Brazil closes the door on Sputnik V and Russia closes …

The health regulatory body of Brazil refused to import Sputnik V into this country, considering that there are still “uncertainties” as to its safety and effectiveness of vaccination against covid-19. The decision was rejected by the producer of this vaccine, the Instituto Gamaleya, holding that the ban has a “political” rather than a scientific and health context.

The decision not to allow the entry of the vaccine produced in the Russian Federation into Brazil was taken by the National Health Surveillance Agency (Anvisa), after an order made in March by several states in this country.

“We will never allow millions of Brazilians to be exposed to products without proper quality testing, safety and efficacy or, at a minimum, given the serious situation we are going through, that there is a favorable relationship between risk and benefit, ”he said. the president of this organization, Antonio Barra Torres.

The rejection was justified by a recommendation from the technical field of Anvisa, which in turn referred to the fact that the vaccine had not yet been approved by the EMA (European Medicines Agency) or the FDA (Federal Food and Drug Administration). ) from the United States.

Another suggestion made by the Brazilian watchdog was that there is still “missing information” in the scientific evidence for approval.

Russia’s response was immediate and it was through the Twitter account of those producing the vaccine. “Anvisa’s delays in approving Sputnik V are unfortunately political in nature and they have nothing to do with access to information or science. “

And to support this claim, he cited that “The US Department of Health, in its 2020 annual report several months ago, publicly stated that the US health attaché” has convinced Brazil to reject the Russian vaccine. “.

He also assured that last March he sent Anvisa a report with the results of the tests carried out, he mentioned as an example that the vaccine is used in Mexico, Argentina, Venezuela and other countries. , and that it has been approved by 61 countries.

In February, The Lancet reported that the Sputnik V is 91.6% efficient. Despite this, Anvisa technicians claimed that this publication does not have the same requirements as approval from regulatory bodies.

“A health assessment is different from an assessment made 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, he clarified. Gustavo Mendes, one of Anvisa’s technical managers.

Anyway, Kremlin spokesman Dmitry Peskov said from the Russian government “we will continue our contacts” with Brazil, adding that “if information is missing, it will be provided. There should be no doubt about it. “

Despite this, Anvisa maintained her position: “I hope that in fact the Sputnik V vaccination process adapts its information and resolves compliance issues quickly, as millions of people need access to safe and effective vaccines.” , added Meiruze Freitas, another of its directors.

The counterpoint was unleashed after a dozen states in the north and northeast of Brazil have signed contracts with the Russian Sovereign Fund (RDIF), which financed the development of Sputnik V, to acquire more than 30 million doses to streamline your immunization plans. The federal government has acquired an additional 10 million.

The Brazilian regulator has authorized two vaccines applied since January, Coronavac and AstraZeneca. Also Janssen, of the American pharmaceutical company Johnson & Johnson, and Pfizer-BioNTech, which has not yet arrived in the country.