Brazilian Company Uniao Quimica Seeks to Hold Clinical Trials of Sputnik V, Authorities Say

BUENOS AIRES (Sputnik) - The Brazilian pharmaceutical company Uniao Quimica, which has an agreement with Russia on the production of the Sputnik V vaccine in Brazil, has submitted an application to the national health regulatory agency, Anvisa, to hold clinical trials of the vaccine, Anvisa said.

"On 29 December, Anvisa received a request to hold phase 3 clinical trials of the 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 to register 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 centre, Vector, already in Phase 3 trials. According to the latest trial results, Sputnik V has an efficacy of 91.4 percent.