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Do you need to ly infect Covid-19 to speed up vaccine development?

 


Dr. Stephen Thomas, Head of Infectious Diseases at SUNY Upstate Medical College, explains his experience of applying for the 2001 malaria vaccine trial and how to assess the risk of human challenge trials seeking a coronavirus vaccine. ..

I was a fellow infectious disease at Walter Reed and the Bethesda Naval Hospital in 2001 and was in training for a rising scientist, so I thought it would be a good idea to volunteer as a research target. If I was going to ask other people if they would volunteer for my research experiment, I thought I should do the same. Fortunately, the test for malaria vaccine started the following month. As part of the trial, I received an injection of the vaccine, and a few weeks after that, the research team decided if the vaccine worked to infect me with malaria.

As the technicians were preparing my “container,” I began to doubt the wisdom of my decision to join. I heard a high-pitched sound of five hungry malaria-infected mosquitoes resembling a large paper cup with a small mesh attached to the top. If the vaccine works, you will not get sick. If that didn’t work, it would be uncomfortable for two weeks. At worst, I felt high fever, chills in my teeth chatting, sweating, nausea, and deep fatigue. Vaccine developers wanted this trial to help them quickly understand whether the vaccine could protect people from malaria. The five mosquitoes I was trying to catch were able to answer them.

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Despite watching many of my fellow malaria vaccine volunteers get sick from encountering mosquitoes, I didn’t. Coincidentally, I found that I had received a malaria vaccine called RTS,S. Field trial..

Some scientists, public health experts, and politicians want to apply similar methods today to speed up the vaccine development schedule for Covid-19, which has infected over 10 million people worldwide. Some people are. They ly infect volunteers with SARS-CoV-2 to better understand the disease and explore what constitutes a protective immune response, and most importantly, which vaccine candidate protects people We suggest to make a quick decision about what is possible. They claim that this is better than waiting for 6-12 months, which is included in the “Operation Warp Speed” plan.

Numerous opinions supporting the SARS-CoV-2 human challenge experiment have been published in the scientific literature. The representatives of Bill Foster (D-IL) and Dona Charara (D-FL), along with the other 34 members, letter In April 2020, we urged the Secretary of Health and Welfare and the Director of the Food and Drug Administration to consider human attack trials as a means to facilitate the development of the Covid-19 vaccine. The World Health Organization went to suggest Standard How can we carry out an human infection ethically?

Assuming that logistics is understandable, there is still the question of whether it is safe.

On the other side, many people, including myself, are worried about the rush. I’m a supporter of the Human Challenge experiment and I’m doing it as part of my research portfolio. However, before embarking on an ly infected person, some important questions need to be answered. Why do we have to challenge the human challenge, how we can do it, and what we can do with it rather than follow traditional development paths.

The first question is probably the easiest. The Covid-19 pandemic has been relentlessly proven, requiring few sparks to ignite outbreaks. Today, new cases are steadily increasing in more than 30 states, causing dangerous stress to the healthcare systems in these locations. The country’s Covid-19 curve bends upwards, so there’s a faint light shining at the end of the pandemic tunnel.

High-volume vaccination with safe and effective vaccines is the best hope to restore curve reversal and the road to recovery, in addition to physical distance, hand hygiene, and universal masking practices. If the Covid-19 Human Challenge Model can speed up vaccine development and deployment schedules, it seems reasonable to pursue this course of action.

It’s not very clear if we can actually develop a human challenge model. Experimental human infections require the use of live viruses, which will infect and replicate human cells. The Centers for Disease Control and Prevention now requires that most work on the use of SARS-CoV-2 should be performed with biosafety level 3 containment, one level below pathogens such as Ebola. This requirement greatly complicates how the virus is produced for human use and how it is transported and processed when infecting research volunteers.

The situation is more complicated without the highly effective treatments available to volunteers.

Assuming that logistics is understandable, there is still the question of whether it is safe. Young and healthy adults appear to be a complete volunteer population because they have a lower risk of adverse outcomes after infection. Is this true? The scientific literature is exploding with the observation of an increased prevalence of adolescents. Symptoms of stroke and other serious illnesses have been reported, CDCAbout 6% of all Covid-19 deaths in the United States occur in people under the age of 50. The situation is more complicated without the highly effective treatments available to volunteers.

Is there also a question of how we can ensure public safety while conducting these experiments? There are many conspiracy theories when it comes to explaining how SARS-CoV-2 emerged. But reality may not be so exciting. Numerous groups and individuals including MyselfWarns the global community about the approach of a pandemic. We have pointed to a series of global health, near misses, as evidence that the planets quickly align, are highly contagious, and are potentially lethal to enter humans. Experimentally infecting humans with SARS-CoV-2 requires a very high level of containment and control of volunteer work to prevent the virus from entering the community. If volunteers test positive for a few weeks after infection, it can be difficult to keep them in a locked-down state, which is not an uncommon event. Problems can also occur if the volunteer decides to quit the experiment during the infection. Enforcement of volunteers is an ethically complex situation that weighs an individual’s right to public health and safety.

The timeline for the availability of a safe and effective Covid-19 vaccine remains unclear. Recent FDA Told Any vaccine must show 50% efficacy compared to placebo, setting the same criteria for success as most seasonal influenza vaccines. Keeping in mind that vaccination is not just about getting a vaccine, it’s also a life-saving task, making the vaccine available to the people at highest risk and ensuring vaccination remains. I will. With the current vaccine rate Hesitation In the US, it is unclear how the public will respond to the Covid-19 vaccine, which was developed on a very active timeline and using tools such as human challenges. What is clear is that without a vaccine to bridge the gap between Covid-19 response and individual public health options, our toughest days are likely to be ahead of us.

Is it possible to overcome the complexities and obstacles of developing the Covid-19 Human Challenge Model? Perhaps. The Covid-19 Human Challenge Model is a very valuable tool for investigating and understanding disease, and how to treat or prevent it? surely. Is it possible to develop a human challenge model fast enough to shorten the time frame for vaccine development compared to well-thought-out traditional routes? It’s unlikely.

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