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3.
Annu Rev Virol ; 7(1): 475-494, 2020 09 29.
Article in English | MEDLINE | ID: covidwho-865856

ABSTRACT

The conduct of clinical trials during the West Africa Ebola outbreak in 2014 highlighted many ethical challenges. How these challenges were addressed, what clinical studies were conducted during that outbreak, and the lessons learned for dealing with future outbreaks were the subject of a National Academy of Medicine committee report titled Integrating Clinical Research into Epidemic Response: The Ebola Experience. This report suggested improvements for research during subsequent emerging or re-emerging outbreaks and is summarized in this review. We also discuss the current Ebola outbreak in the Democratic Republic of the Congo and highlight how the dialogue has changed and how successful clinical trials have been implemented. We conclude with a description of productive efforts to include pregnant women and children in therapeutic and vaccine trials during outbreaks that are currently ongoing.


Subject(s)
Biomedical Research/ethics , Clinical Trials as Topic/ethics , Disease Outbreaks , Ebolavirus/pathogenicity , Hemorrhagic Fever, Ebola/epidemiology , Patient Selection/ethics , Adult , Africa, Western/epidemiology , Antiviral Agents/therapeutic use , Biomedical Research/organization & administration , Child , Clinical Trials as Topic/organization & administration , Ebola Vaccines/administration & dosage , Female , Hemorrhagic Fever, Ebola/immunology , Hemorrhagic Fever, Ebola/mortality , Hemorrhagic Fever, Ebola/prevention & control , Humans , International Cooperation , Male , Pregnancy , Survival Analysis
5.
Trends Biotechnol ; 38(9): 943-947, 2020 09.
Article in English | MEDLINE | ID: covidwho-597298

ABSTRACT

Vaccine solutions rarely reach the public until after an outbreak abates; an Ebola vaccine was approved 5 years after peak outbreak and SARS, MERS, and Zika vaccines are still in clinical development. Despite massive leaps forward in rapid science, other regulatory bottlenecks are hamstringing the global effort for pandemic vaccines.


Subject(s)
Coronavirus Infections/prevention & control , Drug Approval/organization & administration , Hemorrhagic Fever, Ebola/prevention & control , Influenza, Human/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Viral Vaccines/biosynthesis , Betacoronavirus/drug effects , Betacoronavirus/immunology , Betacoronavirus/pathogenicity , COVID-19 , COVID-19 Vaccines , Coronavirus Infections/epidemiology , Coronavirus Infections/immunology , Coronavirus Infections/virology , Ebola Vaccines/administration & dosage , Ebola Vaccines/biosynthesis , Ebolavirus/drug effects , Ebolavirus/immunology , Ebolavirus/pathogenicity , Europe/epidemiology , Global Health/trends , Government Regulation , Hemorrhagic Fever, Ebola/epidemiology , Hemorrhagic Fever, Ebola/immunology , Hemorrhagic Fever, Ebola/virology , Humans , Influenza A Virus, H1N1 Subtype/genetics , Influenza A Virus, H1N1 Subtype/immunology , Influenza Vaccines/administration & dosage , Influenza Vaccines/biosynthesis , Influenza, Human/epidemiology , Influenza, Human/immunology , Influenza, Human/virology , Middle East Respiratory Syndrome Coronavirus/drug effects , Middle East Respiratory Syndrome Coronavirus/immunology , Middle East Respiratory Syndrome Coronavirus/pathogenicity , Pneumonia, Viral/epidemiology , Pneumonia, Viral/immunology , Pneumonia, Viral/virology , Severe acute respiratory syndrome-related coronavirus/drug effects , Severe acute respiratory syndrome-related coronavirus/immunology , Severe acute respiratory syndrome-related coronavirus/pathogenicity , SARS-CoV-2 , Severe Acute Respiratory Syndrome/epidemiology , Severe Acute Respiratory Syndrome/immunology , Severe Acute Respiratory Syndrome/prevention & control , Severe Acute Respiratory Syndrome/virology , United States/epidemiology , Viral Vaccines/administration & dosage , Zika Virus/drug effects , Zika Virus/immunology , Zika Virus/pathogenicity , Zika Virus Infection/epidemiology , Zika Virus Infection/immunology , Zika Virus Infection/prevention & control , Zika Virus Infection/virology
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