Brazil's National Sanitary Inspection Agency (Anvisa) has declined requests from governors of 19 states of the country for temporary permission to import and use a number of foreign-made vaccines, including Russia's Sputnik V, without registration in Brazil. A month ago, it became known that the registration of the Russian vaccine in Brazil was suspended due to a lack of information provided by the manufacturer.
The agency rejected the import request after it was revealed that the Russian vaccine had "significant risks inherent in the product” as well as "serious defects” due to the lack of safety, quality and efficacy guarantees. Based on all the documentation and data provided, Anvisa concluded that the "inherent risks" were too significant.
According to Gustavo Mendes, the head of the biological and medical products department of the Brazilian National Sanitary Inspection Agency, the Russian vaccine contains a reproducible adenovirus, which is a "serious defect."
Technical experts of the agency recommended that the request for the import of the Russian vaccine be rejected "until data to eliminate the identified deficiencies is provided."
Currently Brazil approved emergency applications of the following vaccines against COVID-19:
The developers of the Russian vaccine stated that Brazil's decision to abandon Sputnik V was political in nature. The vaccine makers noted on their official Twitter account that
"the US Department of Health, in its 2020 annual report released a few months ago, publicly admitted that a US spokesperson urged Brazil to abandon the Russian COVID-19 vaccine."
Dmitry Peskov, Kremlin's official spokesman, said that Russia would continue talks with Brazil. If the Brazilian regulator, which rejected the import application, lacks data on the vaccine, the data will be provided accordingly.
Brazil is ranked third in the world in terms of the total number of people infected with COVID-19 — more than 14.3 million citizens. According to official stats, the virus has claimed the lives of more than 390,000 Brazilians. In addition, the number of coronavirus deaths in Brazil since the beginning of 2021 has exceeded the number of deaths from this virus for the entire 2020.
In April alone, Brazil reported 69,282 deaths from COVID (66,573 people died in March). As per the number of deaths, Brazil comes second only to the United States.
The increase in mortality is associated with the identification of new coronavirus strains, the collapse of the healthcare system, the lack of restrictive measures to contain the spread of the disease, as well as the slow pace of vaccination.
Interestingly, Brazil's National Technical Commission for Biosafety, associated with the Ministry of Science, Technology and Innovation, approved the commercial use of the Russian Sputnik V vaccine and allowed to open vaccine production in the country.
To crown it all, Argentina, Brazil's neighboring state, has been vaccinating people with Sputnik V for several months already, quite successfully.
Russia's determination to continue negotiations with Brazil raises questions. As long as the Brazilian authorities openly demonstrate that they are not interested in the Russian vaccine, maybe it is not worth insisting.
Viktor Kheifets, director of the Center for Ibero-American Studies at St. Petersburg State University, believes that the story of the Russian vaccine in Brazil is a matter of bureaucracy.
"In Brazil, they are meticulous about bureaucratic procedures. They motivated the lack of permission by the fact that they did not have enough information from the Gamaleya Center about the safety of the vaccine at the moment. The Lancet article is not a confirmation," the scientist told Pravda.Ru.
"The documentation must be drawn up properly. When they receive it, I believe a different decision can be made. Brazil is a very bureaucratic country in this regard. Therefore, it seems to me, the way out is to provide the most comprehensive information. To crown it all, the Gamaleya Center is ready to provide this documentation," said Viktor Kheifets.