Lancet study confirms Johnson & Johnson Ebola vaccine safe
Drug Approval

Lancet study confirms Johnson & Johnson Ebola vaccine safe

Data show the vaccine regimen induced neutralising antibody responses in nearly all participating adults and children 21 days after the second dose. Adults receiving booster shots two years after the initial vaccination regimen showed strong immune responses

  • By IPP Bureau | September 16, 2021

Data from two papers published in The Lancet Infectious Diseases demonstrated that the Johnson & Johnson’s 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.

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