На главную


Behind the hype are design defects, low study quality, and questionable publication

The original in Russian was published by «Troitsky Variant – Science» (TrV-Science) on November 16, 2020 )

In October, in a letter to the Lancet, we requested a retraction of the article by D. Yu. Logunov et al. [1] that reported a study on a COVID‑19 vaccine developed by the Gamaleya Research Institute. The reason for our letter was that the authors had not responded to our request for sharing individual patient data of their study, as was promised in their data sharing statement in the article. Of course, they could have refused to provide the data, but we have not had the privilege of receiving any answer. We consider this a gross violation of publication ethics that, according to the Lancet’s editorial policies adhering to COPE guidelines [1], warrants a retraction of the article.  Our letter has not been published, while events related to vaccine development are unfolding rapidly. Vaccination of the population in our country has been started outside of clinical trials based on the results of [2], which requires explaining our concern. Below we provide an analysis of the study’s flaws based on the published report and its supplementary appendix.


Commentary on the publication of preliminary results of the Sputnik-V vaccine phase 3 trial

Vasily Vlassov, Olga Rebrova, Valerii Aksenov

Russian Society for Evidence-Based Medicine

February 05, 2021

The authors declare that they have no conflicts of interest regarding any COVID-19 vaccines.

Despite the announcement of the preliminary results of a randomized controlled trial (RCT) of the first Russian vaccine in November 2020 and the promise of a future full publication in an international journal to take place in November, the publication took place only on February 2, 2021 (1). Given the tremendous social significance of this development and decisions regarding citizens of this country, we considered it necessary to publish the following commentary on this article.