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Montevideo, May 13th 2021 - 18:51 UTC

 

 

Anvisa asks STF for more time to decide on the use of Sputnik V in Brazil

Wednesday, April 21st 2021 - 09:35 UTC
Full article
Lack of sufficient information about the vaccine’s quality, effectiveness and safety makes it impossible for Anvisa to authorize the use of the vaccine Lack of sufficient information about the vaccine’s quality, effectiveness and safety makes it impossible for Anvisa to authorize the use of the vaccine

While Argentina has already started trials to produce the Russian Sputnik V vaccine against covid-19, Brazil’s National Health Surveillance Agency (Anvisa) has filed a petition before the Federal Supreme Court (STF) for additional time to evaluate a registration request for the very same immunization shot.

According to Globo TV, the lack of sufficient information about the vaccine’s quality, effectiveness and safety make it impossible for Anvisa to authorize the use of the vaccine, even despite the documents received from Argentina, which successfully uses the Russian vaccine.

The STF had authorized importing Sputnik V to Brazil without Anvisa's approval if the experts' agency fails to decide by the end of April. The hearing was initiated by the government of Maranhao. The authorities of this Brazilian state, along with other northeastern regions, took part in a joint purchase of Sputnik V, which is still not approved by Anvisa.

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. On March 27, 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 million doses of Sputnik V in Brazil per month.

Last week, it was announced that an Anvisa delegation would pay a visit to Russia to inspect Sputnik V production facilities between April 15 and 23. During the visit, Brazilian experts expect to receive more information about the Russian vaccine’s production cycle, which is needed for deciding on its emergency use and imports.

(Tass)

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