The second Ebola vaccine! The Johnson and Johnson Preventive Vaccine Program (®, Mvabea ®) received the world's first approval in the European Union!
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Last Update: 2020-07-15
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Source: Internet
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Author: User
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, July 02, 2020 /PRNewswire/ --BiovalleyBIOON/ Johnson and Johnson (JNJ) recently announced that the European Commission (EC) has approved its Jansen PharmaceuticalS' Ebola Vaccine Program (2-injection Immunity) - Zabdeno ® (Ad26.ZEBOV) and Mvabea ® (MVA-BN-Filo) for active use in the prevention of The Ebola virus in Zairenoted that the approval marks the world's first regulatory approval for the Ebola vaccine that Jansen has developedThe vaccine program also marks the first regulatoryly approved vaccine product in the Jansen vaccine pipelineThe vaccine program has been approved for regulatory approval in less than six years since the outbreak in West Africa in 2014, thanks to a global public-private partnershipthe vaccine program is: (1) zabdeno ® as the first vaccine, which is based on Jansen's AdVac technology development, and (2) 2 months (about 8 weeks) after the Mvabea ® as a second vaccine, the vaccine is based on The Bavarian Nordic's MVA-BN technologythe vaccine programme will be used to support the provision of preventive vaccination in countries and regions most at risk of Ebola outbreaks and other high-risk groups such as health care workers, biosecurity level 4 laboratory staff, military personnel deployed in affected areas, airport staff and visitors to high-risk countriesJansen is currently working with the World Health Organization (WHO) on vaccine prequalification, which will help speed up the registration of his preventive Ebola vaccine programme in African countries and promote wideaccess to vaccines among those most in needapproval is based on data support 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 immunobridge 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 strain"This European approval of Jansen's Ebola vaccine program is a landmark moment for both our company and in the global fight against the deadly Ebola virus," said Paul Stoffels, Vice Chairman and Chief Scientific Officer of theJohnson and Johnson Executive CommitteeBuilding on our long heritage, we are committed to developing vaccines to help overcome the threat posed by some of the world's deadliest infectious diseases"The approval of our Ebola vaccine marks progress in achieving our vision of delivering potentially transformative vaccines to communities most at risk of fatal infectious diseases," said DrMathai Mammen, global head of research and development atJansen Not only is it the first vaccine from our vaccine pipeline, it is also the first vaccine to be developed and approved using Jansen AdVac ® The same technology has also been used to develop candidate vaccines against new coronaviruses (SARS-CoV-2), Zika, respiratory syncytial virus (RSV) and HIV Ebola virus is the cause of Ebola haemorrhagic fever (EHF), an acute viral hemorrhagic infection characterized by 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 's worst Ebola outbreak to date is the West African outbreak, which killed nearly 30,000 cases and more than 11,000 deaths in 2014-2016 The Democratic Republic of the Congo (DRC) currently has two outbreaks, the first of which began in 2018 and is the world's second-worst Ebola outbreak on record, and has since resulted in more than 3,000 cases and more than 2,000 deaths, with a death rate of 65 per cent Jansen supports vaccination programmes in the DRC and neighbouring Rwanda to prevent the spread of the Ebola virus outside the affected areas In May 2019, the World Health Organization's (WHO) Strategic Expert Advisory Group on Immunization (SAGE) recommended the use of Jansen's Ebola vaccine programme as part of efforts to contain the DRC outbreak To date, more than 50,000 people in DCR and Rwanda have been vaccinated through this initiative Taking into account clinical trials
and vaccination programs, about 60,000 people have so far been vaccinated against Jansen's preventive Ebola vaccine program note that in 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 years of age and older to prevent Ebola virus disease (EVDD) caused by The Zaire virus 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 (BioValleyBioon.com) original source: Johnson and Johnson S Announces European Commission Approval for Janssen's Mad Ebola
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