Русская версия здесь
The vaccine Sputnik V might work. But there is no way to know, because the published results, in two Lancet papers, are untrustworthy. There is now rather solid evidence that the peer-reviewed clinical trial data, which many nations use to approve the Russian vaccine, does not match the real results, as revealed by a Moscow Times leak. The Sputnik V claims in The Lancet even appear “fraudulent”, as some analysts put it.
In any case, the vaccine is likely to have very severe adverse effects and may be even unsafe, given the aggressive cover-up by the Russian authorities, statements from authorities abroad, and anecdotal reports from those who took the vaccine. And yet, the vaccine became a highly political issue while being forced upon people in Russia and in other countries.
Sputnik V is the biggest PR campaign by Vladimir Putin’s regime. The first officially registered COVID-19 vaccine in the world has been approved long before the the clinical trial data was obtained. Sputnik V just had to work 100%, anything else would be treason for a vaccine developed by the Russian military at the Gamaleya National Research Centre for Epidemiology and Microbiology in Moscow.
Sputnik V was originally meant not as a way to protect Russian citizens (Putin himself didn’t seem to believe in the seriousness of COVID-19 till recently), but as Russia’s peaceful weapon of conquest, it was supposed to bind nations to Russia in a campaign of vaccine diplomacy. Kremlin’s land-grabbing war on Ukraine, support for murderous dictators in Belarus and Syria, fake news campaigns and election interferences in USA and Europe, murders, attempted murders and imprisonments of Russian dissidents like Navalny: all forgiven because Russia provided the vaccines while the western nations were hoarding for themselves.
It almost worked, but then came trouble. It was the infamous Soviet-style халтура (pronounced haltura), a deliberately shoddy way of manufacturing things, for which no English word exists. Because almost everything in the Putin’s model state USSR failed, or, when it worked, always reliably poisoned its own citizens, the Russian Sputnik V vaccine proved no different.
First of all, Sputnik V may have been sold to many nations, but the Russian production capacities could not keep up with the sales. So the customers, especially those in Latin America, got angry and started cancelling the long-placed orders with the with the Sputnik V vendor, the Russian Direct Investment Fund (RDIF).
In Brazil, a showdown came when the national regulatory authority stopped Sputnik V which the Jair Bolsonaro regime has been heavily touting. ANVISA refused approval for the Russian COVID-19 vaccine, an import permission was also denied, despite 14 Brazilian states already having placed orders. Some reasons:
“flaws in product development were identified in all stages of clinical studies (phases 1, 2 and 3). There is also an absence or insufficiency of quality control, safety and efficacy data.”
One other reason why the Brazilian ANVISA refused to approve Sputnik V is because the vaccine contains an adenovirus which is still able to replicate. Every virologist knows how dangerous this is, except Russian virologists who know not to know better. Here is ANVISA’s assessment, as pdf.
ANVISA mentions that their evaluation is not the same as a peer review a scientific journal, sniping at The Lancet where the results of the phase 3 clinical trial were originally published:
Denis Y Logunov , Inna V Dolzhikova , Dmitry V Shcheblyakov , Amir I Tukhvatulin , Olga V Zubkova , Alina S Dzharullaeva , Anna V Kovyrshina , Nadezhda L Lubenets , Daria M Grousova , Alina S Erokhova , Andrei G Botikov , Fatima M Izhaeva , Olga Popova , Tatiana A Ozharovskaya , Ilias B Esmagambetov , Irina A Favorskaya , Denis I Zrelkin , Daria V Voronina , Dmitry N Shcherbinin , Alexander S Semikhin , Yana V Simakova, Elizaveta A Tokarskaya, Daria A Egorova, Maksim M Shmarov, Natalia A Nikitenko, Vladimir A Gushchin, Elena A Smolyarchuk, Sergey K Zyryanov, Sergei V Borisevich, Boris S Naroditsky, Alexander L Gintsburg Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia The Lancet (2021) doi: 10.1016/s0140-6736(21)00234-8
The mismatch between the Lancet fiction and the real vaccine concoction was something Slovakian authorities also discovered, for which Russia accused them of “sabotage”. The Brazilian regulator didn’t believe the paper’s claim of 91.6% vaccine efficacy: “Conclusions on effectiveness were limited due to flaws in design, conduction and inadequate analyses“. The Russians were also accused of having failed to record or suppressed serious adverse events:
There was more:
“In addition, inadequate characterization studies of the vaccine were detected, including with regard to the analysis of impurities and contaminating viruses during the manufacturing process, in addition to the lack of validation / qualification of quality control methods, among several other aspects. It was also verified the absence of reproductive toxicity tests, which allow to verify if the product may or may not be harmful to the reproductive cells.”
