After Russia broke the news that it had developed the world’s ‘first coronavirus vaccine’ with pomp, hope and questions soared in equal measure among the public that has prepared during the 6 months of the pandemic. Now, the head of Russia’s Direct Investment Fund, Kirill Dmitriev, has said that clinical trials of the Sputnik-V vaccine will take place in India this month, among other countries. Preliminary results of the phase III trial will be published in October-November this year.
The trials will also take place in Saudi Arabia, the United Arab Emirates (UAE), the Philippines and Brazil. The daughter of Russian President Vladimir Putin has also been inoculated with the vaccine developed by the Gamaleya Center. While experts have continuously issued precautions against the vaccine that they say has not yet undergone all the necessary tests and trials, Putin has assured against it. To answer some of these questions and concerns, the Russian state newspaper ‘Sputnik News’ has published a FAQ about the long-awaited vaccine. Read more to know:
Question 1: Did you steal your vaccine?
No, we did not steal it. The vaccine uses a unique two-vector human adenovirus technology that no one else in the world currently has for COVID-19. Vectors are engineered viruses, unable to reproduce, that carry genetic material from the coronavirus spike. Our technology uses two different human adenoviral vectors, Ad5 and Ad26, for a first and a second injection. This technology helps overcome pre-existing immunity to adenoviruses. Russia has benefited from the COVID-19 modification of an existing two-vector vaccine platform developed in 2015 for Ebola fever, which went through all phases of clinical trials and was used to defeat the Ebola epidemic in Africa. in 2017.
Admittedly, after initial hype, this question was dismissed even by Russia’s most strident critics, because it was unfounded. But it is still important to highlight it as we saw attempts to paint the Russian vaccine in dark colors even before it was registered.
Question 2: When will the results of the phase 1 and 2 clinical trials be published?
They were published on September 4 in The Lancet, one of the oldest and most respected medical publications in the world, after going through a thorough peer-review process. This is just the beginning of a series of posts. The key points of the Lancet article are:
Phase 1-2 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 vaccine candidates ranged from 1 to 25 percent.
In 100 percent of the participants in clinical trials, Sputnik V elicited a stable humoral and cellular immune response. The virus-neutralizing antibody level of the volunteers vaccinated with Sputnik V was 1.5 times higher than the antibody level of the severe COVID-19 patients who had recovered from COVID-19. In contrast, the British pharmaceutical company AstraZeneca demonstrated the antibody level of its volunteers in its clinical trial at a level roughly equal to the antibody level of those who had recovered from the coronavirus. T-cell immunity was formed with both types of special CD4 + and CD8 + cells in all volunteers who participated in the Sputnik V vaccine clinical trials. These special cells recognize and destroy SARS-CoV-2 infected cells and form the basis of long-term immunity.
Specialists from the Gamaleya National Research Center for Epidemiology and Microbiology were able to demonstrate the effectiveness of the human adenoviral vector platform, despite concerns that vaccinated people might have pre-existing immunity to human adenoviruses. The optimal safe dose has been determined, allowing an effective immune response to be achieved in 100 percent of those vaccinated in the trials, even those who have recently had an adenovirus infection. Concern for pre-existing immunity to adenoviral infections was the main reason for the emergence of alternative methods such as the monkey adenoviral vector or mRNA platforms that have not been studied or tested for many years. The proven effectiveness of Sputnik V reduces the need for rushed development of such platforms at the expense of security.
By using two different vectors, based on the human adenovirus serotypes Ad5 and Ad26, in two separate injections, it is possible to achieve a more effective immune response. Whereas in the case of using the same vector for two injections, the immune system launches defense mechanisms and begins to reject the drug in the second injection. Therefore, the use of two different vectors in the Sputnik V vaccine avoids a possible neutralizing effect and provides a stronger and longer-lasting immune reaction.
Question 3: Were there too few participants in the Sputnik V phase 1-2 tests?
On the surface, the Sputnik V trial with 76 participants appears smaller in size compared to the 1,077 people that, for example, AstraZeneca had in its phase 1-2 studies. However, the design of the Sputnik V test was much more efficient and based on better assumptions. AstraZeneca ran their test early on with a one-shot model, but that was a false assumption, as only a two-shot model can provide long-lasting immunity, as AstraZeneca conceded after testing. As a result of incorrect initial assumptions, AstraZeneca tested the two-shot model on only 10 people out of 1,077. Overall, the number of people who received two injections in the Sputnik V trial was 4 times the similar number in the AstraZeneca trial. Most of the media overlooked this point.
Question 4: Will there be clinical trials in more people?
Post-registration studies involving more than 40,000 people began in Russia on August 26, before AstraZeneca began its phase 3 trial in the US with 30,000 participants. Clinical trials in Saudi Arabia, the United Arab Emirates (UAE), the Philippines, India and Brazil will begin this month. Preliminary results of the phase 3 trial will be published in October-November 2020.
Question 5: Why is the vaccine already eligible for the emergency use registry?
Due to the very positive results of phase 1-2 trials and because the human adenoviral vector-based delivery platform has proven to be the safest vaccine delivery platform for decades, including through 75 international scientific publications and in more of 250 clinical trials.
Scientists provided compelling data on the safety of the use of human adenoviral vaccines and drugs around the world based on studies since 1953. According to records, more than 10 million US military personnel have received human adenoviral vaccines since 1971. A cancer treatment, Gendicine, based on adenoviral vectors has been administered to more than 30,000 people in China over the course of 15 years. Clinical trials of vaccines based on human adenoviral vector technology using the same vectors as Sputnik V have already involved more than 25,000 people worldwide. Since 2015, more than 3,000 people have been given human adenoviral vector-based vaccines against Ebola fever and Middle East Respiratory Syndrome (MERS) created at the Gamaleya Center.
So Russia registered the vaccine because it had a previously approved safe and efficient human adenovirus delivery platform for other diseases. Since Sputnik V’s registration in Russia, other countries have also announced plans to follow the Russian approach to registering the emergency use of their vaccines. Sinovac Biotech’s vaccine received similar approval in China. The UK government and the head of the US Food and Drug Administration (FDA) Stephen Hahn have pointed to the possibility of expedited registration for British and US vaccine manufacturers respectively, despite their reservations. previous.
Question 6: Does anyone else use similar technology for their vaccines?
Some other companies are using human adenoviral vector-based platforms for their COVID-19 vaccines. For example, Johnson & Johnson uses only the vector Ad26 and China’s CanSino only Ad5, while Sputnik V uses both vectors. The work of Johnson & Johnson and CanSino not only validates the Russian approach, but also shows the advantage of Sputnik V, as studies have shown that two different vectors produce better results than one.
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