10 April 2021

The Surprising Success of Sputnik V

By Christian Esch, Jens Glüsing and Christina Hebel

Last week, Vladimir Putin finally got vaccinated against COVID-19. For almost half a year, the Russian president has been tirelessly praising the vaccine developed in Russia. Sputnik V, he has said, is the "best vaccine in the world." Nevertheless, he was disinclined to take it himself, and even withdrew from the public eye for a time. Now, though, it appears that he has changed his mind.

But there's a catch. No information was provided about which vaccine he chose to use. Nor were any images or video footage provided. Why not? "As to being vaccinated on camera, well he has never been a fan of that," Putin's spokesman said. "He doesn't like that."

Putin's delayed and covert vaccination fits well with the strange story of Sputnik V, the first vaccine approved for COVID-19 in the world. It is a success story, to be sure, but there are some pretty large qualifiers.

Millions of people around the world have already been vaccinated with Sputnik V and more than 50 countries have approved it. Images from faraway countries like Argentina, Bolivia and Venezuela show pallets stacked with vials full of Sputnik V being welcomed. The world needs help, and Russia is there to provide it: That's the message.

But many places don't completely trust the Russian offer. And nowhere is that mistrust as pronounced as it is in Europe. But even in Russia, Sputnik V is viewed with some skepticism.

The vaccine continues to be dogged by the fact that its introduction was less than perfectly transparent. It was similar to Putin's recent vaccination: You have to believe it, because you're not going to see it. The result is that Sputnik V has become a matter of faith – as if the vials weren't full of vaccine, but of a cocktail of politics and medicine.
"Provocations" from the West

The birthplace of Sputnik V is the Gamaleya Research Institute of Epidemiology and Microbiology on the outskirts of Moscow. For more than two decades, it has been under the leadership of Alexander Ginzburg, a cheerful biologist with a chortling laugh. It's not easy get permission to visit him in his wood-paneled office: The institute answers to the Health Ministry, which rarely allows visitors. The Kremlin has warned of "provocations" in the Western media. On the other hand, though, the U.S. film director Oliver Stone, who is a friend of Putin's, dropped by the Gamaleya Institute recently and was vaccinated with Sputnik V.

Ginzburg doesn't share the ministry's concerns. Thank God, he says, that Sputnik V is now receiving more positive attention abroad than in the past – both in the media and in scientific circles.

It has almost been an entire year since Ginzburg was vaccinated with Sputnik V. The institute first began developing its vector vaccine, made up of two components, back in February 2020. Inactivated flu viruses (so-called adenoviruses) were used as a carrier to transport genetic material from the coronavirus pathogen into the cells of the human body.

"We staff members were vaccinated before the monkeys, right after the mice and at the same time as the hamsters and guinea pigs."

Alexander Ginzburg, Director of the Gamaleya Research Institute of Epidemiology and Microbiology

Gamaleya had experience with vector vaccines, having developed one for the Ebola virus as well. The institute merely had to fill its carrier with a new payload. The researchers obtained the necessary COVID-19 viral material in mid-March from a clinic in Moscow, where a patient, who had picked up the infection in Rome, was receiving treatment.

Ginzburg said he was administered the vaccine on March 30, at a time when animal testing was still underway. "We staff members were vaccinated before the monkeys, right after the mice and at the same time as the hamsters and guinea pigs."

Still, the decision to receive the vaccination at such an early stage wasn't quite as daring as Ginzburg makes it sound. The Gamaleya Institute had already developed a comparable vaccine for a similar coronavirus – the one that causes MERS, the virus behind the 2012 outbreak in Saudi Arabia. And that vaccine, says Ginzburg, had already been tested on humans. Basically, MERS provided the researchers at the Gamaleya Institute with an unexpected head start on the development of a COVID-19 vaccine.

The research group was led by Denis Logunov, a sturdily built 42-year-old. A week ago Monday, he received personal praise from Putin for his work on Sputnik V in a televised video call. "I want to see this man and I want the entire country to see him," the president said.
David vs. Goliath

Logunov is visibly offended by the hail of criticism of the Sputnik V vaccine that came from abroad. It was particularly strong around the time the vaccine was approved in Russia – despite the fact that the results of the Phase I and II testing hadn't yet been released and Phase III testing hadn't even started yet. It looked as though Russia was taking shortcuts.

