Developers of Russia’s Sputnik V COVID-19 vaccine believe that the refusal of the Brazilian Health Regulatory Agency (Anvisa) to allow its import is politically motivated, the vaccine’s Twitter account said.
“The delay by the Brazilian Health Regulatory Agency (Anvisa) to issue permission for the import and use of the Sputnik V vaccine in the country is unfortunately of political nature and has nothing to do with access to data on the vaccine or science,” the developers said on their official Twitter account.
Besides, the developers recalled that in 2020 the US tried to hinder Brazil’s effort to purchase the Russian vaccine as part of Washington’s general efforts on countering “the bad influence” on the states in North and South America.
Earlier on Tuesday, the Brazilian regulator did not allow the import and use of Russia’s Sputnik V vaccine in the country. The regulator’s meeting took more than four hours. The regulator’s experts presented their conclusions and shared views on the Russian vaccine’s safety and efficacy.
The Brazilian regulator explains the delays with considering the application for registering Sputnik V by the lack of the whole package of documents for the drug.
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.