The company’s two-dose vaccine regimen for the prevention of Ebola virus disease consists of Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo).
The 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 two-dose regimen was well-tolerated and induced antibody responses to the Zaire ebolavirus species 21 days after the second dose in 98% of all participants.
A booster vaccination with Ad26.ZEBOV, administered to adults two years after the initial vaccination, induced a strong immune response within seven days, said J&J.
“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 J&J’s chief scientific officer, Paul Stoffels.
The data was from the Phase 3 EBOVAC-Salone clinical study, which 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, 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.
EU approval, WHO prequalification
J&J received authorization from the EU in July 2020 for its Ebola vaccine, becoming only the second company to receive approval, behind Merck, for such jabs.