"It was an emergency authorization," Logunov says. The vectors used in the vaccine, he says, were well-established – a major difference to the new development techniques used by some of the competing vaccines, such as the mRNA approach used by BioNTech and Moderna.

Logunov believes the criticism from abroad is hypocritical. "It's offensive," he says. "You really are carrying out experiments on people, but you accuse us of doing so, even though we are using components that have been tested hundreds of thousands of times." The Gamaleya Institute sees itself as David in a battle against the Goliath of the international pharmaceuticals industry. They feel they are being treated unfairly.

Institute head Ginzburg says: "I can understand the skepticism. From outside, the process looked overly hasty, as though we were trying to be the first. That maybe played a role. But it was done in accordance with the rules for approval and against the background of the de facto war-like situation in which we found ourselves."

It was only in February 2021, half a year after the vaccine was approved, that the Phase III results were released in the journal The Lancet. Those trials indicated that Sputnik V has an efficacy of 91.6 percent, higher than the vaccine developed by AstraZeneca.

Criticism has quieted noticeably since then, but it hasn't gone away completely. Some researchers are demanding access to the raw data from the trials, others believe there are inconsistencies between the number of trial participants and the efficacy calculation, and still others have speculated about possible manipulations. Logunov has rejected all such allegations.

Naming the Vaccine

Kirill Dmitriev is the man responsible for marketing Sputnik V around the world. A former banker, Dmitriev went to both Stanford and Harvard, and his rapidly spoken Russian is frequently peppered with English. In describing the European reservations that he is trying to overcome, Dmitriev – speaking via Zoom from his office in Moscow – uses the terms "anxiety" and "overthinking."

Dmitriev is head of the multibillion-dollar, state-owned Russian Direct Investment Fund (RDIF), which invested in the development and production of the vaccine. Dmitriev is well-connected. His wife attended university and continues to work with Katerina Tikhonova, Putin's presumed daughter, who leads a foundation promoting innovation.

If the Gamaleya Institute is the birthplace of the COVID-19 vaccine, then Dmitriev is the one who christened it, having come up with the name Sputnik V. Initially, it was simply called Gam-Covid-Vac, which is how it is still referred to on Russian vaccine certificates. But it is bought and sold under the name Sputnik V.

"We underestimated the degree to which Sputnik would be associated with a race in the West."

Kirill Dmitriev, head of the state-owned Russian Direct Investment Fund

The V stands for "vaccine," but also for "victory." And "Sputnik," of course, is a reference to Moscow's triumph in the race for space between the superpowers: That was the name of the first satellite launched into orbit by the Soviet Union in 1957. "Americans were surprised when they heard Sputnik's beeping," Dmitriev said back in July 2020. "It's the same with this vaccine. Russia will have got there first."

This kind of chest-pounding rhetoric did the vaccine no favors abroad. These days, Dmitriev is a bit less strident. "We underestimated the degree to which Sputnik would be associated with a race in the West." He says that in such a crisis, cooperation is more important than competition.

Currently, relations are particularly difficult with the European Union. "Europe has the impression that Sputnik V is doing all it can to force its way into the EU. As if Russia would absolutely need it. In truth, though, it's the other way around: Europe needs Sputnik," says Dmitriev. Russia, he says, must first take care of itself and it has plenty of other partners.

Dmitriev believes that the pharmaceutical concerns and their lobby are behind the reservations against Sputnik V. "They wanted to kill Sputnik from the very beginning. First, they claimed that we had stolen the recipe, then that we hadn't registered it properly, then that it was ineffective or dangerous," he says. "And now, with all of those objections cleared up, comes the final argument: It is a Russian vaccine."

Politicians in Brussels are waiting to see if the European Medicines Agency (EMA) will recommend that the vaccine be authorized. "We are shocked that the European Commission hasn't yet begun negotiations for the purchase of Sputnik," Dmitriev says, adding that Europe started talks with other producers before authorization was complete.

EU Approval?

