BUENOS AIRES (Pakistan Point News / Sputnik - 30th December, 2020) The Brazilian Uniao Quimica pharmaceutical company, which has an agreement with Russia on the production of the Sputnik V vaccine in Brazil, has submitted an application with the national health regulatory agency, Anvisa, to hold clinical trials of the vaccine, Anvisa said.
"On December 29, Anvisa received the request for holding phase 3 clinical trials of Sputnik V vaccine. The request was filed by the Uniao Quimica laboratory," the statement said.
The request will be processed within 72 hours.
"Anvisa's permission is a necessary condition for holding research aimed at registration of a vaccine or a drug in the future," the agency added.
In late October, the Russian Direct Investment Fund (RDIF) and Uniao Quimica filed documents for the registration of Sputnik V with the Brazilian regulator. In accordance with the arrangements on technology transfer, the production of the Sputnik V vaccine will be launched in Brazil in the near future.
Russia has been among the leaders of COVID-19 vaccine development, with two of its products, Sputnik V and EpiVacCorona, created by the Siberian research center, Vector, already in Phase 3 trials. According to the latest trial results, Sputnik V has an efficacy of 91.4 percent.
