Our history of combating the Ebola virus goes back more than 20 years. The Zaire ebolavirus has claimed the lives of tens of thousands of individuals, mainly in Africa, since it first appeared in 1976, and the cadence of new outbreaks is increasing. In our efforts to develop a vaccine to halt the spread of this deadly virus, we have focused on Zaire ebolavirus and conducted more than 15 clinical trials sponsored by Johnson & Johnson and multiple collaborations since 2002.
Today, Johnson & Johnson’s two-dose Ebola vaccine regimen comprising ZABDENO (Ad26.ZEBOV) and Bavarian Nordic’s MVABEA (MVA-BN-Filo) is indicated for active immunization of disease caused by the Ebola virus (Zaire ebolavirus species) in individuals ≥1 year of age. Following Marketing Authorization granted by the European Commission in July 2020, the regimen was granted WHO WHO World Health Organization Prequalification in April 2021—the first Johnson & Johnson vaccine to receive WHO Prequalification—and will help advance preparedness strategies for countries with the potential for Ebola outbreaks. Additionally, in March 2022, the Ghana Food and Drugs Authority granted conditional Marketing Authorization to the Johnson & Johnson Ebola vaccine regimen, becoming the first African regulatory authority to approve the regimen for commercial use.
Proven safety and immunogenicity of our Ebola vaccine regimen: Confirming previous clinical trial findings, results from our EBOVAC-Salone Phase 3 study conducted in Sierra Leone found that our Ebola vaccine regimen is safe and generates strong immunity in both children and adults. Data from two papers published in The Lancet Infectious Diseases demonstrated that the regimen generated robust antibody immune responses in adults and children (ages 1 – 17) with the immune responses persisting in adults for at least two years. The data also showed that booster vaccination, administered to adults two years after the initial vaccination, induced a strong immune response within seven days.
This is a vaccine that can be used more broadly, including to protect children from being infected by Ebola, so this is a very important finding that can be worked into the process of preparing supplies.
Similarly, newly published data in PLOS Medicine demonstrated that Johnson & Johnson’s Ebola vaccine regimen was well tolerated and induced a robust immune response in both healthy adults and adults living with HIV.
Milestone vaccinations in Rwanda: In 2021, we achieved a significant milestone in our support to the Government of Rwanda’s UMURINZI campaign: completion of the full vaccination of more than 200,000 Rwandans against Ebola with the Johnson & Johnson Ebola vaccine regimen. This vaccination program also represented the first large use case of the VMP, a suite of digital technologies that integrates biometric identification, mobile phone messaging and data management into a single tool that empowers healthcare workers and vaccination teams to drive successful, multidose vaccination campaigns.
Ongoing, the INGABO study, which was established as part of UMURINZI to evaluate the vaccine in healthy pregnant women, continues. As of March 2022, the study is 95% enrolled and is critical to advancing our vision of preventing Ebola outbreaks.