Clinical trials COVID Brazil – Brazilian company seeks OK for Phase 3 trials for Russia’s Sputnik vaccine.

Anvisa requires late stage testing in Brazil to fully register the vaccine, which is already being used to inoculate people in Argentina.
Clinical trials COVID Brazil

Brazilian pharmaceutical company met with health regulator Anvisa on Monday seeking approval to conduct Phase III clinical trials of Russia’s Sputnik V COVID-19 vaccine, which it plans to make in Brazil for national immunization and for export.

União Química has previously requested emergency use authorization for the vaccine, made by Moscow Gamaleya Institute and marketed by the Russian Direct Investment Fund (RDIF).

Anvisa requires late stage testing in Brazil to fully register the vaccine, which is already being used to inoculate people in Argentina.

“We have no doubt it will be approved. It is just a question of timing and satisfying all of Anvisa’s requirements,” said Fernando Marques, União Química’s chief executive officer and its main owner.

“By April, we expect to be producing 8 million vaccines a month,” he told reporters.

Russia is ready to deliver 10 million ready-made doses in the first quarter and can start shipping them as soon as Anvisa green-lights emergency use, Marques said.

He said diplomats from Argentina, Uruguay, Paraguay and others have already approached the company regarding obtaining the vaccine, which has an efficacy of 91.4%, according to the Gamaleya Institute.

That compares with 50.38% for Sinovac’s vaccine, which is the first to be used in Brazil, whose government is scrambling to secure vaccine to inoculate Brazilians against the second-deadliest coronavirus outbreak outside of the United States.

União Quimica is one of several foreign producers on which Russia will rely to fulfill its large-scale vaccine export deals, which exceed Russian production capacity.

Twelve countries have approved the use of Sputnik V, including Paraguay, Bolivia, Venezuela and Argentina in South America.

Brazilian a native or inhabitant of Brazil More (Definitions, Synonyms, Translation)

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