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BRASILIA and RIO – A Brazilian volunteer who participated in the clinical trials of the vaccine developed by the University of Oxford and the AstraZeneca laboratory died of complications from Covid-19, last Thursday. The National Health Surveillance Agency (Anvisa) was formally informed of the incident on Monday.
According to Anvisa, the vaccine developers have already shared with the agency the data of the investigation carried out by the International Safety Evaluation Committee on the case. Anvisa informed GLOBO that the case is under evaluation.
The report found from sources linked to the international study and that are not identified by legal obligations that the volunteer did not receive the dose of the vaccine, but the substance used as a placebo. However, due to legal secrecy, neither the laboratory, nor the centers responsible for the tests, nor Anvisa officially report whether the volunteer received the placebo.
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According to Anvisa, the International Committee suggested continuing the studies with the vaccine. Neither the laboratory nor Anvisa reported whether the volunteer received a placebo or a dose of the immunizer.
In a note, Anvisa said that “based on the ethical confidentiality commitments provided in the protocol, the regulatory bodies involved receive partial data regarding the research carried out by this committee, for which they suggested continuing the study. Therefore, the process remains under evaluation ”.
Anvisa also affirmed that the data of the volunteers are kept confidential due to the confidentiality principles of the study, highlighting that “the Agency has fulfilled, fulfills and will fulfill its institutional mission of protecting the health of the Brazilian population.”
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In a note, the person in charge of the tests in Rio de Janeiro, the D’Or Institute for Research and Education (Idor) informs that “following international standards of clinical research and respecting the criteria of confidentiality of medical data, we cannot publicly confirm the participation of no volunteers in the clinical study with the Oxford vaccine “.
The institute further notes that “after including more than 20,000 test participants worldwide, all recorded medical conditions were carefully evaluated by the independent safety committee, teams of researchers, and local and international regulatory authorities. The rigorous analysis The data collected so far has not raised doubts about the safety of the study, its continuity is recommended, it should be remembered that it is a randomized, blinded study, in which 50% of the volunteers receive the immunizer produced by Oxford. In Brazil, approximately 8,000 volunteers have been vaccinated to date ”.
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Sue Ann Costa Clemens, director of the Institute for Global Health at the University of Siena (Italy) and a researcher at the D’Or Institute for Research and Education, explains that research should only be stopped if something unexpected happens, such as the British volunteer with suspected sclerosis cross. At that time, the study was discontinued worldwide. And it resumed, when it was found that it had nothing to do with the vaccine.
According to her, contracting Covid-19 during testing of a Covid-19 vaccine at a time of pandemic is not an unexpected event, but an assessment factor. It is possible that the patient did not receive the vaccine, but the placebo.
The doctor was at the forefront of the fight against the pandemic.
The volunteer who died was a 28-year-old doctor who, since March, had been on the front line of care for Covid-19 patients in ICU and emergencies. He worked in a private hospital and another in the municipal network, both in the North Zone of Rio.
Former medical student and beloved at the Federal University of Rio de Janeiro (UFRJ), where he graduated in 2019, he stood out for his dedication and tireless work. This week, the institution published a tribute in his memory on its social networks. Although in the front line, friends say that he was always ready to help others and did not lose his good humor. He was tireless.
His death surprised and shocked those closest to him because the doctor, according to them, was in good health and did not suffer from any comorbidity. He reportedly received a dose of the AstraZeneca / Oxford vaccine in late July. He fell ill in September and his condition worsened until his death.
Called AZD1222, the AstraZeneca / University of Oxford vaccine is made with a genetically modified simian adenovirus. This acts as a “transport” for a Sars-Cov-2 protein, called a spike protein, or S, that the coronavirus uses to invade human cells.
This type of platform, considered innovative and promising, has never before been used in vaccines on the market. Studies with the same strategy – and different viruses – have failed against HIV.
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The strategy now is to use adenovirus, which has also been altered so as not to replicate, to “present” the coronavirus to the human defense system, which would then produce antibodies to attack protein S. the vaccine is not capable of causing Covid-19, which that would increase security.
Experts say that, in theory, there are three possibilities to explain the child’s death. The first is that he belonged to the placebo group, the one that received the meningitis vaccine and not the Covid-19 immunizer. All volunteers know they are bound by this. That is, he was not protected at any time and had prior knowledge of this possibility.
As the studies are conducted in a “double-blind” format, to ensure the adequacy of the data, neither patients nor scientists know who took what. This information is kept in a closed system. Only then is it possible to know if, in fact, the vaccine protected someone.
A second possibility is that you took a dose, but it was not enough to protect you from developing Covid-19. A second dose was being given to the volunteers precisely because studies showed that two applications provided a more robust response from the defense system. It is unclear if the dead volunteer took a second dose.
A third possibility is that it has not been protected and Covid-19 has been aggravated by a phenomenon known as antibody dependent amplification (ADE). This is a phenomenon that can occur in some viral infections. In it, antibodies can intensify the effects of the disease, rather than reduce them.
The best known case of ADE occurs with dengue. Dengue hemorrhagic fever, the severe and sometimes fatal form, affects those who have had dengue before. That is why the dengue vaccine is recommended only to those who have ever had the disease, which can be caused by four subtypes of the virus.
