This controversial coronavirus study may speed up vaccine research – BGR

• Although the development of coronavirus vaccines is progressing rapidly, in the best-case scenario, viable drugs may not be available to the general public until early 2021.
• A more controversial human trial may accelerate development: Challenge trial..
• The World Health Organization has developed guidelines for deliberately infecting volunteers with COVID-19 to ensure that vaccine candidates are effective and safe.
• For more stories, please visit the BGR homepage..

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As of mid-April, more than 115 teams are working on drug candidates, so the research on coronavirus vaccines has started smoothly. Some of them show promises in laboratory testing and have reached various stages of human testing. If all goes well, the first COVID-19 vaccine may be ready for deployment this fall under an emergency use permit. It will be readily available to the public in early 2021. For most of these drugs, the theoretical estimate is 12-18 months. It’s still much faster than other vaccines, but it can still result in long wait times. And once the first vaccines are ready, we need to wait for the government to mass-produce them

However, there are faster ways to develop vaccines, but they are controversial because they increase risk. That said, the World Health Organization (WHO) is not against vaccination testing and has issued guidelines for vaccine manufacturers who want to accelerate the situation.

Challenge trials, as the name suggests, involve volunteers observing the direct pathogen infection and whether the drug works. It may sound familiar, but it’s because some U.S. lawmakers are proposing this. a few weeks ago.. There is even a website compiled by the supporters of the COVID-19 Challenge Trial 1 day early.. Over 14,000 people from over 100 countries signed up for these studies. This is a significant increase from 3,500 volunteers from 52 countries registered two weeks ago.

Challenge trials have been used in the past for other vaccines such as smallpox, yellow fever, malaria, typhoid fever, cholera, and influenza. WHO explains.. However, these studies are usually done for diseases that already have effective treatments. Currently, there is no cure for COVID-19.

With COVID-19, vaccine manufacturers need to infect volunteers with an untreated virus. And the vaccine given to them may not work. Those patients develop severe COVID-19 cases and are at risk of dying. Therefore, the WHO proposes eight criteria for a challenge study and states that studies should include patients aged 18 to 30 years to minimize the risk of COVID-19 complications.

The advantage of a challenge trial is that the results are much faster because the study is similar to animal subject studies. Human volunteers need to spend time in hospitals to prevent the disease from spreading to others, but scientists can take a closer look at them. They will be able to test them regularly and study the efficacy and side effects of the drug.

The current vaccine under test does not use a challenge trial. The higher the phase, the more volunteers are needed and they need to be observed for a long time. This is because these volunteers were not intentionally infected with the disease. They may still be exposed to it, and researchers will perform regular tests to see if the vaccine is working.

Some scientific communities support COVID-19 challenge exams. “There is this new consensus among everyone who takes it seriously,” Director of Professor Nir Eyal of the Population-Level Bioethics Center. Said Parents.. He said the risk of dying COVID-19 for someone in their twenties was 1 in 3,000, similar to the risk associated with donating a kidney.

“The big news is that WHO doesn’t say that challenge trials are banned,” Eyal added. “It specifies reasonable steps as to how they can be deployed.”

Professor Andrew Pollard leads a promising vaccine program. Jenner Institute at Oxford UniversitySaid there was “great interest” in the challenge trial. “There is currently no emergency treatment, so we need to be very careful in our challenge research.” Parents.. “But I don’t think it should be excluded, because in situations where it’s very difficult to evaluate some of the newer vaccines that come around because there aren’t too many illnesses around, it’s that It could be one of the ways you can get the answer, faster. “

However, it is unclear when or where such challenge trials for the COVID-19 vaccine candidate will begin. Now that the position of the World Health Organization is known, some laboratories developing these drugs may begin to consider their own challenge trials.

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