‘Sputnik V’vaccine made in Russia▶ Click here for a larger view
Brazil’s health authorities have rejected approval of the Russian-made new coronavirus infection (Corona 19) vaccine’Sputnik V’, TAs news agency reported on the 17th (local time).
On the 15th, Uniang Kimica, a large Brazilian pharmaceutical company, approved the emergency use of Sputnik V to the National Hygiene Monitoring Bureau (Anvisa) of the Ministry of Health, together with the’Russian Direct Investment Fund’ (RDIF), which is responsible for exporting and producing Sputnik V overseas. Requested.
According to reports, the National Sanitation Bureau of the Ministry of Health of Brazil said, “The application for (emergency use approval) did not meet the minimum standards, so I was rejected as Unian Kimika.” There were also problems,” he explained.
The National Hygiene Monitoring Bureau pointed out, “It is not enough to apply for permission to conduct phase 3 (for emergency use approval). Phase 3 must actually proceed.”
The surveillance bureau received a request for permission to conduct phase 3 from Unian Kimika at the end of December, but did not permit it after requesting additional data.
According to Russia’s Rianovosti news agency, Unian Kimika has already started production of Sputnik V vaccine in Brazil, and is expected to supply 10 million doses (one dose) in the first quarter, and 150 million doses within this year.
However, the refusal of the authorities to approve urgent use is expected to disrupt the production schedule.
The Sputnik V vaccine, which Russia first approved in August last year, skipped phase 3 and approved immediately after phases 1 and 2, raising concerns about efficacy and safety.
Russia, however, began vaccinating its citizens with this vaccine in early December, and is actively engaged in the production and export of the vaccine.
Until now, the former Soviet Union states Belarus, Argentina, Venezuela, Bolivia, Paraguay in South America, Serbia in the Balkans, Algeria in Africa, and Palestine in the Middle East have approved the Sputnik V vaccine and have started or are promoting vaccinations to their own citizens.
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