What we know and what we do not know about the Russian COVID-19 vaccine

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It is not a competition and the Sputnik-V vaccine will probably not be approved for use in other countries without the results of the Phase III tests, he stressed.

The data that have become known to date for the vaccine announced by Russia The representative of Greece in international organizations for the coronavirus, Elias Mosialos, quoted the fight against the coronavirus, noting that the information is limited regarding the Sputnik-V vaccine.

Specifically mentioned in a post on facebook:

“Apart from the announcements made by President Putin himself and other officials, and the fact that it was approved by the Ministry of Health for use, so far we know the following.

How does the vaccine work?
Researchers at the Gamaleya Institute of Epidemiology and Microbiology in Moscow, in collaboration with the Burdenko Central Military Clinical Hospital, developed an interesting technical approach and developed the COVID-19 vaccine, which they named Sputnik-V. The vaccine basically consists of 2 parts. Both are based on viruses that cause the common cold, 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 for its vaccine. These 2 are as I said similar vaccines that have undergone clinical trials where participants developed antibodies to the virus and had no serious side effects.

Why is this approach interesting?
After vaccination, the body may develop antibodies to the vector (the adenoid), so a booster vaccine with the virus vector may become useless. Two-step vaccination with 2 different adenoviruses can bypass this issue.

What do we know about preclinical vaccine trials?
In an interview in May, the director of the Gamaleya Institute of Epidemiology and Microbiology, Alexander Gintsburg, explained that the speed was due to the use of an already developed platform – for the MERS virus – to build this vaccine, and that experiments have already been performed in small animals that have shown that the vaccine elicits neutralizing antibodies.
(https://minzdrav.gov.ru/news/2020/05/18/13979-aleksandr-gintsburg-rasskazal-v-intervyu-telekanalu-rossiya-1-o-hode-razrabotki-vaktsiny-ot-koronavirusa).
These results have not been published.

What do we know about clinical trials for the vaccine?
According to the site monitoring the clinical trials (https://clinicaltrials.gov/ct2/show/NCT04437875), initially 38 people (18-60 years old) would receive the first dose of adenovirus 26. Three weeks later, they would receive the booster dose of adenovirus 5. However, the results of the study have not yet been published in a scientific journal.
In the same interview, Alexander Gintsburg stated that the vaccine can be administered intramuscularly and can be produced in solid or liquid form.

How many people have received the vaccine?
Exact numbers have not been announced. The registered Phase I clinical trial refers to 38 individuals. In an interview with Argumenty i Fakty, Deputy Defense Minister Ruslan Tsaliko said the Phase II clinical trial of the vaccine was completed in July.

Why are larger studies needed?
As I have repeatedly emphasized, it is phase III that determines whether vaccines really protect people from infection and whether they are effective.
Clinical trials in a large number of people also allow researchers to detect rare side effects that may not occur in smaller studies. That is, if a side effect of the vaccine has an incidence of 1 in 1,000 people it will obviously not occur in a study of 100 people.

Did the Russians win the fight for the COVID-19 vaccine?
Unfortunately it is not a competition and the Sputnik-V vaccine will probably not be approved for use in other countries without the results of the Phase III clinical trials.
The third phase of clinical trials has not been done for the Russian vaccine.

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