An Ebola Drug Trial Ended Early Because It Was So Successful. That Could Change How Doctors Handle Future Outbreaks

A year into an Ebola outbreak in the Democratic Republic of the Congo (DRC), researchers have halted an experimental drug trial there because early results appear so promising. The drugs will be made available to more patients in the DRC, hopefully saving lives as the current outbreak continues. But the decision to end the trial early has implications that go beyond the DRC: it could also change the way infectious disease treatments are studied in years to come. The trial, which began last November and enrolled 681 patients at four sites in the DRC, was meant to test four experimental Ebola therapies: ZMapp (an antibody cocktail from Mapp Biopharmaceutical), remdesivir (an antiviral from Gilead Sciences), mAb114 (a monoclonal antibody licensed by Ridgeback Biotherapeutics), and REGN-EB3 (another antibody cocktail made by Regeneron Pharmaceuticals). After less than a year, the latter two appeared so successful that an independent board overseeing the trial recommended that it end early, according to an announcement from one of the study’s co-sponsors, the U.S. National Institute of Allergy and Infectious Diseases (NIAID). All future patients in the trial will receive either mAb114 or REGN-EB3, and the drugs will also be available to patients in Ebola treatment centers throughout the DRC. That’s big news not only because it provides hope that more Ebola patients will survive the often-fatal hemorrhagic fever, which has no previously known cure. Beyond that, the stu...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized Infectious Disease Source Type: news

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By Folake OlayinkaAug 15 2020 (IPS) In 1918, the Spanish Flu, a deadly influenza caused by the H1N1 virus, decimated the world. Over the course of four successive waves, it infected 500 million people, about a third of the world’s population at the time, resulting in 50 million deaths. More recently between 2014 and mid-2016 , the Ebola virus epidemic was the most widespread outbreak of Ebola virus disease in history—causing devastating  loss of life and socioeconomic disruption in the West Africa region, mainly in Guinea, Liberia and Sierra Leone. These outbreaks, as well as SARS and MERS, each have ...
Source: IPS Inter Press Service - Health - Category: International Medicine & Public Health Authors: Tags: Democracy Headlines Health Source Type: news
Discussions with the U.S. Food and Drug Administration (FDA) have taken place to define the required data set for filing US licensure. About Janssen’s Ebola Vaccine Regimen The Janssen preventive Ebola vaccine regimen, Ad26.ZEBOV and MVA-BN-Filo, utilizes a non-replicating viral vector strategy in which viruses – in this case adenovirus serotype 26 (Ad26) and Modified Vaccinia Virus Ankara (MVA) – are genetically modified so that they cannot replicate in human cells. In addition, these vectors carry the genetic code of several Ebola virus proteins in order to trigger an immune response.Janssen’s vac...
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Discussions with the FDA are ongoing to define the required data set for filing Janssen’s Ebola vaccine regimen under the FDA’s Animal Rule licensure pathway. About Janssen’s Ebola Vaccine Regimen The Janssen investigational preventive Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo) utilizes a viral vector strategy in which viruses – in this case adenovirus serotype 26 (Ad26) and Modified Vaccinia Virus Ankara (MVA) – are genetically modified so that they cannot replicate in human cells. In addition, these vectors are modified to safely carry the genetic code of an Ebola virus protein in order...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news
In early April, about four months after a new, highly infectious coronavirus was first identified in China, an international group of scientists reported encouraging results from a study of an experimental drug for treating the viral disease known as COVID-19. It was a small study, reported in the New England Journal of Medicine, but showed that remdesivir, an unapproved drug that was originally developed to fight Ebola, helped 68% of patients with severe breathing problems due to COVID-19 to improve; 60% of those who relied on a ventilator to breathe and took the drug were able to wean themselves off the machines after 18...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 Source Type: news
One of the worst symptoms of any plague is uncertainty—who it will strike, when it will end, why it began. Merely understanding a pandemic does not stop it, but an informed public can help curb its impact and slow its spread. It can also provide a certain ease of mind in a decidedly uneasy time. Here are some of the most frequently asked questions about the COVID-19 pandemic from TIME’s readers, along with the best and most current answers science can provide. A note about our sourcing: While there are many, many studies underway investigating COVID-19 and SARS-CoV-19, the novel coronavirus that causes the illn...
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NIH COVID-19 SIG Lecture Series NIAID has a long-standing dual mandate to maintain a robust portfolio of research in its key focus areas and to respond to emerging and re-emerging infectious diseases (EIDs). With this mandate, NIAID has also sought to improve EID-response preparedness, working in partnership with other U.S. government research entities, industry, academia, and international public-health organizations. This preparedness planning helped the institute respond rapidly to COVID-19. NIAID tapped existing coronavirus expertise and other assets to stand up research programs spanning basic virology and immunology ...
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President Donald Trump’s declaration of a national emergency is designed to speed federal support to parts of America that are struggling to prepare for a coming surge of COVID-19 cases, unlocking $50 billion in aid, giving hospitals and doctors more freedom to handle a potential tsunami of sick patients and scrambling to make tests available. In a Rose Garden press conference Friday, Trump presented the emergency measures as proof that, “No nation is more prepared or more equipped to face down this crisis.” But for epidemiologists, medical experts and current and former U.S. public health officials, the ...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 Source Type: news
Ebola virus is a large, negative-strand RNA virus composed of 7 genes encoding viral proteins, including a single glycoprotein (GP). The virus is responsible for causing Ebola virus disease (EVD), formerly known as Ebola hemorrhagic fever (EHF), in humans. In particular, Bundibugyo (BDBV), Zaire (EBOV), and Sudan (SUDV) species have been associated with large outbreaks of EVD in Africa and reported case fatality rates of up to 90%. Transmission of Ebola virus to humans is not yet fully understood but is likely due to incidental exposure to infected animals. EVD spreads through human-to-human transmission, with infection re...
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While the threat of the new coronavirus in the United States remains limited, a network of U.S. government agencies are already furiously ramping up efforts to contain the disease, should an outbreak occur. “We are working to keep the risk low,” said Health and Human Services Secretary Alex Azar, who is leading the federal government’s response, at a press conference Friday. So far, the overwhelming number of new cases of the virus, which originated in Wuhan, China, remain in China. There are only 11 confirmed cases in the U.S. The good news, some officials and infectious disease experts tell TIME, is t...
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As a new strain of coronavirus moves from the Wuhan province of China to other parts of the world, including the United States, public health leaders are advising government officials to embrace a deliberate, measured response. But with President Donald Trump at the helm of an often unpredictable administration, infectious disease and epidemic experts tell TIME they’re concerned about which officials will have the President’s ear, and how the Commander-in-Chief will manage his Twitter presence during a potential pandemic. On Friday, Health and Human Services Secretary Alex Azar announced that, against the advi...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized 2019-nCoV Infectious Disease White House Source Type: news
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