Apparently it’s a state secret under which conditions Sputnik V is being manufactured. Russia refused to share technical reports and “on Russian soil, the inspection team was denied access to the facilities of Gamaleya, the institute that developed the vaccine.“
Russia reacted predictably, with unhinged tirades about an “attack on its sovereignty“, i.e. an act of war, and announced to sanction Brazil for its “Russophobia” by cancelling meat and soy imports. All because Putin is unable to understand that a public health authority answers to the public and not to the whims of a paranoid kleptocratic despot with penchant for toy cars, pole dancing and expensive toilet brushes.
Sputnik V vs EU
Russian authorities are also perfectly aware they have no chance of getting an approval with the US FDA, certainly after Trump’s departure. But they did expect to succeed with the EU counterpart, the European Medicines Agency (EMA), by playing European politicians against each other. The welcome side effect would be a damage to the European Union, who knows, maybe Kremlin could even convince more countries to exit it. In fact, Hungary, ruled by the Putin groupie Victor Orban, is happily vaccinating its population with Sputnik V even if the vaccine is not approved by EMA and hence invalid in the EU.
Slovakia also purchased Sputnik V, only to find out that their own regulatory agency made trouble, and then the Slovak people weren’t interested either. Even the former PM and now finance minister Igor Matovic, who aggressively pushed for Sputnik V national approval outside of the EMA procedure, and who still decries an anti-Russian conspiracy, refused to get a Sputnik V jab. Hence, 160k out of 200k shots the county bought from Russia for €2 million were slotted to be given away to Balkan neighbours. Question is if these nations really want it: WHO found safety issues with a Sputnik V factory in Russia,”with cross-contamination and sterility, as well as with tracing and identifying batches of vaccines“.
German politicians were also preparing massive Sputnik V orders and even setting up production factories in Bavaria, all while demanding from EMA to cease its “russophobia” and immediately approve Sputnik V. That all has been cancelled, officially on the grounds that there are enough EMA approved vaccines in stock by now.
EMA has remained silent so far, they just don’t approve Sputnik V despite the demands. From time to time, hints came that Russian manufacturer, the Gamaleya Institute, still denies EMA inspectors the access to its 7 production facilities and refuses to provide the EU authority with complete clinical trial data. Now we know why, thanks to a Moscow Times investigation:
“A confidential report into Russia’s Sputnik V coronavirus vaccine prepared by its developers to support its authorization around the world, has “severe inconsistencies” and differs from data previously published by Russia on Sputnik V’s clinical trials, a group of independent experts told The Moscow Times.
The 136-page document — obtained by The Moscow Times and titled “Interim Clinical Study Report” — was written in January 2021. […]
Scientists who reviewed the document found a number of discrepancies between the information it contains and what has previously been disclosed by Sputnik V’s developers, including in a landmark Feb. 2 peer-reviewed report in leading medical journal The Lancet, which found the vaccine to have 91.6% efficacy.
Flaws in the newly-obtained report range from apparent typos and basic numerical errors — such as mislabelled statistics and table headings — to more serious concerns, including unexplained changes in the number of patients in the study.”
Putin’s Russia is not USSR. Things get leaked here, and end up in the free press. The Moscow Times continues:
“This report was drafted in mid-January. It is labelled “confidential property” of the Gamaleya Research Center, and was designed to be shared with “investigators, members of ethics committees, and experts,” according to a statement on the front cover. […]
The scientists who reviewed the document highlighted frequent changes in the number of patients who were said to have been included in the study. In different places in the report the number of patients “randomized” — assigned to either the placebo group or the trial vaccine group for a first dose — is stated as being both 21,977 and 22,022 on the same day, Nov. 24, 2020.”
Experts were asked to comment:
“Within an analysis, the number of patients randomized should be consistent — there should be no difference, not even one digit difference. And here there are several differences,” Gillibert said.
Andreev added: “It’s not clear where the remaining 45 randomized volunteers end up. If those got infected, they would have shifted the efficacy significantly.”
An even larger unexplained discrepancy, the scientists said, comes at another point in the study report, where it is stated that as of Jan. 15, 2021, some 33,760 volunteers had been randomized. That’s despite the developers saying they had ceased taking in new volunteers as of Nov. 24, 2020, when only 22,000 had been randomized.”
The clinical trial results in The Lancet must be as trustworthy as anything in Pravda:
“In The Lancet article, Sputnik V’s developers said 20 cases of Covid-19 — the study’s first control point for analysis — had been identified by Nov. 18, 2020. But a table of every Covid-19 infection among the volunteers in the study report shows that 20 cases had been reached more than two weeks earlier on Nov. 1, 2020. […]
Out of a group of 19,866 patients, it reported 16,795 individual side effects — a ratio of 85%. Since many patients reported more than one side effect, this does not reflect the likelihood of an individual Sputnik V recipient experiencing a side effect. But in The Lancet report, the same ratio was just 65%, based on an analysis of only 12,296 patients.”
