MOSCOW — The Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, and the State of Bahia (Brazil), through its Health Secretariat have signed a cooperation agreement to supply up to 50 million doses of the Russian vaccine Sputnik V, the world's first registered coronavirus vaccine, to Brazil.

Deliveries are expected to start in November 2020 subject to approval by Brazil's regulators with the consideration of results of post-registration trials. The agreement will also enable the parties to distribute the vaccine across Brazil in the future.

The agreement underlines that many countries recognize the importance of having a vaccine based on a human adenoviral vector platform in the coronavirus vaccine portfolio. The human adenoviral vector platform is a well-researched vaccine platform that has been proven safe over decades including through 75 international scientific publications and in more than 250 clinical trials.

On Sept. 9, RDIF and the pharmaceutical company Landsteiner Scientific announced an agreement for the supply of 32 million doses of the Russian Sputnik V vaccine to Mexico, which would help vaccinate 25% of the population. Deliveries are expected to start in November 2020 subject to approval by Mexico's regulators.

On Aug. 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 a human adenoviral vector platform.

Detailed information on the Sputnik V vaccine, the technological platform of human adenoviral vectors, and other details are available at sputnikvaccine.com

On Sept. 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. Phase I and Phase II trials demonstrated no serious adverse events and a stable immune response in 100% of participants.

Post-registration clinical trials of the Sputnik V vaccine involving 40,000 volunteers are currently ongoing. The preliminary results of these trials are expected to be published in October-November 2020.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said: "Russia is a leader in the development of vaccines against coronavirus and uses safe technologies proven over time. Sputnik V is based on a proven human adenoviral vector platform while other coronavirus vaccines use novel platforms, namely monkey adenoviral vectors or mRNA.

“The recent developments in the global pharmaceutical industry with suspended trials of an experimental coronavirus vaccine show the importance of a diversified approach to vaccine supplies. The signings of agreements to supply Sputnik V internationally demonstrate many countries recognize that human adenovirus-based vaccines are an absolute must-have for their national drug portfolio, as this platform has proven safe and effective over decades.

“Clinical trials of the Russian vaccine have shown no serious adverse events, with Sputnik V generating a stable humoral and cellular immune response in 100% of participants in the clinical trials. In contrast, vaccines based on novel platforms have yet to prove their safety and currently have no data on carcinogenicity or effects on fertility. We are pleased to make such an important contribution in the fight against the pandemic through providing the safe and effective Sputnik V vaccine to our partners in Brazil."

Aleksandr Rumyantsev, president of Dmitry Rogachev National Research Center, Russian Academy of Sciences academician, Doctor of Medical Sciences, professor, said: "Unlike many innovative foreign technologies, the Russian-produced vaccine differs favorably in terms of using a human adenovirus platform that has been tested over time, has proven to be sound, and whose history covers dozens of years of study and use.

“And this is the key moment when the issue arises of what to select: either a carrier that has been successfully used for a long time, and proven its worth, or a new technology (for example, a monkey adenovirus) that requires making exhaustive observations of those that have been vaccinated, and then waiting for it to stand the test of time."

Dr. Fabio Vilas-Boas Pinto, health secretary of the State of Bahia, said: "The government of the State of Bahia, in Brazil, is very pleased with the agreement signed with the Sovereign Wealth Fund of the Russian Federation, which will guarantee access to the Sputnik V vaccine for the Brazilian people, as soon as it is approved by the Brazilian national regulatory authorities.

“As it is a vaccine built using human adenovirus, which is one of the safest and most effective vaccine development platforms in the world, we believe that the results of the ongoing phase 3 clinical trials will confirm the data observed in phases 1 and 2." — PRNewswire