Last week, a team of Russian scientists published the effects of two phase 1/2 vaccine trials for a new Covid-19 vaccine developed in Russia, according to the study published in The Lancet, one of the world’s leading medical journals.
The vaccine has already gained a lot of attention after Russian leader Vladimir Putin announced that he would start administering it widely, before Phase 3 trials begin. As I wrote last month, it is not a smart concept to skip those Phase 3 trials.
However, the effects of the initial trials of either vaccine appear to be quite good. Although the trials were small, with only 76 subjects, 100% of the subjects had a strong antibody response and none of them had anything but mild reactions to This suggests that any of the vaccines may simply be effective, even if it is too much. soon (after only 76 people) to be on a giant scale.
However, there is a problem.
Three days after the publication of the newspaper, Enrico Bucci of Temple University described a number of obvious duplications in the figures presented in the Russian newspaper. He published his findings in his as a “note of concern” that dozens of other scientists had signed.
I read the document and looked at all the numbers, and it’s transparent that anything is with the data.
Let’s take an example to see what happens. Here is a small part of Figure 2A of the document:
Each small column of points shows a different organization of nine subjects, where the height of a point indicates the point of antibodies discovered in those subjects. Note that the nine subjects in the red box (cases added to accentuate) on the left have a tendency to those in the box on the right. These are absolutely independent subjects, and such a scheme is incredibly unlikely.
It might have happened by chance, but the challenge is that apparently it’s not the only duplication. Professor Bucci knew at least thirteen cases in which sets of effects are either between two other moments or two other sets of subjects. very similar to the one shown here.
The simplest explanation is that knowledge of some experiments was simply copied from other experiments. As reported in the Moscow Times, the studio’s lead author, Denis Lugonov, said there were no errors in knowledge. did not provide his raw knowledge and The Lancet did not want it, other scientists cannot determine it.
What do we deserve to do with him? The main points of the test are obviously explained and Russian vaccines use a design (a modified adenovirus to involve the complex PROTEIN SARS-CoV-2) that is similar to other vaccines that so far seem safe and effective. Therefore, it is quite imaginable that this vaccine will work, and will be smart for the world if it does, but dubious knowledge raises the question of whether the scientists behind this phase 1/2 trial have actually conducted all the experiments they describe. The examination concludes by noting that a phase 3 clinical trial with 40,000 participants is planned. Let’s hope to give positive and original results.
[I take my hat off to Retraction Watch for attracting me to this studio. ]
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I am Professor Emeritus of Bloomberg in Biomedical Engineering, Computer Science and Biostatistics at Johns Hopkins University. From 2005 to 2011 I the Horvitz
I am Professor Emeritus of Bloomberg in Biomedical Engineering, Computer Science and Biostatistics at Johns Hopkins University. From 2005 to 2011, I was Professor of Computer Science at Horvitz and Director of the Center for Bioinformatics and Computational Biology at the University of Maryland, College Park. UMD, I at the Genomic Research Institute, where I made a number of genomes of many bacteria, adding those used in the 2001 anthrax attacks. In TIGR, component I of the Human Genome Project and co-founder of the allocation of flu virus sequencing (that’s when I discovered the vaccine movement). My research organization develops software for DNA series analysis, and our (free) software is used in clinical laboratories around the world. at Yale University, and my PhD at Harvard University, and I have published more than 250 clinical articles. Follow me on Facebook or Twitter, or visit my lab page, http://salzberg-lab. org.