Anvisa evaluates proposal for Russian vaccine tests in Brazil

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Chief of Cuban Epidemiology, Francisco Durán, said that the country is expected to have access to the vaccine in the first quarter of 2021


© Reproduction / SEE
Chief of Cuban Epidemiology, Francisco Durán, said that the country is expected to have access to the vaccine in the first quarter of 2021

Technicians of the National Health Surveillance Agency (Anvisa) this week discuss the terms of the Sputnik V phase 3 clinical trial proposal, the vaccine developed in Russia against Covid-19. At the beginning of the month, the government of Paraná announced the forecast of the beginning of tests until the end of October.

The tests are expected to involve 10,000 volunteers who will receive two doses of the drug with an interval of 21 days between applications. Information from the local government indicates that there will be a priority of participation for health professionals from university hospitals and people who are part of risk groups, such as diabetics and hypertensive patients.

Sought by VEJA, the Casa Civil do Paraná, involved in all the negotiation of Brazilian studies of the drug, stated that at this moment there are meetings to align the information that will be contained in the official protocol – which is the request for authorization of tests – which delivery forecast for next week.

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This type of approval takes, on average, 72 hours to be approved. The very short term is the result of cooperative work carried out by Anvisa technicians since the beginning of the pandemic. In order not to compromise the quality of the service, several internal processes were rethought, including the holding of meetings with study proponents (as with the authorities of Paraná), so that requests are made in a more assertive manner.

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Mexico, another country quoted to receive the drug tests, is also expected to start applying for October. In Brazil, there are four vaccines for Covid-19 currently being tested, 34,860 Brazilian volunteers will be selected to collaborate in scientific efforts.

Safety and effectiveness

At the beginning of the month, research published in the respected scientific journal The Lancet pointed out that the Sputinik vaccine is capable of developing immune response sem serious side effects. The analysis was the result of a preliminary study with a group of 76 healthy volunteer patients. These analyzes were carried out between 18 June and 3 August by researchers from the Russian Ministries of Health and Defense.

The result was widely publicized precisely because there was a wave of mistrust about the drug since its registration in record time, in August – when no one knew the results of the initial Phase 1 and 2 tests. The first batch of the vaccine was released to Russians two weeks ago.

Pandemic in Brazil

This Thursday, the 24th, the moving average of new notifications of the disease was 28,902.3 and that of new deaths was 696.1. The weekly moving average is calculated from the sum of the number of cases and deaths in the last seven days, divided by seven, number of days in the counted period – which allows for a better assessment by canceling daily variations in the record and sending data by the agencies public health, a problem that occurs mainly on weekends.

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