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The country’s regulators became the first in the world to approve a possible vaccine against the virus, despite warnings from the global authorities against cutting corners . A Russian health care regulator has become the first in the world to approve a vaccine for the coronavirus, President Vladimir V. Putin announced on Tuesday, though the vaccine has yet to complete clinical trials. The Russian dash for a vaccine has already raised international concerns that Moscow is cutting corners on testing to score political and propaganda points. Mr. Putin’s announcement came despite a caution last week from the World Health Organization that Russia should not stray from the usual methods of testing a vaccine for safety and effectiveness. Mr. Putin’s announcement became essentially a claim of victory in the global race for a vaccine, something Russian officials have been telegraphing for several weeks now despite the absence of published information about any late-phase testing.
“It works effectively enough, forms a stable immunity and, I repeat, it has gone through all necessary tests,” Mr. Putin told a cabinet meeting Tuesday morning. He thanked the scientists who developed the vaccine for “this first, very important step for our country, and generally for the whole world.” Western regulators have said repeatedly that they do not expect a vaccine to become widely available before the end of the year at the earliest. Regulatory approval in Russia, well ahead of that timeline, could become a symbol of national pride and provide a much needed political lift for Mr. Putin. The Russian vaccine, along with many others under development in a number of countries in the effort to alleviate a worldwide health crisis that has killed at least 734,900 people, sped through early monkey and human trials with apparent success. Vaccines generally go through three stages of human testing before being approved for widespread use. The first two phases test the vaccine on relatively small groups of people to see if it causes harm and if it stimulates the immune system. The last phase, known as Phase 3, compares the vaccine to a placebo in thousands of people. This final phase is the only way to know with statistical certainty whether a vaccine prevents an infection. And because it’s testing a much larger group of people, a Phase 3 trial can also pick up more subtle side effects of a vaccine that earlier trials could not.
The Food and Drug Administration in the United States has said that a new coronavirus vaccine would need to be 50 percent more effective than a placebo in order to be approved. The Russian scientific body that developed the vaccine, the Gamaleya Institute, has yet to conduct Phase III tests on tens of thousands of volunteers in highly controlled trials, a process seen as the only method of ensuring a vaccine is actually safe and effective. Around the world, more than 30 vaccines out of a total of more than 165 under development are now in various stages of human trials. The Russian vaccine uses two strains of adenovirus that typically cause mild colds in humans. They are genetically modified to cause infected cells to make proteins from the spike of the new coronavirus. The approach is similar to a vaccine developed by Oxford University and AstraZeneca that has shown promise in early testing and is now undergoing Phase III tests in Britain, Brazil and South Africa.....
