The world's first Ebola vaccine! Merck's Ervebo was approved in the first batch of 4 African countries to prevent the Zaire Ebola virus!

February 15, 2020 / BIOON / -- Merck & Co recently announced that the first four African countries, including the Democratic Republic of Congo (DRC), have approved their Ebola vaccine, ervebo (rVSV ∆ g-zebov-gp, V920, live attenuated vaccine) Ervebo was first approved in the European Union on November 11, 2019 and in the United States on December 20, 2019 for active immunization of people aged 18 and over to prevent Ebola virus disease (EVD) caused by Ebola Zaire Ervebo is the world's first regulatory approved Ebola vaccine, marking a historic milestone It should be noted that the duration of protection provided by ervebo is unknown, and the vaccine can not protect other kinds of Ebola virus or Marburg virus When used in combination with antiviral drugs, immunoglobulins (Ig), and / or blood or plasma transfusions, the efficacy of the vaccine is unknown The approval of the first four African countries means that continuous and pioneering progress has been made in promoting the global public health against the future of Zaire Ebola virus disease, which is facilitated by unprecedented cooperation between the World Health Organization (who), the African vaccine Management Forum (avaref), African governments, the European Drug Administration (EMA) and MSD These approvals are the result of the successful implementation of the who plan for the introduction and launch of the rvsv-zebov Ebola virus vaccine in the African countries The plan aims to coordinate actions and contributions to the distribution and promotion of ervebo, contribute to near parallel regulatory reviews and lead to the approval of vaccines in several risk countries within 90 days of who prequalification Kenneth C Frazier, chairman and chief executive officer of MSD, said: "we thank who for its leadership in building a way forward for accelerating the prequalification and licensing of this vaccine in the most at-risk countries This important milestone is yet another example of the partnership that has emerged to respond to the epidemic While our fight in Ebola is far from over, this milestone shows what we can do when we work together to tackle the most challenging diseases that threaten people and communities " At present, Ervebo has been registered with the national health authorities in the following African countries (the Democratic Republic of Congo, Burundi, Garner and Zambia) More approvals from African countries are expected in the near future As previously announced, MSD is in the process of producing the licensed dose and is expected to launch in the third quarter of 2020 Mushadong is working closely with the U.S government, the World Health Organization (who), the United Nations Children's Fund (UNICEF), and the Alliance for vaccines (GAVI) to plan how the final approved dose will support future public health preparedness and response to Zaire's Epstein-Barr virus disease During this transitional period, MSD will continue to work urgently with who and partners to ensure the uninterrupted supply of research Zaire Ebola vaccine (V920) to support the international epidemic response in the Democratic Republic of the Congo and neighbouring countries Ebola virus (Ebola) is the main cause of Ebola hemorrhagic fever (EHF), which is an acute viral hemorrhagic infectious disease Its symptoms include fever, headache, joint and muscle pain, fatigue, diarrhea, vomiting, stomach pain, loss of appetite and abnormal bleeding These symptoms can occur within 2-21 days after infection, but most commonly within 8-10 days Ebola virus is not a water borne or food borne disease, nor is it transmitted through the air It is transmitted by direct contact with the body fluids of the infected person or the instruments (such as needles) that have been contaminated by the virus Ervebo (V920) uses a defective vesicular stomatitis virus that can infect domestic animals, and replaces one gene of the virus with that of Ebola virus The V920 was originally developed by the Canadian public health agency (PHAC) and later licensed to newlink genetics in 2010 At the end of 2014, when the outbreak of Ebola in western Africa reached its peak, MSD signed a global exclusive licensing agreement from newlink to obtain the Ebola vaccine Since then, MSD has been working closely with a number of external partners, with partial funding from the U.S government, to carry out a wide range of clinical development projects, including the biomedical advanced research and Development Administration (BARDA) of the U.S Department of health and human services, the threat reduction Administration (dtra) of the U.S Department of defense and the joint vaccine acquisition program (jvap), etc The pilot supply activities of V920 are supported by some federal funds provided by BARDA according to contract No hhso100201700012c MSD is responsible for the research, development, manufacturing and supervision of V920, and has committed to work closely with other stakeholders to accelerate the continuous development, production and distribution of vaccines In addition to ervebo, Johnson & Johnson's Ebola preventive vaccine program, the two shot immunization program (ad26.zebov, mva-bn-filo), entered the accelerated evaluation in the European Union in early November 2019 The vaccine scheme is as follows: (1) ad26.zebov is used as the first immunization vaccine, which is developed based on the advac technology of Janssen; (2) after about 8 weeks, mva-bn-filo is used as the second immunization vaccine, which is based on mva-bn technology of Bavarian Nordic company Currently, Johnson & Johnson is cooperating with who to register the vaccine program in African countries Photo from: in addition to preventive vaccines, labiotech.eu has several biotech companies developing therapeutic drugs In particular, mab114 from Ridgeback biotherapeutics and regn-eb3 from Zaiban are worth mentioning Mab114 is a therapeutic monoclonal antibody, which originated from the Ebola epidemic in Kikwete, Democratic Republic of Congo in 1995 In that outbreak, survivors remained anti Ebola antibodies 11 years after they were infected with Ebola Researchers isolated antibodies from these survivors, among which mab114 is the most promising one Regn-eb3 is a mixture of three kinds of all human IgG1 monoclonal antibodies It was developed by regenerator and used in the treatment of Ebola virus infection In 2019, mab114 and regn-eb3 were awarded breakthrough drug qualification (BTD) by the US FDA The BTD awards of the two drugs are based on the interim data of pamoja tulinde Maisha (pallm, joint life saving) study The study tested four therapies, including three antibody therapies (antibody cocktail zmapp, three monoclonal antibody mixture regn-eb3, mab114) and an antiviral drug remdesvir (Gilead company), in which zmapp was used as a control Preliminary assessment results from 499 subjects published in August this year showed that subjects treated with regn-eb3 and mab114 had a greater chance of survival than those in the other two groups The specific data are as follows: (1) the mortality rates of the patients treated with remdesvir, ZM app, mab114 and regn-eb3 were 53%, 49%, 34% and 29% respectively; (2) in the patients treated early after infection and with lower blood virus level, the mortality rates were 33%, 24%, 11% and 6% respectively At present, the mortality rate of the whole Ebola epidemic is 67% Based on the above data, the pall study was terminated in advance and regn-eb3 and mab114 were selected as drugs for randomized treatment of all future patients in the extended period to further evaluate the safety until the final clinical trial results were obtained Original source: ervebo (Ebola Zaire vaccine, live) now registered in four African countries, within 90 days of reference country app app roval and who Prequalification