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Elias Mosialos described the results of the first two phases of the Russian coronavirus vaccine as encouraging.
Sputnik-V, as the Russian vaccine is called, produced antibodies in 100% of the volunteers who participated in the first two phases of clinical trials, according to preliminary results published in the internationally renowned medical journal Lancet.
“The volunteers who received the vaccine showed small to moderate side effects, and the results are encouraging,” Elías Mosialos said in a Facebook post, but added that, as in all clinical trials, there is no guarantee that they will be verified in phase 3.
“Phase 3 is what determines whether the vaccines really protect against infection,” said the LSE professor. At the same time, he noted that clinical trials in large numbers of people allow researchers to detect rare side effects that may not occur in smaller studies.
Elías Mosialos’ position in detail
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 no serious side effects have occurred). Russian researchers have used this approach because after vaccination, the body can develop antibodies against the vaccine vector (the adenoma). 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, in Phase I, one dose of adenovirus 5 or one dose of adenovirus 26 was administered intramuscularly on day 0 and the safety of the two components was evaluated separately for 28 days. In phase 2, which started no later than 5 days after the 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 stressed, 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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