Thus far, the only EU member states that have authorized Sputnik are Hungary and Slovakia, with both having decided to move ahead on their own without the EU. An authorization for the entire bloc is still months away, and the EMA only started its rolling review in early March. Russia, though, applied for the review on January 21, Putin claimed last week. EMA denies that assertion. Indeed, it looks as though the application was not filed correctly.

In April, EMA experts will travel to Russia to visit production facilities and hospitals in addition to examining the clinical data. Gamaleya Institute head Ginzburg has assigned 10 staff members to assist the process.

The two doses of Sputnik V Foto: Alexander Zemlianichenko Jr / dpa

"Russia now has to deliver sufficient data and allow and independent review," says European parliamentarian Peter Liese, health policy spokesman for the European People's Party group in European Parliament. He is extremely skeptical of the rapid approval of the vaccine last August in Russia. "That wasn't an authorization. That was fake," says Liese.

The longer the approval process lasts, the smaller the role Sputnik V will play in overcoming the pandemic in Europe. Thierry Breton, the European internal market commissioner, says that Europe has "absolutely no need for Sputnik V" since the bloc will have sufficient vaccine from other suppliers by summer to meet its needs. Liese, though, disagrees. "We have to take whatever is available, as long as it meets EMA criteria."

But would the Russians be able to deliver? "We don't have enough vaccine doses for Latin America, Africa and Asia," Dmitriev says. "But after June, we would be able to deliver vaccine doses for 50 million people within three to four months."

If the vaccine is approved, Germany alone could produce dozens of millions of doses by the end of the year, Dmitriev claims. The company R-Pharm in Bavaria will take the lead, with two other companies potentially joining the effort.
Triumph in Latin America

As Europe hesitates, though, the vaccine has enjoyed great success elsewhere. One region, in particular, has turned into a focal point of vaccine diplomacy: Latin America.

Sputnik developer Logunov: Praise from Putin Foto: Denis Sinyakov / DER SPIEGEL

On the same Monday that Putin in Moscow praised Sputnik V developer Logunov, an Airbus A330-200 belonging to the airline Aerolineas Argentinas landed in Buenos Aires. Two government ministers were there to welcome the arrival along with a presidential adviser. The plane was carrying 500,000 doses of Sputnik V, the eighth delivery thus far. And each one has been cause for celebration. Since December, Argentina has received 3,299,000 doses of Sputnik V, part of the 20 million ordered by the government. The deliveries from Moscow have all been on time, and, at around $10 per dose, the price is right.

That makes Argentina the most important market for Sputnik V in South America – and a giant laboratory for the controversial vaccine. Latin America has been hit particularly hard by the pandemic, and Moscow's help is more than welcome. In addition to Argentina, Brazil, Mexico, Bolivia, Venezuela, Paraguay and Nicaragua have placed orders for Sputnik V. Left-leaning governments in particular have shown few qualms about buying up the Russian vaccine.

Like Argentinian President Alberto Fernández before him, Mexican President Andrés Manuel López Obrador called Putin personally on Jan. 25 and ordered 24 million doses. His country is home to one of the highest COVID-19 morbidity rates in the world.

Brazilian President Jair Bolsonaro, whose denialism transformed his country into one of the worst coronavirus hotspots in the world, is avoiding the Russian vaccine for ideological reasons. But several Brazilian states run by governors from opposition parties have ordered 37 million doses, in cooperation with the Health Ministry. Despite the fact that Sputnik V hasn't even been authorized in Brazil.

The U.S. government also appears to see vaccine choice as a matter of faith. In its 2020 Annual Report, the U.S. Department of Health included a section heading entitled: "Combating malignant influences in the Americas." The report went on to claim success in an effort "to persuade Brazil to reject the Russian COVID-19 vaccine." It isn't clear what arguments were used in that effort and the Bolsonaro administration has not commented.
A Slow Pace of Vaccination in Russia

There is, though, one country that wishes it was receiving more assistance from the Russian government, and that country is Russia itself. Whereas exports of Sputnik V are being celebrated, the vaccination campaign at home is faltering. Strangely enough, there isn't just a lack of vaccine doses, but also of those willing to be vaccinated.

