Putin, who is known to his secret family, said one of his daughters had already been vaccinated on initial tests and felt “fine” with claims to protect the vaccine.
Now, as the coVID-19 wave hits the country, with a record number of new infections and deaths, the vaccine, called Sputnik V, is far from available to the general public.
Russia has reached a bleak level of 1. 5 million instances and at least 26,269 deaths, experts have already questioned Russia’s counting methods.
Russia approved the vaccine after testing it on dozens of subjects on a non-blind examination and before Phase 3 trials, which must identify its protection and efficacy, which led to the skepticism of the foreign network and accusations that it could have fired the gun. political gain.
Alexander Gintsburg, director of the Gamaleya Institute that developed the vaccine, told CNN in an exclusive interview last week at the Valdai Discussion Club, a Moscow-based expert group where Putin makes an appearance, that another 17,000 people have participated in Phase 3 trials so far. stated that so far only 6,000 have earned the two doses needed to complete vaccination.
The vaccine is indicated for use in others aged 18 to 60, according to its instructions, as no large-scale trials have been conducted on other age equipment, but despite this, Gintsburg said other people over the age of 60 could simply continue to use the vaccine. .
International experts in virology question Russia’s claims that security has been proven. “People who have been immunized with this vaccine will not know if they will be or will expand a serious disease until they find the virus,” Konstantin Chumakov, senior virologist at the Global Virus Network, told CNN.
“And to do that, you want to vaccinate a lot of other people and just wait for them to swell up and see if they will have a lower incidence or if they will have a more serious illness. There is simply nothing that can update clinical trials. “
By comparison, as of October 26, BioNTech-Pfizer reported that it had recruited 42,113 participants from a possible 44,000 in the Phase 3 trial in the United States for its candidate vaccine, with 35,771 more people receiving its dose at the time.
Moderna, the first company to launch Phase 3 clinical trials in the United States on a COVID-19 vaccine, said Thursday that another 25,650 people gained their injection so far among the approximately 30,000 registered participants.
The Russian vaccine “is probably two to three months late,” Chumakov said. “Modern and Pfizer have practically finished recruiting patients and are now in the phase of examining the onset of the disease in immune and placebo subjects. “
The immediate progression and approval of Sputnik V, explained by the Gamaleya Institute, was imaginable because it is based on two of its past progressions, Ebola vaccines and Middle East respiratory syndrome, MERS. guinea with only 2,000 people.
Chumakov notes that none of these vaccines have been completely legal through foreign agencies or sufficiently proven to say it is effective and safe, and the Russian Ebola vaccine was not tested in Guinea until after the outbreak.
“This particular institute has developed several prototype vaccines, I wouldn’t call them vaccines,” Chumakov said. “I don’t think this institute has developed a vaccine in over 30 years. They are very intelligent in creating prototypesArray . . . However, I don’t think they like to bring products to market. “
Russia’s own estimates of its ability to mass produce the vaccine vary significantly depending on who requests it.
In July, the director of the Russian Direct Investment Fund, Kirill Dmitriev, said the sovereign fund planned to produce more than 30 million doses by the end of 2020. But Russian Trade and Industry Minister Denis Manturov said earlier this month that the numbers were “impossible. “
“Having 30 million doses until the end of the year is impossible, it doesn’t make sense,” Manturov said in an interview with Bloomberg TV.
The Department of Industry and Commerce did not provide CNN with the exact number of doses made so far, but said the purpose of increasing production to 300,000 doses to the end. October and 2. 3 million through the end of the year.
Gintsburg told CNN that Russia could produce about five million per month by December, and said it would receive enough doses to vaccinate 70% of the Russian population in about a year.
But unless Russia particularly increases production through five million doses according to the month, the country will only produce about 60 million doses in that time period, meaning it would vaccinate about 30 million other people well with any of the extra doses. 146 million Russians.
One wonders whether Russia will increase production to achieve the newest targets, however, more and more sites are preparing to be put online to produce Sputnik V in the coming weeks while Phase 3 testing is being conducted.
All Russian regions have won pilot batches of Sputnik V, the Ministry of Health announced in late September, but at least 10 regions reported that the first source was low, between 42 and 44 doses, according to a CNN account based on statements from fitness officials and media reports.
