Johnson & Johnson Ebola Vaccine Regimen Demonstrated Robust and Durable Immune Response in Adults and Children in Data Published in The Lancet Infectious Diseases

• Data show the vaccine regimen induced neutralizing antibody responses in nearly all participating adults and children 21 days after the second dose
• Adults receiving booster shots two years after initial vaccination regimen showed strong immune responses
• The data support the potential prophylactic use of the Johnson & Johnson Ebola vaccine regimen to protect adults and children

NEW BRUNSWICK, N.J., September 13, 2021 – Data from two papers published in The Lancet Infectious Diseases demonstrated that the Johnson & Johnson (the Company) Ebola vaccine regimen, Zabdeno^® (Ad26.ZEBOV) and Mvabea^® (MVA-BN-Filo), generated robust humoral (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 with Ad26.ZEBOV, administered to adults two years after the initial vaccination, induced a strong anamnestic (immune) response within seven days. These findings support the potential prophylactic use of the vaccine regimen, which was developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) in collaboration with Bavarian Nordic A/S, and 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 3 EBOVAC-Salone clinical study and showed that the vaccine regimen was well-tolerated and induced antibody responses to the Zaire ebolavirus species 21 days after the second dose in 98 percent of all participants. There were no safety signals of concern.

“These peer-reviewed data support the prophylactic use of the Johnson & Johnson Ebola vaccine regimen to protect people at risk of Ebola, which is essential to our vision of preventing Ebola outbreaks before they can begin,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson. “Recent and ongoing outbreaks in Africa underscore that the threat of Ebola is not going away, which is why we collaborated to develop a vaccine regimen capable of inducing long-term immunity against Ebola and are now working to ensure that it is accessible to people in need.”

The EBOVAC-Salone study was conducted in Sierra Leone and is the first to assess the safety and tolerability of the Johnson & Johnson Ebola vaccine regimen in adults in a region affected by the 2014-2016 West African Ebola outbreak, which was the worst on record. It is also the first study evaluating the Johnson & Johnson Ebola vaccine regimen in a randomized, double-blind, controlled trial in a pediatric population.

Phase 3 Study Design (NCT02509494)
This Phase 3 study was designed to gather information on the safety and immunogenicity of the two-dose, heterologous (containing different vaccine components administered at different timepoints) Johnson & Johnson Ebola vaccine regimen. In this regimen, Ad26.ZEBOV was administered intramuscularly as the first dose vaccination followed 56 days later by MVA-BN-Filo as the second dose vaccination.

The study was divided into two stages. In stage one, 43 adults aged 18 years or older were vaccinated to gain information about the safety and immunogenicity of the two-dose vaccine regimen. In stage two, 400 adults and 576 children or adolescents (including 192 in each of the three age cohorts of 1-3, 4-11 and 12-17 years of age) were vaccinated. Consenting adults participating in stage one of the study were administered a booster dose of A26.ZEBOV two years after the first dose.

The study was conducted at three clinics in Kambia District, Sierra Leone. Long term follow-up of the study participants is underway.

Johnson & Johnson’s Commitment to Ebola & Pandemic Preparedness
Johnson & Johnson is one of the few innovative healthcare companies in the world today that is actively advancing science across multiple disease areas with the aim of strengthening public health.

The Company accelerated the development of its Ebola vaccine regimen in 2014 in response to the 2014-2016 outbreak in West Africa, which caused more than 11,000 deaths. In 2019, in response to the second-worst outbreak, which took place 2018-2020 in the Democratic Republic of the Congo (DRC), Johnson & Johnson announced it would provide its Ebola vaccine regimen to assist immunization efforts in the affected region and in neighboring Rwanda through the UMURINZI vaccination campaign. This marked the first widespread deployment of Ebola vaccines in an outbreak setting. The UMURINZI campaign, which is led by the Rwandan Ministry of Health, recently achieved its endpoint of fully vaccinating 200,000 individuals against Ebola.

In May 2021, Johnson & Johnson announced it would donate thousands of 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. The program began by vaccinating health workers, other frontline workers and others at increased risk of exposure to the Ebola virus in Sierra Leone.

In June 2021, Johnson & Johnson welcomed a new recommendation by the Strategic Advisory Group of Experts (SAGE) on Immunization for the WHO that supports the use of the Johnson & Johnson Ebola vaccine regimen both during outbreaks for individuals at some risk of Ebola exposure, and preventively, in the absence of an outbreak, for national and international first responders in neighboring areas or countries where an outbreak might spread.

To date, more than 250,000 individuals participating in clinical trials and vaccination initiatives have received at least the first dose of the Johnson & Johnson Ebola vaccine regimen, including 200,000 who have been fully vaccinated.

Johnson & Johnson Ebola Vaccine Regimen
The European Commission-approved and World Health Organization-Prequalified Johnson & Johnson preventive Ebola vaccine regimen, Zabdeno^® (Ad26.ZEBOV) and Mvabea^® (MVA-BN-Filo), utilizes a non-replicating viral vector strategy in which viruses – in this case adenovirus serotype 26 (Ad26) and Modified Vaccinia Virus Ankara (MVA) – are genetically modified so that they cannot replicate in human cells. In addition, these vectors carry the genetic code of several Ebola virus proteins in order to trigger an immune response. The Ebola vaccine regimen was developed and is manufactured using Janssen’s proprietary AdVac^® technology.

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 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.

Learn more at www.JNJ.com/Ebola.