In addition, there are discrepancies in the data on the number of participants in clinical trials
The article by the team behind the Russian vaccine against COVID-19, published in the Lancet, said that the effectiveness of Sputnik V against the coronavirus was 9.1.6%. The publication contains interim data from the third phase of vaccine trials.
In the scientific community, however, there is serious doubts about the correctness of the information provided, Der Spiegel points out.
The Russian side hoped that the publication in the most prestigious medical journal Lancet would improve the reputation of the vaccine, but experts continue to point out gaps and inconsistencies that arouse mistrust.
As early as September, about 40 specialists, led by renowned molecular biologist Enrico Buchi, who heads the Resis Institute of Scientific Ethics, asked a number of questions about the Russian vaccine, but which so far have not been answered.
The decision of the Russian government to register the vaccine for use before the three phases are completed of clinical trials in all cases is unacceptable, points out Buchi.
The Resis Institute analyzes the data contained in the new publication in The Lancet and points out a number of points that raise doubts.
In the first place, experts point out lack of transparency. Both the world scientific community and the one in Russia do not have access to the data from the process of drug development. The only answer the scientists received from the Russian side to their questions was: “The Department of Security will consider the inquiries.” According to Buchi, such behavior is outrageous.
During the third phase of the Sputnik V trials, data were available for four died, but only two of them have details, according to the institute.
Along with that there is discrepancies in the data on the number of participants in clinical trials. The Lancet mentions two different numbers – in one place it is claimed that the participants are 21,977, in another – 21,862.
Efficiency data also raise questions. In 15% of the participants in the placebo group who were not injected with the vaccine, antibodies appeared on day 42 of the study. They may have been infected with the coronavirus and passed the infection asymptomatically, but it remains unclear whether this factor has been taken into account in the calculations.
It is also not clear why the number of people in the “vaccinated group” is much larger during the midterm trials than in the final report published in The Lancet, the researchers note.
At the same time in the article published in The Lancet the number of people who have become infected is constantly changing, although they were vaccinated with “Sputnik V”. The “results” say that after 21 days, only 16 of about 15,000 participants were diagnosed with coronavirus. Another section of the report states that COVID-19 cases in the same group were 61 on day 20.