Statement on the SAGE Recommendation Regarding the J&J Ebola Vaccine Regimen

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.

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