Tucked away in a sand-brick building with an office advertising medical exams and a dirty wooden door, it doesn’t look like a state-of-the-art medical lab. But it was here that, if you believe that President Vladimir Putin, Russia won the global race to develop a vaccine against Covid-19.
Praising developers at the state-run Gamaleya National Center for Epidemiology and Microbiology, Putin declared in August that Russia had registered a vaccine for public use, making it the first vaccine in the world to gain such authorization. Russia named it Sputnik V after the Soviet-era satellite that started the space race in 1957, a clear sign of the geopolitical importance Putin has placed on the project.
The president’s live TV ad missed a key point. Russia approved the vaccine after trials in fewer than 80 people, and larger trials are needed to assess safety and efficacy that are underway. Putin’s claim of victory has met with skepticism and disapproval from health experts in the West, where the vaccines will have to be tested on tens of thousands of subjects before being licensed.
The vaccine will be ready for wide distribution later this year or early next, officials say. That’s roughly the same schedule as the rivals’ shots in the US, UK and China. Initial results of the final stage studies will not be ready until November, with full data expected next year.
“Overall, I would say that Russia is a bit behind the leading Western candidates,” said Rasmus Bech Hansen, CEO of Airfinity Ltd., a London-based company that tracks Covid-19 drug and vaccine development, ” but it is not far behind. “
Putin’s August announcement already yielded a key result for the Kremlin: It put vaccine efforts previously under Russia’s radar on the map, sparking a flood of requests from governments around the world to buy or produce. the vaccine. In late September, the head of the state fund backing the project said he had orders for 1.2 billion doses.
“We did a survey in 12 key countries and Sputnik’s name recognition is 80%,” Kirill Dmitriev, director of Russia’s Direct Investment Fund, said in an interview. “But it is not public relations. We are trying to save people.” He says that Sputnik is three or four months ahead of its rivals.
With the fourth highest number of cases in the world, but with a health expenditure per capita much lower than in most Western countries, Russia needs a vaccine. Faced with an increase in cases, Moscow has joined other European capitals to tighten restrictions. Russian labs are working on another two dozen candidates.
For years, Putin has lobbied to rebuild Russia’s prowess in long-neglected life sciences, arguing that success could one day determine global winners and losers. With little footprint in global pharmaceutical innovation, the Kremlin has used vaccines as soft-power tools to gain influence in developing countries.
Named after a legendary Soviet microbiologist, Gamaleya was the largest producer of a tuberculosis vaccine in Russia. In 2015, Putin praised the development of an Ebola vaccine. About 2,000 people received it in Guinea in 2017-2018, according to the Gamaleya website. But in the recent outbreak in the Democratic Republic of the Congo, new vaccines from Merck & Co. and Johnson & Johnson were used.
Still, Gamaleya had made his way with the audience that mattered at home. The Ebola vaccine uses adenoviruses, relatively harmless cold viruses, which can produce proteins that boost 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 to spread earlier this year, it took Gamaleya scientists only a few weeks to adapt their MERS adenovirus vectors for the new pathogen. After testing in mice, guinea pigs and monkeys, the center director and key scientists injected themselves with the vaccine.
“My goal was not to be the first in the world; it was to protect my loved ones, “Denis Logunov, Gamaleya’s deputy director of research and head of the laboratory that developed the vaccine, said in July.
Gamaleya garnered key financial backing from Russia’s Direct Investment Fund, whose boss, Dmitriev, meets regularly with Putin and works on some of the president’s most sensitive global assignments. RDIF studied more than two dozen vaccine initiatives in Russia and chose Gamaleya and its human adenovirus-based technology because it had been used for years for other diseases, Dmitriev said. He accepted the project and received photos together with his family in April.
“We trust the vaccine because we know the platform is incredibly safe,” he told Bloomberg Television on September 7.
As the coronavirus spread, disgusting officials and members of the business elite Dmitriev and Gamaleya quietly offered injections to hundreds of powerful people in Russia.
