Last Tuesday (08), the expectation of launching an efficient vaccine against the new coronavirus received a blow, printed in headlines around the world. With orders for at least 2.94 billion doses made by several countries and already in the last testing stage, the pharmaceutical company AstraZeneca and researchers at the University of Oxford announced a pause in experiments carried out with the substance under development. The United States, South Africa, Brazil and the United Kingdom were affected by “non-detailed” adverse events “that occurred with a volunteer. And what do the experts say about the subject?
“I hope it is not related to the vaccine, as it has looked promising so far,” said Florian Krammer, virologist at the Icahn School of Medicine (USA). This is because, first, it is necessary to identify whether the patient in question received the immunizer or the placebo and what was the origin of its manifestations, in an investigation process that is already underway and that the person responsible for the studies considers “an action of routine that should happen whenever there is a potentially unexplained illness in one of the trials “.
Unfortunately, you need to consider the worst case scenario. “[Se a ocorrência] is definitely or even probably connected [com a vacina], may be the end of the candidate. Otherwise, the blockage can be lifted in a matter of weeks, “explained Marie-Paule Kieny, a researcher at the French National Institute for Medical and Health Research (INSERM).” Clinical control shows that there are controls and functioning balances, despite of political pressure, which reminds everyone, even presidents, that, for vaccines, safety is paramount “, he adds. The problem is that, as it is not known exactly what happened, there is no way to measure the real impacts of the situation.
In-depth investigations are being carried out.Source: Unsplash
Ignorance and concern
In Brazil, the Oxford vaccine is being tested on about 5,000 people in the experiment that started in June and is coordinated by the Federal University of São Paulo (Unifesp). There is an agreement between the government and AstraZeneca that guarantees access to 100 million doses, of which 30 million would be delivered between December and January and 70 million over the first two quarters of 2021. The contract has not yet been signed.
This morning (09), British Health Minister Matt Hancock, in an interview with SkyNews, stated that the case is “obviously a challenge. But in fact, it is not the first time this has happened, and it is a normal process in clinical tests “, referring to the first stoppage of the studies, something confirmed by sources to the journal Nature. At the time, detailed investigations showed that the individual was diagnosed with an “unrelated neurological disease [à vacina]”.
The lack of transparency regarding the news is a concern of Paul Komesaroff, doctor and bioethicist at Monash University (Australia). “The tests are all publicly supported, the disease is the greatest threat to humanity in 100 years, drug development processes are highly politicized and the result will only be successful if public trust can be guaranteed and maintained,” he said.
Impacts will only be known with the disclosure of details of the event.Source: Unsplash
What comes next?
Now, the biggest difficulty is to find out what happened. “This can be difficult to discover,” said Jonathan Kimmelman, a bioethicist who studies clinical trials at McGill University (Canada). If the committee assigned to the task is successful, we will know the candidate’s future. In any case, the priority is to keep the volunteer safe and receive the best possible medical treatment, as defended by Kimmelman.
Finally, Paul Griffin, an infectious disease researcher at the University of Queensland (Australia) is confident that, according to him, the “adverse event” may include the registration of a participant entering a hospital for any reason, which is supported by security protocols. “I have full confidence that the designated group will quickly assess the situation and make the results of the investigation public,” he explained.