Good Science, Bad Marketing? Russia's Sputnik Vaccine Is Plagued By Controversy, Missteps

In January, Vasily Vlassov, 67, got sick with COVID-19. He was lucky, the Moscow academic said. His symptoms weren’t bad, and he’s had no lingering aftereffects.

He said he could get vaccinated with the homegrown, Russian-designed Sputnik V, the first coronavirus vaccine in the world to be approved by a national government for use. But he hasn’t, and doesn’t plan to any time soon. Why?

He doesn’t trust it.

“I want a better understanding of the efficacy and safety of the vaccine. Unfortunately, as more time goes on, I have less faith in the quality of it,” said Vlassov, a medical doctor, epidemiologist, and researcher of public health at Moscow’s Higher School of Economics.

Russia was first out of the gate with a vaccine, with the Kremlin hailing Sputnik V's approval in August as a triumph. But despite a later positive report in the peer-reviewed science journal The Lancet, the buzz from being first has been clouded by concerns about whether it rushed the process for political reasons.

Distribution has been plagued by marketing missteps and self-inflicted wounds, experts say. Russia’s vaccination of its own population is seriously lagging compared to other major industrial countries. Production problems have also hampered its use inside and outside Russia, and tarnished what might have been a fresh reminder of Russia’s scientific potential.

“If what Russia wanted was kudos and credit for having developed one of the first earlier, very probably safe and effective vaccines for COVID-19 -- and it would have been well-deserved kudos and credit -- a better strategy would have been transparency from the very beginning,” said Judy Twigg, a professor of political science at Virginia Commonwealth University and expert on global health issues in Russia and Eurasia.

“They’ve shot themselves in the foot here, by jumping the gun through regulatory processes to begin with, and then stretching the story about this vaccine in their public-relations campaign from the very beginning,” she told RFE/RL.

Early Doubts

Announcing his government’s approval of Sputnik V on August 11, Putin called it “a first and very important step for our country, and generally for the whole world.” He thanked the scientists involved in the effort.

The Sputnik V vaccine itself was developed by one of Russia’s most renowned and respected scientific institutes: the Gamaleya National Center of Epidemiology and Microbiology in Moscow.

A medical worker administers a dose of Sputnik V in Moscow on April 7. The vaccine was heralded as a success, even though it hadn’t undergone the typical three-phrase process of clinical tests.

Last spring, as the pandemic spread like wildfire around the world, Gamaleya announced it had developed an effective “vector” vaccine, employing an adenovirus -- a family of viruses that are known for causing common colds -- to do its work. Adenovirus vaccines are considered more stable and don’t need to be kept at super-low temperatures.

That compares with other major vaccines now being employed around the world, such as Pfizer-BioNTech and Moderna, which use a bit of genetic coding to generate an antibody response in the body.

Another U.S. vaccine, developed by Johnson & Johnson, uses the same adenovirus technology but requires just one dose. By contrast, the Gamaleya vaccine requires two doses, utilizing two separate adenoviruses to achieve what some scientists have said could be a superior outcome, with better, longer-term results.

But the Russian vaccine came under intense scrutiny from the outset, due to the fact that its promoters heralded it as a success even though it hadn’t undergone the typical three-phrase process of clinical tests, relying instead on smaller numbers of volunteers and also military personnel.

Russia also did not initially release full data sets of the trials for public and peer review, something that is standard practice.

In February, six months after the initial announcement, the first peer-reviewed study of Sputnik V, involving about 20,000 people in Russia, appeared in the British medical journal The Lancet. The study found a 91 percent effectiveness rate, which is comparable to other major vaccines.

But outside researchers and scientists have questioned the underlying data used in the published papers on Sputnik V, including what they say are inconsistencies in data provided from the Phase I and Phase II stages of the Russian clinical trial.

“Our concern is not connected to the way they work in the labs, but is how they communicate what they do: how transparent they are, how they publish data,” said Enrico Bucci, an Italian biochemist who teaches at Temple University in the United States and who has co-published letters in The Lancet and elsewhere alleging flaws in the Russian methodology.

“This is a really important point: No one is questioning the skill and integrity of the Russian scientists who were involved, and the Russian scientific institutions that have been involved,” Twigg said.

“Nobody is questioning Gamaleya’s scientific skill and integrity. It’s the politics and the PR. It’s the people at the higher levels of the organization chart who are doing a disservice to those scientists and those scientific institutions by overstating the case prematurely, for what the vaccine is and what it can do,” she said.

Sputnik V got a small dose of good news on April 15, when Russian news agencies reported the country’s health-care regulator, Roszdravnadzor, had not detected any cases of blood clots arising from the use of the shot, an issue that has dogged the AztraZeneca vaccine and which is now responsible for a pause in using the Johnson & Johnson vaccine in the United States.

'Greatest Achievement'

Russia has since approved two more vaccines: EpiVacCorona was approved in October, while CoviVac was approved in February. But it’s Sputnik V that has captured an outsize share of the public attention, due mainly to the marketing and promotion of the Russian Direct Investment Fund.

