As the number of cases COVID-19 in the world continues to grow, it is obvious that there is an urgent need for an effective vaccine. In General, it is predicted that it will be available in 12-18 months, but some scholars consider innovative ways to accelerate its development and testing. One of the discussed methods involves injection of healthy adults living coronavirus, says ABC News.
This strategy, called a test a test, usually never considered for the testing of the deadly virus, for which there are effective drugs, but these are unusual times.
Vaccine trials usually slow and cumbersome process, because researchers need to inject the drug to thousands of patients, and then wait until some of these people will be exposed to the virus naturally.
Trial trial in healthy adult volunteers divided into two groups. One group gets placebo and the other a potential vaccine. After enough time has elapsed to ensure that the vaccine caused the appropriate protective immune response, both groups administered the virus, to understand whether a vaccine provides any level of protection.
“If all you care about is how many people are exposed to the relevant pathogen, and then turns out to be infected or protected by vaccine, the research involving live virus look like a shorter and simple way to achieve this result,” said Dr. Alex John London, Professor of ethics and philosophy and Director of the Center for ethics and policy at Carnegie-Mellon.
Some scientists suggest that after the test phase I and II to determine the correct dose and initial safety of a potential vaccine, a traditional phase III can be omitted in favor of trials. Taking into account that the test is one of the 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 can save a test to understand how it is justified — given the risks for the participants, says Dr. Jennifer Miller, associate Professor at Yale school of medicine and founder of Good Pharma. — How much time do you need to save to justify the risks to participants? Month is probably not enough, but how about five months?”
Only healthy adults that do not have comorbidities will be allowed to pass the virus in the first phase, designed to test the efficacy of a vaccine against the coronavirus. The next step, designed to check the safety of the vaccine, will help adults who are most susceptible to serious symptoms COVID-19, including the elderly and people with underlying diseases. At this stage volunteers will receive either placebo or a potential vaccine, but will not be injected with a virus. The aim was to determine if there are any side effects associated with the vaccine. As soon as potential vaccine will be safe in this more vulnerable group, it will be ready to enter the market.
Pilot tests have been used before, but usually in the context of the disease, which is already a medicine, e.g., malaria. Proven treatment for a new coronavirus does not exist, which increases the risk associated with the testing of the vaccine. Introduction to the volunteers live virus can lead to serious consequences.
“We need to devise a strategy, the trial itself and the effects, before we begin to act quickly and get unintended consequences, said Dr. Jay Bhatt, a former medical Director of the American hospital Association. — This test can lead to serious infections, complications and even death. Young and healthy people may be less risk, but also not zero.”
Alex John London agreed, adding: “the Researchers directly infect people, and many who know about this, I feel uncomfortable with the understanding that the subjects may become ill and get injured or even die because they were infected by a specific pathogen. So one danger is that in the pilot studies we deliberately put someone exposure to pathogens capable of causing harm.”
Business in an ethical dilemma. Should grown, with full information, to risk their lives for the good of society? Doctors, nurses, firefighters, police and military usually risk their safety for the benefit of others. Is it something else? Website 1 Day Sooner already recruiting volunteers who are willing to take that risk.
Rigorous and responsible scientific investigation may have a high social value — risks for participants in trials should be kept to a minimum. The number of volunteers should be limited to the people who are the least likely to die from infection.
“The trials, including the trial, must respond to the needs of the population, she said. In this case, the parties to the test should be people with a high risk of infection with coronavirus, regardless of participation in testing, for example, because they live in a “hot spot” of the virus. It is very important”.
Bhatt said, “When we conduct such a test, we should consider the consequences. This test shall be conducted in a fair and ethical manner. I would be very concerned that testing someone will take advantage of vulnerable, uneducated or poor people, or those who have a hopeless situation. Equity in health is also an ethical imperative here.”
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