China News Service, February 20 (Bian Lei) After about a year of controversy, the world's first new coronavirus "human challenge test" finally landed in the United Kingdom and was recognized by the country's ethical institutions.
In the past year, the new crown epidemic has swept the world and has caused more than 110 million people to be infected and 2.45 million lives lost.
Since this "human challenge test" requires healthy volunteers to "test the poison with their bodies," whether the test should be used or not has quickly sparked controversy around the world.
Data map: On December 8, 2020, local time, the United Kingdom began vaccinating the new crown vaccine, giving priority to nursing home staff, people over 80, and front-line medical and social workers.
Supporters cry out that the trial has a positive effect on understanding the virus and vaccine development; critics strongly prove that the trial will bring about ethical and practical problems, which may not only harm volunteers, but even make the public lose the existing vaccines. confidence.
Nowadays, after being introduced into the long and arduous war epidemic, the experiment will further hurt people's nerves.
What are the risks and hidden dangers of the experiment?
Can researchers weigh the balance between volunteer safety and virus research?
Can the sacrifice of volunteers get the desired result?
Too many questions waiting to be answered.
Data map: On December 8, 2020, the United Kingdom began vaccinating the new crown vaccine.
The picture shows medical staff vaccinating 90-year-old woman Margaret Keenan.
[Young people who will "test poison"]
On February 17, 2021, Imperial College said that the country’s ethics institution approved a new crown "human challenge test" program.
At present, the project has received funding from the British government and will be jointly developed by Imperial College, the medical company hVIVO, and the Royal Free National Health System Trust in London.
As soon as the news came out, it attracted worldwide attention.
The biggest controversy among them is that the originally healthy volunteers need to "try drugs with their bodies" for research.
British media pointed out that during the study, the new coronavirus will be dripped into the nasal cavity of volunteers.
After that, they will be isolated in the hospital for 14 days.
During this period, the medical team will closely monitor.
"In this way, subjects are'challenged' by the virus. This is different from a standard vaccine clinical trial, (in the latter trial) the vaccine is given to those who are naturally infected with the virus." "India Express News introduced on February 18.
The first research phase will analyze the minimum amount of virus that causes the new coronavirus infection.
At this stage, it is planned to recruit no more than 90 healthy young people between 18 and 30 years old.
The international authoritative journal Nature published in March 2020, "Should scientists infect healthy people with the new crown to test the vaccine?"
According to the article, choosing young and healthy people can greatly reduce the risk of trials.
In the future, British media pointed out that a small number of volunteers may be vaccinated with the approved vaccine first and then exposed to the mutated virus to help find the most effective new coronavirus vaccine-however, this phase of research has not yet been approved.
Data map: On January 31, 2021, people in San Francisco, the United States, were vaccinated at the large-scale new crown vaccination site at San Francisco City College.
Photo by China News Agency reporter Liu Guanguan
[How to ensure a safe and controllable environment? 】
"My team has used other respiratory viruses to safely conduct human challenge studies for more than 10 years. No study is completely risk-free."
Chris Qiu, the person in charge of the New Crown "Human Challenge Test", said.
In a communiqu issued on February 17, 2021, Imperial College stated that the test will be carried out in a safe and controlled environment.
The communiqué stated that in view of the limited understanding of the mutated new coronavirus, the test will use the virus that spread in the UK in March 2020; while the volunteers will be exposed to the virus in a special isolation facility; for the safety of the volunteers, the researchers will Close monitoring, medical staff can provide treatment at any time.
In addition, after the test is over, the volunteers are required to undergo two virus tests, and only those with negative results can leave.
In May 2020, the WHO issued guidance on such trials, stating that under certain conditions, the trial is “ethically acceptable, but the trial must be carefully designed and conducted” to minimize the harm to volunteers; When "higher risk, higher uncertainty, and the public's trust in research are extremely important", the experiment should be conducted with "higher standards."
Data map: On January 5, 2021, the United Kingdom adopted the third stringent blockade, and there are few pedestrians on the streets of London.
The picture shows pedestrians near Tower Bridge in London.
["One foot into the unknown ethical realm"]
Since the sound of discussions surrounding the new crown "human challenge test", people seem to have stepped into an unknown ethical field with one foot.
It is not only Britain that faces ethical dilemmas.
Prior to this, in the United States, Canada, the Netherlands, etc., there were voices "in favor of experiments", including officials, ethicists and even Nobel Prize winners.
The British "Guardian" once reported that approvers pointed out that despite the new vaccine data, conducting a "human challenge test" "still has value."
Global vaccine supplies are tight, and wealthy countries have ordered most of them.
"The'human challenge test' of next-generation vaccine candidates will help ensure that there are enough vaccines around the world."
"Human challenge research has long been successfully used, dating back to the end of the 18th century." Such tests have played a vital role in promoting the development of treatments for malaria, typhoid fever, cholera and influenza. Some analysts pointed out.
On the evening of January 24, 2021, a step on the Arnswald square in Berlin, Germany, was filled with candles to mourn the deceased of the new crown. A sign saying "Let the deceased of the new crown be seen" was placed on the steps.
Photo by China News Agency reporter Peng Dawei
However, unlike the previous "human challenge test", the US "New York Times" analyzed that there is still no definite cure for the new coronavirus.
"For malaria, volunteers stretch their arms into a room full of mosquitoes to bite and infect the mosquitoes, but there are so-called rescue drugs to treat the patients."
The Proceedings of the National Academy of Sciences further pointed out in November 2020: The core proposition of “testing or accelerating vaccine development” is flawed; the relationship between risk and effect is very uncertain and may even be unacceptable; It may further exacerbate people's distrust of existing vaccines.
In addition, is it reasonable to expect young people to participate in the experiment on the premise that they may lose their lives?
François Bellis, a research professor at Dalhousie University in Canada, pointed out that after a volunteer has contracted the new crown, or suffered complications, he and his family may also be in "psychological dilemma" for a long time.
"When I think of the human challenge model, I think,'Can I get this information through other methods?'" said Beth Kirkpatrick, a professor of microbiology and molecular genetics at the University of Vermont in the United States. "If I can find another This way, we usually don’t choose this path."
In any case, researchers are already calling on volunteers to participate in the new crown "human challenge test."
As for the results of this study of healthy young people, can they represent a wider population?
How much can the experiment contribute to vaccine development?
If the experiment fails, will the volunteers’ lives be endangered and will fall into a greater ethical and moral dilemma?
In the face of doubt, the experiment is still in the "eye of the storm", and the road ahead is difficult.
(Finish)