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Coronavirus pandemic

Brazilian watchdog requests court to extend Sputnik V review period

Earlier, the court authorized importing Sputnik V to Brazil without the national pharmaceutical regulator's approval, if the governmental agency fails to make any decision regarding its use by the end of April

RIO DE JANEIRO, April 21. /TASS/. Brazil’s National Health Surveillance Agency (Anvisa) requested the country’s Federal Supreme Court to give it more time for considering a registration request for Russia’s Sputnik V anti-coronavirus vaccine, the Globo TV channel has reported.

According to the channel, the watchdog says it is impossible to authorize the use of the vaccine, because there has been insufficient information about the vaccine’s quality, effectiveness and safety. At the same time, Anvisa earlier confirmed receiving documents on Sputnik V from Argentina, which successfully uses the Russian vaccine.

Earlier, the court authorized importing Sputnik V to Brazil without the national pharmaceutical regulator's approval, if the governmental agency fails to make any decision regarding its use 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 making a decision about its emergency use and imports.

Military operation in Ukraine

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