'I wouldn't take it, certainly not outside a clinical trial right now' where patients are closely monitored, former FDA commissioner Dr. Scott Gottlieb told CNBC.
Russia plans to begin its first large-scale, phase three trials of its vaccine Wednesday, even though health officials have already cleared it for public distribution. Putin said one of his daughters has been inoculated with the vaccine. However, no data has been published on Russia's trials thus far, contributing to the international skepticism of Putin's announcement earlier Tuesday.
Researchers have yet to publish any data on the vaccine trials thus far, including information on the safety, efficacy or possible long-term side effects. Gottlieb, who is the former U.S. Food and Drug Administration commissioner, said that wouldn't fly with American regulators. "We certainly wouldn't allow a vaccine to be used for mass distribution at this point based on the data we have at hand," he said. "We just don't know if the vaccines are safe and effective at this point."
He said Russia has cleared its vaccine based on what would be the equivalent of an early stage clinical trial, completing testing on 100 to as many as 300 patients. Covid-19 vaccines in the U.S., by comparison, are being tested on tens of thousands of patients before the FDA will approve any for mass distribution.
"Our vaccines here in the U.S. are in phase three clinical trials. They're getting dosed in thousands of patients as we speak. They've cleared phase one, phase two study, so they've been tested in a hundred and in some cases a couple hundred of patients. That's about where Russia is right now," said Gottlieb, who sits on the board of pharmaceutical company
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