BRASILIA (Reuters) – Russia’s Sputnik V COVID-19 vaccine has requested regulatory approval to launch Phase 3 trials in Brazil, Brazilian health regulator Anvisa said late on Tuesday.
The Sputnik vaccine is being developed by Moscow’s Gamaleya Research Institute and marketed by the Russian Direct Investment Fund (RDIF). Brazilian partner Uniao Quimica, a pharmaceutical company, entered the request with Anvisa, the regulator said.
Anvisa said it would review the request within 72 hours.
The southern Brazilian state of Parana has already agreed to test and produce the Russian vaccine, while Bahia state in the Northeast plans to participate in trials and buy doses the vaccine.
Phase 3 trials are considered the gold standard because patients are randomized to receive either treatment with the drug being tested or a placebo, without participants or doctors knowing which group they are in.
(Reporting by Jake Spring; Editing by Leslie Adler)