Brazilian Denise Abranches participates as a volunteer in the Oxford vaccine study Camila Svenson
When dentist Denise Abranches offered her arm to receive the experimental coronavirus vaccine, she was not afraid.
She was deeply moved by the patients she saw die on the premises of the São Paulo Hospital, where she coordinates the dental center and takes care of the oral health of patients intubated by covid-19.
“I am every day with my hands on this virus.
Literally, because I manipulate the patient's saliva.
I was already afraid of my exposure, today I see it as an opportunity to help people ”, he says.
Health professionals, exposed to the virus, are the target audience for the experimental tests.
So, as soon as she learned that São Paulo State University would participate in the Oxford vaccine trials, she crossed the street to the Reference Center for Special Immunobiologicals (Crie) and volunteered.
In June, Abranches was the first person outside the UK to receive the drug, although she does not know whether she received the vaccine or the placebo.
“I responded to the summons because it was necessary to inform health professionals, and I exercised my role as a citizen as an act of love.
Right now, the need for a vaccine is the most important thing, ”he says.
The days following the application of the drug were of maximum attention.
Abranches had to monitor his temperature daily, keep an electronic diary to report any reactions or symptoms, and answer questions that the medical team asked him on WhatsApp.
He underwent blood draws and lost count of how many RT-PCR tests he did during the entire process.
All as part of an intense monitoring of the volunteers, normal and necessary in a study that needs to evaluate if this vaccine is in fact capable of protecting against covid-19.
"I did not present any symptoms at any time," he says.
From June until now, the investigation has faced a series of changes and mishaps.
The trial, which provided for the application of one dose of the vaccine, was expanded to two.
The monitoring of his health status continues to this day in the communication channels he has with the study's medical team.
Throughout the entire process, the dentist says she was not afraid or suspicious.
He says that his confidence in science was not affected even when the Oxford vaccine tests were suspended in September because a participant presented symptoms of multiple sclerosis (when it was confirmed that such condition was not related to the vaccine, these were resumed).
Or even after one of the Brazilian volunteers died last week.
His death does not appear to be related to the vaccine.
“My encounter with the virus is daily.
I was not afraid of the vaccine at any time.
When we give consent, we are aware that some adverse effect may occur, but there is a whole medical team that is available to help us with anything, "he says.
The difficulty of recruiting volunteers for the tests
If at first the search for volunteers was not a problem for the clinical trials of the vaccines under study in Brazil —there are four in phase three in the country—, the ideological dispute that arises around drugs in the field Politician and frequent announcements by leaders about dates for the presentation of results began to alienate the candidates and represented a new obstacle in the race for the coronavirus vaccine.
Recruiting volunteers is a challenge for testing the Chinese pharmaceutical Sinovac, Coronavac.
Although the Government of São Paulo has said that this is one of the most advanced, the research still needs to get the last 4,000 participants to apply the drug and produce results that certify its ability to effectively protect against covid-19.
This week, the dispute reached a new level when President Jair Bolsonaro disapproved of the Health Ministry's plan to purchase millions of doses of the Sinovac vaccine, an option developed at an institute in São Paulo, under the control of his political opponent and aspiring president João Doria.
"We need a collective effort to mobilize health professionals," says Fábio Leal, infectious disease physician and research director at the University of São Caetano do Sul, one of the Sinovac vaccine testing centers.
Doctors, because of their exposure to the virus, are the main target of the investigations.
Only by analyzing the degree of infection in participants in the group that received the placebo is it possible to conclude whether the vaccine actually protects.
“We also need to combat this erroneous and ideological idea that vaccines have nationality.
Today, health products are globalized.
Nothing is made in a single country.
So much so that a vaccine that in principle is North American or English may be being produced with raw material from China ”, adds the infectologist.
Leal says that since that ideological dispute began to gain strength, the number of volunteers has been reduced.
Disinformation among health professionals, both in relation to the safety of vaccines and the promises that they will be available to the public as soon as possible, would also have contributed to a scenario of difficulties in recruiting participants.
“Many of them, faced with the discourse that the vaccine will be available soon, end up choosing to wait.
Instead of participating in the study, they imagine that in a short time they will have access to the vaccine that is confirmed to be effective and safe, but for this to happen, we just need them to be volunteers ”, he explains.
In addition, Leal also highlights that there is suspicion that, by participating in the clinical test, the professional does not have access to the vaccine after its registration.
This happens because, in the different ongoing studies, only a part of the volunteers actually receive the drug.
The rest receive a placebo.
But he guarantees that Coronavac's own clinical study foresees the vaccination of the placebo group as soon as the vaccine is confirmed to be effective, even before it is included in the immunization program of São Paulo (which acquired it) or the country.
"Those who received the placebo will be the first to be vaccinated," he says.
To be tested in humans, vaccines must provide evidence of safety and the ability to produce an immune response both in the laboratory and in animals.
Participants are closely monitored and any incidents - apparently drug related or not - are investigated by an independent scientific committee.
For this reason, both Leal and Abranches trust that cases such as the death of the Oxford vaccine volunteer last week should not influence the decision of those who intend to participate in the study.
The fact that some volunteers contract COVID-19 also does not jeopardize the efficacy of the vaccines under evaluation.
First, because they may have received the placebo.
Second, because not even the vaccines already registered necessarily represent an absolute protection, 100% effective.
The flu vaccine, for example, is less than 50% effective, after decades of improvement.
The degree of efficacy of the drug is what will determine the portion of the population that needs to be vaccinated to reach a level of collective protection against the virus.
For the Oxford vaccine volunteer, Denise Abranches, participating in the vaccine tests is being an agent of an important chapter in the history of humanity.
“I am part of something that is going to bring a vaccine for my mother, which I have not seen for months, for my family, for you and for people around the world.
What I tell my colleagues is to take this act of love, of responsibility.
I will always be remembered because I am here, taking a risk for the good of the world.
The benefit is immense ”, he concludes.