COVID-19 Puts the World Health Organization ’s Emergency Use Listing (EUL) to Work

The World Health Organization’s Emergency Use Listing (EUL) provides an approach for assessing medicines, vaccines, and diagnostics that could help address an outbreak classified by the WHO as a Public Health Emergency of International Concern (PHEIC). Robyn Meurant, executive director, regulatory services, IVDs and medical devices for NSF International, describes the EUL as “akin to the U.S. FDA’s Emergency Use Authorization” and says it could help countries that are “without great means to do testing.” Before joining NSF International, Meurant acted both as a professional officer and an advisor to WHO and assisted with the development of the EUL for IVDs in 2014. MD+DI asked Meurant a few questions about the WHO’s EUL and how it could help IVD and device manufacturers respond—and healthcare systems manage—the COVID-19 pandemic.   What is the Emergency Use Listing (EUL) for WHO and how would it pertain to diagnostics manufacturers? Meurant: The World Health Organization’s Emergency Use Listing, or EUL, was developed in 2014 in response to the Ebola outbreak in three west African nations. Akin to the FDA’s Emergency Use Authorization (EUA), it’s an assessment for medicines, vaccines, and devices used to address an outbreak classified by the...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news

Related Links:

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
The COVID-19 pandemic has had significant global consequences, with healthcare systems stretched to their limits, a growing death toll, and economic devastation as economies came grinding to a halt. The pandemic and its aftereffects will be with u...
Source: Medgadget - Category: Medical Devices Authors: Tags: Exclusive Medicine Public Health Source Type: blogs
An infectious outbreak can conclude in more ways than one, historians say. But for whom does it end, and who gets to decide?
Source: NYT Health - Category: Consumer Health News Authors: Tags: Epidemics Coronavirus (2019-nCoV) Plague Smallpox Ebola Virus Influenza Epidemic (1918-19) Rats Antibiotics Bubonic Plague Fleas Microbiology Deaths (Fatalities) Vaccination and Immunization your-feed-science your-feed-health Source Type: news
This article is part of #TIME100Talks: Finding Hope, a special series featuring leaders across different fields sharing their ideas for navigating the pandemic. Want more? Sign up for access to more virtual events, including live conversations with influential newsmakers.
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 TIME 100 TIME100 Talks video Source Type: news
On Oct. 2, 2001, a 62-year-old photojournalist named Bob Stevens became the first victim of a coordinated series of anthrax attacks to be admitted to hospital. Stevens inhaled the deadly pathogen after opening one of several letters laced with anthrax spores which were mailed to the offices of prominent senators and media outlets across the U.S. Over the next seven weeks, he and four others would die as a result of their exposure. For a shell-shocked nation still reeling from the single deadliest terrorist attack in human history on September 11, it was a disturbing realization that there was a new wave of challenges to Am...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 Source Type: news
A young boy in Pakistan receives an oral polio vaccine (OPV). Credit: Ashfaq Yusufzai/IPSBy Laura MackenzieMay 6 2020 (IPS) Interruptions to vaccination programmes caused by the COVID-19 pandemic could result in new waves of measles or polio outbreaks, health experts warn. A growing number of one-off immunisation campaigns and national routine vaccine introductions are being delayed amid social distancing and other measures to curb the spread of SARS-CoV-2, leaving millions unprotected. With both preventive campaigns and routine immunisations impacted, “we’ll have an increasing number of children who will becom...
Source: IPS Inter Press Service - Health - Category: International Medicine & Public Health Authors: Tags: Global Headlines Health TerraViva United Nations Source Type: news
By Osamu KusumotoTOKYO, May 5 2020 (IPS) The new coronavirus (COVID-19) continues to wreak havoc across the world, as the number of infections and deaths rapidly rise. It has the potential to infect anybody regardless of age or gender. There are grave concerns that the economic fallout from COVID-19 may be comparable to that of the Great Depression. According to Johns Hopkins Coronavirus Resource Center, there are 2,064,668 confirmed cases of COVID-19 and 137,124 deaths due to SARS-CoV-2 (the virus causing COVID-19). In Japan as of noon April 15, there were 8,100 cases of COVID-19 , 119 deaths, and 901 patients discharged ...
Source: IPS Inter Press Service - Health - Category: International Medicine & Public Health Authors: Tags: Asia-Pacific Economy & Trade Global Headlines Health Humanitarian Emergencies Poverty & SDGs Source Type: news
By ANISH KOKA, MD A number of politically tinged narratives have divided physicians during the pandemic. It would be unfortunate if politics obscured the major problem brought into stark relief by the pandemic: a system that marginalizes physicians and strips them of agency. In practices big and small, hospital-employed or private practice, nursing homes or hospitals, there are serious issues raising their heads for doctors and their patients. No masks for you When I walked into my office Thursday, March 12th, I assembled the office staff for the first time to talk about COVID.  The prior weekend had been...
Source: The Health Care Blog - Category: Consumer Health News Authors: Tags: COVID-19 Medical Practice Physicians Anish Koka medical autonomy Pandemic Source Type: blogs
In just a few months, the COVID-19 pandemic has crossed borders and oceans, killing thousands, sickening millions, and forcing millions more to reckon with the economic and personal chaos of closures and lockdowns. Yet as the global infection count rises, the crisis has also given rise to acts of ingenuity. The pandemic has set off a global race for both an effective vaccine and for the accurate, rapid-response tests that will be necessary before workplaces can safely reopen. Vaccines and tests are essential, but they’re not the only front on which to combat the virus. In the face of an urgent threat, scientists have...
Source: TIME: Science - Category: Science Authors: Tags: Uncategorized COVID-19 Source Type: news
Authors: Sahu KK, Mishra AK, Lal A Abstract With each passing day, more cases of Coronavirus disease (COVID-2019) are being detected and unfortunately the fear of novel corona virus 2019 (2019-nCoV) becoming a pandemic disease has come true. Constant efforts at individual, national, and international level are being made in order to understand the genomics, hosts, modes of transmission and epidemiological link of nCoV-2019. As of now, whole genome sequence of the newly discovered coronavirus has already been decoded. Genomic characterization nCoV-2019 have shown close homology with bat-derived severe acute respirat...
Source: Monaldi Archives for Chest Disease - Category: Respiratory Medicine Tags: Monaldi Arch Chest Dis Source Type: research
More News: African Health | China Health | COVID-19 | Ebola | Ebola Vaccine | Emergency Medicine | Epidemiology | International Medicine & Public Health | Laboratory Medicine | Marketing | Medical Devices | Outbreaks | Pandemics | Vaccines | WHO