Not the first time for that journal to have published fraud and left it standing to protect the journal’s reputation.
Evidence of fraud
The new revelation by The Moscow Times are shocking, but definitely not surprising. Quite the opposite, the fraud was suspected even before the phase 3 results appeared in The Lancet. In September 2020, the Gamaleya Institute published the results of phase 1/2 trial of Sputnik V, also in The Lancet.
Denis Y Logunov, Inna V Dolzhikova , Olga V Zubkova , Amir I Tukhvatullin , Dmitry V Shcheblyakov , Alina S Dzharullaeva , Daria M Grousova , Alina S Erokhova , Anna V Kovyrshina , Andrei G Botikov , Fatima M Izhaeva , Olga Popova , Tatiana A Ozharovskaya , Ilias B Esmagambetov , Irina A Favorskaya , Denis I Zrelkin , Daria V Voronina , Dmitry N Shcherbinin , Alexander S Semikhin , Yana V Simakova , Elizaveta A Tokarskaya, Nadezhda L Lubenets, Daria A Egorova, Maksim M Shmarov, Natalia A Nikitenko, Lola F Morozova, Elena A Smolyarchuk, Evgeny V Kryukov, Vladimir F Babira, Sergei V Borisevich, Boris S Naroditsky, Alexander L Gintsburg Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia The Lancet (2020) doi: 10.1016/s0140-6736(20)31866-3
It was likely the same editor and the same reviewers who later approved the follow- up paper about phase 3 results. These scholars, countable on one hand, plus the Editor-in-Chief Richard Horton, now bear full responsibility for the Sputnik V mess worldwide. Hope they sleep well.
Btw, here is how competent Lancet editors and reviewers really are: an utterly fake study of chloroquine and COVID-19, made-up by a fraudster out of thin air, passed editorial gatekeeping in The Lancet with flying colours. That fraud caused enormous damage and gave ammunition to covidiots and antivaxxers to reject all science in favour of quackery.
Already when the first Logunov et al paper about Sputnik V appeared, it was criticised for shady data. The Moscow Times reported in September 2020:
“There are very strange patterns in the data,” Enrico Bucci, a biology professor at Temple University in the U.S. who has published an open letter highlighting the concerns told The Moscow Times.
“By strange patterns I mean there are duplicate values for different [groups of] patients … which cannot be,” Bucci said, in reference to results concerning the production of antibodies by groups of patients who had been tested with different formulations of the vaccine.”
[Bucci is a Turin-based Italian research integrity entrepreneur and not really a proper professor at the Temple University in USA, but that is another story.]
In January 2021, The Lancet issued an Erratum for the first paper about the phase1/2 trial data, where the Russian authors replaced several numbers on blood antibody titres. In February 2021, the authors issued another Erratum for their freshly printed Lancet paper with the phase 3 data, where they basically admitted to have been rigging trial participant numbers. They however refuse to release the raw data till this day, and the journal does not mind at all.
There were also critics inside Russia. As Vasily Vlassov, Olga Rebrova and Valerii Aksenov of the Russian Society for Evidence-Based Medicine wrote in February 2021:
“It should be recalled that the vaccine received Emergency Use Authorization in Russia after reduced phase 1-2 trials involving an unacceptably small number of healthy young volunteers. The publication of these trial results raised doubts about the study’s quality among specialists in Russia and abroad (2). The published corrections to the article, not accompanied by explanations of the origin of the text’s errors, only exacerbated the distrust of the report (3). That is why the results of the phase 3 RCT have long been expected by Russian society.
[…] the published results are obtained in selective groups, and there are signs of unjustified exclusion of cases. […]
34% of cases were excluded from the safety analysis. The authors explain this by delaying obtaining information, which does not seem entirely convincing, given the information technologies used and the importance of the issue. The data on deaths are insufficient.”
The Lancet initially refused to publish the letter of the Russian critics, and published the follow-up paper by Logunov et al about the phase 3 clinical data instead. But eventually the journal gave in when Vlassov teamed up with Bucci, Florian Naudet and other western co-authors, and in April 2021 published a critical letter to editor in Lancet‘s competitor journal, The BMJ (Naudet et al 2021). The team’s criticism was then accepted by the Lancet editors and appeared in May 2021:
Enrico M Bucci, Johannes Berkhof, André Gillibert, Gowri Gopalakrishna, Raffaele A Calogero, Lex M Bouter, Konstantin Andreev, Florian Naudet, Vasiliy Vlassov Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial The Lancet (2021) DOI: 10.1016/S0140-6736(21)00899-0
Their concerns were about the many numerical irregularities in the published trial data, and the Gamaleya authors’ staunch refusal to share raw data and even the trial protocol, while stealthily changing the preregistered trial design.
