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Housed in a yellowish-brown building with a sign announcing medical exams and a weathered wooden door, it looks nothing like a modern medical laboratory. But it is here, if we believe in President Vladimir Putin, that Russia has “won” the global race to develop a vaccine against COVID-19.
Hearing from vaccine developers at the Gamaleya State Center for Epidemiology and Microbiology, Putin announced in August that Russia had registered a COVID-19 vaccine for mass use, the world’s first vaccine approved for humans.
Russia called it Sputnik V, the first artificial satellite launched by the former Soviet Union to launch a space race in 1957, clearly underscoring the geopolitical importance Putin attaches to the project.
An important aspect of the president’s announcement on live television was omitted. Russia has confirmed that the vaccine has been tested in fewer than 80 people and more detailed tests are needed to assess its safety and efficacy.
After Putin announced victory, Western health experts made no secret of skepticism and disapproval: Tens of thousands of people in the West will have to undergo tests before they are allowed to use them.
The vaccine will be ready for large-scale distribution later this year or early next, officials say. Vaccines developed by competitors from the United States, the United Kingdom, and China at around the same time.
Preliminary results of the final phase of the survey will be available no earlier than November, with detailed data expected next year.
“Overall, I’d say Russia is a bit behind the leading Western candidates,” said Rasmus Bech Hansen, chief executive of Airfinity Ltd., a London-based company that oversees the development of the anti-COVID drug and vaccine. -19. – But not too much. “
Putin’s August report has already yielded an important result for the Kremlin: It has exposed a hitherto tacit effort to develop the vaccine, fueling a stream of requests from governments around the world to buy or manufacture the vaccine. At the end of September, the head of the state fund, according to the project, announced that it had received orders for 1.2 billion. dose.
“We conducted a survey in twelve key countries, which showed that Sputnik’s visibility is 80 percent,” said Kirill Dmitriev, director of the Russian Direct Investment Fund (RDIF). – But it’s not self-promotion. We are trying to save people ”. According to K. Dmitrijev, Sputnik is three to four months ahead of its competitors.
Russia, which has the fourth highest number of coronavirus cases in the world but a much lower position in health care spending per capita than most Western countries, urgently needs the vaccine. Faced with a jump in cases, Moscow, like other European capitals, has tightened restrictions. Russian labs are still working on two dozen possible vaccines.
For many years, Putin has been working to revive Russia’s power in the long-ignored life sciences, arguing that successful one-day efforts will highlight global “winners” and “losers.”
With Russia’s relatively limited involvement in global pharmaceutical innovation, the Kremlin is using vaccines as soft-power tools to gain influence in developing countries.
Named after the legendary Soviet microbiologist, Gamaleya was Russia’s largest producer of a tuberculosis vaccine. In 2015, Putin praised his Ebola vaccine. About 2,000 people were vaccinated against it in Guinea in 2017-2018, according to the Gamaleya website. But during a recent outbreak in the Democratic Republic of the Congo, people have been vaccinated with the Merck & Co. and Johnson & Johnson vaccines.
However, Gamaleya has reached his target audience. The Ebola vaccine uses adenoviruses, relatively harmless cold-causing viruses that can produce proteins that boost the immune system against specific pathogens. In addition, Gamaleya used an appropriate method to develop an experimental vaccine against another coronavirus; Middle East Fatal Respiratory Syndrome, ARRS (MERS).
When COVID-19 began to spread this year, it took Gamaleya researchers just a few weeks to adapt their ARRS adenovirus vectors to the new pathogen. After testing mice, guinea pigs and monkeys, the director of the center and leading scientists were vaccinated with this vaccine.
“My goal was not to be the first in the world, the most important thing was to protect my dearest people,” said Denis Logunov, deputy director of research at Gamaleya and head of the laboratory that developed the vaccine.
Gamaleya’s main financial sponsor is the Russian Direct Investment Fund (RDIF), whose director, K. Dmitrijev, meets regularly with Putin and works on some of the president’s most sensitive global tasks.
RDIF has tested more than two dozen test vaccines in Russia and chose Gamaleya and its human adenovirus-based technology because it has been used for many years for other diseases, Dmitriev said. In support of the project, he was vaccinated in April with his entire family.
“We are confident about the vaccine because we know the platform is incredibly safe,” he told Bloomberg Television on September 7.
As the coronavirus spread, COVID-19 also affected various officials and members of the business elite, prompting Dmitriev and Gamaleya to offer to vaccinate hundreds of influential Russians without much publicity.
