MOSCOW – Russia boasts that it’s about to become the first country to approve a COVID-19 vaccine, with mass vaccinations planned as early as October using shots that are yet to complete clinical trials -- and scientists worldwide are sounding the alarm that the headlong rush could backfire.
Moscow sees a Sputnik-like propaganda victory, recalling the Soviet Union’s launch of the world’s first satellite in 1957. But the experimental COVID-19 shots began first-in-human testing on a few dozen people less than two months ago, and there’s no published scientific evidence yet backing Russia’s late entry to the global vaccine race, much less explaining why it should be considered a front-runner.
“I’m worried that Russia is cutting corners so that the vaccine that will come out may be not just ineffective, but also unsafe,” said Lawrence Gostin, a global public health law expert at Georgetown University. “It doesn’t work that way. ... Trials come first. That’s really important.”
According to Kirill Dmitriev, head of Russia’s Direct Investment Fund that bankrolled the effort, a vaccine developed by the Gamaleya research institute in Moscow may be approved in days, before scientists complete what’s called a Phase 3 study. That final-stage study, usually involving tens of thousands of people, is the only way to prove if an experimental vaccine is safe and really works.
Health Minister Mikhail Murashko said members of “risk groups,” such as medical workers, may be offered the vaccine this month. He didn't clarify whether they would be part of the Phase 3 study that is said to be completed after the vaccine receives “conditional approval.”
Deputy Prime Minister Tatyana Golikova promised to start “industrial production” in September, and Murashko said mass vaccination may begin as early as October.
Dr. Anthony Fauci, the top U.S. infectious disease specialist, questioned the fast-track approach last week. “I do hope that the Chinese and the Russians are actually testing a vaccine before they are administering the vaccine to anyone, because claims of having a vaccine ready to distribute before you do testing I think is problematic at best," he said.
Questions about this vaccine candidate come after the U.S., Britain and Canada last month accused Russia of using hackers to steal vaccine research from Western labs.