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

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 ...
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Discussions are ongoing with the U.S. Food and Drug Administration regarding the approval of the vaccine regimen in the U.S. WHO Prequalification is often a prerequisite for national registrations of new vaccines and medicines in developing countries. Johnson &Johnson now looks forward to collaborating with the WHO’s African Vaccine Regulatory Forum (AVAREF) to progress national registrations of the Company’s Ebola vaccine regimen. The Company’s Ebola vaccine regimen is designed to be used proactively to induce immunity against Ebola virus disease in adults and children. Johnson &Johnson’s C...
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