Statement on the SAGE Recommendation Regarding the Johnson & Johnson Ebola Vaccine Regimen
New Brunswick, NJ (June 4, 2021) – Johnson & Johnson welcomes the recommendation by the Strategic Advisory Group of Experts (SAGE) on Immunization for the World Health Organization (WHO) in support of the use of Johnson & Johnson’s two-dose Ebola vaccine regimen, Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo), both during outbreaks for individuals at some risk of Ebola exposure and preventively, before outbreaks, for national and international first responders.
This is an important milestone for our Ebola vaccine and our mission to help prevent and control Ebola outbreaks. It follows Marketing Authorisation by the European Commission in July 2020 and WHO Prequalification in April 2021. We are now focused on securing national registrations for the vaccine in Ebola-affected countries in Africa.
Our vision is to stop Ebola outbreaks before they start. That’s why, in partnership with Bavarian Nordic, we developed a two-dose vaccine with the goal of inducing long-term immunity against the virus. The frequency of Ebola outbreaks – including the current outbreak in West Africa – and the persistence of the Ebola virus in those infected underscore the importance of advancing new prevention strategies. This includes proactive vaccination efforts, such as the WHO early access clinical program we are supporting in West Africa, that aim to help prevent the further spread of the virus.
Johnson & Johnson accelerated the development of an Ebola vaccine during the 2014 Ebola crisis. Since then, we have sponsored 15 clinical trials across three continents that have demonstrated the regimen to be safe and capable of inducing an immune response. Beginning in 2019, we coordinated with the governments of the Democratic Republic of the Congo (DRC) and Rwanda to support the deployment of the regimen in response to the second-worst Ebola outbreak on record, which took place in the DRC’s North Kivu region from 2018-2020.
We acknowledge and are grateful to our global strategic partners who have helped to support and co-fund the Ebola vaccine regimen, including Bavarian Nordic A/S, the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH) at the U.S. Department of Health and Human Services (HHS) and the Innovative Medicines Initiative (IMI) funded through the EU Horizon 2020 program.
About Johnson & Johnson’s Ebola Vaccine
The Johnson & Johnson Ebola vaccine regimen was developed 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 235,000 people have received at least the first dose of the Ebola vaccine, including 190,000 who have been fully vaccinated with both doses.
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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.