How Russian biotech trampled protocols — and challenged the West — in race for Sputnik V vaccine
By Robyn Dixon,
Andrey Rudakov Bloomberg News
MOSCOW — Russian science — and President Vladimir Putin’s ambitions of turning the country into a global technology powerhouse — is having something of a moment.
Russia’s Sputnik V coronavirus vaccine now has a globally recognized seal of approval after British medical journal the Lancet published a peer-reviewed paper last week that put the vaccine in the same league as Western doses — with 91.6 percent efficacy 21 days after the first shot and 91.8 percent for those over 60 years old.
For Russia’s biotech industry, the results are heady validation after facing Western skepticism, fueled largely by Russia’s decision to release the vaccine before medical trials were complete — even using researchers as test subjects.
It’s also a powerful calling card for Sputnik in a world desperate to expand vaccine supply lines.
Sputnik V is registered in at least 16 other countries or territories, mainly in the former Soviet Union, the Middle East and Latin America. The European Union, facing vaccine supply shortfalls, is now looking at possibly clearing the way for Sputnik and a Chinese vaccine.
Sputnik’s apparent success capped an audacious, and at times seemingly reckless, push that reflected Russia’s capacity for scientific improvisation. Russian experts piggybacked on existing vaccines developed in the Gamaleya National Center of Epidemiology and Microbiology but ran roughshod over normal scientific protocols.
After the fall of the Soviet Union, funding for science collapsed and researchers flocked to the West. Putin has tried to re-energize stagnant Russian science, pouring money into universities and research labs. In 2018, he called for more published research and practical applications.
In the past decade, Russia has built several cutting-edge science institutions such the Skolkovo Institute of Science and Technology, also called Skoltech, outside Moscow. But a lingering Soviet mentality sets bureaucratic barriers for collaboration with foreign scientists or imports of research materials.
Sputnik as ‘outlier’
Ilya Yasny, head of scientific research at Moscow-based investment fund Inbio Ventures, called the Sputnik V development “more of an outlier” than a signal that Russian medical science has emerged as a serious global contender.
“The main problem is regulation,” he said. “Our laws and guidelines are, I would say, 15 years behind the European Union.”
Olga Maltseva
AFP/Getty Images
Production of Russia’s Sputnik V vaccine in Strelna, Russia, on Dec. 4.
Three years ago, Putin announced a national research strategy that promised 900 new laboratories, including 15 world-class research centers focused on mathematics, genomics, materials research and robotics.
He said many Russian drug developers still saw the global standard for clinical trials — three stages and broad demographic testing — as “unnecessary hurdles.”
[Russia’s vaccine volunteers swap stories — and antibody readings — as amateur researchers]
To gain lasting credibility, experts say, Russian scientists need to publish more papers in peer-reviewed international journals like the Lancet and collaborate with foreign scientists.
But Russia is heading in the other direction.
It has been trailing the world for many years in publications in major international scientific journals, according to a study of 22 million scientific papers from 2005 to 2017 by Vít Macháček and Martin Srholec from the Institute for Democracy and Economic Analysis in Prague. Scandals around plagiarism and duplication in Russian scientific research saw the Russian Academy of Sciences announce the retraction of more than 800 scientific papers in January 2020.
Putin’s 2012 “Project 5-100” poured money into select Russian universities, targeting 21 institutions and aiming to get five into the top 100 globally by 2020. It failed. Only one, Lomonosov Moscow State University, made it to number 84 in the QS World University rankings. The Times Higher Education rankings included none.
Russian and Soviet science has always focused the most resources on nuclear physics, weapons and space. Putin often boasts of the country’s deployment of hypersonic missiles, a development that could presage an arms race.
Still, Russia has chalked up some solid achievements in medical research, including the development of an Ebola vaccine and a vaccine for Middle East respiratory syndrome, or MERS, another coronavirus outbreak first reported in 2012.
And money is flowing. On Friday, Putin dubbed 2021 as Russia’s “Year of Science,” and the government pledged science and medical research funding of $280 billion to 2030.
Lancet as ‘checkmate’
Andrey Rudakov
Bloomberg News
A nurse prepares to administer a dose of the Sputnik V vaccine at a center in Moscow on Jan. 20.
