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Call it the 21st century’s Sputnik moment.
Two weeks ago, the leading medical journal The Lancet published glowing results for Russia’s Sputnik V coronavirus vaccine, triggering a wave of optimism in the EU that the jab might help fill a gap where Western manufacturers had overpromised but underdelivered.
Some EU leaders, including foreign policy chief Josep Borrell, sought to congratulate Moscow on its success — only to see Russia humiliate him on its home turf.
Now, some Kremlin watchers say the report in The Lancet should have sounded alarm bells instead, and prompted the EU to apply closer scrutiny. They warn that Sputnik is a geopolitical tool that Moscow is using to manipulate Western democracies, exacerbate divisions and present Russia as a pandemic savior.
“It’s a nightmare,” said German Green Viola von Cramon-Taubadel, an MEP who sits on the European Parliament’s foreign affairs committee. Likening Russia’s Sputnik strategy to its sports doping scandal, she called it an “urgent matter” that demands the EU’s attention.
Muddying the debate further is the fact that Russia keeps insisting approval from the European Medicines Agency is imminent, while the regulator insists it has not yet received any data.
All this bears the signs of a global disinformation campaign — trumpeting Sputnik while sowing doubts on the safety and efficacy of Western vaccines — and is a well-trodden geopolitical strategy by Moscow, according to Nico de Pedro, head of research and senior fellow at the Institute for Statecraft, a Spanish think tank.
“When [the Russians] have something that they consider a strategic relevance to the Kremlin, they put significant efforts in promoting the vaccine, but also in undermining other vaccines,” said de Pedro, pointing to consistent messaging in Russian state-owned media.
Russian media claimed last week, for example, that the EMA is already assessing an application for Sputnik V — a statement consistently disputed by the EU regulator. Other articles accuse U.S. drugmaker Pfizer of faking clinical trials or claim that top U.S. immunologist Anthony Fauci and philanthropist Bill Gates were arrested over vaccines. Some of these reports, collated by the Commission, directly assert that the West is criticizing the Russian vaccine “because it can’t accept Russia’s primacy.”
“It’s very transparent,” said de Pedro. “It’s clearly from the Kremlin, it’s top down.”
Sputnik has been approved in 29 countries to date — including in Latin America, where Russia Today is a mainstream channel — as well as in traditional Russian allies, he notes. But he also points to a pitfall in this strategy: It’s difficult to protect the Russian population from an aggressive anti-vaccine campaign toward the West while promoting uptake of Sputnik V domestically.
Indeed, few people are getting vaccinated in Russia, even though it’s readily available, he points out. That points to the underlying paradox: “If you have been lying … then, the moment you tell the truth, no one is going to believe you.”
Sputnik’s advocates see things quite differently. Kirill Dmitriev, chief executive of the Russian Direct Investment Fund, which promotes Sputnik abroad, told POLITICO in a recent interview that it was his team that has been victim of a disinformation campaign. And he insisted the vaccine is “the best in the world.”
In his version, it’s not trolls in St. Petersburg that are to blame but unnamed forces undermining the reputation of Russian science in the Western media. Sputnik, said Dmitriev, is one of “five or six different vaccines” that can help stop the pandemic.
In a written reply issued Wednesday to questions sent by POLITICO, the Sputnik team wrote that media critiques “undermine the international efforts to produce enough safe and effective vaccines.”
“Sputnik V has faced such groundless criticism from the beginning and all of it has proved wrong,” they wrote.
Regardless of this swirling debate, more countries are warming up to Sputnik. Slovakia and Croatia are the latest to show their support for the Russian vaccine and are in talks with Russia over possible deals.
The issue is most “dangerous” when EU countries turn to Russia to fill their vaccine vacuum, warned Germany’s von Cramon-Taudabel.
Example A is Hungary, which approved Sputnik V under emergency EU rules on January 21. While such unilateral approval is allowed — on the condition that the member state, not the drugmaker, bears liability — the move has put the EU in a precarious position, she warned, pointing to the recent surge of interest in Central and Eastern Europe.
Emergency approval “undermines the entire joint EU vaccination strategy,” von Cramon-Taudabel said. And with Russia controlling the laboratories and clinics where Sputnik was tested, she added, it’s doubtful that international data and ethics requirements for an EU approval will have been met.
“We want to have high standards,” she said. “[But] this is not possible when you can have bilateral emergency approval.”
She also notes that Russia has already succeeded in stoking tensions in Ukraine by delivering a “symbolic amount of doses” to the occupied territory in the east, according to a recent conversation she had with Ukrainian Prime Minister Denys Shmyhal.
Shmyhal himself is also a critical voice, warning last week that Russia is using Sputnik to gain political influence in other Central and Eastern European countries. His country is relying on China and the COVAX global facility to deliver doses and has banned registration of Russian vaccines.
To counteract Moscow’s campaign, Kyiv needs “a very strong signal that we are getting support from the European Union in terms of vaccination,” he said.
Lithuanian Prime Minister Ingrida Šimonytė is also staking out her opposition to the Russian jab, and has said her country will shun Sputnik even if the EMA approves it. There’s “no doubt” that Russia’s efforts to sell the vaccine to Europe are “yet another geopolitical game,” she warned.
