Russia clears coronavirus vaccine, insists safe as scientists sound alarm bells – National

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MOSCOW – Russia on Tuesday became the first country to approve a coronavirus vaccine for use in tens of thousands of its citizens despite international skepticism about the injections that have not completed clinical trials and have not been studied only on dozens of people for less than two months.President Vladimir Putin said in announcing the approval that one of his two adult daughters had already been vaccinated. He said the vaccine has undergone the necessary tests and has been shown to provide long-lasting immunity against the coronavirus, although Russian authorities have offered no evidence to support the claim of its safety or its efficiency.

“I know it has been shown to be effective and forms stable immunity,” he said. “We must be grateful to those who took this very important first step for our country and the whole world.”

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However, scientists from Russia and other countries have sounded the alarm, saying rushing to offer the vaccine before Phase 3 trials – which normally last for months and involve tens of thousands of people – could backfire. them.

“Fast-track approval will not make Russia the leader of the race (for the vaccine), it will simply put consumers of the vaccine in unnecessary danger,” the Russian Association of Clinical Trials Organizations said on Monday, urging officials government officials to postpone vaccine authorization without completing. advanced testing.

The vaccine developed by the Gamaleya Institute in Moscow uses a different virus – the common adenovirus that causes the common cold – which has been modified to carry the genes for the “spike” protein that covers the coronavirus, in order to prime the body to recognize if a COVID-19 infection happens.

This is similar to vaccines developed by CanSino Biologics in China and the UK University of Oxford and AstraZeneca.








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Advanced clinical trials are expected to start on Wednesday, Kirill Dmitriev, managing director of the Russian Direct Investment Fund, told reporters. The fund financed the development of the vaccine.

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The study of the trials will cover several countries, including the United Arab Emirates, Saudi Arabia, the Philippines and possibly Brazil, and will involve “a thousand people,” Dmitriev said. In the meantime, the vaccine will be offered to tens of thousands of people who volunteer to be vaccinated.

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In the meantime, the vaccine will be offered to tens of thousands of people. Deputy Prime Minister Tatyana Golikova said doctors’ vaccination could start as early as this month. Russian authorities have said medical staff, teachers and other at-risk groups will be the first to be vaccinated.

Large-scale production of the vaccine will begin in September, officials said, and mass vaccination could begin as early as October.

“We expect tens of thousands of volunteers to be vaccinated in the coming months,” said Dmitriev. “So people outside of clinical trials will have access to the vaccine in August, and some, already on a large scale, in October.”

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Gamaleya Institute director Alexander Gintsburg said that initially there will only be enough doses to deliver the vaccine in 10 to 15 of Russia’s 85 regions, according to the Interfax news agency.










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The Associated Press was unable to find any documentation in the files of the Russian Ministry of Health stating that permission to start the advanced tests had been granted. The department did not respond to a request for comment.

The World Health Organization list of vaccine candidates for human testing still lists the product Gamaleya as in preliminary safety trials, which involve giving a low dose to a small number of people.

President Putin said that one of his daughters had received two vaccines. “She took part in the experiment,” said the Russian leader, adding that she had minor side effects, such as a slight fever, and that she “was feeling fine and had almost a number of antibodies. “.

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The health ministry said in a statement on Tuesday that the vaccine is expected to provide immunity against the coronavirus for a period of up to two years, citing “(past) experience of using vector vaccines with the regimen administration in two doses ”.

However, since Russia has yet to release scientific data on its first clinical trials, scientists at home and abroad find these assurances unconvincing. No vaccine has ever been developed for any coronavirus, including SARS and MERS, and new immunizations typically take years to develop.

“The collateral damage resulting from the release of any less than safe and effective vaccine would insurmountably worsen our current problems,” Imperial College London professor of immunology Danny Altmann said on Tuesday.










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Russia has so far recorded 897,599 cases of the coronavirus, including 15,131 deaths. When the pandemic hit Russia, Putin ordered state officials to shorten the length of clinical trials for potential coronavirus vaccines.

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Becoming the first country in the world to develop a vaccine was a matter of national prestige for the Kremlin, which is trying to assert Russia’s image as a world power. State television stations and other media have praised the scientists working there and presented this work as the envy of other nations.

Gintsburg of the Gamaleya Institute raised eyebrows in May when he said he and other researchers had tried the vaccine on themselves before human studies began.

Human trials began on June 17 with 76 volunteers. Half received an injection of a vaccine in liquid form and the other half of a vaccine in soluble powder form. Some in the first half of the year were recruited into the military, raising concerns that the military may have been pressured to participate.

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As Russia rushes to become the first to create a vaccine, the United States, Britain and Canada accused Russia last month of using hackers to steal vaccine research from laboratories Westerners.

As the trials were declared completed earlier this month, questions have arisen about the vaccine’s safety and effectiveness.

“It is not possible to know whether the Russian vaccine has been shown to be effective without submitting scientific papers for analysis and then there may be data quality issues,” Keith Neal, Emeritus Professor of Disease Epidemiology infectious diseases from the University of Nottingham, said in a statement.

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The World Health Organization said all vaccine candidates should go through full stages of testing before being deployed. Experts have warned that vaccines that are not properly tested can cause harm in many ways – from negative impact on health to creating a false sense of security or loss of confidence in vaccinations.

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© 2020 The Canadian Press



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