RDIF and the Gamaleya National Research Center of Epidemiology and Microbiology announce the publication in leading medical journal The Lancet of the results of clinical trials of Phase I-II of the Russian vaccine Sputnik V demonstrating its safety and efficacy
Moscow, September 4, 2020 – The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and the Gamaleya National Research Center of Epidemiology and Microbiology of the Ministry of Health of the Russian Federation announce the publication of a scientific article on the results of Phase I-II clinical trials of the world's first registered coronavirus vaccine, Sputnik V. The article was published in one of the world's most respected medical journals The Lancet at: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31866-3/fulltext
A research paper by the Gamaleya National Research Center of Epidemiology and Microbiology on the results of Phase I-II clinical trials of the Sputnik V vaccine published in The Lancet (one of the leading international medical journals) is the first of a series of publications. In September, complete animal trial results of the vaccine will be presented for publication. The trial was conducted in primates, Syrian hamsters and transgenic mice, and showed 100% protective efficacy of the vaccine (the results on primates and Syrian hamsters were obtained before clinical trials). First results of the ongoing post-registration clinical trials involving 40,000 volunteers are expected to be published in October-November.
The scientific publication in The Lancet proves the high safety and efficacy of the Russian vaccine and also provides detailed data on the results of the clinical trials. The article contains both the key qualitative and quantitative characteristics of the Sputnik V vaccine, favorably distinguishing it from other vaccines that are only just undergoing clinical trials in various countries and have no data on carcinogenicity or the effects on fertility.
- Phase I-II clinical trials of Sputnik V showed no serious adverse events (SAE, Grade 3) for any of the criteria, while the incidence of serious adverse events for other candidate vaccines ranged from 1% to 25%.
- In 100% of participants in the clinical trials, Sputnik V generated a stable humoral and cellular immune response. The level of virus-neutralizing antibodies of volunteers vaccinated with Sputnik V was 1.4-1.5 times higher than the level of antibodies of patients who had recovered from COVID-19. In contrast, in its clinical trial the British pharmaceutical company AstraZeneca found the level of antibodies in its volunteers was virtually equal to the level of antibodies of those who had recovered from coronavirus. T-cell immunity with both types of CD4+ and CD8+ special cells was formed in all volunteers participating in clinical trials of the Sputnik V vaccine. These special cells recognize and disrupt the cells infected by SARS-CoV-2.
- Specialists from the Gamaleya National Research Center of Epidemiology and Microbiology proved the effectiveness of the human adenoviral vectors platform despite concerns that vaccinated people could have preexisting immunity to human adenoviruses. The optimal safe dosage has been determined, allowing an effective immune response in 100% of those vaccinated, even in those who have recently had an adenovirus infection. This reduces the significance of developing new vaccines based on platforms that have not been studied and tested over many years.
- Through the use of two different vectors - based on human adenovirus serotypes Ad5 and Ad26 - in two separate shots, it is possible to achieve a more effective immune response. Whereas in the case of using the same vector for two shots, the immune system launches defense mechanisms and begins to reject the drug in the second injection. Thus, the use of two different vectors in the Sputnik V vaccine avoids a possible neutralizing effect. Furthermore, other vaccines based on only one vector could not provide a level of antibodies higher than in people who had COVID-19.
The article provides links to previous studies supporting the safety of vaccines based on human adenoviruses:
- Since 1953, more than 250 clinical trials have been carried out and more than 75 international publications have been issued confirming the safety of vaccines and medical drugs on this basis;
- Medicines based on human adenoviral vectors have been used in practice for more than 15 years. In particular, these are vaccines against Ebola and Gendicine - a drug for the treatment of cancer - which has been used in China for more than 12 years.
- The number of participants in clinical trials of the Russian vaccine Sputnik V in Phase I-II, who had two injections, is 4 times higher than the number of participants with two injections in AstraZeneca trials.
The US and UK authorities have already announced their intention to follow Russia's example and begin to apply mechanisms for emergency use authorization of vaccines. At the same time, regulators in these countries note the possibility of emergency use authorization only for those vaccine platforms that have already proven their effectiveness and safety. To date, the only technology that meets these criteria is a platform based on human adenoviral vectors. It has proven its safety in numerous studies over several decades.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, commented:
“The publication in The Lancet, one of the most reputable medical journals in the world confirms the high safety and efficacy of the Russian vaccine Sputnik V and demonstrates the recognition of Russian scientists by the global scientific community. The pre-eminence of the Gamaleya National Research Center of Epidemiology and Microbiology led by Alexander Gintsburg and Denis Logunov is confirmed by the outstanding results of their work - advanced vaccines that save a huge number of people's lives. The publication in The Lancet shows Russia's openness and readiness for dialogue, and is also a powerful response to skeptics who unreasonably criticized the Russian vaccine. During a pandemic, it is especially important to use a vaccine platform with proven safety, as Sputnik V does, so as not to leave the world without an effective protection from coronavirus, but also not to risk people's lives using untested experimental technologies. We are now witnessing a change in the global approach towards the registration of vaccines with the USA, UK, China and other countries following Russia's path in fast-tracking registration.”
On August 11, the Sputnik V vaccine developed by the Gamaleya National Research Center of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against COVID-19. Details on Sputnik V vaccine are available at www.sputnikvaccine.com
Russian Direct Investment Fund (RDIF) is Russia's sovereign wealth fund established in 2011 to make equity co-investments, primarily in Russia, alongside reputable international financial and strategic investors. RDIF acts as a catalyst for direct investment in the Russian economy. RDIF’s management company is based in Moscow. Currently, RDIF has experience of the successful joint implementation of more than 80 projects with foreign partners totaling more than RUB1.9 tn and covering 95% of the regions of the Russian Federation. RDIF portfolio companies employ more than 800,000 people and generate revenues which equate to more than 6% of Russia’s GDP. RDIF has established joint strategic partnerships with leading international co-investors from more than 18 countries that total more than $40 bn. Further information can be found at www.rdif.ru
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