Brazilian volunteer who participated in the Oxford trials took placebo, not vaccine | Vaccine

What is known about the case

• Volunteer was 28 years old and a recently graduated doctor
• He died due to complications from Covid-19.
• After evaluation by an independent committee, the tests were not suspended.
• AstraZeneca and Oxford demand confidentiality clauses not to reveal more details of the case
• Developers say the committee saw no security concerns related to the case
• Anvisa said that the process is still under evaluation, but did not determine the suspension of the study.

The National Health Surveillance Agency (Anvisa) reported that it was notified of the death on October 19, and that it was informed that the independent committee accompanying the case suggested that the study continue.

“The process is still under evaluation,” the agency said. (see full note below).

• Volunteer was a former UFRJ student; academic center laments empty and is lost

Both the developers (AstraZeneca and the University of Oxford) and those involved in the application of the tests (Unifesp and IDOR) note that they are prevented from giving more details for ethical reasons, but noted that there was no indication to suspend the study. In addition, they recalled that the research is based on a “blind randomized study, in which 50% of the volunteers receive the immunization produced by Oxford”.

In a statement, the University of Oxford emphasized that incidents with participants in the control group are reviewed by an independent committee and that “careful analysis” did not raise concerns about the safety of the clinical trial.

The pharmaceutical company AstraZeneca informed the G1 who also cannot provide additional details due to confidentiality clauses, but emphasized that all review processes were followed. “These evaluations did not raise concerns about the continuity of the ongoing study,” the company said in a statement.

The microbiologist Natália Pasternak says that you have to be cautious and calmly analyze what happened. “The people who participate in the clinical trials are people, they can die from the most diverse causes. It may have absolutely nothing to do with the vaccine,” explained the scientist, who also pointed out that the investigation of the case can take time and days .

According to Pasternak, the decision to open the information is at the discretion of the investigator and the sponsor of each investigation. The independent committee, which receives and analyzes the information on the evidence, can recommend whether or not to open data on the case.

“For now, it is a serious effect, of course death is a serious effect, but this is normal in clinical trials and needs to be evaluated,” he added.

Tests and agreement in Brazil

The vaccine developed in collaboration between the AstraZeneca laboratory and the University of Oxford is the federal government’s main commitment for a future vaccination campaign against the new coronavirus.

The study is in phase 3 of the trials and they began in Brazil in June. At this stage, the effectiveness of the vaccine is verified by monitoring thousands of volunteers. In the country, 8 thousand volunteers already participate in the study.

Before phase 3, its safety was verified in research with a smaller number of volunteers and there were no serious reactions, only mild reactions. (read below).

The Ministry of Health foresees the disbursement of R $ 1.9 billion for the AstraZeneca / Oxford project, and expects to offer 100 million doses in the first half of the vaccine, if the studies confirm its effectiveness and safety. It also plans to produce another 165 million doses in Brazil in the second half.

Oxford vaccine safety

A study with preliminary results of the Oxford vaccine (AZD1222) was published on July 20, in the scientific journal “The Lancet.” The research cites reactions considered mild and moderate and does not speak of serious side effects:

• Pain after vaccination: 67% without paracetamol; 50% with paracetamol.
• Fatigue: 70% without paracetamol; 71% with paracetamol.
• Headache: 68% without paracetamol; 61% with paracetamol.
• Muscle pain: 60% without paracetamol; 48% with paracetamol.

The initial tests, of phases 1 and 2, were carried out in England, with 1,077 volunteers, divided into two groups: 543 people received the experimental vaccine and another 534 received a meningitis vaccine (the control group) – 56 Participants in the experimental vaccine received prophylactic paracetamol.

Anvisa note on the death of the volunteer

Next, see the complete positioning disclosed by Anvisa:

“In relation to the death of the Oxford vaccine testing volunteer, Anvisa was formally informed of this fact on October 19, 2020. Data related to the investigation carried out by the International Safety Assessment Committee was shared with the Agency. that based on the ethical confidentiality commitments provided in the protocol, the regulatory bodies involved receive partial data referring to the research carried out by this committee, which suggested that the study should continue, so the process remains under evaluation.

Therefore, Anvisa reiterates that, in accordance with national and international regulations on Good Clinical Practices, data on clinical research volunteers must be kept confidential, in accordance with the principles of confidentiality, human dignity and protection of the participants.

Anvisa undertakes 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.

The Agency has fulfilled, will fulfill and will fulfill its institutional mission of protecting the health of the Brazilian population. “

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