Russians, too, are slowly warming to Sputnik after some initial hesitation. A survey published Feb. 2 by the Levada Center, an independent polling agency, found only 38 percent of Russians were willing to vaccinate in December. Of those who were unwilling, 30 percent planned to wait for the results of clinical trials.
At the dowdy first-floor corridor in Moscow municipal clinic No. 5, nurse Irina Vasilyeva syringed up 0.5 milliliters of Gam-COVID-Vak — otherwise known as Sputnik V. She sighed as queues for the vaccine grew.
“It seems as if the whole of Russia decided to get vaccinated today,” she said on a holiday morning, Russian Christmas Eve on Jan. 6.
Russian officials, meanwhile, have basked in the Lancet glow.
“There are no arguments left for critics of this vaccine. The article in the Lancet is a checkmate,” said Kirill Dmitriev, head of the Russian Direct Investment Fund, which backed the vaccine’s development.
Kremlin spokesman Dmitry Peskov called the research publish in the Lancent as evidence that Russia was right to register the vaccine before Phase 3 trials.
Stephen Morrison, director of the Global Health Policy Center at the Center for Strategic and International Studies in Washington, noted the Lancet’s validation came at “a good moment” for Russia as the E.U. struggles with its slow vaccine rollout.
[AstraZeneca and Russia’s Sputnik V lab to share data in seeking coronavirus vaccine advances]
But so far, no drug or vaccine developed by Russia alone has received approval for use across the E.U. — the next potential big step for Sputnik V on the international stage.
Natalia Kolesnikova
AFP/Getty Images
People queue to receive an injection of Russia’s Sputnik V vaccine at a Moscow department store Jan. 20, just days after Russia launched mass coronavirus vaccinations.
Supply glitches and other problems have left E.U. supplies low with its two main vaccines: one developed by AstraZeneca and Oxford University, and another by U.S.-based Pfizer and Germany’s BioNTech.
German Chancellor Angela Merkel said Wednesday that Sputnik was welcome in Europe if it won approval.
“It does say something about the quality and integrity of the scientific enterprise within Russia, which a lot of people disparage or dismiss as decayed and obsolete and underfinanced and underpowered, and that so many of their scientists had fled to greener pastures in Europe and North America,” Morrison said. “This would seem to fly in the face of that.”
David Holden, Regius professor of infectious diseases at Imperial College London, said Sputnik “appears to have been well designed,” in an interview commenting on the Lancet paper.
“Overall,” he said, “I think it’s very encouraging indeed.”
Scientific shortcuts
Yet Russian researchers cut some corners to get there.
Gamaleya chief Alexander Ginzburg and dozens of other colleagues injected themselves with the vaccine in April even before it had been tested on monkeys. He said Russia fast-tracked the vaccine by merely tweaking a MERS vaccine they had already developed.
But a Germany-based Russian science journalist and molecular biologist, Irina Yakutenko, called the Sputnik push “not a good way to do science.”
“There was not enough research on animals before they started to use it on people,” she said.
[The global race for a coronavirus vaccine could lead to this generation’s Sputnik moment]
“I hope they won’t decide that now we can develop drugs using this shortcut way,” Yakutenko added. “To develop drugs, you need the best medical science, and you should do everything according to the protocols. It takes a long, long time. It takes a lot of money.”
Other critics have taken aim at Russia data that underpinned the Lancet article.
“There is a gross lack of transparency” in the Sputnik V trial, said Italian biologist Enrico Bucci, adjunct professor at Philadelphia’s Temple University,
In September, he and 14 other scientists co-wrote a letter to the Lancet criticizing earlier Sputnik V research published in the journal. The group also did not obtain data they requested from Russia, he said.
Yasny, of Inbio Ventures, also criticized the lack of transparency and said it was possible the efficacy of the vaccine was exaggerated, although he still believed it was a good vaccine.
He said Russia’s reflexive resistance of Western levels of transparency and medical science norms only undermines confidence. In Argentina, where Sputnik V is being rolled out, only 39 percent trust the Russian vaccine, according to polling firm Poliarquía.
“In my opinion, they should publish as much information as they can,” Yasny said. “But this is not in their DNA. They prefer to conceal things.”
Isabelle Khurshudyan in Moscow, Mary Beth Sheridan in Mexico City and Ana Vanessa Herrero in Caracas, Venezuela, contributed to this report.
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