Committee saw no cause and effect relationship between the Oxford vaccine and adverse symptoms, says Anvisa director | Vaccine

The test of the British vaccine was suspended around the world last Tuesday (8), after a volunteer faced serious adverse effects. This Saturday, the AstroZeneca laboratory announced the general resumption of the tests, but did not detail the conclusions on the case.

“What is very important is that the independent committee verified that there is no causal link, there was no causal link,” Barra Torres said in an interview with GloboNews.

“So, this information, without going into details, is important and it really was what allowed the studies to advance with the greatest safety. Because there was no causality between what happened and the vaccine test,” he continued.

Anvisa received official information from the British government and the laboratory on the case of the volunteer this Saturday. Hours later, the agency announced that it approved the resumption of the tests in Brazil.

In the official statement issued, the AstraZeneca laboratory only said that “the international Independent Committee for the study has completed its investigations and recommended the resumption of vaccination in the studies.”

The company did not elaborate on the committee’s findings or mention the volunteer who would have faced serious adverse reactions.

Last week, The New York Times reported that the patient had transverse myelitis, an inflammatory syndrome that affects the spinal cord. The president of Anvisa mentioned the same syndrome in the interview with GloboNews.

“In these processes there is a whole issue, a confidentiality for these studies to be carried out. Included, in the preservation of the people of the volunteers themselves. But there is no doubt, you yourself mentioned this hypothesis of transverse myelitis, this is already in the public domain ”, Torres said, before explaining the conclusions of the independent committee.

• SPECIAL: Meet the Covid-19 Vaccine Candidates
• The Oxford vaccine has had 5,000 volunteers vaccinated in Brazil without serious reactions, says Unifesp

In Brazil, there were no reports of serious adverse events, according to Anvisa. In the country, the research is coordinated by the Federal University of São Paulo, through the Reference Center for Special Immunobiologicals (Crie / Unifesp).

Anvisa approved the resumption of tests of the “Oxford vaccine” in Brazil after receiving official information from the company AstraZeneca, responsible for the development of the vaccine in conjunction with the University of Oxford, in the United Kingdom.

This Saturday clinical trials of the vaccine resumed in the United Kingdom. However, until the end of the morning, Anvisa was still waiting for official data from the British government and the laboratory. The analysis started and ended this afternoon.

“After evaluating the adverse event data, their causality, and the safety data set generated in the study, Anvisa concluded that the benefit / risk ratio remains favorable and, therefore, the study can be resumed.“the regulatory agency said in a note.

In the statement, Anvisa says that “it will continue to monitor all adverse events observed during the study and, if any serious situation is identified with the Brazilian volunteers, it will take appropriate measures to ensure the safety of the participants.”

Also in a note, AstraZeneca reported that tests in Brazil will resume next Monday (14).

>> read the full notes at the end of this article

“AstraZeneca is committed to the safety of study participants and to the highest standards of ethics and good practices in clinical studies. The company will continue to work with health authorities around the world and will inform you when other clinical trials may be resumed. to Provide the vaccine in a comprehensive, equitable and non-profit manner during this pandemic, “says the laboratory.

The Ministry of Health issued a note on the resumption of tests in “all participating countries”, but did not confirm the date reported by the laboratory.

“It should be noted that Pasta’s priority is the safety of all volunteers involved in the tests, which is based on the international standard of Good Clinical Practice – rigorously followed by Brazil,” says the ministry.

Read the full notes published by the Ministry of Health, Anvisa and AstraZeneca below:

The Ministry of Health informs that clinical trials with the ChAdOx-1 nCoV-19 vaccine, developed by the University of Oxford with the AstraZeneca laboratory, will resume in all participating countries. The decision was informed to Brazil this Saturday morning (12).

It should be noted that Pasta’s priority is the safety of all volunteers involved in the tests, which is based on the international standard of Good Clinical Practice – rigorously followed by Brazil.

The Ministry of Health also reiterates that in addition to the AstraZeneca vaccine, it also monitors more than 200 ongoing studies. The goal is to find an effective and safe solution for the cure and prevention of Covid-19. No effort will be spared to make available to Brazilians, as soon as possible, an effective vaccine, in quantity and quality, to serve the population.

Anvisa specialists met this Saturday afternoon (09/12) to evaluate the resumption of the clinical study of the Oxford vaccine. The evaluation performed considered information received from the British regulatory agency (MHRA), the Independent Clinical Study Safety Committee and the study sponsoring company, AstraZeneca.

After evaluating the data of the adverse event, its causality and the set of safety data generated in the study, Anvisa concluded that the benefit / risk ratio remains favorable and, therefore, the study can be resumed.

It is important to note that Anvisa will continue to monitor all adverse events observed during the study and, if any serious situation is identified with the Brazilian volunteers, it will take appropriate measures to ensure the safety of the participants.

The clinical trials of the AstraZeneca Oxford coronavirus vaccine, AZD1222, will restart in Brazil on Monday 09/14, following the confirmation issued by the National Health Surveillance Agency (Anvisa) today 09/12 that the restart is safe .

On September 6, the safety process foreseen in the research protocol caused a voluntary pause in vaccination in all global trials to allow review of safety data by independent committees and international regulators. The International Independent Committee for the Study completed its investigations and recommended resumption of vaccination in the studies.

This opinion was also shared with the regulatory agencies, which carry out their due reviews and evaluations, defining the conduct to be followed locally. In the UK, the MHRA (UK Health Regulatory Authority for Medicines) recommended follow-up to the September 11 studies, and Anvisa issued its opinion on September 12, formalizing that trials in Brazil can be resumed.

AstraZeneca and the University of Oxford, as study sponsors, cannot release further medical information. All researchers and study participants will be updated with the relevant information and this will be disclosed in global clinical registries, in accordance with the clinical trial and regulatory standards.

AstraZeneca is committed to the safety of study participants and to the highest standards of ethics and best practices in clinical studies. The company will continue to work with health authorities around the world and advise when more clinical trials can be resumed to provide the vaccine in a comprehensive, equitable and non-profit manner during this pandemic.