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It was through Twitter that Carla Freitas learned that a team from the University of Oxford, England, was looking for volunteers to test one of the first vaccines against covid-19. In those last days of April, little was known about the disease caused by the new coronavirus and even less about a potential vaccine, but the Portuguese, who went to London to study in 2011, decided to take a risk. He was aware of the risks, but he also knew that the university had a great reputation for developing vaccines and would not accept it for study if there was something medically that does not allow it.
The 31-year-old Portuguese, who finished her masters in 2012, began working the following year as an occupational therapist at the British National Health Service (NHS, in the original acronym). In April of this year, when covid-19 cases exploded in many countries, Carla had an experience similar to that of many colleagues: she began treating patients with covid-19. Initially, these were less serious cases, but the situation changed rapidly and the UK became one of the countries most affected by the European pandemic.
“I started to have very direct contact with the effects the coronavirus was having on people. I had a patient I was following for six months who died of the virus. It was a very bad experience in my career, I was someone I already had a bond with and it was very difficult to overcome. My job was to do the functional assessment and help plan each person’s discharge. There have been cases where one day the patient was fine and the next day he died. It is a very cruel disease, people seem to evolve positively and, suddenly, things change ”, says Carla on the phone with PÚBLICO.
Realizing that “the only way out of this pandemic would be a vaccine”, he decided to volunteer for the first phase of clinical trials of the therapy that the UK AstraZeneca laboratory and the University of Oxford were developing, which already took place in May.
Despite being in good health and meeting almost all of the team’s requirements – including the ability to walk or drive to the vaccination site – Carla felt she would not be accepted to be a health professional and to be part of the essential worker group. who continued working even during the first imprisonment imposed by the Boris Johnson government. But scientists were struggling to recruit volunteers because much of the British population was ordered to stay home. And the Portuguese woman ended up being part of the group of people who would be vaccinated.
Tiredness and headache
After an initial health assessment and undergoing various tests (such as antibodies), Carla learned that she was not and had not been infected with SARS-CoV-2 (an automatic exclusion criterion) and could be vaccinated. next day. “It was sudden, I didn’t expect it. It was my first time in a clinical trial, but because I work in a hospital setting, I’m quite used to certain things. When I arrived, they gave me a hospital bracelet, which scared me a bit, but the team was always extremely professional and showed me all the information I had available so far, ”he says.
For the Oxford team, covid-19 has come to strengthen the process of preparing a type of vaccine that had already begun with the prevention of other coronaviruses, as the volunteer recalls. They were already working to combat SARS (severe acute respiratory syndrome), which was first identified in 2003, and that research served as the basis for this new vaccine.
After applying the vaccine, Carla and the remaining 1076 volunteers were observed for an hour to measure blood pressure and oxygen levels. Half received the placebo and the other half the potential covid-19 vaccine. Only at the end of all phases of the experiment will the volunteers know which one they have received.
Everyone, without exception, brought home a list of things to do in the first week and in the following months: measure their temperature, check symptoms, contact the team if they felt something out of the ordinary. Each week they have to answer a long questionnaire – whether they have been with someone with covid-19, whether they have traveled, whether they have been to the movies, whether the people they live with have had symptoms – and they have to have blood tests frequently.
Carla, who always had the flu shot to work in the health field, says she has had some secondary symptoms that she doesn’t normally have. “I felt very tired the first day and immediately thought it was associated with the vaccine. Over the next few days I got quite severe dizziness and headaches, which I don’t usually have. I took medication and had no problems from that point on. “
A second dose
Even before the Oxford and AstraZeneca team published those preliminary trial data they revealed that the vaccine has an efficacy that can range between 62% (two full doses) and 90% (half dose followed by a full dose), a depending on the dosing regimen used, Carla was asked to be vaccinated again with the same vaccine she had received in May.
This difference in dosage prompted the University of Oxford to announce, days later, that some of the vials used in the test did not have the right concentration of the vaccine, meaning that some volunteers received half a dose. The university added that it had discussed the issue with regulators and agreed to complete the test. The production problem has been solved, they announced. The pharmaceutical company AstraZeneca has already anticipated that it will carry out an “additional study” to validate the efficacy results.
Carla was informed of these changes and agreed to be vaccinated again in October, even though it was part of the first trial phase in May. You will not know yet whether you received the two-dose control vaccine or the two-dose or one-and-a-half dose covid-19 vaccine. Nothing changes in the process, but it will have to be followed until October 2021, one year after the second vaccination.
The released preliminary results have not yet been reviewed by peers or published in a scientific publication, which is expected to happen as soon as full clinical trial results are available. Please wait until this publication notices this difference in effectiveness.
“Monthly visits [para acompanhamento] they are optional and I can withdraw at any time, but my goal is to continue. I think it is a way to contribute to science because, as a health professional, I have seen people hospitalized, even colleagues, and I felt that I could not be in control of the situation. In April, and even now, there was little we could do to get out of this pandemic, but I think this is one of them, ”says the neurology therapist. For participating in this study, and if you complete it to the end, you will receive £ 625, approximately € 716.
What happens if the vaccine is not approved?
Carla says the NHS has already made “huge preparations,” such as vaccinating many health care professionals against the flu, to free people to distribute the covid-19 vaccine. “We have already been told that in December we should receive one of the vaccines,” says the Portuguese.
British newspapers say the UK regulator could approve the vaccine from the Pfizer and BioNTech consortium, which is 95% effective, within days. But what if this or another option is approved before the Oxford / AstraZeneca vaccine or if, something that is also on the table, is not approved at all?
In these cases, since Carla is part of one of the priority groups, she will have the right to call investigators and ask if she has received the placebo or the covid-19 vaccine. “I was told there would be complete transparency and that they would explain the risks, if any, of getting another vaccine. They made it very clear and all the volunteers received this guideline, ”he says.
The Oxford vaccine still lacks the final results of Phase 3 clinical trials, but the UK has already secured 100 million doses, along with another seven million doses of Moderna’s vaccine and 40 million doses from Pfizer / BioNTech, all are awaiting regulatory approval.
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