RIO DE JANEIRO, April 27. /TASS/. Members of a scientific and technical committee for biological safety at Brazil’s Ministry of Science, Technology and Innovation (MCTI) have recognized Russia’s Sputnik V COVID-19 vaccine as safe, the committee’s head, Paulo Barroso, said.
"This is the third COVID-19 vaccine, which we are reviewing <...> and we have unanimously come to a conclusion that it is safe," the scientist said during the ministry’s live broadcast on Twitter.
According to Brazil’s legislation, the approval by the committee for biological safety is necessary for all drugs manufactured with the use of GMO technologies. The committee consists of 54 scientists.
Brazil’s National Health Surveillance Agency (Anvisa) has not approved the use of Russia’s vaccine so far. The regulator explains the delay with considering the request for registering Sputnik V by the lack of the full 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.