MOSCOW, October 30. /TASS/. The Russian Direct Investment Fund (Russia’s sovereign wealth fund - RDIF) and the Brazilian company Uniao Quimica Farmaceutica Nacional have submitted documents to Brazil’s National Health Surveillance Agency (ANVISA) to register Russia’s Sputnik V anti-coronavirus vaccine, the RDIF said in a press release on Friday.
According to the press release, RDIF, Uniao Quimica Farmaceutica Nacional and the Government of the State of Parana "announce the pre-submission of preliminary documents" to ANVISA, in order to register Russia’s Sputnik V vaccine, "in conformity with the Brazilian regulatory procedures."
"RDIF and Uniao Quimica, with the support of the Government of the State of Parana, are proactively cooperating with Brazil’s National Health Surveillance Agency (ANVISA), which has played a fundamental and sensible role until this moment in order to ensure the registration of the Sputnik V vaccine in the country as soon as possible. The registration will enable the start of the production and distribution of the vaccine in Brazil," Kirill Dmitriev, head of RDIF said as quoted by the press release.
The documents were filed to the Brazilian regulator on October 29, 2020, RDIF said.
On August 11, Russia became the first country in the world to register a coronavirus vaccine named Sputnik V, which was developed by the Gamaleya Research Institute of Epidemiology and Microbiology of the Russian Health Ministry. The injection passed clinical trials in June-July. The vaccine is based on an already known platform that was used to create a number of other injections. The Russian Health Ministry underlined that judging by the experience of using such vaccines, they are capable of providing a long-term immunity for up to two years. The post-registration trials of Sputnik V began in Moscow on September 7, volunteers received the first vaccine already on September 9. Overall, the trials include 40,000 people, 10,000 of them had placebo instead of the vaccine.