FDA approved the first Ebola vaccine to be launched in the United States

Emervebo is approved for listing in the United States! Today, the U.S Food and Drug Administration (FDA) announced that it has approved the emerebo vaccine for the prevention of Ebola virus disease, which is the first FDA approved vaccine for the prevention of Ebola virus disease The FDA has also awarded Ervebo the name of breakthrough therapy to promote vaccine development and scientific evaluation Ervebo is a single dose, genetically modified, inactivated vaccine containing a protein of the Ebola virus According to Yao Zhi's reporter, on September 17 this year, FDA accepted the biological product license application (BLA) of MSD, and gave priority to the Ebola trial vaccine (V920) in the ongoing Ebola virus disease prevention review of MSD On the 11th of last month, the ervebo vaccine was approved by the European Commission for conditional marketing The FDA said EVD cases are rare in the United States Patients are usually those who travel to the United States after infection in other countries, or are infected after treatment of EVD patients Anna Abram, FDA's Deputy Commissioner for policy, legislation and international affairs, said: "although the risk of Ebola infection in the United States is very low, the U.S government remains firmly committed to fighting the devastating Ebola epidemic in Africa, including the current epidemic in the Democratic Republic of the Congo Today's approval is an important step in FDA's joint cooperation with the U.S Department of health and human services, as well as in close coordination with international partners such as the World Health Organization, to continue efforts to fight the Ebola virus These efforts, including today's landmark approvals, reflect FDA's unwavering commitment to leveraging expertise to promote the development and delivery of safe and effective medical products to meet urgent public health needs and prevent and treat infectious diseases " EVD is contagious and is transmitted through direct contact with blood, body fluids and tissues of infected wildlife or people, as well as objects (such as bedding and clothing) contaminated by these body fluids The incubation period of EVD is usually 2-21 days The symptoms include fever, fatigue, muscle pain, headache and sore throat The second is vomiting, diarrhea, rash, kidney and liver dysfunction, sometimes with internal and external bleeding Individuals who provide care for EVD patients, especially those who do not use the right infection control and prevention measures, have the highest risk of infection Since the 1970s, the confirmed EVD outbreak has mainly occurred in sub Saharan Africa Scientists believe that the virus content in some infected wild animals is very low In very few cases, people will be infected with EVD after direct contact with infected animals But when the virus spreads between people, it will lead to the outbreak of EVD From 2014 to 2016, three West African countries (Guinea, Liberia and Sierra Leone) witnessed an EVD outbreak caused by Ebola virus, resulting in more than 28000 EVD cases and more than 11000 deaths The Democratic Republic of Congo is currently experiencing the second largest EVD outbreak in the world In 2018, the World Health Organization (who) and the Democratic Republic of the Congo started using ervebo as a research vaccine to help alleviate the epidemic, under a registered drug delivery plan However, whether vaccinated or not, appropriate infection control and prevention measures must be implemented to prevent the transmission of Ebola virus Peter marks, director of FDA's Center for biological product evaluation and research, said: Ebola virus disease is a rare, serious and often fatal disease regardless of national boundaries Vaccination is very important to prevent the outbreak of Ebola virus and prevent the spread of Ebola virus in the outbreak The approval of ervebo by FDA is a major milestone to help prevent Ebola virus and advance the prevention work of the U.S government The research methods used to study the efficacy and safety of the vaccine are precedent in public health emergencies, which may help to create a model for future research in similar situations FDA is committed to continuing work between the U.S government and international partners to prevent future outbreaks of Ebola and mitigate the current outbreak in the Democratic Republic of Congo A study conducted in Guinea in 2014-2016 provided evidence of the approval of ervebo The study was a randomised vaccination study in which 3537 contacts of laboratory confirmed EVD patients, as well as contacts of contacts, received "immediate" or "21 day delayed" ervebo vaccination By comparing 2108 EVD cases in the immediate vaccination group with 1429 cases in the delayed vaccination group, ervebo was determined to be 100% effective in patients with symptoms less than 10 days of vaccination In the immediate group, no EVD cases were observed, while in the 21 day delay group, 10 EVD cases were observed In addition, 477 Liberians, about 500 Sierra Leoneans and about 900 Canadian, Spanish and American people were assessed for their ervebo antibody responses The antibody responses in Canada, Spain and the United States were similar to those in Liberia and Sierra Leone Some 15000 individuals were assessed for their safety in Africa, Europe and the northern United States The most common side effects are pain, swelling and redness at the injection site, as well as headache, fever, joint and muscle pain and fatigue Due to the importance of EVD vaccine prevention for public health, FDA and MSD worked closely to complete the safety and effectiveness assessment of ervebo in less than six months The approval of ervebo also marks an important milestone in public health preparedness and response Reference sources: 1 Http://suo.im/5ozszy 2 Http://suo.im/6qawoj 3 Http://suo.im/5wvgfj 4 Http://suo.im/5a1ife The author's opinion is only on behalf of the author, not on behalf of the position of yaozhi.com Welcome to exchange and supplement in 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