The Russian Vaccine.

InTheRaceAgainstTheVariants

SupplyMattersVille

The Gamaleya Research Institute in Moscow, which operates under the purview of the Russian Health Ministry, has published results of a late stage clinical trial using its two step adenoviral vector-based vaccine in the Lancet.

Here is the kicker from the Summary/Abstract of the paper:

...This interim analysis of the phase 3 trial of Gam-COVID-Vac showed 91·6% efficacy against COVID-19 and was well tolerated in a large cohort...


Derek Lowe summarizes the presented data over at his very well-regarded Science Translational Medicine blog:

In the end, we have data on about 15,000 patients who were vaccinated, and on about 5,000 in the placebo control group. Volunteers got a dose of an adenovirus-26 vector vaccine, followed 21 days later by a dose of the identical construct in an adenovirus-5 vector...

{snip}

...Counting from the day of the second dose, there were 16 cases of disease in the vaccinated cohort, and 62 cases in the controls. That comes out to a two-dose vaccine efficacy of 91.6%, with a 95% confidence interval of 85.6% to 95.2%. In no subgroup (age, gender, etc.) was it lower than 87%. As with most of the other trials, this is largely based on symptomatic disease – the participants were checked by PCR at the beginning and on the day of the second dose, but at no other times. Importantly, and in line with the other vaccine trial data we’ve seen so far, there were no cases at all of moderate or severe disease in the vaccinated group after the date of the second dose...

{snip}

So these data look strong, strong enough that a single-dose trial is underway as well (and that will make an interesting comparison with J&J’s Ad26-vector vaccine, for which we have single-dose data with a two-dose trial underway). We’ll be getting more real-world data on this one, as it’s being deployed in several countries , and it will certainly be worth seeing how it handles the variant strains that we’re seeing now....

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Now.

The Lancet is  a top of the ladder clinical research journal so I am confident that the conclusions made are solid based on the data presented.

However, and this is not a scientific opinion but rather a socio-political one, it is difficult to ignore the fact that Russian state actors have fiddled with 'presented' data in other realms when the national interest stakes are high, most notably when it comes to athlete doping.

I really hope I'm wrong about this but, regardless, I think we should wait to see confirming data from trials and/or independently monitored clinical data from other jurisdictions before jumping for joy at that 90+ percent number. Such additional data will also allow inferences to be made regarding the efficacy of the Sputnik regimen against the COVID variants as Dr. Lowe gently notes.

OK?


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One other thing that sticks the craw, particularly when vaccine 'nationalism' may be at play here, is the fact that the Gamaleya Institute explicitly states that it 'is the world's leading research institution'...



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