Authorities in the Yamal-Nenets region, which won 42 doses of the vaccine, told TASS that delivery is confusing due to “special temperature situations during shipping and storage. “
Most coronavirus vaccine pioneers require a garage at below-zero temperatures, leading to more demanding situations for governments to identify chains from functional sources. The Pfizer vaccine should be kept at -70 degrees C (-94 degrees F), while the Modern vaccine should be kept at -20 degrees C (-4 degrees F) and Sputnik V at -18 degrees C (-0. 4 degrees Fahrenheit).
“I have a lot of respect for them as scientists, but unfortunately they don’t appreciate the magnitude of the disruptions they will face to bring this product to market,” Chumakov said.
“There is a wonderful distance between the experimental pattern that can be ready in the lab and its shipment to mass production and distribution,” he added. “I think it’s a very arrogant attitude that, well, we just synthesized it in two weeks and it’s over, we have a vaccine. They have a prototype. And until it’s tested, there’s still a prototype. “
Public Frenzy
Although the Phase 3 essay is in its infancy, senior Russian officials have made public announcements about their vaccines in meetings with Putin. Clips of state television broadcast by Defense Minister Sergei Shoigu taking the photo at one of the clinics. In early October, Putin announced that dozens of his relatives and running around him had been vaccinated.
Putin did not specify which of his daughters took the vaccine because he rarely calls them by name, even referring to them as “these women” when he asked last year about their corporations in Russia. Alexey Venediktov, a well-connected editor of Echo Moscow Radio Station, said Katerina Tikhonova, was widely seen as Putin’s youngest daughter, the one who shot dead in the first trials.
Gintsburg in the past told CNN that the Gamaleya Institute had not won any commando and had no “connection to the Kremlin,” rejecting a suggestion that there was political tension to boost vaccine production.
Tikhonova heads the Innopraktika organization, which says its project is to introduce clinical advances around the world and has a long list of key Russian leaders such as Gazprom, Rosatom and Transneft as board members. Kirill Dmitriev of THE RDIF is also a board member. Directors and his wife, Natalia Popova, is the deputy director of Innopraktika.
Popova told state television that she had become aware of “how the vaccine was born in the closed laboratories of the Gamaleya Institute” and that she was among the first people to obtain Sputnik V, even before her husband.
Russian officials and the state media have also touted Sputnik V as astonishing against other Western vaccines. THE DRIF has stated that its drug is “based on a well-researched platform of human adenoviral vectors with proven protection and efficacy”, unlike those based on mRNA and chimpanzee adenovirus, such as the British vaccine. Astrazeneca.
Earlier this month, British officials criticized Russia for what was a disinformation crusade opposed to the AstraZeneca vaccine, called “monkey vaccine” through some Russians, after a wave of social media posts with unfounded memes suggesting that the drug can turn other people into monkeys. .
The Kremlin has denied the allegations and THE DRIF has said it condemns social media posts attacking the vaccine. RDIF’s portfolio company, R-Pharm, signed an agreement with AstraZeneca this summer to produce the British vaccine in Russia.
“I don’t think this vaccine is better or worse than other similar products, because many adenovirus-based vaccines have been in progression lately and are being tested. So this one is probably fine, but we want to be aware and we don’t have yet,” Chumakov said, adding that some vaccines are about to be authorized, lately there is no fully authorized and widely used adenovirus vaccine.
In addition to public relations, Russia aspires to economic benefits.
Last week, Putin told the leaders of russia’s PTR or Union of Industrialists and Entrepreneurs, Russia’s largest business pressure group, that Sputnik V “is a smart deal and that the humanitarian component is clear,” adding that it could generate $100 billion in profits worldwide, news firm RIA Novosti reported.
RDIF announced that it had entered into agreements with several countries, including India, Brazil and Egypt, to obtain millions of doses of Sputnik V, but the fund may face licensing difficulties in expanding Sputnik production globally due to other standards.
“I think in the United States, in Europe, in countries that adhere to foreign product development, testing and certification standards, I would definitely not fly, it’s definitely a gamble,” Chumakov said.
However, country officials say they plan to implement mass vaccination in the coming months, even though national surveys show that most Russians do not need to be vaccinated.
A Russian who hasn’t taken the Sputnik V vaccine so far is the president, and his spokesman told CNN he’s still thinking about it.
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