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    Home > Active Ingredient News > Immunology News > The world's first Ebola vaccine! Ervebo of MSD has been approved by FDA to prevent Zaire type Ebola virus!

    The world's first Ebola vaccine! Ervebo of MSD has been approved by FDA to prevent Zaire type Ebola virus!

    • Last Update: 2019-12-21
    • Source: Internet
    • Author: User
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    December 21, 2019 / BIOON / - Merck & Co recently announced that the U.S

    Food and Drug Administration (FDA) has approved the Ebola vaccine ervebo (rVSV ∆ g-zebov-gp, V920, live attenuated vaccine) for active immunization of people aged 18 and over to prevent Ebola virus disease (EVD) caused by Ebola Zaire

    This approval is nearly four months ahead of the target date of PDUFA on March 14, 2020

    Previously, the FDA granted ervebo a breakthrough drug qualification

    In November, ervebo won the first batch in the EU

    Ervebo is the world's first regulatory approved Ebola vaccine, marking a historic milestone

    Dr

    Roger M

    Perlmutter, President of MSD research laboratory, said: "FDA's approval of this vaccine is another important milestone in the global response to Ebola virus disease and a great achievement of a unique global partnership

    While acknowledging this incident, I would like to pay special tribute to the heroic efforts of the front-line response personnel for the current outbreak in the Democratic Republic of the Congo

    We are proud and honoured to play a role in supporting their important activities, and we remain focused on the important work ahead

    " 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 its partners to ensure the uninterrupted supply of the Zaire Ebola research vaccine (V920) in support of the ongoing international response efforts of the Democratic Republic of the Congo

    At the request of who, MSD has so far donated more than 275000 1.0 ml doses of V920 to who

    For example, MSD has also cooperated with the African vaccine regulatory Forum (avaref) to submit an application to African national regulators, which will allow the vaccine to be registered in African countries deemed by who as facing the risk of Ebola epidemic

    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 early November, 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

    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 discussing with FDA the data needed for regulatory purposes, and 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 early September this year, the U.S

    FDA granted Ridgeback biotherapeutics a breakthrough drug qualification for mab114, 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

    The BTD award is based on interim data from the pamoja tulinde Maisha (palm, 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

    Source: Merck announcements FDA approval for ervebo ® (Ebola Zaire vaccine, live)
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