For the Russian researchers it was like an accolade: An article in “The Lancet” certifies that the Sputnik V vaccine was 91.6 percent effective. On Tuesday, the renowned journal published the first interim results of a clinical phase III study.
This means that the previously controversial Gam-COVID-Vac – also known as Sputnik V – ranks among the most established corona vaccines worldwide. The vaccines from Moderna and Biontech / Pfizer have an effectiveness of 95 percent, AstraZeneca, on the other hand, is significantly below that, while the vaccine from Johnson & Johnson is 66 percent.
So Sputnik V plays in the premier league of vaccines. Therefore, in the past few days, Chancellor Angela Merkel, Health Minister Jens Spahn and the EU Commission have considered approval.
With the “Lancet” contribution, the good reputation of the controversial vector vaccine against Covid-19 has been restored – at least that is the hope on the Russian side. But the professional world remains skeptical.
Numbers salad and unexplained deaths
In September around 40 experts around the well-known molecular biologist Enrico Bucci, who heads an institute for scientific integrity called Resis in Italy, criticized the Russian data situation. At the time, you mainly pointed out the noticeable duplication in the diagrams of the publication.
Half a year later, the doubts remained: “The decision of the Russian government to make the vaccine available before Phase III is still unacceptable,” Enrico Bucci, who teaches at the University of Philadelphia, told SPIEGEL.
The development of the Sputnik V vaccine is also atypical for Russian conditions. “I am not criticizing biomedical science in Russia as a whole, but rather this unique process,” says Bucci. Even with the pandemic, such an incomplete and opaque procedure could not be justified.
His institute therefore took another look at the “Lancet” publication. The researchers point to six points that are “cause for concern” and remain unresolved despite the new publication:
There is a serious lack of transparency. Scientists, including from Russia according to Bucci, still have no access to raw data on vaccine development. The answer they received was that a “security department” would examine the inquiries. Russian doctors also confirm this to SPIEGEL. Such behavior on the part of both the Gamaleja State Research Center for Epidemiology and Microbiology in Moscow and “The Lancet” is “outrageous,” according to Bucci.
So far, four deaths have been reported as a result of a Sputnik vaccination. Details about the circumstances are only available from two people.
There are inconsistencies in the number of test subjects: The “Lancet” article mentions two figures: In one place there were 21,977 study participants, in another place 21,862 participants are listed.
Questions arose when calculating the effectiveness: 15 percent of the participants in the placebo group developed antibodies on day 42. Very likely they would have been infected during that time and an asymptomatic course of Covid-19. It is unclear whether this was included in the calculations.
In addition, it is not clear why the number of subjects in the “vaccination group” is much higher in the interim studies than in the final report in “The Lancet”.
In the »Lancet« report there are also rotations among the participants who were infected with Covid-19 despite the Sputnik vaccination: According to the study’s findings, only 16 of around 15,000 test subjects were infected after 21 days, elsewhere of the paper, there were suddenly 61 Covid cases in this group on day 20.
A statement about the effectiveness can therefore not be made seriously after such numbers and contradictions, says Enrico Bucci. The deaths could certainly be cleared up, but here too the Italian researcher would like more openness. “The Sputnik vaccine could certainly be a valuable addition to Europe,” says the researcher. “However, the data must finally be accessible and complete.”
Speculation about data falsification
Criticism also comes from Russia. Few medical professionals dare to publicly question the country’s research policy. Epidemiologist Vasily Vlasov from the Moscow Higher School of Economics is an exception. “It is unfortunate that the scientific community does not have access to the raw data because that leaves room for speculation about data falsification,” said Vlasov in a statement on the “Lancet” report that SPIEGEL has received. The statement is signed by the Russian Society for Evidence-Based Medicine, of which he is Vice President. The company has been promoting transparent research in Russia since 2003 and has repeatedly criticized the public health system as ailing.
Just like his Italian colleague Bucci, Wlassow criticizes in his report the unexplained disappearance of test subjects in the phase III study, which first appear in the interim reports and then apparently disappear again in the course of the test. In the vaccination group there were at least 74 test persons. The fluctuations in the total number of subjects are also unusual: the study does not make it transparent why people were eliminated in the various phases of the test or were no longer counted by the study authors. “There are indications of unjustified exclusion of test subjects,” write Vlasov and his colleagues. However, it cannot be said with certainty whether this falsifies the information on the effectiveness of the vaccine.
Vlasov also criticizes the fact that asymptomatic cases were not included in the study. The effectiveness of the vaccination therefore does not relate to protection against infections with Sars-CoV-2, but against illness with Covid-19. It could be that asymptomatic infections were more common in the vaccine group than in the placebo group. “This can lead to a significant overestimation of the protective effect of Sputnik V,” they say. However, other manufacturers such as Biontech / Pfizer, Moderna and AstraZeneca have initially only tested the effectiveness of their vaccines with a view to Covid-19 diseases instead of Sars-CoV-2 infections.
There were also discrepancies with the long-term consequences of the vaccination: 34 percent of the subjects were excluded from the safety analysis after the test period. The reasons given for this are “not convincing”. This also applies to the description of the deaths. “In addition, the” Lancet “text contains a number of technical errors, ambiguous formulations and typing errors,” criticize the Russian doctors.
The critics of the Russian phase III study independently of one another came to similar conclusions: Despite the publication in the renowned journal »The Lancet«, there are many inconsistencies. Neither Enrico Bucci nor his Russian colleague Vasily Vlasov denies that Sputnik V is very likely an effective vaccine. But whether this is really more than 90 percent and how safe the substance is is at least questionable, according to the researchers. This also applies to infection after a vaccination.
Collaboration: Julia Merlot