The new math
Such statements coming from countries formerly under Soviet control may not be too surprising. But the publication of the vaccine data in a renowned scientific journal was a coup for the Sputnik team, reporting in the Lancet on February 2 a 91.6 percent efficacy rate in protecting against symptomatic disease.
However, those glowing results are now being questioned.
Enrico Bucci, an adjunct professor of biology at Temple University in Pennsylvania, laid out some critiques in Germany’s Der Spiegel and then wrote a longer takedown on his blog with a number of colleagues.
Bucci had already gone public with his worries when Sputnik published preliminary data last year, and he continues to have misgivings.
“From a scientific point of view, it’s a step forward,” said Bucci, who also co-founded a company called Resis Rsl that conducts data integrity verification.
But no matter “how beautiful a scientific idea might be,” verification is key, and here Sputnik has come up short, he contended. In particular, he pointed to inconsistencies in the published material as well as the Sputnik team’s refusal to give independent researchers access to the raw data to double check the anomalies.
Some of the apparent errors noted by Bucci in his paper were minor: Sixteen people recorded as positive for COVID-19 become 61 in a different part of the study, explainable as a simple error in transcription. More worrying for Bucci, however, is the paper’s exclusion of several thousand people who had been vaccinated.
The Lancet study, which is based on data from November 24, includes 14,964 participants in the vaccine group who received both shots. But a November 11 interim data analysis published by RDIF notes that over 16,000 volunteers had been vaccinated with both vaccine doses. And a second data analysis published on November 24 said 19,000 volunteers had received both doses.
There’s no explanation for why they weren’t included in the Lancet study, he said, adding that it could mean that unfavorable data around safety or efficacy is being covered up.
This lack of transparency isn’t something he sees with other vaccine-makers, even with the Chinese ones, where “you have plenty of data and no inconsistencies,” he said.
Bucci said he’s writing a letter to The Lancet with his colleagues to highlight all these concerns.
For its part, the RDIF team rejects his claims, saying that his paper “contains false allegations” about the clinical trial.
Other researchers have taken a more balanced view. Jeremy Rossman of the University of Kent points out that none of the other vaccine-makers had granted outsiders access to their raw data. But he agrees that there’s some reason for concern. Slip-ups in the study gave him a pause, he said, as did the fact that not everyone who was vaccinated was included in the study. This wasn’t explained and could suggest cherry-picking of data, he added.
The fact that over 30 percent of the trial participants were excluded from the safety analysis also drew his attention. The official reason — that the data couldn’t be verified in time for those participants — wasn’t good enough for him.
“Data verification can take a little bit of time … but they should have delayed the paper,” he said.
Some of the incongruities could be explained by the rush to publish, he believes. But he thinks the authors should have waited a little longer and made sure that “the numbers are all clearly explained.”
“I hope that there is a clear explanation, and that it’s not indicative of anything,” he said.
Bucci, for his part, still thinks the vaccine most likely is safe. But the Sputnik team still needs to publish the data to confirm this, he said.
The Russian approach
Meanwhile, confusion continues to reign over whether RDIF has filed any data with the EMA.
In its written response to POLITICO, the fund said that it submitted an application for a rolling review of Sputnik on January 29. It added that the agency has appointed “a team of rapporteurs” and that it expects the agency to make an announcement shortly.
“The appointment of rapporteurs indicates that the application has been accepted and is being processed,” the RDIF said. Statement to the contrary are examples of “biased attacks” from competitors “who are jealous of the success of the Russian vaccine,” it added.
The EMA begs to differ. It said as recently as last week that it “has to date not received an application for a rolling review or a marketing authorization for the vaccine.” It also points to its real-time list of submitted COVID-19 vaccine applications, which include jabs from Johnson & Johnson, CureVac and Novavax — but not Sputnik.
If the application does go through the EMA, it would be an unusual step for Russia, which has “almost no experience in submitting locally manufactured human medicines’ data to the EMA for review,” said Nelli Morgulchik, a consultant with the pharma consultancy CBPartners’ Central and Eastern Europe Team.
Ever since Russia approved the vaccine in August 2020, RDIF is managing its EMA submission in-house rather than giving it to a contractor more familiar with the EU regulator, she said, citing Russian sources.
But the fund contests this claim as well. It said that the application has been supported by “qualified consultants” with a “consistent track record of working with” EU regulators.
It also claims that German Chancellor Angela Merkel “personally offered help” from the Paul-Ehrlich Institute, the country’s federal institute for vaccines and biomedical drugs. That likely refers to a Merkel statement in January, when she offered the institute “because perhaps [Russia] does not fully agree with the approach that the EMA is calling for and the documents.”
Still, the lack of Western approval has not stopped other countries that may have less rigorous assessment processes — especially for an emergency approval — from green-lighting Sputnik, noted Elena Subbotina, also a consultant with CBPartners. These countries may have few or no vaccines yet from BioNTech/Pfizer, Moderna and Oxford/AstraZeneca, leaving many parts of the globe with unmet need, she added.
With international demand rising in these markets, say some experts, the bigger issue right now for Sputnik is manufacturing. Current Sputnik orders top “200 million doses across more than 20 markets without an evident manufacturing capacity to deliver on these contracts short-term,” Subbotina said. The RDIF has already acknowledged delays in scaling up production for some of its international contracts.
All things considered, the EMA application “may not be an immediate priority” for Russia, she said.
This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email [email protected] for a complimentary trial.