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Video: Time Vs Ethics: Should Volunteers Be Infected With Coronavirus To Get A Vaccine Quickly?
Time vs ethics: should volunteers be infected with coronavirus to get a vaccine quickly?
Routine vaccine research takes a long time: scientists have to observe thousands of people for months. But does the pandemic justify accelerated research protocols that involve deliberately infecting people with coronavirus? Let's take a look at this issue in an article dedicated to the start of World Immunization Week
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The emergence of an effective vaccine against the new coronavirus SARS-CoV-2 should ease the burden of morbidity and mortality from COVID-19. Its creation is referred to as favorable options for ending the pandemic and ending quarantine measures.
1daysooner, a website that brings together researchers and activists advocating accelerated research on COVID-19 vaccines, indicates that a vaccine just one day early will save 19,500 lives. Let's figure out what limits the speed of research of a vaccine against SARS-CoV-2 and what prevents "gasping".
Course - acceleration
Many potential vaccines are currently being tested, three of which are already being tested in humans. Scientists usually say that the optimistic forecast for the timing of a vaccine is one to one and a half years. If successful, this time frame can be called a record: it always took more time for a new vaccine to appear before.
The developers try to shorten the research and development time as much as possible. For example, one of the most famous vaccine candidates, mRNA-1273, was skipped on animal studies. The Oxford Vaccine Research website lists other ways to accelerate, including the use of already studied delivery systems for new vaccines. In an emergency, a large dose of a new vaccine can be produced even before clinical trials are completed. Then, if the tests are successful, it can be immediately widely used. In addition, new vaccines will be unconditionally given the green light by regulatory agencies and will be quickly approved for use.
How is it usually done
Typically, the proposed vaccine is first tested on animals. After that, the appearance of the vaccine "on the shelves" is preceded by three phases of clinical trials. This process usually takes years.
Phase 1 research. On a small group of healthy volunteers, the safety of the future vaccine is tested: its first introduction into the human body takes place. In parallel, scientists are beginning to monitor the production of antibodies.
- Phase 2 exploration. In a larger group of volunteers, the effectiveness of the vaccine is studied, the optimal doses and administration protocols are selected. The criterion of effectiveness at this stage is the appearance of antibodies against a specific infection in the blood of participants. But the presence of these antibodies cannot guarantee protection against disease in real life.
- Phase 3 exploration. Real-world performance testing. This is the longest stage, in which thousands of people must participate. Usually, people who are at high risk of infection are selected to participate in such studies. Participants who receive the experimental vaccine or placebo live normal lives. When the study is over, scientists calculate how many people have become infected in each group.
Complexity of standard schemes
Phase 3 is not only the longest (it usually lasts at least six months). In the current situation, it can be difficult. During a pandemic, people make efforts not to get infected, including social distancing. If all study participants from the placebo group have the opportunity to effectively hide from the virus, then we will not soon learn about the effectiveness of the vaccine. Theoretically, if everyone “hides” themselves well, we will never know the results.
“A lot of people will try to be careful, self-isolate, and it can take a very long time before results appear that can be interpreted,” says Nir Eyal, a professor at Rutgers University.
Developers of SARS-CoV-2 vaccines recognize these difficulties. The Oxford group of scientists writes that the results of a study of their vaccine may become known in the fall of 2020 in the case of a "best case scenario." They themselves call these plans "ambitious" and indicate that everything will depend on the number of cases of transmission.
It can be done faster
There are ways to get around the long and difficult Phase 3, these are challenging human trials. They imply a deliberate attempt to infect study participants. This tactic would allow you to know the effectiveness of the vaccine in just a few weeks.
Today, this approach for developing a vaccine against COVID-19 is not recognized as ethical, but there is a scientific debate about it. Scientists from several large academic centers talk about the specifics of provocative tests in the current situation, their article was published in The Journal of Infectious Diseases.
“In a challenging human trial, volunteers would receive either a vaccine or a placebo and then exposed them to the virus to determine the effectiveness of the vaccine. The participants would then be monitored for two weeks to see if […] the incidence in the vaccinated group would be lower than in the placebo group,”explains Peter Smith, professor at the London School of Hygiene and Tropical Medicine and co-author of the article …
“All volunteers with confirmed infection would receive superior COVID-19 treatment, including priority over any limited life-saving resources, in cutting edge facilities. During the study, until the end of the infectious period, the participants would remain isolated in safe and comfortable places,”the scientists write in The Journal of Infectious Diseases.
Is it ethical at all?
Scientists propose a design of a provocative test involving humans that involves minimal risk to its participants. It would include only residents of areas with a high risk of infection, aged 20-45 years, without concomitant diseases.
The study population is assumed to be people with a high probability of contracting COVID-19 and a low risk of complications of the disease. Perhaps their infection in a hospital setting can provide better protection against severe disease outcome than accidental infection. In addition, accelerating vaccine availability will prevent thousands of infections worldwide and save many lives. Therefore, Smith et al find the benefit / risk ratio of such a study acceptable.
Today there is no consensus among scientists on how ethical this approach is. Among his opponents is Matthew Memoli, an immunologist at the American National Institute of Allergy and Infectious Diseases. He believes that we do not know enough about the SARS-CoV-2 coronavirus to afford such research. Although it is known that, on average, younger people are less likely to end up in hospital with this infection, it remains quite unpredictable.
Seema Shah, a bioethics specialist at Northwestern University, has written about this kind of research before. In her opinion, in order to be sure that the benefits outweigh the risks, it is necessary to develop a universal research protocol, in the creation of which many groups of scientists should participate. In a commentary to Vox, she said that such research looks promising, but for this promise to come true, "it takes a lot of things to fall into place."
One way or another, the idea of a provocative test involving people has already found its supporters. On the 1daysooner website, 2,384 volunteers have been registered for potential participation as of April 24, 2020.