Research on the new crown vaccine is advancing at an alarming rate and some preliminary results are expected by the end of the year,media BGR reported. The British government is actively exploring the idea of launching a challenge trial in which volunteers will receive experimental drugs before contracting the virus. The World Health Organization (WHO) has approved the controversial test, but governments and vaccine manufacturers remain reluctant to start research to expos volunteers to deadly pathogens. Despite this, tens of thousands of people have signed up for the challenge trial.
Hundreds of new crown vaccines are currently under development. Results from the first two phases of clinical trials have shown that about a dozen drugs are effective and safe. The third stage must prove that these experimental drugs can block infection or reduce the severity of the virus. There are also many reservations about the COVID-19 vaccine. More Americans are wary of vaccines than they were a few months ago, as they become a tool to advance the political agenda. The scientific community is trying to ensure that political factors do not affect the safety of vaccines, and the FDA’s new guidelines make it difficult for any candidate to seek or obtain an emergency authorization to use the vaccine before the November 3 presidential election. The guidelines say the company needs to observe volunteers for two months before the approval process begins.
But other countries are looking at a more drastic way to test the vaccine’s effectiveness. The UK is considering deliberately infecting some volunteers, rather than exposing them to COVID-19 to see if the drug works. And thousands of people are ready to be exposed to the virus and save others.
The topic of vaccine challenge trials was raised many times in the summer, with a website called “1 Day Sooner” accepting entries for such programs. But it seems that Britain favours such a controversial experiment. COVID-19 will not be the first disease to test the vaccine with a challenge trial. But THERE is no cure for COVID-19, which means there is no other option for patients who are deliberately infected. If the vaccine doesn’t work, they’ll have to deal with the next infection like the average patient. CNN explained that cholera, typhoid fever, malaria and the common cold are some examples of challenge trials that have been used.
The UK is in active talks about the COVID-19 Challenge Trial, which will be the first in the world. But some companies developing the current new vaccine will not be involved — the list includes AstraZeneta, Sanofi and BioNTech.
“It’s not clear whether the first vaccine being evaluated is necessarily the best vaccine,” Peter Smith of the London School of Hygiene and Tropical Medicine told CNN. “I think there’s a good reason to explore challenging trials to evaluate a large number of potential COVID-19 vaccines in development.”
The discussion of the challenging trial is so deep that the British Health Research Agency (HRA) already has a team on standby to assess the ethics behind the scheme.
“There is very little zero-risk research,” said HRA director Terence Stephenson. “Every day, in this country and in other countries, health care professionals volunteer to put themselves at risk to take care of others.”
“In their judgment, people may be willing to do this for the benefit of the wider community – I’m not personally surprised.”
WHO agreed in principle to the coronavirus challenge trial a few months ago and has developed agreements for such projects. There are also critics of the COVID-19 challenge trial. One of the main problems with the trials is that they may be limited to young, healthy people and do not represent the population as a whole.
Another question is about the control group. Clinical trials divided people into two groups, and volunteers didn’t know if they were getting a real drug or a placebo. Control groups are required to assess the effectiveness of the drug in routine trials. CNN explained that some people don’t think the challenge trial will require a placebo group because everyone gets a candidate vaccine and then gets the virus. It was also suggested that human error could lead to incorrect conclusions without a control group. As a result, some volunteers had to be infected with the virus after being given a placebo vaccine.
“The question is, “In essence, if you vaccinate a group of volunteers and you challenge them, and they don’t get sick, is it because the vaccine is protective, or because there’s a problem with the way you challenge them that they’re not infected?” And you can’t answer that question explicitly unless you have a control group. “
As with conventional trials, challenge trials do not guarantee the necessary positive results from candidate vaccines.
It is unclear when the challenge trial will begin and how long it will take to produce results. But nearly 40,000 people in 166 countries have signed up to volunteer for Day One, and that number will continue to grow.