Known as the RDIF, the multibillion-dollar sovereign wealth fund has created a slick video that drew a direct line to the vaccine from its namesake: the Soviet Union’s pioneering orbiting satellite, launched in 1957.

The RDIF has also used a Twitter account to promote the shot and praise the countries that have approved its use -- but also to mock other vaccines and highlight adverse complications, such as the pause in AstraZeneca in Europe due to concerns about blood clots. It was later cleared by European regulators.

The RDIF’s chief executive, Kirill Dmitriyev, is believed to have close connections to the Kremlin, and his wife reportedly has a close relationship with one of Putin’s daughters.

The RDIF did not respond to multiple messages and e-mails from RFE/RL seeking comment.

But in a meeting with Putin on April 2, Dmitriyev again extolled the vaccine, calling it “truly the greatest achievement of Russian science” and saying that was “acknowledged by the entire world,” according to a Kremlin transcript.

Vaccination Rates, Vaccine Hesitancy

Outside of Russia, about 40 countries are using or are scheduled to start using Sputnik V. In the European Union, where regulators have asked Russia for more data on the clinical trials, only Hungary has gone ahead and started using it. Other countries -- including the Czech Republic and Slovakia, frustrated with the EU’s slow vaccination pace -- have also moved to acquire Sputnik V doses. So has Germany’s Bavaria region.

But that has been clouded by questions by European officials, including European Council President Charles Michel who last month cast doubt on Russia’s motives for promoting Sputnik V, saying Moscow had orchestrated widely publicized efforts to supply the vaccine abroad.

Experts say Russia does not have the manufacturing capability to ramp up Sputnik V production to meet national demands while also fulfilling foreign orders.

Slovakia’s agreement to acquire the vaccine was seen as another endorsement for Sputnik V. But it later emerged that it was a secret deal signed by then-Prime Minister Igor Matovic, who was later forced to step down by government officials worried about Russian influence.

Weeks later, Slovakia’s drug regulator publicly questioned the Russian vaccine and suggested there might be serious quality problems with its manufacture. The agency also said its delivered doses of Sputnik V appeared to be different than those reviewed by The Lancet.

That sparked a series of caustic posts from the RDIF-run Twitter handle, which called the Slovak announcement “fake news” and accused the agency of “an act of sabotage,” but did not provide evidence for either claim. It also demanded all the Russian doses be returned.

Vaccine contracts are often shielded from public view, Bucci said; Slovakia’s with Sputnik V was no exception.

“The problem was that it was signed before anyone could agree on it,” Bucci said.

Production Woes

The other issue clouding Sputnik V successes is production. Experts say Russia does not have the manufacturing capability to ramp up production to meet national demands for vaccinating the Russian population and also fulfill foreign orders, and that has resulted in some supply shortages.

It’s also resulted in the unusual situation of Russia having to import its own vaccine from foreign manufacturers, which include India and South Korea, something Dmitriyev pointed out to Putin.

“According to our assessment, we believe that Russia is not only one of the current leaders in the world in terms of vaccination rates, but we can provide vaccines to all people in Russia who want to be vaccinated before June using the production capacities in Russia and abroad,” he asserted.

In fact, Russia is not a leader in vaccination rates. Despite having a four-month jump on other countries’ vaccinations efforts, Russia -- as of the first week in April -- had given at least one dose of a vaccine to only around 6 percent of its population.

By comparison, more than 48 percent of Britain’s population has received at least one shot; in the United States, the figure is 37 percent; in Germany and France, the percentage is around 15 percent.

“The main factor is production: They need desperately to scale up production, and it is unclear to me and others whether they can fix this,” Bucci said.

Public opinion polls show Russians deeply skeptical of vaccines in general -- as much as 60 percent of the population.

“What ended up happening is two problems simultaneously,” Vlassov told RFE/RL. “The research was done at a very high level, research for the vaccine. But at the same time, evidently there were many elements of the research, analysis, and data that weren’t done at the same level, at a comparable level to Western counterparts.

“The second problem: marketing, unfortunately. Marketing is an incomplete science” in Russia, he said.

Also in contrast to the RDIF’s aggressive marketing outside of Russia, there are few signs of a mass-marketing or public-relations campaign within Russia. A handful of billboards have popped up in some Russian cities, featuring photographs of doctors exhorting Russians to get vaccinated.

Given the Kremlin’s control over the dominant TV channels and its influence with major national publications, the lack of a concerted national advertising campaign has perplexed observers. So has Putin’s reluctance to get his vaccine in public, before photographers and TV cameras -- an easy way to promote the effort.

In general, Vlassov said, even if there was a concerted marketing campaign within Russia, it would probably have a hard time overcoming the biggest obstacle: “In general, Russians don’t trust the government. They don’t trust state institutes, agencies,” he said. “In my opinion, it is the major reason for anti-vaccine behavior.”