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Putin, who is famous for being secretive about his family, said one of his daughters had already been vaccinated as part of early-stage trials and he felt “good” to increase the vaccine’s safety claims.
Russia has passed a grim milestone of 1.5 million cases and at least 26,269 deaths, although experts have cast doubt on Russia’s counting methods.
Russia approved the vaccine after testing it on several dozen subjects in an unblinded study and prior to Phase 3 trials, which are key to establishing its safety and efficacy, prompting skepticism from the international community and accusations that there could be jumped down the political track. Profits.
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 think tank where Putin often makes an appearance, that 17,000 people participated in Phase 3 trials but acknowledged that only 6,000 so far have received both doses necessary to complete vaccination.
The vaccine is indicated for use in people 18 to 60 years of age, according to its instructions, as large-scale trials have not been conducted in other age groups. But despite this, Gintsburg said people over 60 can still take it.
International virology experts question Russia’s claims of proven safety. “People who were immunized with this vaccine will not know whether they will be protected or develop serious illness until they find the virus,” Konstantin Chumakov, a senior virologist at the Global Virus Network, told CNN in an interview.
“And to do this, you need to immunize many people and wait until they become infected and see if they will have a lower incidence or a more serious disease. There is nothing that can replace clinical trials.”
Moderna, the first company to start U.S. phase 3 clinical trials of a Covid-19 vaccine, said Thursday that 25,650 people have received their second injection out of about 30,000 enrolled participants.
The Russian vaccine “is probably two to three months late,” Chumakov said. “Moderna and Pfizer basically finished enrolling patients and are now in the observation phase to look at disease incidence in placebo and immunized individuals.”
The rapid development and approval of Sputnik V, explains the Gamaleya Institute, was made possible because it is based on two of its previous developments, the vaccines for Ebola and MERS, the Middle East respiratory syndrome. The Ebola vaccine, Gintsburg said previously, was approved for trials in Guinea in just 2,000 people.
Chumakov notes that none of these vaccines have been fully licensed by international bodies or tested enough to say that they are effective and safe, and the Russian Ebola vaccine was tested in Guinea only 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 the last 30 years. They are very good at developing prototypes … but I don’t think they have experience bringing products to market.”
Production challenges
Russia’s own estimates of its ability to mass produce the vaccine vary widely depending on who you ask.
The Industry and Commerce Ministry did not provide CNN with the exact figure for how many doses have been made so far, but said the goal was to increase production to 300,000 doses by the end of October and 2.3 million by the end of the year.
Gintsburg told CNN that Russia could produce about 5 million a month in December, which, he said, would make it possible to obtain enough doses to vaccinate 70% of the Russian population in about a year.
But unless Russia significantly raises the production of 5 million doses a month, the country will only be able to produce about 60 million doses in this time frame, which means that it could effectively vaccinate about 30 million people with both doses, of more than 146 million Russians.
It remains questionable whether Russia will be able to ramp up production to meet the latest targets, but more sites are preparing to go online to produce Sputnik V in the coming weeks while Phase 3 testing takes place.
All Russian regions have received pilot batches of Sputnik V, the Health Ministry said in late September. But at least 10 regions reported that the first supply was relatively small, between 42 and 44 doses, according to a CNN tally based on statements by health officials and media reports.
Most of the leading-edge coronavirus vaccines require storage at freezing temperatures, posing additional challenges for governments to establish working supply chains. Pfizer vaccine should be stored at -70 ° C (-94 ° F), while Moderna vaccine requires storage at -20 ° C (-4 ° F) and Sputnik V at -18 ° C (-0.4 ° F ).
“I have a lot of respect for them as scientists, but unfortunately they probably don’t appreciate the scale of problems they will face in bringing this product to market,” Chumakov said.
“There is a great distance between the experimental sample that can be prepared in the laboratory and taken to mass production and distribution,” he added. “I think it is a very arrogant attitude that, okay, we have synthesized it in two weeks and here we go, we have a vaccine. They have a prototype. And until it is tested, it will remain a prototype.”
Public relations frenzy
What Sputnik V lacks in participants and data, it has made up for in public relations.
Although the phase 3 trial is in the early stages, senior Russian officials made public announcements about his vaccination in meetings with Putin. State television published videos of Defense Minister Sergei Shoigu taking the photo at one of the clinics. In early October, Putin announced that dozens of his family members and employees working around him were vaccinated.
Putin did not specify which of his daughters took the vaccine, as he rarely calls them by name, even referring to them as “these women” when asked last year about his business in Russia. Alexey Venediktov, a well-connected editor-in-chief of Moscow’s Echo radio station, said Katerina Tikhonova, believed to be Putin’s youngest daughter, was the one who received the vaccine in the early stages of the trials.
Gintsburg previously told CNN that the Gamaleya Institute received no instructions and has “no ties to the Kremlin,” dismissing a suggestion that there was political pressure to speed up production of the vaccine.
Tikhonova heads the Innopraktika organization, which says her mission is to bring scientific developments to the corporate world and has a long list of heads of key Russian state-owned companies such as Gazprom, Rosatom and Transneft as board members. Kirill Dmitriev of RDIF is also a member of the board, and his wife, Natalia Popova, is the deputy director of Innopraktika.
Popova told state television that she was able to see “how the vaccine was born in the closed laboratories of the Gamaleya Institute” and was one of the first people to receive Sputnik V, even before her husband.
Russian officials and state media also touted Sputnik V as superior to some other Western vaccines. RDIF repeatedly said its drug is “based on a well-studied human adenoviral vector platform with proven safety and efficacy”, as opposed to those based on mRNA and chimpanzee adenovirus, such as the UK’s AstraZeneca vaccine.
The Kremlin denied the allegations, and RDIF said it condemns social media posts attacking the vaccine. RDIF’s portfolio company R-Pharm also 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 there are a lot of adenovirus-based vaccines in development right now and they are being tested. So this is probably fine, but we need to have data and we don’t have it yet,” he said. Chumakov, adding that while some vaccines are close to being licensed, to date there is no fully licensed and widely used adenovirus vaccine.
Economic boost
In addition to public relations victories, Russia is aiming for economic gains.
Last week, Putin told the leaders of the RSPP or the Union of Industrialists and Entrepreneurs of Russia, Russia’s largest business lobby group, that Sputnik V was “good business and the humanitarian component is clear,” adding that could generate $ 100 billion in revenue worldwide. reported the RIA Novosti news agency.
RDIF announced that it had reached agreements with several countries, including India, Brazil and Egypt, to supply millions of doses of Sputnik V. But the fund could face licensing difficulties in trying to expand Sputnik production globally due to different standards.
“I think in America, in Europe, in countries that really adhere to international product development, testing and licensing rules, this wouldn’t work, it’s definitely a gamble,” Chumakov said.
However, the country’s officials say they plan to implement mass vaccination in the coming months, even though state polls show that most Russians do not want to be vaccinated.
A Russian who is not taking the Sputnik V vaccine so far is the president, and his spokesman told CNN he is still thinking about it.