Veliky Novgorod is one example. At first glance, the old city with its citadel and golden domes seems untouched by the coronavirus pandemic. Stores, restaurants, museums and theaters are all open, while masks are a rarity. As elsewhere in the country, most measures to combat the spread of the virus have long since been suspended, with Russia apparently holding the deceptive conviction that it has managed to successfully navigate the pandemic.
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The vaccine has been approved in more than 50 countries. Foto: Fethi Belaid / AFP

Mariya Granz was one of the first in the city to be vaccinated. That was back in September, at a time when doctors had priority. "It was frightening," says the medical doctor, "as though I was flying into space myself." She says that aside from a slight fever after the second dose, side effects were minimal. The 41-year-old is organizing the city's vaccination campaign.

Slightly over 7,000 residents of Veliky Novgorod have received at least one dose of the vaccine, not even 5 percent of the adult population. "That isn't much," she says. Moscow has given her a target of 60 percent of the adult population by the end of June.

Getting there, though, won't be easy, and there are a lot of hurdles along the way. In the vaccination room of Polyclinic Nr. 4 on the Saturday before last, they ran out of vaccine for those receiving their first doses. One of the two refrigerators where the vaccine is stored was completely empty, with a new shipment only expected in two days. That meant they were only able to administer the vaccine to those coming in for their second doses. One disappointed visitor could barely contain his anger as he left without his jab.

Irina Istomina, acting deputy health minister for the Novgorod oblast, speaks of a "previously announced delay in delivery" and insists that there is no shortage of vaccine. By the end of March, she says, she is expecting to receive doses for an additional 12,000 people.

Just recently, a video conference between Putin and the vaccine producer focused on the need to ramp up production. According to the president, Russia has thus far managed to produce enough Sputnik V doses for 20 million people. The industry minister has promised that another 17 million doses will be produced in April. But RDIF head Dmitriev has high hopes for overseas production, particularly in India. By the end of the year, 700 million people are to have been vaccinated with Sputnik V.

At the current pace, Russia will need three years before half the population has received at least one dose of vaccine.

Indeed, the largest problem Russia is currently facing isn't a lack of vaccine, but a lack of people willing to get it. According to a survey conducted by the independent pollsters from the Levada Center, only 30 percent of respondents are willing to receive the Sputnik V vaccine. Part of that, though, is the consequence of the Kremlin having spent months playing down the threat posed by the virus.
No Need to Wait

The state media completely ignores the excess mortality of 465,000 people since the beginning of the pandemic. The highly contagious coronavirus mutations also go largely unmentioned. And this despite the fact, says Gamaleya head Ginzburg, that Sputnik V has proven effective against the British variant.
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People waiting to be vaccinated at the GUM department store on Red Square Foto: NATALIA KOLESNIKOVA / AFP

There are no concerns in Russia of people jumping the line to get vaccinated early. Indeed, those who want to be vaccinated can generally get an appointment quickly, regardless of age or underlying health conditions. And nowhere is the wait as short as it is in Moscow.

Health officials have set up a vaccination station under the glass ceiling of the well-known GUM luxury department store on Red Square. It is midday and jazz music is playing quietly from the speakers. Young volunteers eagerly greet the few people who show up. No registration is needed, just a passport and a mobile phone number.

Ivan Sakharov, a 20-year-old economics student, says that his circle of friends is divided. Half of them, he says, don't trust Sputnik V and are wary of the side effects. "I don't want to infect my grandmother, so I'm getting vaccinated," he says.

Sakharov briefly closes his eyes as the vaccine is injected into his upper arm, and then he gets a free ice cream as a reward.

A first dose of the vaccine has been administered to 6.3 million Russians, with 4.3 million having received both. Those numbers are astoundingly low given how early the country was able to launch its vaccination campaign. Even in Germany, far more people have received their first dose. At the current pace, Russia will need three years before half the population has received at least one dose of vaccine.

One might think that the researchers at the Gamaleya Institute would be disappointed in their compatriots. But Ginzburg is philosophic. "It takes time for such a decision to mature in people," he says.

It's almost as if not just Putin, but also the Russian people, view Sputnik V more as an achievement that can help Russia's standing in the world than as a contribution to the health of the country's population. Something best observed and admired from a great distance – just like the accomplishment of the satellite back in the 1950s.

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