“The vaccine is the only way to get back to normal life,” said Andrey Guryev, an executive director of fertilizers who was inoculated over the summer. “It is important that Russia is one of the first countries to have it.”
The early-stage trials included only 76 people, mostly military personnel. Others who received it were formally enrolled as volunteers for the trials and monitored, but no data on them has been published.
The research, peer-reviewed and published in the Lancet medical journal only after Putin’s approval announcement, still raised questions from scientists who said the results of some volunteers seemed too similar to be plausible. While Gamaleya specialists have responded, more details should be provided, said Enrico Bucci, a biologist at Temple University in Philadelphia.
“We would like to have access to the full data record,” said Bucci, one of the authors of a letter to the journal criticizing Gamaleya’s study. “The data we asked for was not provided” in the response the Russian researchers gave to The Lancet, he said.
The policy of Covid-19 vaccines, and which countries will get them first, has shaken a field where scientists normally work in relative obscurity. After US President Donald Trump hinted that a vaccine could be authorized before the Nov.3 election, drug makers joined in a pledge to uphold safety standards and avoid shortcuts.
Sputnik developers, on the other hand, encouraged Putin to move his vaccine into the public sphere. After a visit to the Gamaleya laboratories by Russia’s health minister in early April, the project was brought to Putin to seek his support. In a televised video meeting a few days later, the center’s director, Alexander Gintsburg, asked the president to sign an expedited approval process, based on promising animal data.
“We will do everything possible to speed up administrative procedures,” Putin replied.
Before August 11, the Gamaleya vaccine was just one of hundreds of projects around the world, lagging behind pioneers like Moderna Inc., the University of Oxford working with AstraZeneca Plc, and the Pfizer Inc. partnership. 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 long-lasting antibodies and cellular immunity,” he told government officials at the televised meeting. “I know it well because one of my daughters has received this vaccine. In that sense, she participated in the experiment. “
Dmitriev, the head of RDIF, followed with a whirlwind of appearances on international broadcasts. Russian state television featured senior officials and politicians receiving shots and deliveries of the first small issues to regions across the country. More than 6,000 people have received the vaccines since their approval in August and are reporting using a special app.
While China has also released a vaccine for use outside of clinical trials, it has not claimed approval. Many of those who receive vaccines are in the military, where experimental vaccines have often been used for national security reasons.
“In China, we see more adherence to standards and transparency about what is happening,” said Airfinity’s Hansen. “Ultimately, it is in the state’s own interest.”
Meanwhile, Putin goes ahead and orders an ad campaign to help Russians choose which vaccine to use. RDIF announced agreements with India, Brazil and Mexico to supply or produce the vaccine locally. Putin touted the vaccine in a speech to the United Nations, offering to provide it free of charge to the organization’s staff around the world.
To help strengthen their case, RDIF officials say they will release provisional data on between 25,000 and 30,000 people in the phase 3 trial that is taking place in late October or early November. The “mass vaccination” will start before then, Dmitriev said.
Industry leaders are struggling to figure out how to deliver what was promised. Fewer than 150,000 doses have been produced, although RDIF says it is targeting 10 million a month by December.
“It’s just a race to make news when our speakers say there is demand for another 100 million doses,” said Alexey Repik, whose R-Pharm Group has been contracted to produce Sputnik V. “We don’t have enough vaccine to cover ours needs. still “.
Despite the hype, Putin has not tested the vaccine himself. Visitors must quarantine themselves before meeting him face-to-face or sitting remotely at official events.
Experts share his caution. Covax, the $ 18 billion initiative to roll out future Covid-19 vaccines around the world, would need to see the results of a full efficacy and safety trial with adequate potency along with a regulatory review to “participate” in the vaccine from Russia, said Seth Berkley, official executive director of Gavi, the Vaccine Alliance, one of the partners in the international effort.
“But we’re talking to them,” he said, “and I think if they have a product that will ultimately be useful or not, science will have to say it, not politics.”
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