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Anvisa authorizes resumption of Oxford vaccine testing

In Brazil, the Reference Center for Special Immunobiologicals at the Federal University of São Paulo is ahead of the tests

Anvisa authorizes resumption of Oxford vaccine testing, In Brazil, the Reference Center for Special Immunobiologicals at the Federal University of São Paulo is ahead of the tests
Anvisa continues to carefully monitor any side effects resulting from the application of the vaccine.

Sep 15, Health Surveillance: Clinical studies with the Oxford vaccine, from the United Kingdom, can now be resumed in Brazil. The decision of the National Health Surveillance Agency (Anvisa) guarantees security to volunteers who want to participate in the experiment. The tests had been suspended after the news that a volunteer abroad had a reaction to the product, which was discarded.


Anvisa's deputy chief executive, Antonio Barra Torres, explained that there was a technical analysis of the information provided by the AstraZeneca laboratory, the University of Oxford and the UK regulatory authority. “The study by the independent committee pointed out that there was no causal link between the aforementioned event and the vaccine that was applied to the volunteer. The reason why, then, it was possible to authorize the resumption of tests in national territory, guaranteeing the safety of our volunteers ”.


The Federal University of São Paulo (Unifesp), which coordinates clinical trials of the vaccine in Brazil through the Reference Center for Special Immunobiologicals (Crie / Unifesp), reported that all centres participating in the study in the country resumed the application of the drug in volunteers this week. The vaccine is in phase 3 of clinical trials, which is the most advanced stage of the analysis of effectiveness.


According to Unifesp, five thousand volunteers, in all, can participate in the tests. The majority, 4,600, have already been vaccinated and have had no record of serious health complications. Anvisa continues to monitor any side effects resulting from the application of the vaccine.


For the director of the Agency, the suspension of the tests was an attitude of transparency to ensure the safety of the process. “The pause in tests on the Oxford vaccine in Brazil and the decision to resume them is proof of transparency.

In our understanding, this transparency is one of the factors that make volunteer testers in Brazil feel safe and we can continue to search for effective vaccine platforms with quality and safety, ”he said.


Vaccine production

In late July, the Oswaldo Cruz Foundation (Fiocruz), from the Ministry of Health, and AstraZeneca signed a document that will provide the basis for the agreement between the laboratories on the transfer of technology and the production of the vaccine against Covid-19, in case its effectiveness and safety is proven. The agreement between Fiocruz and AstraZenecA is the result of cooperation between the Brazilian and British governments, announced on June 27.


On August 6, President Jair Bolsonaro signed a provisional measure that opens an extraordinary credit of R $ 1.9 billion to enable the production and acquisition of the 100 million doses of the vaccine.


According to the Ministry of Health, Brazil is expected to become self-sufficient in the full production of the vaccine in the second half of 2021.


Brazil currently has four vaccines under test against the coronavirus, including the one produced in Oxford. According to Anvisa, they have 22,000 Brazilian volunteers, distributed among the following states: São Paulo, Rio de Janeiro, Rio Grande do Sul, Minas Gerais, Paraná, Federal District, Bahia and Rio Grande do Norte.

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