Brazilian Pharmaceutical Company Applies to Regulator for Permit to Urgently Use Sputnik V

Source: Sputnik V Official website

Brazil’s pharmaceutical company Uniao Quimica and the Russian Direct Investment Fund (RDIF) submitted an application on Friday to the Brazilian national sanitary watchdog Anvisa for permit to urgently use the Russian Sputnik V vaccine against the coronavirus, the company said in a statement, TASS reported.

“Uniao Quimica and RDIF registered on January 15 an application to Anvisa for temporary urgent use in Brazil of 10 mln doses of Sputnik V vaccine,” the company’s press service said. “Uniao Quimica believes that as the COVID-19 pandemic escalates in Brazil and across the world the state and business are to do everything to combat it, particularly taking urgent and exceptional measures,” the statement said.

It is planned to supply to Brazil the volume of the Russian vaccine against the novel coronavirus infection that was mentioned in the application to the regulator, in the first quarter of this year, the company noted. Moreover, Uniao Quimica will launch production of the Russian vaccine at its facilities in Brasilia (Federal district) and Guarulhos (Sao Paulo state) as part of a bilateral technology transfer agreement.

Uniao Quimica applied to Anvisa for permission to hold Phase 3 clinical trials of the Russian vaccine in the country at the end of December, which is an obligatory requirement for obtaining a permit to use the vaccine. The regulator said then that the permission is usually provided within 72 hours after the application, though later it requested additional information.

On August 11, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by Russia’s Health Ministry and became the world’s first registered vaccine against COVID-19.