Russia’s version of America’s Operation Warp Speed vaccine project is located far from the Kremlin on a sleepy side street on the outskirts of Moscow.
Tucked in a sandy-brick building with an office advertising medical tests and a dingy wooden door, it doesn’t look like a cutting-edge medical laboratory. But it was here that, if you believe President Vladimir Putin, Russia won the global race to develop a vaccine against COVID-19.
Praising the developers at the state-run Gamaleya National Center of Epidemiology and Microbiology, Putin declared in August that Russia had registered a shot for public use, making it the first vaccine worldwide to gain such clearance. Russia named it Sputnik V after the Soviet-era satellite that set off the space race in 1957 — a clear signal of the geopolitical importance Putin has attached to the project.
The president’s live-TV announcement glossed over one key point. Russia approved the vaccine after tests in fewer than 80 people, with larger trials needed to assess safety and effectiveness just underway. Putin’s claim of victory has met with skepticism and disapproval from health experts in the West, where shots will have to be tested in tens of thousands of subjects before being cleared.
The vaccine will be ready for wide distribution late this year or early next, officials say. That’s roughly the same schedule as shots from rivals in the U.S., U.K. and China. Initial results from final-stage studies won’t be ready until November, with full data expected next year.
“Overall I’d say Russia is a little bit behind the leading Western candidates,” said Rasmus Bech Hansen, CEO of Airfinity Ltd., a London-based firm that tracks COVID-19 vaccine and drug development, “but not far behind.”
Putin’s August announcement has already delivered one key result for the Kremlin: It put Russia’s previously under-the-radar vaccine efforts on the map, triggering a rush of requests from governments around the world to buy or produce the shot. By late September, the head of the state fund backing the project said it had orders for 1.2 billion doses.
“We did a survey in 12 key countries and name recognition for Sputnik is 80 percent,” Kirill Dmitriev, head of the Russian Direct Investment Fund, said in an interview. “But it’s not PR. We’re trying to save people.” He says Sputnik is three to four months ahead of rivals.
With the fourth-largest number of cases in the world but per capita health care spending far lower than in most Western countries, Russia needs a vaccine. Facing a spike in cases, Moscow has joined other European capitals in tightening restrictions. Russian labs are working on another two dozen candidates.
For years, Putin has pushed to rebuild Russia’s prowess in long-neglected life sciences, arguing success might one day determine global winners and losers. With little presence in global pharma innovation, the Kremlin has used vaccines as soft-power tools to win influence in developing countries.
Named for a legendary Soviet microbiologist, Gamaleya was Russia’s biggest producer of a tuberculosis vaccine. In 2015, Putin praised its development of a shot against Ebola. About 2,000 people received it in Guinea in 2017-2018, according to Gamaleya’s website. But in the recent outbreak in the Democratic Republic of Congo, new inoculations from Merck & Co. and Johnson & Johnson were used.
Still, Gamaleya had broken through with the audience that mattered at home. The Ebola vaccine used adenoviruses, relatively harmless cold viruses, that can make proteins that stimulate the immune system against specific pathogens. Gamaleya also used the technique to develop an experimental inoculation against another coronavirus, the deadly Middle East respiratory syndrome.
As COVID-19 began spreading earlier this year, it took Gamaleya scientists only a few weeks to adapt their MERS adenovirus vectors for the new pathogen. After testing on mice, guinea pigs and monkeys, the center’s director and key scientists injected themselves with the vaccine.
“My goal wasn’t to be first in the world; it was to protect my loved ones,” Denis Logunov, a deputy research director at Gamaleya and head of the lab that developed the vaccine, said in July.
Gamaleya got a key financial backer in the Russian Direct Investment Fund, whose chief, Dmitriev, meets regularly with Putin and works on some of the president’s most sensitive global assignments. RDIF studied more than two dozen vaccine efforts in Russia and chose Gamaleya and its human adenovirus-based technology because it had been used for years for other illnesses, said Dmitriev. He embraced the project, getting shots along with his family in April.
“We are confident in the vaccine because we know the platform is incredibly safe,” he told Bloomberg Television Sept. 7.