There are simple reasons Gamaleya can’t cough up the data. They cooked it. The results make no sense in the realistic setting, only in an unrealistic, fabricated one. Here are the conclusions by Kyle Sheldrick:
“So we’re really left with two possibilities:
– The authors could somehow guarantee IN ADVANCE they would get far more homogeneous data than was statistically likely (i.e. fraud).
– The authors got very very unexpectedly homogenous data between groups, so decided to add on an analysis that only makes sense in this setting AFTER they had already seen their very lucky data (i.e. the “if you’ve got it, flaunt it” principle).”
Sheldrick analysed the Sputnik V trial pre-registration NCT04530396 and its changes history:
“On 27th of August 2020, the researchers submitted their plan for decade by decade analysis to the registry. The month BEFORE the trial even started.
The researcher planned this analysis, which no other vaccine manufacturer did, which had a tiny chance of working as it was wildly under-powered, that relied on the wildly improbably lucky data they collected. The only real explanation here is that they knew what their results were before they injected the first patient. It’s a smoking gun for fraud.”
Or maybe they are clairvoyant at Gamaleya, did we exclude that possibility? At least they didn’t exaggerate the vaccine efficacy to go over 100%, that would be something even The Lancet couldn’t defend.
Liars and Antivaxxers
Russia is currently in the middle of another deadly COVID-19 wave. The official statistics are scary enough, and the real rates of deaths and hospitalisations are at least 5 times higher. It even scared the Antivaxxer-in-Chief, president Putin himself. Putin, who got vaccinated only recently (or so he says) with who know which vaccine, has been consistently urging the Russian people to get Sputnik V. Now the regime increased the pressure. Either get vaccinated, or lose your job.
Many Russians opt for alternative Russia-made vaccines they deem to be as safer (there are two more on offer), while nobody seriously believes any of those actually works, given their speedy approvals in absence of reliable trial data. On offer are two other home-made vaccines, neither of which has been published as a research paper or released any trial data, only government announcements. Seriously, I am not exaggerating.
Because the Lancet-“certified” Sputnik V is in short supply, Russians are occasionally lured to get a Sputnik V vaccine and then, without ever being told, get something else instead, for example the vaccine called EpiVacCorona, which is not yet properly tested, officially “100%” effective and unofficially doesn’t work at all. That one is a vaccine made of recombinant SARS-CoV2 spike protein, plus aluminium adjuvant, and why Russian authorities think this is enough to work is based on nothing but blind faith. The other vaccine is CoviVac, made from the inactivated SARS-CoV2 virus. There is no reason to trust that CoviVac or EpiVacCorona work, starting with the absence of any published evidence that the viral antigen is correctly folded to be recognised by the immune system as such. Never mind the utter absence of any clinical trial data.
Putin’s policy has always been the Zero-Sum Game. Meaning, the only way to compete with other is to damage them, because you are not able to achieve anything by yourself. Since the beginning, Russian media and “experts” have been warning of the dangers of “western vaccines” like the mRNA-based ones by BionTech and Moderna. Especially AstraZeneca’s vaccine became a popular target of Russian disinformation. Because that vaccine is based on a chimp adenovirus, Russian TV kept claiming, in all seriousness, that it would turn humans into monkeys. Btw, here Derek Lowe debunks Russian state disinformation which seeks to disparage other vaccines so theirs looks best.
After many months relentless scaremongering in Russian state-controlled TV and other media against “western” COVID-19 vaccines by Astra Zeneca and Biontech/Pfizer, the Russian government was successful in making its population afraid of all COVID-19 vaccines, in particularly Russia’s own Sputnik V. Thing is, Russians don’t trust their government either. Many treat the lying criminal state the same way it treats them: they purchase fake vaccination certificates, because in Putin’s corrupt Russia everything can be bought for a bribe.
It is all very sad for Russian scientists and doctors. Many of them are highly qualified, hard-working and honest people. Russian research institutions are in principle perfectly able of making an effective and safe COVID-19 vaccine, but the mafia-run oppression state ordered something else: a turbo-vaccine with no less but 100% efficiency, to be delivered Stakhanov-style in record time. Like in the old USSR, nobody dares to report to their superiors any production difficulties, safety concerns or side effects from clinical trials, because all attempts at quality control will be deemed in best case as sabotage and in worst case as “extremism” or treason. Taking any initiative or responsibility was literally a guaranteed suicide mission under Stalin, and the Soviet citizens got trained never to try it ever since. People get sacked, jailed and even killed under mysterious circumstances for much less in today’s Russia.
And now Putin demands of his own Russian people to die for him. Typical of a death cult regime.
Note: some of the information in this article appeared previously in various issues of Schneider Shorts.