Volunteers want to catch COVID-19 as part of vaccine testing. WHO is skeptical

1 Day Sooner, a group of scientists and researchers, is recruiting volunteers for potential COVID-19 vaccine research. Volunteers would be infected with the SARS-CoV-2 coronavirus, and the entire procedure would speed up work on an effective vaccine. At the moment, on the organization’s website, the counter shows that 24 volunteers from 292 countries have signed up.

The race for the COVID-19 vaccine

The race for the COVID-19 vaccine continues. Currently, more than 90 vaccines are in various phases of research. The company Moderna, which has completed the first phase of clinical trials on humans and obtained the approval of the US Food and Drug Administration (FDA) for the second phase, has come the furthest.

ZobaczThe first human trials of the COVID-19 vaccine are showing positive results

Meanwhile, the organization 1 Day Sooner is looking for candidates for human provocation trials to accelerate the introduction of the COVID-19 vaccine to the market. How would deliberately infecting volunteers help?

A series of tests are required to develop a vaccine against any disease. To begin with, an experimental vaccine is tested in animals, and if the results are promising, scientists apply for permission to conduct clinical trials in humans. These studies are divided into 3 phases. 1 Day Sooner wants to advance Phase XNUMX, where the vaccine is tested on thousands of volunteers to test its effectiveness.

Phase three clinical trials typically last several years and follow thousands of volunteers to assess differences in disease rates between the vaccinated and unvaccinated control groups. The groups are not artificially exposed to the pathogen, but can only “catch” it in the natural environment, which significantly extends the research.

This is where the idea of ​​1 Day Sooner comes in. By gathering a sufficient number of volunteers who intentionally become infected with the SARS-CoV-2 coronavirus (both in the vaccinated and control groups), observations on the effectiveness of vaccination can be accelerated.

As we read on page 1 of the Day Soooner, given the unprecedented urgency in fighting the COVID-19 pandemic, regulators and researchers are likely to try somewhat unconventional ways to accelerate Phase XNUMX clinical trials. One of these methods is to conduct a third phase study among people at high risk of infection, such as healthcare professionals. It is they who are constantly exposed to contact with the pathogen.

Another solution is to gather a group of people who intentionally become infected with the SARS-CoV-2 coronavirus. But who would want to risk their health? It turns out quite a lot of people. So far, 24 volunteers from 292 countries have signed up.

CNN reached out to one of the people who expressed a wish to participate in the provocation research. 20-year-old student Abie Rohirg, when asked why she made such a decision, said the award was worth the risk.

«I know there are dangers and if something went wrong it would be very difficult for my family. But someone has to undertake it, »she told CNN.

Risks to Volunteers Testing Vaccines

We can read about the potential qualification for provocation studies to accelerate the licensing of the coronavirus vaccine in The Journal of Infectious Diseases. Three scientists – Nir Eyal, Marc Lipstich and Peter G. Smith propose to perform this type of tests in compliance with appropriate ethical standards.

The article reads, inter alia, that replacing conventional Phase III testing with human challenge testing could reduce the time it takes to complete the vaccine licensing process by many months.

Scientists also agree that exposure of volunteers to contact with the coronavirus can be fatal, so volunteers participating in the study must be aware of the risks and make the decision to proceed with the research on their own and based on the latest knowledge about the disease.

In the proposed study, the researchers assume that the volunteers are people previously uninfected with the coronavirus, with a relatively low risk of complications from infection, and from an area with a high baseline risk of natural infection. That is, young people (20-45 years old) without chronic diseases who live in areas affected by the COVID-19 pandemic.

During the study, the volunteers will be kept in a controlled environment, so that in the event of severe symptoms of the disease, they will receive the best possible treatment right away. Josh Morrison, member of 1 Day Sooner and Executive Director of Waitlist Zero (an organ donation support group) told Nature: “We want to recruit as many people as possible to take part in the research and pre-qualify them as potential participants in provocation trials.”

Human provocation research has the support of US politicians. 35 members of congress, led by Bill Foster and Donna Shalal, called on Alex Azar and Stephen Hahn (FDA Commissioner) to use their powers to rapidly evaluate and approve human challenge testing of the COVID-19 vaccine.

However, there are still many ethical problems. WHO acknowledges that although the human challenge research contributed to the “significant scientific knowledge that led to advances in drug and vaccine development”, this method may appear to be contrary to the guiding principle of medicine – first do no harm.

WHO stresses the importance of such research being conducted within an ethical framework in which genuinely informed consent is given. Human challenge studies should be undertaken with great care, caution and supervision.

What’s your opinion? Would you volunteer to test the COVID-19 vaccine? Write to us on [email protected]

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