As the coronavirus spread, sickening officials and members of the business elite, Dmitriev and Gamaleya quietly offered shots to hundreds of Russia’s powerful people.
“The vaccine is the only way to return to normal life,” said Andrey Guryev, a fertilizer CEO who was inoculated over the summer. “It’s important that Russia is one of the first countries to have it.”
Early-stage trials included just 76 people, mostly military personnel. Others who received it were formally signed up as volunteers for trials and monitored, but no data on them have been released.
The research, peer-reviewed and published in the Lancet medical journal only after Putin’s approval announcement, still raised questions from scientists who said results from some volunteers appeared too similar to be plausible. While the Gamaleya specialists have responded, more details should be released, said Enrico Bucci, a biologist at Temple University in Philadelphia.
“We would like access to the full data record,” said Bucci, one of the authors of a letter to the journal criticizing the Gamaleya study. “The data we were asking for were not provided’’ in the response the Russian researchers made to the Lancet, he said.
The politics of COVID-19 vaccines — and which countries will get them first — have roiled a field in which scientists normally work in relative obscurity. After U.S. President Donald Trump hinted that a vaccine might be authorized before the Nov. 3 election, drugmakers banded together in a pledge to uphold safety standards and avoid shortcuts.
Sputnik’s developers, on the other hand, encouraged Putin to move their vaccine to the public sphere. After a visit to Gamaleya’s labs by Russia’s health minister in early April, the project was taken to Putin to seek his support. On a televised video meeting a few days later, center Director Alexander Gintsburg asked the president to sign off on an accelerated approval process, based on promising animal data.
“We’ll do everything to accelerate the administrative procedures,” Putin replied.
Before Aug. 11, Gamaleya’s vaccine was just one of hundreds of projects worldwide, trailing front-runners including Moderna Inc., the University of Oxford working with AstraZeneca PLC, and the partnership of Pfizer Inc. and BioNTech SE. Putin’s announcement of the approval of Sputnik V seemed to change all that.
“We are the first to register one,” Putin said. “It forms lasting antibody and cellular immunity,” he told government officials in the televised meeting. “I know that well because one of my daughters has had this vaccination. In that sense, she participated in the experiment.”
Dmitriev, the RDIF chief, followed with a whirlwind of international broadcast appearances. Russian state television featured top officials and politicians getting the shots and deliveries of the first small numbers to regions around the country. More than 6,000 people have gotten the shots since approval in August and are reporting back using a special app.
While China has also released a vaccine for use outside clinical trials, it hasn’t claimed approval. Many of those getting shots are in the military, where experimental immunizations have often been used for national security reasons.
“In China, we see more adherence to standards and transparency about what’s going on,” Airfinity’s Hansen said. “Ultimately it’s in the state’s own interest.”
Meanwhile, Putin is pushing ahead, ordering an advertising campaign to help Russians choose which vaccine to use. RDIF announced deals with India, Brazil and Mexico to supply or produce the vaccine locally. Putin touted the shot in a speech to the United Nations, offering to provide it for free to the organization’s staff worldwide.
To help strengthen their case, RDIF officials say they will release interim data from about 25,000-30,000 people in the phase 3 trial now underway at the end of October or early November. “Mass vaccination” will begin before that, Dmitriev said.
Industry leaders are struggling to figure out how to produce what’s been promised. Fewer than 150,000 doses have been made, though RDIF says it’s targeting 10 million a month by December.
“It’s just a race to make news when our speakers say there’s demand for another 100 million doses,” said Alexey Repik, whose R-Pharm Group has signed on to produce Sputnik V. “We don’t have enough vaccine to cover our own needs yet.”
Despite the hype, Putin hasn’t tried the vaccine himself. Visitors must quarantine before meeting him face-to-face or sit at a distance in official events.
Experts share his caution. Covax, the $18 billion initiative to deploy future COVID-19 vaccines around the world, would need to see results from a full, properly powered efficacy and safety trial along with regulatory review to “engage” on Russia’s vaccine, said Seth Berkley, chief executive officer of Gavi, the Vaccine Alliance, one of the partners in the international effort.
“But we are talking to them,” he said, “and whether they have a product that will ultimately be useful or not I think will have to be told by the science, not by the politics.”