Johnson & Johnson announced Wednesday that the European Commission has granted marketing authorisation for its vaccine regimen to prevent Ebola virus disease caused by the Zaire ebolavirus species in people aged one year and older. The regimen includes Zabdeno (Ad26.ZEBOV) as the first dose, based on Johnson & Johnson's AdVac viral vector technology, and Mvabea (MVA-BN-Filo) as the second dose, based on Bavarian Nordic's MVA-BN technology, administered approximately eight weeks later.
Mathai Mammen, global head of Johnson & Johnson's Janssen R&D unit, remarked "not only is it the first vaccine to emerge from our vaccines pipeline, it is also the first approved vaccine to be developed using Janssen's AdVac technology," the same that is being used to develop vaccine candidates against SARS-CoV-2, as well as Zika, respiratory syncytial virus and HIV.
The EU decision for the Ebola vaccine regimen follows a recent positive opinion adopted by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). Johnson & Johnson said the approval was backed by 11 early-, mid- and late-stage clinical trials evaluating the safety and immunogenicity of the vaccine regimen in more than 6500 adults and children aged one year and older across the US, Europe and Africa.
According to Johnson & Johnson, the regimen is specifically designed to induce long-term immunity against the Ebola virus, and will be used to support preventive vaccination in countries most at risk of outbreaks, as well as for other at-risk groups such as healthcare workers. In May last year, an advisory group with the World Health Organization recommended use of Johnson & Johnson's Ebola vaccine regimen as part of efforts to contain an outbreak in Africa, with the company noting that over 50,000 people in the Democratic Republic of the Congo and Rwanda have so far been vaccinated through that initiative alone.
Meanwhile, the company said discussions with the FDA have taken place to define the required dataset for filing US licensure. Merck & Co.'s Ebola vaccine Ervebo (rVSVΔG-ZEBOV-GP), also known as V920, was cleared last year by regulators in Europe and the US.
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