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Coronavirus pandemic

Pharmaceutical company requests permission for Sputnik V trials in Brazil

Brazil's national sanitary watchdog Anvisa will analyze the research protocol within 72 hours

© Stringer/TASS

RIO DE JANEIRO, December 30. /TASS/. Brazilian pharmaceutical company Uniao quimica, a partner of the Russian Direct Investment Fund (RDIF), has filed a request to the country’s national sanitary watchdog Anvisa for Phase 3 clinical trials of the Sputnik V vaccine.

"Late on Tuesday (29/12), Anvisa received a request for permission to hold Phase 3 clinical trials of the Sputnik V vaccine. The request was filed by the Uniao quimica lab. <…> Anvisa will analyze the research protocol within 72 hours," the watchdog’s press service said late on Tuesday.

The agency reaffirmed that national trials are obligatory for obtaining state registration for any medicine in Brazil.

According to Anvisa, a series of meetings with representatives of Uniao quimica took place in recent weeks. During these talks, the regulator was informed about details of the future research, including how many volunteers will take part in the trials and what institutions will host the studies.

So far, Brazil's National Health Surveillance Agency (Anvisa) has approved clinical trials of four COVID-19 vaccines in the country: Sinovac Biotech, AstraZeneca, Pfizer and Janssen-Cilag. In late October, the Russian Direct Investment Fund announced that it, together with the Brazilian company Uniao Quimica Farmaceutica Nacional, had submitted to Anvisa a preliminary set of documents to register Sputnik V. The documents were filed to the Brazilian regulator on October 29, 2020, the fund said.

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