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The clinical trials of the Russian vaccine Sputnik-V against the coronavirus were mentioned in a post on his personal Facebook account by the LSE Professor of Health Policy, Elias Mosialos.
It is recalled that according to the results published in the medical journal “The Lancet”, the Russian vaccine against the coronavirus produced antibodies in 100% of the participants.
Elias Mosialos post on the Russian vaccine:
Results of the non-randomized I / II clinical trial of the Russian Sputnik-V vaccine, which was tested in 76 healthy adult male and female volunteers aged 18 to 60 years, were published today in the Lancet.
As I mentioned, the Russian vaccine actually consists of 2 components. Both are based on the common cold viruses, adenovirus 5 and adenovirus 26. This approach is similar to other COVID-19 vaccines (for example, the Chinese vaccine from CanSino Biologics Inc. is based on adenovirus 5, while Johnson & Johnson uses adenovirus 26 and there have been no serious side effects).
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The Russian researchers used this approach because after vaccination the body can develop antibodies against the vaccine vector (adenovirus). Therefore, a second booster dose with the virus carrier may be useless. Two-step vaccination with 2 different adenoviruses can avoid this problem.
According to the publication, Phase I was administered intramuscularly on day 0 with one dose of adenovirus 5 vaccine or one dose of adenovirus 26 and the safety of the two components was evaluated separately for 28 days. In Phase 2, which began no later than 5 days after Phase 1 vaccination, they were administered intramuscularly and the double / booster vaccine was tested. That is, the adenovirus 26 vaccine dose was administered on day 0 and the adenovirus 26 dose was administered on day 2 (the figure shows the design of the clinical trials).
The volunteers who received the vaccine had mild to moderate side effects, and the results are encouraging.
But, as in all clinical trials, there is no guarantee that they will be verified in Phase III. As I have repeatedly emphasized, it is Phase III that determines whether vaccines actually protect people from infection and whether they are effective.
Clinical trials in large numbers of people also allow researchers to detect rare side effects that may not occur in smaller studies. That is, if a side effect from the vaccine has an incidence of 1 in 1000 people, it obviously will not occur in a study of 80 people. No vaccine had been approved – before the Russian one – with such a small sample of voluntary I / II clinical trials, and without the results of Phase III, a large number of volunteers and a global analysis of the results.
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