If fathers are in danger, send their daughters over. This is what happened in the ancient legend of Iphigenia, which had to be sacrificed to the angry goddess Artemis – in exchange for safe conduct for her father Agamemnon. Similar to the Hellenistic model, Vladimir Putin’s daughter was also supposed to pave the way for her father a few weeks ago: towards a vaccine against the coronavirus.
Russia had “Sputnik V” as the first corona vaccine in the urgent procedure approved for wide use worldwide, although the agent has so far hardly been tested in clinical studies. Putin publicly announced that his daughter had been injected with the vaccine and that she had tolerated it well. The announcement was apparently intended to increase confidence in the vaccine. Who would have a drug given to their own daughter if it wasn’t absolutely safe?
The hasty approval caused international criticism. Now there are still doubts about the already shaky scientific basis of the vaccine.
“Statistically highly unlikely”
Respected researchers from several countries question the authenticity of the data that their Russian colleagues received in early September in the journal “Lancet” submitted as evidence of the effectiveness of the vaccine. It is about the suspicion of clumsy manipulation. Did the scientists responsible for the vaccine come up with their results, or did they use Photoshop to improve them?
The abnormalities start with the second image of the study, criticize researchers around the well-known molecular biologist Enrico Bucci. The areas in question are circled in bright colors. They show a conspicuous number pattern in the data sets. Several test persons had exactly the same antibody level in their blood on alternating days. The value of the T cells that are supposed to fight the coronavirus is also identical. The subjects received different forms of the vaccine.
Just a coincidence? Bucci argues that it is highly unlikely that the exact same numbers will come out in the individual groups, even though different things are tested. “It’s like throwing the dice and getting exactly the same sequence of numbers several times,” he said “Moscow Times”.
The data looked as if they had been edited with Photoshop, argues Andrea Cossarizza, immunologist at Modena University in Italy. The numbers are too similar, the results are unlikely from a statistical point of view. Together with other researchers, the two have one open letter to “Lancet” in which they request the publication of the raw data.
Such a “Note of Concern” is exactly the path that scientists take when, in their opinion, there is justified criticism of a study. Normally this is only of interest to a small professional community, but the world is waiting for the vaccine that the study is about.
If Russia were to be the first country to come up with a safe immunization, it would be a welcome show of force for the Kremlin. It is not for nothing that the name “Sputnik V” is linked to the legendary space program of the Soviet Union.
“You don’t normally see something like that in studies”
Was the political pressure on the researchers so great in the end that they consciously fantasized about the desired results?
The open letter is initially only a suspicion, a demand among scientists. This is not proof of manipulation. It is true that the signatories are renowned researchers. But the journal that published the study is also well-known. Before results are published in the “Lancet” they have to withstand the scrutiny of independent specialist colleagues.
“For researchers, this means: lower your pants,” said Clemens Wendtner, an infectious disease specialist at the Munich Clinic Schwabing, who has already published in specialist journals such as “Nature”, the SPIEGEL. All data would have to be disclosed. This is one of the reasons why the appendix of many studies is often significantly longer than the text itself. Research results can only be checked if you have all the data.
So far, the researchers responsible for “Sputnik V” at the state-owned Gamaleja Institute have not disclosed their data to the public. “Actually, this should be common practice when searching for corona vaccines,” says Wendtner. After all, the drug should be administered to millions – if not billions of people. “The key question will now be how the verification process went before publication and whether the Lancet had any insight into the raw data.”
“Lancet” has asked the authors of the study for a statement to clarify open questions. “We are following the situation closely,” said the trade journal at the request of SPIEGEL. The study was reviewed by international experts for Covid-19.
In the best case scenario, doubts can be quickly dispelled. But what if not?
“The colleagues around Bucci have already looked at the data very carefully,” says Wendtner. The identical antibody levels may still be explainable, but the same values are particularly noticeable when detecting T cells. “You don’t normally see something like that in studies,” says Wendtner. Admittedly, this is not proof of manipulation, but it is definitely a reason to take a look at the raw data.
Millions of vaccine doses have already been ordered
It wouldn’t be the first time researchers have deliberately leveraged the testing process. It was not until the beginning of June that “Lancet” had to withdraw a decisive corona study after it became known that the entire data basis for the analysis was probably fictitious. (More on this read here.) “Lancet” was duped. Even then, researchers stated that the review process – known as peer review – was not intended to uncover deliberate deceptions.
But if the deceptions seem as obvious as the allegations suggest, couldn’t the Russian researchers have falsified better? This question can probably only be answered by looking at the raw data.
“Sputnik V” is based on weakened adenoviruses, which are considered harmless to humans. With the help of genetic engineering, the researchers smuggled corona genetic material into them, which does not make you sick, but is intended to fool the immune system into an infection. The body – according to the theory – then sets up defenses that also protect against a real infection with the coronavirus.
However, there is little experience with such piggyback vaccines. In the case of “Sputnik V” the results were promising. The vaccine appeared to produce a stronger immune response than a real infection. Russia’s state fund Foreign Direct Investment Fund (RDIF) has already reported tens of millions of orders, even though only a few dozen subjects took part in the first studies.
Millions of other vaccine candidates have also been ordered; none of them passed the crucial phase III studies. In the final phase of approval, the agent is injected into tens of thousands of test subjects in order to uncover possible side effects.
A risky game
Unlike other vaccines, “Sputnik V” already has a kind of provisional approval, the first nationwide mass immunization is planned for the end of the year – systemically important professions such as teachers and doctors in particular are to be vaccinated before the final phase of the study is completed.
If the doubts about “Sputnik V” cannot be dispelled, Putin will probably only be able to generate confidence in the vaccine in other ways, given the lack of scientific facts. Maybe he’s getting himself vaccinated?
Other high-ranking politicians have been immunized in front of the cameras. Hopefully they don’t pay as high a price as Iphigenia.