Russia has named its first approved COVID-19 vaccine ‘Sputnik V’ for foreign markets, a reference to the world’s first satellite. The move has been hailed by Moscow as evidence of its scientific prowess, but the vaccine is still yet to complete final trials.
Despite concerns among some experts at the speed of its approval, Russian business conglomerate Sistema says it expects to put the vaccine into mass production by the end of the year.
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Russian President Mr Putin this morning announced the approval of the vaccine, insisting it was safe and had even been administered to one of his daughters.
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Russian health workers treating COVID-19 patients will be offered the chance of volunteering to be vaccinated in the coming weeks, according to a source.
Kirill Dmitriev, head of the country’s RDIF sovereign wealth fund, said Russia had already received requests from more than 20 countries for one billion doses of its newly-registered vaccine.
But the speed at which Russia is moving to roll out the vaccine has prompted some international scientists to question whether Moscow is putting national prestige before solid science and safety.
Speaking at a government meeting on state television, Mr Putin dismissed concerns about the vaccine, developed by Moscow’s Gamaleya Institute.
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Vladimir Putin has said the vaccine is safe and had even been administered to one of his daughters
He said: ”I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks.”
The Russian president said he hoped mass production would start soon.
The vaccine’s approval by the health ministry comes before the start of a larger trial involving thousands of participants, commonly known as a Phase III trial.
Such trials, which require a certain rate of participants catching the virus to observe the vaccine’s effect, are normally considered essential precursors for a vaccine to receive regulatory approval.
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Russia has named its first approved COVID-19 vaccine ‘Sputnik V’ for foreign markets, a reference to the world’s first satellite
Russian health workers treating COVID-19 patients will be offered the chance of volunteering to be vaccinated in the coming weeks
The Moscow-based Association of Clinical Trials Organizations (ACTO), a trade body representing the world’s top drugmakers in Russia this week urged the health ministry to postpone approval until that final trial had been successfully completed.
In a letter to the ministry, it said there were high risks associated with registering a drug before that happened.
It said: ”It is during this phase that the main evidence of a vaccine’s efficacy is collected, as well as information on adverse reactions that could appear in certain groups of patients: people with weakened immunity,people with concomitant diseases and so forth.”
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Some international experts have also questioned the speed at which Russia approved its vaccine.
Peter Kremsner from the University Hospital in Tuebingen, currently testing CureVac’s COVID-19 vaccine in clinical trials, said: “Normally you need a large number of people to be tested before you approve a vaccine.
“In that respect, I think it’s reckless to do that approve it if lots of people haven’t already been tested.”
Duncan Matthews, a professor of intellectual property law at Queen Mary University of London, said news of a potential COVID-19 vaccine was to be welcomed, “but safety must be the priority”.
He added: ”The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have fast-track approval procedures for emergency humanitarian use and we need to see evidence that Russia is adopting an equally prudent approach.”
More than 100 possible vaccines are being developed around the world to try to stop the COVID-19 pandemic. At least four are in final Phase III human trials, according to WHO data.