Anvisa receives official information to evaluate the resumption of tests of the Oxford vaccine for Covid-19 | Vaccine

At the end of the morning, Anvisa said it was waiting for data from the UK Health Authority (MHRA). However, with the information from the laboratory, the agency announced that it will begin, in the next few hours, the analysis protocol on the continuity of the tests in Brazil.

“Anvisa reiterates that it is committed to the rapid analysis of all data. At the same time, it works to guarantee the safety of the participants in the clinical study in Brazil,” the statement said (read in full below).

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This Saturday the clinical trials of the vaccine developed jointly by the University of Oxford and the pharmaceutical company AstraZeneca resumed in the United Kingdom.

The Brazilian Ministry of Health said it is awaiting the release of Anvisa and the National Research Ethics Committee (Conep) so that “the studies can also continue with Brazilian volunteers.”

However, the release of Anvisa depended on the submission of this information by the British authorities.

On Tuesday (8), vaccine tests were temporarily suspended after a volunteer had an adverse reaction.

Details of the case were not released for reasons of confidentiality of the participants, but the newspaper “The New York Times” reported that the patient had transverse myelitis, an inflammatory syndrome that affects the spinal cord.

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).

Suspension of clinical trials is a standard procedure that occurs whenever unexplained illness arises in one of the participants.

“In large trials like this one, some participants are expected to be unwell and all cases must be carefully analyzed to ensure a careful safety assessment,” Unifesp explained in a note.

The Brazilian Health Ministry said on Saturday that, in addition to the AstraZeneca vaccine, it also monitors more than 200 ongoing studies.

“No effort will be spared to make available to Brazilians, as soon as possible, an efficient vaccine, in quantity and quality, to serve the population,” he said in a statement.

Nine vaccines in the last phase of testing

In addition to the Oxford University candidate with British pharmaceutical company AstraZeneca, eight more vaccines are in the third and final phase of human testing, the last before launch.

• Janssen Pharmaceutical Companies (USA)
• Moderna / National Institute of Allergy and Infectious Diseases (USA)
• BioNTech / Fosun Pharma / Pfizer (Germany and USA)
• Sinovac (China)
• Wuhan / Sinopharm Institute of Biological Products (China)
• Beijing Institute of Biological Products / Sinopharm (China)
• CanSino Biological Inc./ Beijing Institute of Biotechnology (China)
• Gamaleya Research Institute (Russia)

Read, below, the full note released by Anvisa this Saturday afternoon:

“The National Sanitary Surveillance Agency received, this Saturday afternoon (September 12), from the company AstraZeneca, the information necessary to start the reactivation analysis of the clinical study with the vaccine from the University of Oxford in Brazil.

After the announcement of the resumption of the study in the United Kingdom, carried out by the University of Oxford, the National Health Surveillance Agency will follow, in the next few hours, the analysis protocol necessary to evaluate the application.