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Gustavo Romero, from the University of Brasilia, is brandishing the Sinovac vaccine, which is recently being tested at the University Hospital. The trial, led through the Butantan Institute, aims to recruit 9,000 fitness in 12 Brazilian hospitals.
Science COVID-19 reports are supported by the Pulitzer Center and the Heising-Simons Foundation.
SO PAULO – Brazilian physiotherapist Graziela Domingues leads a lifetime war opposed to COVID-19. As head of the rehabilitation team at the Emilio Ribas Institute of Infectious Diseases Hospital, she is helping COVID-19 patients in the intensive care unit exercise their lungs, taking every imaginable precaution to keep it swollen and bring the virus home. So when Domingues learned that the hospital was recruiting volunteers for a COVID-19 vaccine trial, he didn’t hesitate: “I just need this suffering to end,” Domingues told Science.
More than 6 months after confirmation of the first case of COVID-19 in Brazil, the pandemic still continues, with around 30,000 new cases and 740 deaths consistent with the day. (The total death toll, 136,000, is only that of the United States. ) These discouraging statistics, combined with intelligent medical infrastructure, existing immunization, a well-established regulatory formula, and the joy of clinical trials, have made Brazil an ideal place to verify the existence of COVID-19 in mental vaccines. Vaccines, produced through Western and Chinese companies, are being tested here or soon. Negotiations are underway to also check the Russian Sputnik V vaccine.
In addition to contributing to the global fight against the disease, studies can also give Brazil faster vaccines to be effective through agreements that allow brazil to produce vaccines locally. “The more trials we can attract, the better,” says immunologist Jorge Kalil, a vaccine specializing in the University of Sao Paulo, Sao Paulo.
However, scientists are concerned that high expectations and political promises could lead to unwelcome approvals of vaccines. At a press conference yesterday, for example, the governor of the state of Sao Paulo, Joo Doria, came to “guarantee” that the state would have vaccines for all its citizens early next year and said “we will vaccinate them”, before acknowledging that the vaccine has not yet developed.
Although the number of cases and deaths in Brazil has begun to decline, and President Jair Bolsonaro still minimizes the risks of the disease, Brazilians have flocked to trials. At Emilio Ribas Hospital, for example, about 1,500 more people have registered for a Sinovac. trial of the vaccine, almost double the number planned at the site. Since July, the exam, which is designed and directed through the Butantan Institute in Brazil, has recruited more than 4,000 fitness personnel in 12 hospitals in six states; Target is 9, 000. “There is a waiting list” at each site, says Ricardo Palacios, director of clinical studies at the Butantan Institute. Half of the participants won the Sinovac vaccine, which includes the dead coronavirus, and part won a placebo. “I hope I got the vaccine, not the placebo,” Domingues says.
In late June, Brazil became the first outdoor country in the UK to begin testing a vaccine developed through the University of Oxford and AstraZeneca comprising a genetically modified chimpanzee adenovirus to explicitly explain the complex SARS-CoV-2 protein on its surface. The project, controlled through the Federal University of Sao Paulo (Unifesp), is open to fitness professionals and other equipment with maximum exposure to the virus. So far he has recruited another 4,600 people out of the planned 10,000. More than 30,000 more people have done so, presented to participate alone in Rio de Janeiro and Salvador, according to the Golden Institute of Research and Education (IDOR), which is guilty of conducting the trial in both cities. “This has absolutely maximized our recruitment capacity,” says IDOR President Fernanda. Tovar-Moll. The trial also plans to enroll another 30,000 people in the United States, at least 10,000 in the UNITED Kingdom and 2,000 in South Africa.
The trial leaders chose Brazil “because of the network of experienced and committed researchers who can put the finishing touch on high-quality clinical trials in the region,” said Andrew Pollard, head of the Oxford Vaccine Group and lead investigator for SARS. -CoV- 2 vaccine trials, he wrote to Science in an email. “Everything is done according to the most rigorous protocols,” says Soraya Smaili, pharmacologist and president of Unifesp. With other Oxford vaccine trials, this examination was suspended on September 6, allegedly because a British gamer developed transverse myelitis; it was resumed in Brazil and the UK on 12 September after independent protection supervisors concluded that the adverse occasion was unlikely to be related to the test.
The more we can attract, the better.
Meanwhile, the BioNTech/Pfizer/Fosun Pharma consortium is recruiting 2,000 volunteers in Sao Paulo and El Salvador for a Phase III trial of its messenger RNA vaccine, which is part of a testing program with another 29,000 people that also has sites in the United States. , Argentina and Turkey. Johnson Janssen Vaccine
Trials give Brazil early access to at least two vaccines. As part of its agreement with Sinovac, the Butantan Institute obtained the right to produce 60 million doses of the company’s vaccine in Brazil until early 2021, while the Oswaldo Cruz Foundation (Fiocruz) will produce 30 million doses of the AstraZeneca vaccine until December or January 2021 and, if successful, 70 million more in the first 6 months of next year. These first batches will be formulated and packaged from foreign-made ingredients through either company, but either agreement comes with generation change clauses that will eventually allow vaccines to occur completely if approved for clinical use.
The expectations of politicians and the public are high, especially for the Sinovac and AstraZeneca vaccines, which started earlier and recruited the maximum number of volunteers. “Everyone thinks the vaccine will be available in November, and during the New Year, everyone on the streets [to celebrate],” Kalil said in a video convention with Brazilian science, medicine and pharmacy academies on September 17. “That would be ideal, but I don’t think it is. “
Ricardo Gazzinelli, a vaccine researcher at Fiocruz and president of the Brazilian Society of Immunology, fears that public and political tension will lead to untimely approval in Brazil, along with fears in the United States. Launching a vaccine without sufficient knowledge about efficacy and protection can put other people at risk and erode trust in science, says Gazzinelli: “I think we want to be a little more careful.
Political rivalries in Brazil can increase pressure: Fiocruz is related to the federal government’s Ministry of Health, while Butantan is part of the government of the state of Sao Paulo and Doria is Bolsonaro’s political enemy. Anyone who gets an approved vaccine first can also do so. get a political compliment for it.
There’s already been a lot of promises. Since the Butantan Institute announced its agreement with Sinovac on 11 June, Doria and the director of the Butantan Institute, Dimas Covas, have continually stated that they are convinced that the vaccine will be tested, approved and available for mass distribution in early 2021. “I’m pretty sure January is a very realistic moment,” Covas told Globo TV, Brazil’s largest network, on August 28. The Ministry of Health, which oversees Fiocruz, has a similar timetable. “In January of next year, we started vaccinating everyone,” Health Minister Eduardo Pazuello said at a patron assembly on September 8.
COVID-19 vaccines will have to be approved through the Brazilian Agency for Health Regulation (Anvisa), a renowned federal company with highly qualified technical personnel, but Anvisa is not immune to political influence, being its chosen leader through the president. and Anvisa, Antonio Barra Torres, are army officers, appointed through Bolsonaro, but so far the firm has remained on good terms with scientists.
Domingues expects a smart result, but says he realizes that the bullet in his arm might not be her, if only because it may be a component of the placebo organization of the trial. “I’m very optimistic, but also very aware that I can’t let my guard down yet,” he says.
Herton Escobar is a scientific and environmental journalist in Sao Paulo, Brazil.
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