BATTLE FOR WORLD | September 4, 2020: One of the Russian vaccines test results were published in the leading international scientific journal The Lancet detailing the results from the first two stages of clinical trials.
Two vaccine developers from the Gamaleya Centre, Alexander Gintsburg and Denis Logunov, as well as the CEO of the Russian Direct Investment Fund Kirill Dmitriev, were interviewed by Sputnik News regarding The Lancet article and why it's of importance to the global scientific community.
The Lancet, the world's most influential scientific journal, has published the first two stages of clinical trials results less than a month after the Sputnik V COVID-19 vaccine was registered in Russia.
The timely article responds to foreign criticism, providing long-awaited answers to the West that the Russian vaccine development achievement, the world's first registered coronavirus vaccine, is not only effective but safe.
"In September (2020), a complete study of the vaccine in animals, primates, Syrian hamsters, transgenic mice, in which the vaccine has shown 100% protective efficacy (and results in primates and Syrian hamsters were obtained before clinical trials), will be published. The first results of the ongoing post-registration clinical trial involving 40,000 volunteers will be published in October-November", said the Gamaleya Centre, the developers of the Sputnik V vaccine.
The Lancet article highlights the safety of The Sputnik V vaccine as one of the main conclusions cited in the study. Regarding the first and second-stage clinical trial results, the scientists did not find any serious adverse effects from the vaccine based on the evaluated criteria. - Not all candidate vaccines can boast about such results, because some have recorded up to 25% experiencing serious adverse effects.
The Lancet article presented the evidence of the Sputnik V vaccine treatment's ability to launch and maintain a long-term immune response to the coronavirus in 100% of those vaccinated due to its unique two-stage introduction technology. And Denis Logunov, deputy research director at the Gamaleya Centre, said that a humoral and cellular immune response is achieved, through which is enough to protect a person from COVID-19, observed in 100% of those vaccinated.
"The antibody levels in vaccinated volunteers was 1.4-1.5 times higher than in those who had recovered. For reference, Britain's AstraZeneca vaccine showed an antibody level roughly equal to the antibody level in those who had had the coronavirus infection", said Logunov. In addition, all of the volunteers who received the Sputnik V vaccine developed T-cell immunity, represented by both CD4+ and CD8+ cells, making it possible to recognize and destroy coronavirus-infected cells.
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"We've chosen the optimal safe dosage, providing an effective immune response in 100% of those vaccinated, including those who have recently had adenovirus infections. This reduces the urgency of developing new vaccines based on untested platforms", said Denis Logunov from the Gamaleya Centre.
Unverified platforms that are being used to develop vaccines in some Western companies, which includes mRNA technology (in the Moderna vaccine), and the chimpanzee adenovirus (in AstraZeneca’s vaccine), of which have never been used to create registered vaccines.
And such drugs are badly in need of long-term testing because of concerns about their effect on the body's reproductive functions or the possible high carcinogenic properties that lead to cancer, said the Gamaleya centre.
Russian scientists refer to studies about the safety of their platform, the vector technology, on which the Sputnik V vaccine is based:
"Since 1953, more than 250 clinical trials have been carried out globally, and more than 75 international articles have been published confirming the safety of vaccines and drugs based on this platform", said Denis Logunov. Further emphasizing that "Human adenoviral vectors-based drugs have been used for over 15 years. In particular, these are Ebola vaccines and the anti-cancer Gendicine, which has been used in China for over 12 years".
Gamaleya vs AstraZeneca
Russia is responding to criticism posed by the West about the insufficient number of volunteers for their two-vector vaccine Sputnik V, the scientists noted that they managed to test this system on a wider range of people, and more so than one of the leading vaccine candidates, AstraZeneca, had done.
The British pharmaceutical giant used four times fewer volunteers during the first two-stage trials to gather results about their two-vector vaccine's effectiveness.
"The number of volunteers involved in testing the Russian Sputnik V vaccine during stages 1 and 2, carried out with two injections, was 4 times higher than the number of people AstraZeneca involved", said Dmitriev.
The US Food and Drug Administration announced the possibility of using accelerated registration for vaccine candidates due to the current epidemiological situation, the pandemic and high infection rate, without a third phase clinical trial on tens of thousands of volunteers.
And the British authorities are also studying the possibility of a similar approach to the US. At the same time, these countries’ drug regulators, regarding accelerated registration, said it will only be possible for vaccines that have proven their effectiveness and safety.
"To date, the only one meeting these criteria is a human adenoviral vector platform. It has proven its safety through several decades of numerous studies", emphasized Dmitriev.
Now that The Lancet's publication of the clinical trial results have been published, Kirill Dmitriev, the CEO of the Russian Direct Investment Fund, has presented a few questions to the United States and British vaccine manufactures regarding their COVID-19 vaccine.
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