The risks of rushed science during the coronavirus pandemic.
Driven by urgency, researchers are racing to find solutions against the virus. But studies can often lead to hasty conclusions and hinder public understanding of what is now known to be truly effective.
By Cristiane Bomfim and Fábio de Oliveira, from Agência Einstein - Amid alarming news about the surge in confirmed Covid-19 cases worldwide, Brazilian researchers have recently announced they are studying the development of a vaccine against the novel coronavirus. In the United States, tests of an immunizing agent with the same objective have begun. According to the World Health Organization, there are more than 30 vaccine candidates around the globe. The number of publications regarding the virus and the disease it causes reflects the race among scientists to find answers about the speed of its spread, the rapid progression of the disease in some groups, its treatment, and its cure. To give an idea, as of last Monday, PubMed, a scientific article search tool, had registered 1.364 publications on Covid-19 since January 1st. Meanwhile, the Clinical Trials website, the world's largest database of clinical trials, lists 128 studies cataloged since the first day of the year.
“A pandemic like this generates a lot of activity in the area of scientific research. Science is trying to help as much as it can, that is, by raising hypotheses and conducting research,” says physician Jorge Kalil, director of the Immunology Laboratory at the Heart Institute (InCor) in São Paulo, and coordinator of the project to create a vaccine for Covid-19. The problem, however, is that the rush for answers can result in wasted resources for inconclusive results. “In times of stress like this, the phenomenon we call [missing word - likely "predictive timing"] is common.” Speed Science"This is what happens when you do science at breakneck speed. This eagerness can, in many cases, lead to research not adhering to the required scientific rigor," says Luiz Vicente Rizzo, director-superintendent of research at the Albert Einstein Israelite Hospital. "In the end, scientists end up discovering that many hypotheses were just statistical anomalies."
Another consequence of this anxiety for answers surrounding the new coronavirus is the misinterpretation of results. A recent example is the case of the use of the drug Hydroxychloroquine in the treatment of Covid-19. The news that a study conducted in France with the drug had encouraging results for the treatment of the disease was enough for the product to disappear from pharmacy shelves here. However, the test was done with 36 patients, a very small number of participants. “That's why research continues to be done. Another important thing is that there is no evidence that hydroxychloroquine works as prophylaxis, that is, preventing infection by the virus,” says Rizzo. “Research at this speed and with several groups of scientists working on various fronts is extremely important for science. But not every hypothesis is true. Perhaps it's just a path to new lines of study, and the scientist will be the one who can make this distinction without alarming the population,” says Jorge Kalil. Chloroquine is used to treat malaria, lupus, and rheumatic diseases, and its use without medical indication poses risks of blindness and damage to the liver and kidneys.
Brazil and the United States in the search for a vaccine.
The work in search of a Covid-19 vaccine conducted at InCor uses fragments of the new coronavirus taken from the spikes, or spikes In English, the pointed protrusions on the viral surface resemble a crown – hence the name corona. “The spikes attach to molecules in the human body and allow the virus to enter the cell,” explains Jorge Kalil, coordinator of the project. “The vaccine will stimulate the production of an antibody that binds to the spike, which will neutralize its action,” describes Kalil. This is because the body sees it as if it were the microorganism. The researcher predicts that animal testing will begin in two months and human trials by the end of the year.
Meanwhile, in the United States, clinical trials have begun with the vaccine developed by the pharmaceutical company Moderna Inc. in partnership with the National Institutes of Health. Forty-five young, healthy volunteers participated. They will receive different doses of the immunizing agent, which does not contain the virus – therefore they are not at risk of infection. Scientists will check for any serious side effects before proceeding.
Unlike the Brazilian proposal, the American one uses synthetic messenger RNA molecules, mRNA. It has, so to speak, the recipe for manufacturing proteins. In the case of the vaccine, the proteins would stimulate the immune system to produce antibodies against the coronavirus. According to Kalil, who is also a full professor at the University of São Paulo (USP), this type of immunizing agent is good. "But it is not very immunogenic, triggering a not very strong immune response." He adds: "They skipped the primate testing phase because of the urgency." According to Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), even if the initial experiments are successful, it will take one to one and a half years before a vaccine is given the green light for large-scale use.
The pharmaceutical company Inovio Pharmaceuticals (USA) is also pursuing a DNA vaccine for Covid-19. The company has now received US$5 million from the Bill & Melinda Gates Foundation to accelerate testing of Cellectra 3PSP, a device for administering the vaccine. Still in pre-clinical studies, INO-4800 does not use an attenuated virus, for example, but plasmids, circular double-stranded DNA molecules, synthesized to induce a response from our defenses. Inovio already has a vaccine against another type of coronavirus, the one that causes MERS respiratory syndrome, in the second phase of testing.
Finally, Johnson & Johnson, through its pharmaceutical arm, Jansen, joined forces with Beth Israel Deaconess Medical Center in Boston (USA) to try to develop another vaccine candidate. The tactic is to use a common cold virus to release an antigen inside cells and thus stimulate the immune system. This is the same approach used to produce 2 million doses of the Ebola vaccine, which is not yet licensed but has been made available to 40 people in Rwanda and the Democratic Republic of Congo. Tests on healthy volunteers are expected to begin in the second half of the year.