London. A big news has emerged from the United Kingdom. It is being told that Britain is planning to intentionally infect dozens of healthy young volunteers with the corona virus in the coming weeks. The reason behind this is to find out how the corona virus affects people and the effectiveness of experimental vaccines. The so-called first human challenge study for the corona virus has been approved by the country’s Clinical Trials Ethics Body and is set to begin in mid-March. However this scheme still gives rise to many questions.
1. What is human challenge study?
This is a controlled human infection study in which healthy volunteers are deliberately “challenged” with an infectious disease organism. The World Health Organization states that such research may be particularly valuable for testing vaccines because fewer participants require experimental vaccination to ascertain their efficacy and safety, which is likely due to immunity. Accelerates development.
Human challenge studies can also be used to extract information about a pathogen, such as its ability to cause disease, factors that place people at risk of disease, and the way the body responds to an infection What generates immunity, things like clues about him.
Organizers of the study in Britain say that this type of research has been used for decades for diseases including malaria, typhoid, cholera, norovirus and flu.
2. What does the UK propose to study?
According to a statement released by the UK government on 17 February, 90 healthy adults between the ages of 18 and 30 are being recruited for studies in two fields. The first will test different amounts of the virus to determine the smallest need required to cause an infection and produce an immune response. The researchers said the study would help identify factors such as how the virus spreads and how a corona-infected person transmits infectious particles to the environment.
Subsequently, Kovid-19 vaccines that have been proven to be safe in clinical trials will be applied to a group of volunteers and then exposed directly to the corona virus-infected individuals-environment. This will help identify the immunological response necessary to protect people from re-infection as well as the most effective vaccines.
3. Who is doing this research?
It is run by the UK Government Vaccine Taskforce, Imperial College London, Royal Free London NHS Foundation Trust and clinical research company hVIVO PLC Group. The UK is investing £ 33.6 million (Rs 340 crore per Indian currency) in this research. Volunteers will be compensated for time spent in the study. According to a New York Times report, volunteers will be given more than Rs 4.57 lakh to isolate while being infected and make appointments for the next one year.
4. Are people really volunteering?
Please tell that the corona virus has killed more than 24 lakh people globally since the end of 2019. Bioethicist Arthur Caplan of New York University, who helped develop a vaccine against the rubella virus, and Stanley Plotkin, a physician in Doylestone, Pennsylvania, wrote in a paper in the Vaccine Journal in May that, ethically, these volunteers were forced by the Ethics Committee and Will need to be released from their consent. “Telling volunteers to take risks without coercion or coercion is not exploitation, but benefiting from altruism,” he said.
5. What precautions are being taken?
No study is completely risk-free, but researchers said safety is paramount. The government said the researchers would use a version of the corona virus that has spread in the UK since March 2020 and is a “low risk” for young healthy adults. An expert team will “closely monitor the effects of the virus on volunteers and care for them 24 hours a day.”
The researchers are working closely with the Royal Free Hospital and the North Central London Adult Critical Care Network to ensure the study will not compromise the care of other Corona patients.
The BMJ Medical Journal reported in October that the criteria required for participation included no history or symptoms of Kovid-19, no prior illness, and no known Kovid-19 for heart disease, diabetes, or obesity Not having adverse risk factors. The BMJ stated that participants developing Kovid-19 will be treated with antiviral remedisavir of Gilead Sciences Inc. as soon as the infection is confirmed.
6. What are the concerns with human challenge studies?
The World Health Organization formed an advisory group last year to consider such research in the context of Kovid-19. A December report said some concerns were highlighted in this regard, such as the possibility of serious illness including blood clotting and the lack of reliable, effective measures to address the disease. Some critics have raised concerns about the possibility of long-term effects from corona virus infection.
The WHO report also warns that human challenge studies can lead to misinterpretation and confusion in the public, resulting in increased fear and hesitation against the vaccine — especially if a participant becomes seriously ill or dies. Goes, or there is a breach in security.
Was unnecessarily victimized.
7. WHO’S DOING?
WHO re-organized its advisory group before the end of March to conduct an open forum call with technical experts to discuss the study’s protocol in detail and to review the situation and provide advice and support in making informed decisions. Planned to add.
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