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    Home > Active Ingredient News > Immunology News > Ebola vaccine! Johnson and Johnson's 2-shot vaccine program (Ad26.ZEBOV, MVA-BN-Filo) EU regulatory news, will be approved within 2 months!

    Ebola vaccine! Johnson and Johnson's 2-shot vaccine program (Ad26.ZEBOV, MVA-BN-Filo) EU regulatory news, will be approved within 2 months!

    • Last Update: 2020-06-17
    • Source: Internet
    • Author: User
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    , June 10, 2020 //BiovalleyBIOON/ Johnson and Johnson's Jansen Pharmaceuticals has announced that the European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) has issued an active review recommending approval of its Ebola Vaccine Program (2-pin immunization programme) to prevent Ebola virus disease (EVD) caused by the Zaire Ebola virus strainThe CHMP review will now be submitted to the European Commission( EC), which is expected to make a final review decision within two monthsJohnson and Johnson submitted two Marketing Authorization Applications (MAA) to EMA in parallel to support each of the two-shot immunization programmes (Ad26.ZEBOV, MVA-BN-Filo)In September last year, CHMP granted these MAA accelerated assessmentsthe vaccine program is: (1) Ad26.ZEBOV as the first vaccine, which is based on Jansen's AdVac technology development, and (2) MVA-BN-Filo as the second vaccine after about 8 weeks, based on Bavarian Nordic's MVA-BN technologyTwo MAAs are supported by data from Phase i, Phase II, and Phase III clinical studies that assess the safety and immunogenicity of this vaccine program in adults and children, as well as preclinical studies and immunoconnection analysis dataThese studies have shown that the vaccine programme is well tolerated and produces a strong and long-lasting immune response for the Zaire Ebola strainJansen's Ebola vaccine programme is designed to support the provision of preventive vaccination in countries and regions at risk of AnEbola outbreak and other risk groups such as health workers, biosafety level 4 laboratory staff, nationally deployed troops, airport staff and tourists from high-risk countriesJansen is currently working with the World Health Organization (WHO) on vaccine prequalification to expand access to its Ebola vaccine programme in the most highly needed African countries and to enable it to register in African countriesapproval by the European Commission will help speed up the processIn addition, Jansen is in discussions with the FDA to determine the data needed to submit the Ebola vaccine program under theFDAanimal (effect) regulatory licensing pathwaysthe most recent Ebola outbreak in the Democratic Republic of congo (DRC) in 2018, the second-worst on record in the worldIt has resulted in more than 3,000 cases and more than 2,000 deaths, with a mortality rate of 65 per cent May 2019, the World Health Organization's (WHO) Expert Advisory Group on Immunization Strategy (SAGE) recommended the use of Jansen's Ebola vaccine programme as part of efforts to contain the DRC outbreak In DCR and Rwanda, more than 50,000 people have been vaccinated To date, about 60,000 people have been vaccinated against Jansen's preventive Ebola vaccine program in clinical research and vaccination initiatives "In this outbreak in the DRC, for the first time, vaccines coordinated through an integrated public health response have been deployed on a large scale, including Jansen's new 2-shot vaccine," said Paul Stoffels, Vice Chairman and Chief Scientific Officer of Johnson and Johnson We are pleased with CHMP's positive comments because it brings us closer to achieving Johnson's ultimate vision of further preventing outbreaks and helping the communities most at risk before the Ebola outbreak "The positive advice of CHMP confirms the potential of Jansen vaccine technology and we hope to apply it to a range of existing and emerging epidemiological threats, including the COVID-19 epidemic," said Dr Johan Van Hoof, Head of Global Therapeutics at Janssen Pharmaceuticals If our Ebola research vaccine program is approved by the European Commission, it will be Jansen's first vaccine approval and an important step forward in our efforts to help protect groups at risk of Ebola virus disease We are deeply grateful that our process of accelerating the development and delivery of Ebola vaccines would not have been possible without the expertise and dedication of our multiple partners around the world "
    Ebola virus is the cause of Ebola haemorrhagic fever (EHF), an acute viral hemorrhagic infection with symptoms including fever, headache, joint and muscle pain, fatigue, diarrhea, vomiting, stomach pain, loss of appetite and abnormal bleeding These symptoms can appear within 2-21 days of infection, but are most common in 8-10 days The Ebola virus is not a water-borne or food-borne disease, nor is it transmitted through air, and is transmitted through direct contact with infected persons' bodily fluids or appliances contaminated with the virus, such as needles November 2019, Mershadon's Ebola vaccine Ervebo (V920, rVSV G-ZEBOV-GP, the live detoxification vaccine) was approved by the European Union as the world's first Ebola vaccine for active immunization in people 18 and older to prevent Ebola virus disease (EVDD) caused by Ebola Zaire In December 2019, Ervebo was approved by the U.S FDA In February 2020, Ervebo was approved by the first four African countries (Democratic Republic of the Congo, Burundi, Ghana and Zambia) and will be ratified by more African countries in the future Ervebo (V920) used a defective blister-based ventritis virus that can infect livestock, replacing one of the virus's genes with the Ebola virus The V920 was originally developed by the Public Health Agency of Canada (PHAC) and then licensed to NewLink Genetics in 2010 At the end of 2014, when the Ebola outbreak in West Africa peaked, Mercado signed a global exclusive licensing agreement from NewLink to obtain the Ebola vaccine Since then, Mercado has worked closely with a number of external partners to develop the vaccine in an extensive clinical development project with partial funding from the U.S government ( original source: Johnson and Johnson Receives Positive CHMP Opinion for Janssen's The Saar Maeder Vaccine Ebola Regimen
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