Russia approves vaccine without testing
MOSCOW — Russia has become the first country in the world to approve a vaccine for the coronavirus, President Vladimir Putin announced Tuesday, though global health authorities say the vaccine has yet to complete critical, late-stage clinical trials to determine its safety and effectiveness.
Putin, who told a Cabinet meeting Tuesday morning that the vaccine “works effectively enough,” said that his own daughter had taken it. And in a congratulatory note to the nation, he thanked the scientists who developed the vaccine for “this first, very important step for our country, and generally for the whole world.”
The major powers are locked in a global race for a vaccine that President Donald Trump, Putin and China’s president, Xi Jinping, are treating as a proxy war for their personal leadership and competing national systems. The United States and China have poured billions into the pursuit, and health officials worry that Russia is trying to snatch a victory by cutting corners.
By skipping large-scale clinical trials, the Russian dash for a vaccine has raised widespread concern that it is circumventing vital steps — and potentially endangering people — in order to score global propaganda points. Russia’s vaccine sped through early monkey and human trials with apparent success. But Moscow was cautioned just last week by the World Health Organization not to stray from the usual methods of testing a vaccine for safety and efficacy.
Beyond that, the United States, Canadian and British governments have all accused Russian state hackers of trying to steal vaccine research. Russian officials have denied the accusations, and say their vaccine is based on a design developed years ago by Russian scientists to counter the Ebola virus.
A vaccine is seen as the most likely avenue for defeating the novel coronavirus and alleviating a worldwide health crisis that has killed at least 734,900 people and decimated national economies. 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.
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. Currently, eight vaccines have entered the final phase of mass human testing, including ones produced by Moderna in the United States, Oxford University and AstraZeneca in Britain, and several Chinese companies.
Some Chinese companies have been accused of cutting corners themselves. One offered the vaccine to employees at the national oil company, while another has teamed up with the People’s Liberation Army for human trials.
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 stimulates the immune system. The last phase, known as Phase 3, compares the vaccine to a placebo in tens of thousands of people.
The Russian scientific body that developed the vaccine, the Gamaleya Institute, has yet to conduct Phase 3 trials. That final phase, however, is the only way to know with statistical certainty whether a vaccine can prevent an infection, and how effective it is.