The Lancet and Sputnik: new article, new problems.

Introduction

The Russian Sputnik V vaccine should work much like any others. I am convinced of this because Sputnik V basically can be seen as a combination of a Chinese adenoviral vaccine and a Johnson & Johnson dose. The production problems are linked precisely to the fact of combining two different vaccines in one, with what follows for the simplicity of the process and the quality control; but this does not mean that the idea, from a scientific point of view, is not valid, or that once the vials are obtained, they should not be useful.

I make this premise, to illustrate what happened recently in The Lancet, which is supposed to be a prestigious scientific journal: once again, a manuscript on Sputnik has been published, which should not have passed even a child’s revision. The fact is that Lancet is increasingly accustoming us to improvised revisions, or perhaps even missing ones, given the quality and the quantity of the errors that are found on its glossy pages.

Analysis

The work, on the premise of a well-designed protocol, aims to retrospectively evaluate the efficacy of the vaccination with Sputnik, ChAdOx1 (Astra Zeneca’s vaccine) and BBIBP-CorV (a Chinese vaccine), starting from the incidence of infection and death caused by COVID-19 among vaccinated and unvaccinated subjects, all over 60.

Many confounding factors are considered to correct the potential errors that plague this type of retrospective study: age, gender, comorbidities, geographic origin, and many others.

In the end, among the other conclusions, we learn from the authors that the Russian vaccine works in preventing infection and death among the subjects tested just as well as the Astra Zeneca product, with an efficacy percentage (calculated before Omicron) equal to or greater than 93% as for preventing COVID-19 deaths.

This is welcome and in line with everyone’s expectation, given what we know about adenoviral products: but let’s look at the data published by the Lancet. Let us first consider the table providing details on the population studied. Among those vaccinated with the Chinese product, we find 18,733 deaths out of 95,519 infected despite the vaccine. Of these deaths, 5,208 are >=80 years old, that is, as reported by Lancet, 27.8% of the overall deaths. As you may see in the following figure, the problem is that in the same table we find that of the 18,733 total deaths 7,434 are in their sixties, and this corresponds … again to 27.8% of deaths, according to the authoritative magazine!

A forgivable mistake, you say. Let’s scroll down in the same table. Let’s look at the distribution of sex among those vaccinated with Sputnik. In the 60-69 age group, we find 49.7% of women, and … 80.7% of men!

Okay, perhaps the reviewer was tired. We can go on, always looking at the same table. For each age group and for each vaccine, we found PCR-confirmed COVID-19 cases before the study started. For the Sputnik cases, we have 0.6%, 0.3% and 0.2% for the three age groups included in the study: but the sum should be 100%, as there are no other age groups included in the study for Sputnik!

Continuing in the same table, we then discover that, for the Chinese vaccine, the percentages of those vaccinated among the controls with one or two doses are reported, splitting the data by age; however, again we found meaningless percentages, which cannot be reproduced.

Basically, within the single table that should represent the population studied, there is such an overabundance of erroneous calculations, that one wonders whether a reviewer had examined the manuscript.

This is however not the end of the story.

Let’s have a look at the Kaplan-Meier curves used to demonstrate death prevention by the different vaccines. If you compare the graphs shown for Sputnik to those shown for Astra Zeneca looking at figure E5 in the supplementary materials, it turns out that the curves are the same: the graphs simply appear as copies of each other.

Since the work concludes that protection from death is very similar between Sputnik and Astra Zeneca, it is clear that the Kaplan Meier curves are crucial evidence supporting one of the main conclusions: finding cloned graphics is therefore a serious problem.

Conclusions

It would be nice, considering all the problems highlighted, to be able to access the original data and verify that, in all cases, errors are simply due to sloppiness in data reporting and reviewing; but once more, as the Lancet has accustomed us by now, the original data are not available for the necessary checks, in the sense that the authors reserve the right to provide them in 9 months from publication.

How long will we still have to witness the slaughter of a good scientific idea and a probably useful product, even if of complex production, by bad manuscripts with even worse revisions, published in journals that boast of having made the history of medicine?

Readers and journalists are warned once more: do not take at face value what is published in scientific journals, especially those who, having a history behind them, believe that their prestige allows excusing the lack of serious revisions for articles of utmost importance.