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The controversy of COVID-19 “human challenge” trials

In a few weeks, 90 volunteers between the ages of 18 and 30 will each be given the Coronavirus in order to test vaccines and treatments to combat covid-19. These so-called “Challenge Trials” will take place in the U.K.

The United Kingdom government has received ethics approval to run the world’s first Sars-cov-2 human challenge study. Now the reason for this is to help streamline and improve vaccine testing and discovery; the U.K. government is funding human challenge studies.

Human challenge trials are trials in which participants are intentionally challenged with an infectious disease. Human challenge trials have helped medical science progress over centuries, allowing scientists to observe the progression of an infection from the very moment that the virus enters the body. It was a human challenge trial that helped prevent smallpox along with developing diseases for cholera, typhoid fever, influenza, and dengue fever.

Being effective in the past with other diseases, human challenge studies show why it is important today in order to combat Covid-19. Although the government of the United Kingdom has received ethics approval to go ahead with the trials, it doesn’t necessarily mean that others won’t have their own opinions on the topic. A big dispute regarding the trials would be that the new treatment may have unknown side effects or other risks which might be worse than those from standard treatments that could cause extreme harm to the patients, but people have to keep in mind that scientists are not forcing these people to participate in the tests. The people completely volunteer of their own free will and know what they are getting themselves into.

Although scientists have used challenge trials for hundreds of years, they are known to have a checkered past. Med page today interviewed Daniel Sulmasy, director of the Kennedy Institute of Ethics at Georgetown University in Washington D.C., and this is what he had to say about the checkered history of Challenge Trials.

“Some trials have been widely condemned, such as the U.S. sexually transmitted disease experiments in Guatemala after World War II, or the Willowbrook hepatitis experiments that tested vaccines on children with mental disabilities, which ended only in 1972. We have come a long way from these experiments, using specific criteria to conduct challenging trials. But in the face of a public health emergency such as the COVID-19 pandemic, we ought to be careful about playing too fast and loose about those criteria.” said sulmasy to Medpage Today.

Sulmasy explains how there have been complications with previous trials but none of this deters from the fact that all the patients are volunteers who give their full consent to be in the trials and are also getting paid 4,500 Euros which calculates to about $6,300 in U.S. currency. So, considering the fact that they do not have any problems participating in the trials, there is nothing wrong or unethical about said trials. In truth, these trials will cause more good than harm.

BBC News interviewed Clive Dix, who is the interim chair of the vaccines taskforce, who said, “We have secured a number of safe and effective vaccines for the U.K., but it is essential that we continue to develop new vaccines and treatments for Covid-19. We expect these studies to offer unique insights into how the virus works and help us understand which promising vaccines offer the best chance of preventing the infection.” 

Clive Dix expresses how these trials show scientists how these viruses work and what they can do to conduct the best vaccine to combat the virus while also distributing a vaccine that is safe for the people. 

An analysis given by James Gallagher from a BBC news article explains how the trials work and how they affect the volunteers. Gallagher states, “the trials in the U.K. will start off by focusing on these fundamental scientific questions. But there are also new vaccines in the pipeline, and the virus itself is evolving. Later this year, it will become almost impossible to run large-scale Covid vaccine trials in the U.K. because so many people will have been immunized. But challenge trials involving just a small number of volunteers will still answer crucial questions from how second-generation vaccines compare to whether vaccines protect against new variants.” 

Gallagher spoke about how the challenge trials that consist of just a small number of volunteers may still help to answer crucial questions about the virus and how new vaccines can protect against different variants. 

If people keep bashing challenge studies based on effects that might happen and keeping the mindset that these people are being forced to participate in these trials, then the possibility of this pandemic ending might take longer than expected. So these people will need to understand that these trials are not unethical and indeed help to fight the virus. Patients volunteer on their own behalf with no one forcing them to, while also getting paid in order to discover and learn more about Covid-19 to develop vaccines that can control it. 

These trials started in the U.K. to get them here in the U.S.; the people will need to stop and realize that they will not be forced to do anything and that the people that do volunteer will be helping move the U.S. past Covid-19.

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