Putin, who is a well-known secret about his family, said one of his daughters had already been inoculated as part of an early-stage trial and felt “good” for experiencing large-scale vaccine safety claims.
Russia has passed the alarming target of 1.5 million cases and at least 26,269 deaths, although experts have previously questioned Russia’s calculation methods.
Russia approved the vaccine after trying dozens of subjects in blind study and ahead of stage trials, after allegations from the international community that it could pull atheism and use a gun for political purposes. Benefits.
Alexander Ginsberg, head of the Gamlea organization that developed the vaccine, told CNN in an exclusive interview with CNN last week at the Valdai Discussion Club that the Moscow-based think tank where Putin frequently represents that 17,000 people took part in the Phase 3 trial, but admitted to completing the vaccination. So far only 6,000 have received both doses.
The vaccine is indicated for use in people aged 18-60 years, according to its instructions, and no large-scale tests have been performed on other age groups. But despite this, Ginsberg said people over 60 can still take it.
International virology experts cast doubt on Russia’s proven safety claims. “People who have been vaccinated with this vaccine may not know they will be safe until they are exposed to the virus or develop a serious disease,” Konstantin Chumakov, a top virologist at the Global Virus Network, told CNN in an interview.
“And to do this, you need to vaccinate whole people and wait until they get infected and see if they have a lower incidence that they will have a more serious disease. There is nothing that can change clinical trials.”
Of the approximately 30,000 registered participants, 25,650 received their second shot, Moderna, the first company to launch U.S. Phase 3 clinical trials of the Covid-19 vaccine, said Thursday.
The Russian vaccine is “probably two to three months behind,” Chumakov said. “Moderna and Pfizer basically ended patient registration and are now in the observation phase seeing disease incidence in placebo and immunocompromised individuals.”
The rapid development and approval of Sputnik V is possible, as it is based on their previous two developments, Ebola and MERS, the vaccines for Middle East respiratory syndrome, explains the Gamalaiya Institute. Earlier it was reported in Gintsburg that the Ebola vaccine was approved for trial on only 2,000 people in Guinea.
Chumkov notes that neither vaccine is fully authorized by international organizations or has been sufficiently tested to be effective and safe, and that the Russian Ebola vaccine was given only after an outbreak in Guinea.
“This particular organization, they have developed several prototype vaccines. I will not call them vaccines.” “I don’t think this organization has developed a vaccine in the last 30 years, you know, 30 years. They’re very good at developing prototypes … but I don’t believe they have any experience in bringing products to market.”
Product challenges
Russia’s own estimates of their ability to mass-produce vary greatly depending on who you ask.
The industry and trade ministry did not give CNN an exact figure on how many doses have been made so far but said it aimed to increase production to 300,000 doses by the end of October and 2.3 million by the end of the year.
Ginsberg told CNN. Russia could produce about 5 million a month by December, which he said would be enough to get enough doses for 70% of the Russian population to be vaccinated in about a year.
But unless Russia significantly increases production from 5 million doses a month, the country will be able to produce about 60 million doses in this period alone, meaning it will be able to vaccinate about 30 million people with both doses – more than 146 million Russians.
It is questionable whether Russia will be able to increase production to meet recent targets, but more sites are preparing to go online to build Sputnik V next week while Phase 3 proceedings are underway.
The pilot batch of Sputnik V has been received in all Russian regions, the Ministry of Health said in late September. But according to CNN, based on statements from health officials and media reports, at least 10 regions have reported relatively low first supply between 42 and 44 doses.
Most coronavirus vaccine front-runners require storage at deep stable temperatures, imposing additional challenges on governments to establish a functioning supply chain. The Pfizer vaccine must be stored at -70 ° C (-94 ° F), while the modern vaccine must be stored at -20 ° C (-4 ° F) and the Sputnik V-18 (C (-0.4 ° F). .
“As scientists, I have full respect for them, but unfortunately they do not appreciate the scale of the issue that they will face in bringing this product to market,” Chumakov said.
“There is a huge gap between experimental samples that can be prepared in the laboratory and brought into mass production and distribution.” “I think it’s a very vague trend that, well, we’ve synthesized it in just two weeks and we’re going here, we have a vaccine. They have a prototype. And until it’s tested. Until then, it remains a prototype. ”
PR rage
The lack of participants and data in Sputnik insurance compensates for the PR.
Although the trial is still in its early stages, high-ranking Russian officials have publicly announced their vaccinations in meetings with Putin. State TV ran clips of Defense Minister Sergei Shoigu, including a shot at a clinic. In early October, Putin announced that dozens of his relatives and employees working around him had been vaccinated.
Putin did not mention which of his daughters he vaccinated because he rarely calls them by name, even referring to them as “these women” when asked last year about his business in Russia. Katrina Tikhonova, considered Putin’s youngest daughter, was the only one to receive shots in early-stage trials, said Alexei Venediktov, chief-affiliated editor of Moscow’s radio station Echo.
Ginsberg had earlier told CNN that the Gamalea Institute had not received any notice and that it had “no links to the Kremlin”, rejecting the suggestion that there was political pressure to speed up vaccine production.
Tikhonova is the head of the Inopractica Institute, which says its aim is to bring scientific development to global development and has a long list of heads of major Russian state enterprises as members of the board. Kiril Dimitriev of RDIF is also a member of the board, and his wife Natalia Popova is the Deputy Director of Inoprak Katika.
Popova told state TV that she was able to see “how the vaccine was born in the closed laboratories of the Gamalya Institute” and was one of the first to receive Sputnik V even beyond her husband.
Russian officials and the state media also promoted Sputnik V as better than some other Western vaccines. RDIF has repeatedly stated that its drug is based on a well-studied human adenovirus vector platform with proven safety and efficacy, based on mRNAs and chimpanzee adenoviruses such as the UK’s AstraZeneca vaccine.
The Kremlin has denied the allegations and the RDIF has said it condemns social media posts attacking the vaccine. RDIF’s portfolio firm R-Firm also struck a deal with AstraZeneca this summer to produce a British vaccine in Russia.
“I don’t think this vaccine is better or worse than other similar products because there are a lot of adenovirus-based vaccines in development right now and they’re being tested. So this one is probably OK – but we need to have this data and We don’t have it yet, “Chumakov said, adding that although some vaccines are close to being licensed, there is no fully authorized and widely used adenovirus vaccine to date.
Economic incentives
Aside from the PR win score, Russia is aiming for economic gain.
Last week, Putin told RSPP or the leaders of the Russian Union of Industrialists and Entrepreneurs in Russia’s largest business lobby that Sputnik V “is a good business and the humanitarian component is clear”, adding that it could generate રાજ્ય 100 billion in state revenue worldwide. Run news agency RIA Novosti has reported.
RDIFA announced that it has reached deals with several countries, including India, Brazil and Egypt, to supply millions of doses of Sputnik V, but the fund may face licensing difficulties in an effort to expand Sputnik production due to different standards.
“I think in the United States, in Europe, in countries that really adhere to the international rules of product development, testing and licensing, this will not fly, it is definitely gambling,” Chumakov said.
However, country officials say they plan to bring in mass vaccinations in the coming months, even though state polls show that most Russians do not want to be vaccinated.
A Russian who has not yet received the Sputnik Vine vaccine is the president, his spokesman told CNN, adding that he was still thinking about it.
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