MOSCOW (Reuters) – President Vladimir Putin said Tuesday that Russia was the first country in the world to grant regulatory approval to a COVID-19 vaccine after less than two months of human testing, a resolution hailed in Moscow as evidence of its prowess.
The vaccine still has full final evidence, which generated considerations among some experts at the time of its approval, however, the Russian business conglomerate System said it plans to mass produce until the end of the year.
Russian fitness treating COVID-19 patients will have the opportunity to volunteer for vaccination in the coming weeks, a source told Reuters last month.
Regulatory approval paves the way for the large inoculation of the Russian population, and the government hopes it will allow the economy, which has been hit by the consequences of the virus, to regain its full capacity.
Kirill Dmitriev, director of Russia’s sovereign wealth fund, praised the historic “Sputnik moment,” comparable to the launch of the Soviet Union in 1957 of Sputnik 1, the world’s first satellite.
The vaccine will be announced as “Sputnik V” in the markets, he said.
Dmitriev said Russia had already won foreign applications for one billion doses. International agreements have been reached to produce 500 million doses per year, with the vaccine to be produced in Brazil.
He added that clinical trials are expected to begin soon in the United Arab Emirates and the Philippines.
But about 10% of clinical trials are successful, and the rate at which Russia has progressed, approving a vaccine before the final stages of trials to check protection and efficacy are completed, has worried some scientists, who are concerned that Moscow will grant national prestige. . before security.
Speaking at a government assembly on state television, Putin downplayed those concerns and said the vaccine, developed through the Gamaleya Institute in Moscow, was and had even been given to one of his daughters.
“I know it works effectively, the bureaucracy has strong immunity and, I repeat, has passed all the mandatory controls,” Putin said.
He said he hoped mass production would begin soon.
PHASE III TEST
Approval of the vaccine through the Ministry of Health occurs before the start of a larger trial involving thousands of participants, known as a phase III trial.
These trials, which require a certain number of participants to contract the virus to practice the effect of the vaccine, are considered essential precursors for a vaccine to obtain regulatory approval.
The Moscow-based Association of Clinical Trial Organizations (OTCA), an industry framework representing the world’s leading drug brands in Russia, suggested this week that the Ministry of Health postpone approval until the final trial is effectively completed.
In a letter to the department, he claimed that there were the main dangers associated with registering a drug before that happened.
“It is at this stage that the greatest evidence of the efficacy of a vaccine is collected, as well as data on the adverse effects that would possibly occur in certain patient teams: other people with impaired immunity, others with concomitant diseases, etc.
Some foreign experts also know how fast Russia has approved its vaccine.
“Normally, you want a large number of people to check before passing a vaccine,” said Peter Kremsner of Tuebingen University Hospital, who is lately testing CureVac’s COVID-19 vaccine in clinical trials.
“In this sense, I think it is unwise to do so (approve) if many other people have not yet been tested.”
Duncan Matthews, professor of intellectual property law at Queen Mary University in London, said news of a possible vaccine opposed to COVID-19 will be welcome, “but protection will have to be the priority.”
“The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accelerated approval procedures for emergency humanitarian use and we want to see evidence that Russia is taking an equally cautious approach,” Matthews said in an email comment.
More than a hundred vaccines imaginable are being developed internationally in an attempt to prevent the COVID-19 pandemic. At least 4 are in the final phase of phase III human trials, according to WHO data.
(Additional reports through Maxim Rodionov, Polina Ivanova and Alexander Marrow in Moscow and Caroline Copley in Berlin, Josephine Mason and Kate Kelland in London; written through Gabrielle Tétrault-Farber/ Andrew Osborn; edited through Giles Elgood)
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