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Brazilian regulator decides not to authorize Sputnik V vaccine’s import

The decision was approved by all members of the regulator’s board

RIO DE JANEIRO, April 27. /TASS/. The Brazilian Health Regulatory Agency (Anvisa) has not allowed the import and use of Russia’s Sputnik V COVID-19 vaccine in the country.

The decision was approved by all members of the regulator’s board at a meeting on Monday broadcast on the YouTube portal.

"I want to stress that this decision reflects the current situation and was made on the basis of what we have managed to analyze today," the head of the agency, Antonio Barra Torres, said.

The meeting took more than four hours and considered conclusions of the agency’s experts and their views on the Russian drug’s safety and efficacy.

"One of critical moments, to which we drew attention, is that the vaccine contains adenovirus, which is able to reproduce. So, the virus, which should be used only as a tool of delivering genetic material to human cells, by forming an immune response, reproduces itself," said General Manager of Medicines and Biological Products Gustavo Mendes Lima Santos, explaining his advice on banning the drug’s import.

According to one of the agency’s chiefs, Alex Machado Campos, the keynote speaker on the issue, most countries, which have registered the Russian vaccine, don’t have enough authority in the world. Meanwhile, the official recalled that Sputnik V had not been approved by the European and US regulators.

Uniao Quimica, which represents the Russian Direct Investment Fund (RDIF) in Brazil, submitted a new registration request to Anvisa on March 26. In line with the current legislation, such requests are to be considered within seven days, but the deadline can be put off if some of the required documents were not submitted in time. The next day, Anvisa suspended the review for an indefinite period, saying that it has not yet received some of the requested documents.

This is not the first delay in the Russian vaccine’s review, and Uniao Quimica’s chief Fernando Marques earlier accused Anvisa of deliberate delays for the benefit of other COVID-19 vaccine manufacturers. Earlier, the company announced plans to produce up to 8 mln doses of Sputnik V in Brazil per month.

On April 17-23, a delegation of Brazil’s regulator paid a visit to Russia to inspect the Sputnik V production facilities in Vladimir and Ufa. The goal of this visit by Brazilian experts was to receive more information about the Russian vaccine’s production cycle, which is needed for making a decision about its emergency use and imports.