“The vaccine is the only way to get back to normal life,” said Andrei Gurjev, general manager of a fertilizer manufacturer who got vaccinated in the summer. “Russia is one of the first countries to have it, and that is important.”
Only 76 people, mostly military, participated in the eight-stage trials. Another group that tested the vaccine were volunteers, who were followed up, but their data is not made public.
The research, reviewed and published in the Lancet medical journal only after Putin’s report that he approved the vaccine, continued to raise questions from researchers who said the results of some volunteers seemed too similar to be reliable.
Although the Gamaleya researchers responded to requests for comment, more information should be released, said biologist Enricas Buccis of the University of Philadelphia Temple.
“We would like to have access to all the data records,” said Buccis, one of the authors of a letter to the journal criticizing Gamaleya’s research. “The requested data was not provided in a response from the Russian investigators to the Lancet,” he said.
COVID-19 vaccine policy, and the decisions that decide which countries will receive them first, confuse an area where researchers tend to work relatively closely. After US President Donald Trump hinted that the vaccine could be approved before the Nov.3 election, drug makers have come together to promise to meet the standards and avoid hasty action.
On the other hand, the developers of the Sputnik vaccine urged Putin to bring his vaccine into the public domain. After the Russian health minister visited the Gamaleya laboratories in early April, the project was presented to Putin in anticipation of his support. A few days later, during a television video conference, the center’s director, Alexander Gintsburg, asked the president to approve an expedited vaccine approval process based on promising data from animal testing.
“We will do everything possible to speed up administrative procedures,” Putin said.
As of August 11, the Gamaleya vaccine was just one of hundreds of projects around the world, lagging behind vaccines developed by leaders like Moderna Inc., the University of Oxford in collaboration with AstraZeneca Plc. And Pfizer Inc. and Grupo BioNTech SE. However, after Putin’s announcement of the registration of Sputinik V, the situation has changed.
“We are the first to register a vaccine against a new coronavirus infection,” Putin said.
“The vaccine creates sustainable antibodies and cellular immunity,” he said during a videoconference meeting with members of the government. – I know it very well, because one of my daughters had that vaccine. In that sense, he participated in the experiment. “
Following this presidential announcement, K. Dmitrijev, director of RDIF, gave interviews to several international broadcasters. Russian state television has shown high-ranking officials and politicians vaccinating and delivering the first small batches of vaccines to regions of the country. More than 6,000 people have been vaccinated since the vaccine was approved in August.
Although China has also introduced the vaccine for use outside of clinical trials, it is not announcing its approval. Most of the vaccinations were done in the military, where inoculation of the experimental vaccine is often used for national security reasons.
“In China, we see greater compliance with standards and transparency about what is happening. RB Hansen, CEO of Airfinity.” After all, it is in the interest of the state itself.
Meanwhile, Putin is stubbornly speeding up the process by calling for an ad campaign to help Russians choose which vaccine to vaccinate. RDIF has announced agreements with India, Brazil and Mexico for the supply of vaccines or the production of vaccines on site. Putin praised the vaccine when speaking at the United Nations (UN) and offered the Russian vaccine to UN staff for free.
To strengthen their positions, RDIF officials promise to publish preliminary data on the 25,000-30,000 people participating in the current third phase of the test in late October or early November. The “mass vaccination” will begin before that date, said K. Dmitrijev.
Industry leaders are working to figure out how to achieve what was promised. Fewer than 150,000 doses have been generated, although the RDIF aims to produce 10 million doses by December. per month.
“When our speakers are talking about another 100 million. Demand for doses is a race to what will be the news,” said Alexei Repik, whose R-Pharm Group has signed a contract to make Sputnik V. “We still don’t have enough vaccines for meet our own needs. “
Despite the loud publicity for the vaccine, Putin himself has not tried it. Before meeting him face-to-face, any visitor must quarantine themselves or sit at an appropriate distance during official events.
Experts warn: caution must be exercised. Joint investigation and financing mechanism COVAX, 18 billion. A worthwhile initiative to allow countries to invest in various potential vaccines and ensure early access to approved drugs will have to be based on relevant test results demonstrating efficacy and safety, as well as state experience, to “regulate” the vaccine. Russian, Seth Berkley said. Gavi, CEO of The Vaccine Alliance, partner in international operations.
“But we are talking to them,” he said. “And I think we need to listen to scientists, not politicians, on whether or not their product will ultimately be useful.”
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