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A Brazilian volunteer for vaccine research developed by the University of Oxford with the pharmaceutical company AstraZeneca died of complications from Covid-19. The company did not disclose whether the man received the test immunizer or the placebo, but a source involved in the study said in the report that he was in the second group.
The death was revealed by the newspaper. Or Balloon and confirmed by Status with the National Health Surveillance Agency (Anvisa). The agency says it was notified of the death on Monday 19. According to the agency, the study’s International Safety Assessment Committee, made up of independent investigators, conducted an investigation into the case and concluded that the investigation may continue. in process.
Anvisa says it has received the information and is still analyzing the case, but it is unlikely that it will discontinue the study after the expert committee concludes that there is no risk to the volunteers. “It is important to note that, based on the ethical confidentiality commitments provided in the protocol, the regulatory bodies involved receive partial data on the research carried out by this committee, for which they suggested continuing with the study. Thus, the process is still under evaluation, ”said Anvisa.
The National Research Ethics Commission (Conep) also received clarifications from the researchers and must decide to follow up on the research. According to Jorge Venâncio, coordinator of the agency, the investigation is usually interrupted by doubts about the safety of the tested product. Even if the volunteer was in the vaccinated group, the fact that he got sick would be more related to the efficacy aspect of the immunizer.
“Efficacy issues do not lead to discontinuation of the study.
First, because no vaccine is 100% effective. Secondly, because the clinical study is precisely to see this question: what was the incidence of the disease in each group and analyze if the vaccine works, “he said.
In a note, Astrazeneca said it could not comment on individual cases from the vaccine’s ongoing clinical study. The company states that it strictly abides by the rules of medical confidentiality and clinical studies.
The text further states that “all major medical events are carefully evaluated by the study investigators, an independent safety monitoring committee, and regulatory authorities.” Also according to Astrazeneca, “these evaluations did not raise concerns about the continuity of the ongoing study.”
The University of Oxford itself, where the vaccine was developed, published an official note in which it said that “after careful analysis of the case in Brazil, there are no concerns about the safety of the clinical trial.” The note also says that “an independent review, in addition to that carried out by the Brazilian regulatory agency, recommended the continuation of the test.”
The Federal University of São Paulo (Unifesp), responsible for coordinating clinical trials of the vaccine in Brazil, published a note along the same lines. He said the study is progressing as expected, “with no record of serious vaccine-related complications involving any of the participating volunteers.” He also said that, so far, 8,000 of the 10,000 volunteers who will be recruited have already taken at least one of the doses of the vaccine under test.
The institution sympathized with the victim’s family and stated that, because there are confidentiality and confidentiality commitments regarding the volunteers’ data, the study coordinator in Brazil cannot reveal the participant’s identity or other information.
Participant in the research was a recently graduated doctor from Rio de Janeiro
The volunteer for the AstraZeneca vaccine trial in Brazil was a 28-year-old doctor from Rio de Janeiro, a recent graduate, who worked in the first line of care for covid-19 in public and private hospitals in Rio. He fell ill in September and died on Thursday, the 15th, of complications from the disease. The study participant had no comorbidities.
In a note, the Federal University of Rio de Janeiro (UFRJ), where the doctor graduated in July last year, said that, although he had just graduated, “it spared no effort to face the covid-19 pandemic. ”. The doctor graduated with the distinction of “cum laude”, when he has an accumulated income coefficient equal to or greater than 8. His final grade was 8.7.
Immunization has been proven since June
The Oxford vaccine has been tested in Brazil since June. An estimated 10,000 Brazilian volunteers will be included in the national arm of the clinical trial. Half of them will take two doses of the vaccine under test and the other half will receive a placebo.
Anvisa reported that, “in accordance with the national and international regulations of Good Clinical Practices, the data of volunteers in clinical research must be kept confidential, in accordance with the principles of confidentiality, human dignity and protection of the participants” and stated that ” committed to comply with these regulations, in order to guarantee the privacy of the volunteers and also the reliability of the country to carry out studies of such relevance ”.
In September, testing with this vaccine was stopped for a few days around the world after one participant experienced serious adverse reactions. According to The New York Times, the participant had transverse myelitis, an inflammatory syndrome that affects the spinal cord and is usually triggered by viral infections. The clinical trial was resumed in some countries, including Brazil, after it was observed that the benefit / risk ratio remained favorable, according to Anvisa.
It is considered normal in testing vaccines for temporary suspensions to evaluate any suspicions about the safety of the product.
In the United States, the resumption of clinical trials was expected this week after the FDA (Food and Drug Administration), the country’s regulatory agency, completed its analysis of a serious illness developed by one of the study participants.
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