The Johnson & Johnson Ebola vaccine regimen was developed in collaboration with Bavarian Nordic A/S, and is manufactured using Janssen’s proprietary AdVac® viral vector technology. The AdVac® vaccine platform is also used for the Company’s COVID-19 vaccine. To date, more than 250,000 people have received at least the first dose of the Ebola vaccine, including more than 200,000 who have been fully vaccinated with both doses.
Johnson & Johnson’s Ebola vaccine regimen originates from a collaborative research program with the NIH and received direct funding and preclinical services from the National Institute of Allergy and Infectious Diseases, part of NIH, under Contract Number HHSN272200800056C. Further funding for the Ebola vaccine regimen has been provided in part with federal funds from the Office of the Assistant Secretary for Preparedness and Response, BARDA under Contract Numbers HHSO100201700013C and HHSO100201500008C.
The Innovative Medicines Initiative (IMI) provided funding through the IMI Ebola+ Programme to support a number of consortia that initiated multiple clinical trials and other vaccine development activities. The consortia funded by the Innovative Medicines Initiative 2 (IMI2) Joint Undertaking are EBOVAC1 (grant nr. 115854), EBOVAC2 (grant nr. 115861), EBOVAC3 (grant nr. 800176), EBOMAN (grant nr. 115850) and EBODAC (grant nr. 115847). This Joint Undertaking receives support from the EU’s Horizon 2020 Framework Programme for Research and Innovation and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Johnson & Johnson also acknowledges its many strategic partners in the ongoing global clinical program for the vaccine regimen, including Bavarian Nordic A/S, Centre Muraz, Coalition for Epidemic Preparedness Innovations (CEPI), College of Medicine and Allied Health Sciences (COMAHS, University of Sierra Leone), Democratic Republic of the Congo Ministry of Public Health, Republic of Rwanda Ministry of Health and Rwanda Biomedical Center, Emory University’s Project San Francisco (Kigali) / Center for Family Health Research, Emory University, Epicentre, Grameen Foundation, Inserm, Inserm Transfert, Institut National de Recherce Biomédicale (INRB), London School of Hygiene & Tropical Medicine (LSHTM), Médecins Sans Frontières (MSF), Rinda Ubuzima, Sierra Leone Ministry of Health and Sanitation, Uganda Virus Research Institute (UVRI), Université de Kinshasa (UNIKIN), University of Antwerp, University of Oxford, Walter Reed Army Institute of Research (WRAIR), World Health Organization, World Vision Ireland, Wellcome Trust, Vibalogics, and all the people who have participated in the Ebola vaccine clinical trials.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding a program related to the Johnson & Johnson Ebola Vaccine Regimen. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.