RDIF and União Química file documents for registration of Sputnik V vaccine with regulator in Brazil

RDIF and União Química file documents for registration of Sputnik V vaccine with regulator in Brazil

Moscow, October 30, 2020 –The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), União Química Farmacêutica Nacional and the Government of the State of Paraná announce the pre-submission of preliminary documents to Brazil’s National Health Surveillance Agency (ANVISA), in order to register Russia’s Sputnik V vaccine, the world’s first registered vaccine against coronavirus infection, in conformity with the Brazilian regulatory procedures.

The documents were filed with ANVISA on October 29, 2020.

On August 11, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against COVID-19 based on the human adenoviral vectors platform. Detailed information on the Sputnik V vaccine, the technological platform of human adenoviral vectors, and other details are available at sputnikvaccine.com

On September 4, a research paper on the results of Phase I and Phase II clinical trials of the Sputnik V vaccine was published in The Lancet, one of the leading international medical journals. Post-registration clinical trials of the Sputnik V vaccine involving more than 40,000 volunteers are currently ongoing in Russia and other countries.

Production of the first batches of the Sputnik V vaccine will soon be launched in Brazil as part of the technology transfer agreement between RDIF and União Química. The efforts of all organizations and individuals involved in the development, testing and production of the Sputnik V vaccine in Brazil are aimed at ensuring access to the vaccine for the population as soon as possible based on the principles of transparency, safety and efficacy.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, commented:

“RDIF and União Química, with the support of the Government of the State of Paraná, 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. While the global COVID-19 situation has not yet improved, our partnership on the Sputnik V vaccine will help coordinate the efforts of our countries and provide the Brazilian population with a safe and effective vaccine based on the well-studied platform of human adenoviral vectors”.