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In September, some 40 experts from the team of renowned molecular biologist Enrico Bucci, who heads the Italian institute for scientific reliability Resis, criticized the information provided by the Russians. The researchers then first pointed out the striking duplicate data in the publication charts.
Half a year later, the doubts remained.
“The Russian government’s decision to make the vaccine available without a third phase of testing remains unacceptable,” said Bucci, a professor at the University of Philadelphia, in an interview with Der Spiegel.
According to the biologist, the development of the Sputnik V vaccine is unusual even for Russia. “I am not criticizing the Russian biomedical sciences in general, but this process in particular,” Bucci said. In his opinion, even a pandemic does not justify such an imperfect and opaque approach.
For this reason, his institute reexamined the article published in The Lancet in detail. The researchers point to six points that concern them and, despite the new publication, they remain unclear.
The researchers note a “major lack of transparency,” reports Der Spiegel. As Mr. Bucci said, scientists, including Russia, still do not have access to initial data on vaccine development. Upon request for these data, a response was received that the requests were being reviewed by the “security department.”
This information was also confirmed by Russian doctors in Der Spiegel. The behavior of the Gamalay National Center for Epidemiological and Microbiological Research in Moscow and The Lancet is “astonishing,” Bucci said.
According to a molecular biologist, four deaths are currently reported from Sputnik vaccination. It is true that only details are known about the two dead.
There are discrepancies in the number of people surveyed. The Lancet article gives two figures: 21,977 participants in one study and 21,862 in the other.
Questions were also asked about the calculation of the relative efficiency: 15%. the members of the placebo group developed antibodies on day 42. It is very possible that they became infected and had an asymptomatic form of COVID-19 during that period. It is unclear whether this was factored into the vaccine efficacy calculations, according to Der Spiegel.
It is also unclear why the number of “vaccinated participants” reported in the interim studies is significantly higher than in the final report published by The Lancet.
Additionally, an article published in The Lancet mixed the number of study participants who were vaccinated with Sputnik but still infected with COVID-19: according to study results, 15,000 people in 21 days. only 16 people were infected with coronavirus in the participants, but the next part of the article suddenly mentions 61 cases of COVID-19 in that group in 20 days.
“Given these errors and contradictions, efficiency cannot be taken seriously,” Bucci said. “Of course, the Sputnik vaccine may have been a valuable additional tool in Europe, but the data must be available and complete.”
Criticism also extends from Russia, continues the German magazine. Only a few doctors dare to openly question their country’s research policy. Vasily Vlasov, an epidemiologist at the Higher School of Economics of the National Research University, is an exception.
“It is sad that the scientific community does not have access to the original data, which opens the door to speculation about falsification of data,” Vlasov commented in Der Spiegel’s The Lancet article.
Like his Italian colleague, Mr. Bucci, in his article, Mr. Vlasov vaguely criticizes the subjects who disappeared during the third phase of the investigation, who are only mentioned in the interim reports and then appear to disappear again as it progresses the investigation.
After all, there were 74 in the group of vaccinated participants. Unusual fluctuations in the total number of participants: the study did not explain why some participants were excluded at different stages or why the study authors no longer took them into account.
“There are signs of unjustified exclusion of subjects,” write V. Vlasov and his colleagues. On the other hand, it is not possible to say unequivocally whether such practices distort the data on the efficacy of the vaccine presented in the article.
V. Vlasov also criticizes the decision not to take asymptomatic cases into account during the investigation. “This could result in a significantly overestimated protective effect of Sputnik V,” the document says.
However, other vaccine developers, such as Biontech and Pfizer, Moderna and AstraZeneca, initially tested their vaccines for protection against COVID-19 rather than SARS-CoV-2 infection.
According to the researchers, there are also discrepancies regarding the long-term effects of vaccination: at the end of the trial period, 34% were not included in the safety analysis. Participants. The reasons given are “unconvincing”. As the researchers said, a similar approach was taken when describing fatal cases.
Critics of the third round of Russian trials independently drew similar conclusions: Despite an article in the authoritative journal The Lancet, there are inconsistencies in the study.
Mr. Bucci or his Russian counterpart, Mr. Vlasov, do not deny the fact that Sputnik V is likely to be an effective vaccine.
But does the efficiency really reach more than 90 percent? and how safe this drug is – these things are still in doubt, my researchers. The same can be said about the likelihood of becoming infected after vaccination, reports Der Spiegel.
On February 2, it was announced that the effectiveness of the COVID-19 Sputnik V vaccine developed in Russia reaches 91.6 percent. in The Lancet.
The Sputnik V coronavirus vaccine, named after the first artificial satellite launched by the Soviet Union, was approved by Russia a few months before the end of the latest phase of clinical trials and has received skeptical evaluation by some experts.
However, the third phase of clinical trials with 20 thousand. Recent data from volunteers has shown that the effectiveness of two doses of the vaccine is more than 90 percent.
The developers of the Sputnik V vaccine have been criticized for their inadequate haste, attempts to cut corners and lack of transparency, according to a separate comment published in the journal by Ian Jones, a virologist at the University of Reading, and Polly Roy, a professor of the London School of Hygiene and Tropical Medicine.
“However, the results published here are clear, demonstrating the scientific principle of vaccination, which means that another vaccine can join the fight to reduce the incidence of COVID-19,” the comment said.
According to published results, Sputnik V “is one of the most effective vaccines against the pandemic coronavirus.” Their vaccines, Pfizer / BioNTech and Moderna, are more than 90 percent effective.
Russia has begun mass vaccination of the population from the age of 18 with Sputnik V, without the results of the third phase of clinical trials.
Russia requests the registration of this product in the EU. More than 15 countries are already using Sputnik V to fight the pandemic.
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