England has approved a trial that will inject the coronavirus into healthy people to test a vaccine: is this morally correct?

Is it normal to infect with coronavirus 90 healthy people to acquire new knowledge to save millions of lives? A research ethics board in England found yes it is morally justified to conduct such an infection exposure study in the context of a public health emergency such as a pandemic.

On his recommendation, the government of that country authorized the trial, And in a month, they will be exposing young volunteers who will sign up to the virus. They claim that this controversial lawsuit will be made for understand faster and better how the infection develops and the response of the immune system. But clinical research scientists, ethicists warn that this is an alternative type of trial that can only be performed under limited circumstances when probable benefits are expected that cannot be achieved with traditional trials. .

“This will be the first controlled infection study for COVID-19. It will not include a vaccine, because its goal is to find out what is the least amount of virus infecting most of our volunteers, ”he said. Infobae the doctor Christopher chiu, which is part of the section of infectious diseases in adults at Imperial College London. The trial is part of a collaboration between Imperial College, the Royal Free London NHS Foundation Trust and the company hVIVO who has experience in controlled infection studies for other diseases.

The study will not assess the efficacy or safety of any vaccine in development against COVID-19. They only argue that it will be done to understand how the immune system reacts to the coronavirus and to identify the factors that influence the mode of transmission of the virus, including how an infected person “spits” virus particles into the air.

“EFollow-up studies with vaccines are planned for the future. But we still don’t know which vaccines they will be”Said Dr. Chiu. They believe the study will immediately provide information about a mild, asymptomatic infection, which is one of the main drivers of coronavirus transmission. While the first generation of vaccines are in the process of being distributed, human exposure studies could also be useful in organizing administration times and doses of existing vaccines., find out how long each dose protects and if they are effective against newer variants of the virus. But these are only possibilities for the future.

Although it is surprising that they will infect healthy people with the virus, one of the arguments for this is that there is already a history of these types of studies in the development of vaccines for others. diseases. Another argument is that exposure to the virus will be with the informed consent of the healthy volunteers aged 18 to 30, who will remain in isolation under medical supervision. By not having previous illnesses and being at this age, volunteers would not develop serious photos of COVID-19. Beyond these arguments, Is it ethically justified that such people run the risk of falling ill?

“This is a difficult question to answer because the library is split in two. Testing for exposure to infections can be done ethically, but we must have the assurance that the volunteers can be saved from the disease to which they are exposed ”, he replied. Infobae the philosopher and principal researcher at Conicet Florence moon, who is director of the master’s degree in bioethics at the Latin American Faculty of Social Sciences (FLACSO).

In the case of the COVID-19 exposure trial, there is still no certainty that the volunteers can be cured as the disease is not yet fully understood. And that goes against it. On the other hand, it is true that the research is conducted in a population in which it is considered that there would be serious health problems. In addition, The volunteers would be in a controlled environment and in a central country where control measures are in place and they would take the most well-known variant of the coronavirus. One advantage is that it will only include 90 people and quickly bring in knowledge, Dr Luna said.

But the researcher pointed out another aspect that may be controversial:to the financial compensation that participants will receive. In the case of England, volunteers will be paid for their time, with a sum of $ 6,200 over a year, which will include follow-up testing. “Who will these volunteers be and how much will they be paid for their participation? Paying for trial participation for someone with a modest income is not a dilemma. But it could be different when it comes to a person with no income. Because participation in the trial could be for monetary motivation and not for an altruistic matter. This is a problem not only in infection exposure tests but also in conventional clinical trials ”.

First background

Infection with the coronavirus is still controversial. But it is true that there have been similar experiences in the past with benefits for fighting the disease. In 1774, an English farmer Benjamin Jesty was the first vaccinator in human history. He believed that the people who treated the cows contracted the cowpox virus and were protected against the disease. With this hypothesis, he administered the virus extracted from lesions on the udder of an infected cow to his wife and two children. His intention was to protect his family against smallpox which threatened the health of the population.

Twenty-five years later, the English physician Edward Jenner conducted a more systematic experiment in which he administered a vaccine against the bovine virus to an 8-year-old boy, named James Phipps. Jenner then tested the effectiveness of this vaccine by deliberately exposing the child, without having her consent. He repeated the experiment on other children, including his own son, and concluded that the vaccination gave them immunity against smallpox safely. Jetsy’s experiment and the work of Jenner – who is today regarded as the father of immunology around the world – are antecedents of what are now called “human exposure studies” or ” controlled studies of human infection ”.

Exposure studies have been used to control smallpox, yellow fever and malaria, which have changed the course of global public health. In the aftermath of the coronavirus pandemic, the World Health Organization formed a working group to assess what should be the acceptability criteria for these trials which may have benefits in an emergency, but which are not without risks. In the review that the experts made, they indicated that Over the past 50 years, exposure studies have been safely conducted in tens of thousands of adult volunteers, with their consent, under the supervision of research ethics boards. Recently, these studies have made it possible, for example, to accelerate the development of vaccines against typhoid fever and cholera, and to determine the correlates of immune protection against influenza.

After a debate between the experts, WHO released guidelines for acceptability of exposure trials on May 6 to minimize the risk of infection and not further erode confidence in clinical trials and vaccines globally. The research – recommended in a public document – must meet particularly rigorous standards in cases where: the studies involve exposing healthy participants to relatively high risks; studies involve human interventions for the first time (including exposure) or have a high degree of uncertainty (for example, about infection, disease and sequelae), or public confidence in the research is particularly important, such as during public health emergencies.

In what cases would a trial exposing healthy volunteers be justified? One of the criteria mentioned by the WHO group is that there must be a “strong scientific rationale”, which includes that the study provides knowledge on immune protection, asymptomatic cases and transmission. This point is consistent with the purpose of the trial which was approved in England.

The other criteria are to assess whether the potential benefits of the trial outweigh the risks; that the local population and experts be consulted and allowed to participate; and that there is coordination of researchers, sponsors, officials and regulators.

The place where the study is carried out should have high standards of scientific and ethical research. The selection of participants should ensure that risks are minimized and that there is an independent review committee made up of specialist members. The final criterion is the informed consent of the volunteers, who must be tested to verify whether they understand the benefits and risks of the study. In the case of the trial in England, the call to participate has already started online.

It is striking that he only provides the details of the study after the person has registered and not before. Are you pressuring the person to agree to participate?

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