Why Brazil has not approved the Russian Sputnik V

The Brazilian scientific staff failed to dispel some doubts about the production process of Sputnik V. For Russia, however, the decision is the result of pressure from the United States

(photo: Adobe Stock) Unanimously the board of directors of Anvisa, the health authority of Brazil, voted not to approve the vaccine against Covid-19 produced in Russia Sputnik V. This despite the fact that several Brazilian regions had already signed procurement contracts. Officially, the decision depended on the fact that the technical staff of the South American state was unable to resolve some doubts about the Russian vaccine production process due to lack of information. Russia has already replied that the efficacy and safety of its vaccine has been verified by 61 countries that have already approved its use, and raises the suspicion that behind Anvisa's decision there is actually pressure from the United States. .

Intrinsic risks and serious defects

For the Anvisa experts, the "inherent risks" of the Sputnik V vaccine are "too great" to allow authorization in Brazil. The commission reports that it made the decision taking into account the documentation provided by the Russians and the considerations of foreign regulatory agencies, but also the data acquired in person by the Brazilian inspectors. The inspection phase of the production sites was crucial for Brazil's refusal: it seems that the technicians were not able to complete the visit to the facilities in Russia, that access to the Gamaleya Institute was denied and that during the visit to two other factories there were other problems. Crucial questions remained unanswered, including those about potential adverse events, explained Anvisa's head of drugs and biologics Gustavo Mendes. “At this moment, the inherent risk in production cannot be overcome,” concluded his colleague Ana Carolina Moreira Marino Araujo.

Russia's reply

The Russian Direct Investment Fund ( Rdif), which markets the Sputnik V vaccine abroad, rejected Anvisa's comments: for Russian scientists who have analyzed real-life data on 3.8 million people, Sputnik V is effective against Covid-19 to 97 , 6% (a peer-reviewed study published in the Lancet last February talks about an efficacy rate of 91.6%, we talked about it here); in addition, the safety and efficacy of the vaccine have been evaluated by the regulatory authorities of 61 other countries that have approved its use.

“Anvisa's decision to delay the registration of Sputnik V may have been politically motivated “, Reads a note. "Rdif regrets the numerous attempts by some countries to oppose the Russian vaccine [...] also through pressure on foreign regulators".

Positions also reaffirmed on the official Twitter account dedicated to Sputnik V, with tweet in Portuguese which refers directly to the United States.

O Departamento de Saúde dos Estados Unidos, em seu relatório anual de 2020 há vários meses declarou publicamente que o adido de saúde dos Estados Unidos "persuadiu o Brasil a rejeitar a Russian vacina COVID-19 ".

- Sputnik V (@sputnikvaccine) April 27, 2021



Kremlin spokesman Dmitri S. Peskov, however, has stated in a conference call with reporters that contacts with the Brazilian authorities will continue. “If the data is missing, it will be provided. There should be no doubt about this. ”


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