Coronavirus: Brazil rejected Sputnik for lack of data and Russia talks about “political” decisions

BRASILIA (AFP) .- After the request sent by ten States of Brazil, who, in the midst of the saturation of the health system, try to negotiate more vaccines against the coronavirus, yesterday the health regulator refused to import Sputnik V, believing that it does not have technical data to verify its safety and effectiveness.

“We will never allow millions of Brazilians to be exposed to products without proper verification quality, security and efficiency or, at a minimum, given the serious situation we are going through, that there is a favorable relationship between risk and benefit», Said Antonio Barra Torres, president of the National Health Surveillance Agency (Anvisa).

The five leaders of the entity followed the recommendation of the technical area, which identified various “uncertainties” regarding the safety and efficacy of the drug, the first announced as effective against Covid-19 and one of the most used in the world, including Argentina. They also relied on the fact that it has not yet been approved by the European Medicines Agency (EMA) or the US Federal Food and Drug Administration (FDA).

However, there are reassuring data about the vaccine: in February, the magazine Lancet He reported that Sputnik V had an efficiency of 91.6%, which dispelled doubts about its reliability. In recent days, since the Russian government raised this figure to 97.6%.

In any case, to support their position, Anvisa technicians asserted that publication in the scientific journal does not have the same requirements as approval in regulatory bodies. “A health assessment is different from an assessment carried out by a scientific journal. A review does not aim to recommend or not the use of a vaccine, nor the commitment to verify good clinical practice, nor does it presuppose access to all the raw data and reports ”of the study, said Gustavo Mendes, one of the technical directors of Anvisa.

“Regarding the authorization of Sputnik V in other countries, it seems that most of them are countries without a tradition of regulatory maturity and robustness”, said one of the agency’s directors, Alex Campos, who said the vaccine is not in use in 23 countries where it has been approved. He also spoke of a “sea of ​​uncertainties” and he said that the role of the organization cannot be simply notorious, according to what was published by the newspaper O Globo.

“We observed failures in the adverse event assessments, we could not identify whether the volunteers had received the proper instructions to report the adverse events,” said Anvisa Drugs and Biologics General Manager Gustavo Mendes Lima Santos, who added: “If the validity of these tests is not proven, how can you be confident?”

As a viral vector, the Russian drug is used in more than 60 countries. And in Brazil, the country in the region most affected by the pandemic (reports more than 14 million positives and nearly 400,000 deaths among its 212 million inhabitants), the governors of several states wanted to negotiate 30 million doses to face a curve that keeps rising.

“I hope the Sputnik V vaccination process will adapt its information and resolve compliance issues quickly, as millions of people need access to safe and effective vaccines,” added another Anvisa director, Meiruze Freitas.

In social networks, from the story of the vaccine, they echoed the rejection announced in the last hours and accused the organization of the Brazilian government of Jair Bolsonaro playing politics in the midst of the global crisis.

“Anvisa’s delays in approving Sputnik V are unfortunately political in nature and have nothing to do with access to information or science,” written in a message.

They then highlighted the influence of the US government in the management of the far-right president and added: “The US Department of Health, in its 2020 annual report several months ago, publicly stated that the US attaché to health had persuaded Brazil to reject the Russian vaccine. “

“We will continue our contacts. If any information is missing, it will be provided. There should be no doubt about it, ”Kremlim spokesman Dmitry Peskov added this morning at his daily press conference.

In addition to the two vaccines applied since January, Coronavac and AstraZeneca, the Brazilian regulator has already authorized the use of Janssen immunizers, from the American pharmaceutical company Johnson & Johnson, and Pfizer-BioNTech. Neither has reached the country yet.

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