Scientists may speed up the development of a vaccine against coronavirus, but ethical issues arise

As the number of cases of COVID-19 in the world continues to grow, it is clear that an effective vaccine is urgently needed. In general, it is predicted that it will be available in 12-18 months, but some scientists are considering unconventional ways to accelerate its development and testing. One of the methods discussed involves injecting healthy adults with a living coronavirus, writes ABC News.

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This strategy, called a pilot test, would normally never be considered for testing a deadly virus for which there is no effective cure, but these are unusual times.

Vaccine trials are typically a slow and cumbersome process because researchers must administer the drug to thousands of patients and then wait for some of those people to be naturally exposed to the virus.

In a pilot test, healthy adult volunteers are divided into two groups. One group receives a placebo and the other receives a potential vaccine. After enough time has passed for the vaccine to produce an appropriate protective immune response, both groups are given the virus to see if the vaccine provides any level of protection.

“If all you care about is how many people are exposed to the relevant pathogen and then become infected or protected by the vaccine, then live virus studies look like a shorter, simpler way to achieve that result,” said Dr. Alex John London. Professor of Ethics and Philosophy and Director of the Center for Ethics and Policy at Carnegie Mellon University.

Some scholars suggest that after phase I and II trials to determine the correct dosage and initial safety of a potential vaccine, traditional phase III may be skipped in favor of a trial trial. Given that the trial is one of two steps proposed to replace phase III, experts discuss how much time will actually be saved.

“It would be important to understand how much time a trial can save to understand whether it is worthwhile given the risks to participants,” said Dr. Jennifer Miller, an assistant professor at Yale School of Medicine and founder of Good Pharma. — How much time needs to be saved to justify the risks for participants? A month is probably not enough, but how about five months?”

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Only healthy adults who do not have concomitant diseases will be allowed to undergo virus infection in the first stage, designed to test the effectiveness of the coronavirus vaccine. The next step, designed to test vaccine safety, will be to help adults who are most prone to the serious symptoms of COVID-19, including older people and people with underlying illnesses. At this point, volunteers will receive either a placebo or a potential vaccine, but will not be injected with the virus. The goal is to determine if there are any side effects associated with the vaccine. Once a potential vaccine is found to be safe in this more vulnerable group, it will be ready to enter the market.

Mock trials have been used before, but usually in the context of a disease for which there is already a cure, for example, malaria. There is no proven treatment for the new coronavirus, which increases the risk associated with testing the vaccine. The introduction of live virus to volunteers can lead to serious consequences.

“We need to think through the approach, the trial itself and the implications before we move quickly and end up with unintended consequences,” said Dr. Jay Bhatt, former medical director of the American Hospital Association. “This test could lead to serious infections, complications and even death in people.” Young and healthy people may be at lower risk, but not zero.”

Alex John London agreed, adding: “The researchers directly infect people, and many who know about it feel uncomfortable because they understand that the subjects can get sick and get injured or even die because they were infected with a certain pathogen. So one danger is that in pilot studies, we deliberately expose someone to the effects of pathogenic microorganisms that can cause harm. "

The point is an ethical dilemma. Should fully-informed adults risk their lives for the benefit of society? Doctors, nurses, firefighters, police and military generally risk their safety in the interests of others. Is it something else? Site 1 day sonon already gaining volunteers who are ready to take such a risk.

Careful and responsible scientific research can have high social value - risks to trial participants should be kept to a minimum. Volunteers should only include people who are least likely to die from the infection.

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“Tests, including pilots, must meet the needs of the population,” she said. - In this case, trial participants must be people at high risk of contracting coronavirus, regardless of participation in the trial, for example, because they live in a virus hotspot. It is very important".

Bhatt reiterated: “When we do a test like this, we have to consider the consequences. This trial must be conducted fairly and ethically. I would be very concerned that someone would take advantage of vulnerable, illiterate or poor people, or those in desperate situations, for testing. Health equity is also an ethical imperative here.”

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