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.
The vaccine regimen, which was developed by Janssen Pharmaceuticals, the vaccine division of J&J, in collaboration with Bavarian Nordic, also received prequalification from the World Health Organization (WHO) in April this year, with J&J saying that fact would help accelerate its registration in countries where Ebola is a persistent public health threat.
Both WHO Prequalification and the European Commission authorization were supported by a multi-country clinical program, including 15 clinical studies sponsored by Janssen across three continents.
J&J said discussions are ongoing with the US Food and Drug Administration (FDA) regarding the approval of the vaccine regimen in the US.
Ongoing Ebola outbreaks
Though the ongoing COVID-19 pandemic has overshadowed the threat posed by the Ebola virus, parts of Africa are still grappling with the infectious disease.
The most serious outbreak began in 2014 and the number of cases caused sufficient alarm that pharmaceutical companies worked to rapidly develop vaccine programs against the virus.
Health authorities in Guinea officially declared a new Ebola outbreak in February 2021 after the West African country experienced its first cases of disease since the end of the 2014-2016 Ebola outbreak.
Preliminary data obtained through genetic sequencing suggest that the new outbreak was caused by the same virus strain also responsible for the 2014-2016 outbreak and was likely reintroduced by a survivor, said J&J.
In May this year, the WHO)and the government of Sierra Leone began administering J&J’s Ebola vaccine regimen as part of an early access clinical program aimed at preventing further spread of the disease in West Africa.