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Montevideo, July 3rd 2022 - 23:08 UTC

 

 

Brazil's Anvisa to check Russian Sputnik V manufacturing plant as need for vaccines soars

Saturday, April 10th 2021 - 10:58 UTC
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Anvisa will be among the first foreign regulatory agencies to visit the Sputnik V manufacturing plant. Anvisa will be among the first foreign regulatory agencies to visit the Sputnik V manufacturing plant.

Brazil's National Health Surveillance Agency (Anvisa) will be sending a delegation to Russia next week to conduct an onsite review of the facilities where the Sputnik V vaccine is manufactured, it was announced Friday.

“Two facilities will be inspected. First, between April 15 and 21, three Anvisa staffers will visit a factory producing the vaccine’s active component and the jab itself. After that, between April 19 and 23, inspectors will visit an enterprise responsible for final adjustments and packing,” Anvisa said in a statement.

Anvisa will be among the first foreign regulatory agencies to visit the Sputnik V manufacturing plant.

The Brazilian experts are to gather additional information about the vaccine’s production cycle, which is needed for subsequent analysis of its request for emergency use and imports.

So far, the use of Sputnik V has not yet been officially approved in Brazil. 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. In early January, Uniao Quimica received cell material to manufacture the vaccine and began producing a trial batch of its active components for research purposes. Earlier, the company announced plans to produce up to 8 million doses of Sputnik V per month.

”God willing we will soon be solving that Sputnik issue,” President Jair Bolsonaro had said earlier this week after discussing the issue with his Russian colleague Vladimir Putin.

Meanwhile and as covid-19 cases and deaths soar in Brazil, leading to an increading demand of vaccines, football club Athletico Paranaense announced it would supply immunizers to players, officials and fans with paid membership at no additional cost.

Earlier this week, Brazil’s Congress passed a law allowing private firms to buy vaccines and if it comes into force Athletico said they would buy them, in conjunction with other businesses.

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