Ebola vaccine! Johnson & Johnson's 2-injection vaccine program enters accelerated evaluation in the EU!

　　Pharmaceutical Network November 12 - Johnson and Johnson's Janssen Pharmaceuticals company recently announced that it has submitted two marketing authorization applications (MAA) to the European Medicines Agency (EMA) for approval of a research Ebola vaccine program to prevent Ebola virus disease (EVD) caused by the Ebola virus strain in Zaire Two MAAs have been submitted in parallel to support each vaccine in the 2-needle immunization programme (Ad26.ZEBOV, MVA-BN-Filo) In September, the EMA Human Medicine Products Committee (CHMP) granted these applications to expedite assessment the vaccine program is: (1) Ad26.ZEBOV as the first vaccine, the vaccine is based on Jansen's AdVac technology development, and (2) about 8 weeks later, MVA-BN-Filo as the second vaccine, the vaccine is based on Bavarian's Nordic's MVA-BN technology Two MAAs are supported by data from Phase I, Phase II and Phase III clinical studies that assess the safety and immunoogenicity of this vaccine program in adults and , as well as preclinical studies and immunobridge analysis data To date, more than 6,500 volunteers in the United States, Europe and Africa have participated in more than 10 clinical studies on the Jansen vaccine , Janssen is in discussions with the U.S Food and Drug Administration (FDA) to determine the data needed to submit the above-mentioned Ebola vaccine program under the FDA's animal (effect) licensing pathway In addition, Jansen has partnered with the World Health Organization (WHO) to register the above-mentioned Ebola vaccine programme in African countries at the end of October, Jansen announced that up to 500,000 experimental vaccine programs would be available for new clinical trials organized by the Government of the Democratic Republic of the Congo and global health stakeholders to control the Ebola outbreak in the country "The world's largest Ebola outbreak has occurred in the last six years, and the Democratic Republic of the Congo is currently in the latest outbreak, and we must ensure that we are globally prepared for Ebola," said Dr Paul Stoffel, Vice Chairman and Chief Scientific Officer, executive committee of Johnson and Johnson Given the important role that vaccines can play in responding to the threat of the epidemic, we look forward to the European Authority reviewing our marketing authorization applications for vaccine programmes "
Ebola virus (Ebola) is the cause of Ebola haemorrhagic fever (EHF), an acute viral haemorrhagic infection with symptoms such as 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 of the virus infection, but most often 8-10 days The Ebola virus is not a water-borne or food-borne or air- and is transmitted through direct contact with infected human fluids or devices contaminated with the virus, such as needles In addition to Johnson, the V920 Zaire Ebola vaccine in Mersadon (rVSV?? G-ZEBOV-GP, live vaccine reduction) has also entered the United States and the European Union for priority review, the European Union is expected to be approved by the end of this year, the United States is expected to be approved in March 2020 In addition, Mercadon submitted pre-qualification materials to the WHO and to the African Forum for Vaccine Regulation (AVAREF) 　　V920 uses a defective blister-based mouth disease virus that infects livestock, replacing one of the virus's genes with the genes of the Ebola virus The V920 was originally developed by the Canadian Public Health Agency (PHAC) and then licensed to NewLink In 2010 At the end of 2014, when the Ebola outbreak in West Africa peaked, Mercadon signed a global exclusive licensing agreement from NewLink to obtain the Ebola vaccine, and has since worked closely with a number of outside partners and has undertaken a wide range of clinical development projects with partial funding from the U.S government Mercado, which is responsible for the research, development, manufacturing and regulatory of V920, has committed to working closely with other stakeholders to accelerate the continued development, production and distribution of vaccines in addition to preventive vaccines, several biotech companies are developing therapeutic drugs In early September, the U.S FDA granted Ridgeback Biotherapeutic the single-antidrug mAb114 breakthrough drug, a therapeutic mono-resistance that originated in the 1995 Ebola outbreak in Kikwete, Democratic Republic of congo In that outbreak, survivors remained anti-Ebola antibodies for up to 11 years after contracting Ebola, and researchers isolated antibodies from those survivors, of which mAb114 was the most promising the BTD award, based on interim data from the Pamoja Tulinde Maiha (PALM, Co-Saving Lives) study The study tested four therapies, including three antibody therapies (antibody cocktail ZMapp, three mono-anti-mixtures, REGN-EB3 ( Reibo) and monoclonal antibody mAb114) and an antiviral drug remdevir (Gilead), of which ZMapp was used as a control Preliminary assessments from 499 subjects, published in August, showed that subjects treated with REGN-EB3 and mAb114 had a greater chance of survival than the other two groups The specific data were: (1) remdevir, ZMapp, mAb114, REGN-EB3 treatment of the mortality rate of 53%, 49%, 34%, 29% ;(2) in the early treatment after infection and low blood virus levels, the data were stronger, the mortality rate was: 33%, 24%, 11%, 6% the current death rate for the entire Ebola outbreak is 67 per cent Based on the above data, the PALM study was terminated prematurely and REGN-EB3 and mAb114 were selected as drugs for randomized treatment in all future patients during the extended period to further evaluate the safety of the assessment until the final clinical trial results are obtained original origin: Johnon and Johnon Announce Submion of The European Marketing World, Application for Janen' Invetigation Al Ebola Vaccinen