Understand how covid-19 vaccine will be evaluated – Health

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In the race for vaccine against covid-19, the 16 study centers of the coronavac throughout the country are being stimulated by Butantã Institute accelerate the recruitment of volunteers. At the Emílio Ribas Institute of Infectious Diseases, one of the hospitals participating in the research, a task force was set up to reach the expected number of participants this month.

The unit, which started immunizing volunteers in late July, also started to operate on Saturdays in early September. At the same time, the team working on the study was expanded from 24 to 40 professionals.

Even the director of Emílio Ribas, Luiz Carlos Pereira Júnior, entered the scale to do screening and consultations with those enrolled. “Particularly, I was motivated too much because I am a doctor and I could not shy away from contributing to the team in this project that has such a noble purpose. After the loss of more than one million people in the world, 150 thousand of them Brazilians, helping to stop this tragic statistic is what gives us all this enthusiasm, not only for me, but for the whole team ”, said Pereira Júnior. For six weeks, the director, who is also an infectious disease, reconciles administrative activities on weekdays with attending volunteers on weekends.

The effort is repeated among other professionals, who canceled vacations and work up to 14 hours a day to serve the largest possible number of volunteers.

THE Estadão he was on Friday, 16, at the center and followed the routine of researchers and volunteers, from the first visit to the actual immunization. According Ana Paula Rocha Veiga, infectologist and coordinator of the field study of coronavac at Emílio Ribas, the task force had results. “In the first two months of care, (July and August), we immunized 190 volunteers. With the expansion of services in September, we reached 550 and now we have 750 participants with at least one dose taken ”, she says, excited. A thousand volunteers will participate in Emílio Ribas. Adding all the centers, there will be 13 thousand – half will receive the vaccine and the other half, placebo.

In Emílio alone, there are already about 3 thousand interested registrants to participate. Not everyone, however, will meet the requirements or be available for all stages of follow-up, so screening is important.

In addition to Pereira Junior, Ana Paula he also had his routine messed up with the start of his studies. When the institute’s board invited her to be a field coordinator, she was on her first day of vacation. “I came back from vacation at the time thinking that now is the time to contribute. Most days, I stay here from 7 am to 9 pm, I feel tired, but there is no time to get discouraged. Sometimes I complain of exhaustion to my 80-year-old mother, and she says: go ahead, we need this vaccine ”, says the doctor.

Tiredness is justified. The work at the center is much greater than “just” caring for and immunizing volunteers. Each enrolled participant, before taking the immunizer or the placebo, must undergo medical consultation, blood tests, urine tests and PCR, to rule out an infection by coronavirus. After the results of the tests, the participant is released to be vaccinated. All of these procedures are done on the first visit to the center.

Fourteen days later, the participant returns to Emílio Ribas to take the second dose of the immunizer or placebo. On occasion, he again undergoes consultation and exams. After two visits for the application of the product, the patient goes through six more monthly face-to-face consultations and weekly follow-up by phone or message.

“We finish the service at 7 pm and then I get the list of volunteers that I need to call or send a message to check if everything is fine”, says Ana Paula.

Secrecy

Both doses of coronavac and the placebo ones are kept in the so-called secret room or the secrecy room. Only two nurses have access to the site. They are responsible for releasing the product to the professional who will make the application. Only the workers in this room know which doses are vaccines and which are placebo, but they do not have the information of which one is provided for each volunteer, since the dose is released using a numerical code of the patient broken down on a form where his name does not appear.

All other professionals and the volunteers themselves are, therefore, in the “blind” condition of the study, that is, they do not know whether they are applying or receiving vaccine or placebo. The method is the most recommended for clinical research, because if doctors or patients had this information, they could have influenced behaviors, which would increase the risk of biased results.

In the secret room, the temperature cannot exceed 20ºC and the doses are in refrigerators with temperatures between 2ºC and 8ºC. In one of the refrigerators, there are the boxes with red labels, referring to the placebo doses. Coronavac doses are included in the green label packages. All are removed from the packaging before being delivered to the application professional.

After receiving the first dose, the participant receives a diary in which he must note the temperature of the following days and other symptoms that may appear, such as pain, nausea, swelling at the application site, among others. The first dose is always applied to the right arm. The second, on the left arm.

Among the volunteers, the biggest anxiety is knowing when they will be told if they have taken a placebo or the vaccine. “I signed up because I wanted to help with the research, but also because I hope that I got the real vaccine and that it is effective. I work as a dentist and it is risky because we move people’s mouths. I would be more relaxed if I were protected, ”says Elizabeth Paisana Yshay, 50, who has already taken both doses of coronavac or placebo.

The nurse Silvana Morais, 53, took the first dose this week after being encouraged by a fellow doctor to participate. “He told me the vaccine was safe and I applied out of solidarity. The more people who are available, the faster we will have a vaccine for everyone, including SUS ”, she defends.

The volunteers will be followed up for one year, but if the results of efficacy appear before that and the product registration is obtained, even the participants who received a placebo are entitled to receive the vaccine, according to ethical regulatory standards of clinical studies.

The infectologist Ana Paula he says that there are volunteers who travel from the interior of São Paulo to collaborate. The purpose of opening the agenda for attending Saturdays was to receive volunteers who, due to work commitments or living far from the capital, could not attend during the week.

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I see a lot of motivated people. There are those who have lost relatives and friends and make it a reason to participate, to help. Among the volunteers and our team, the power of the union in the face of this new threat has been very strong

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