Dr. Scott Gottlieb, former commissioner of the US Food and Drug Administration, said on CNBC Tuesday that Russia is not ahead of the US when it comes to vaccine development.
“I think in terms of their development right now, they’re a little bit behind where we are with the vaccines that we have,” Gottlieb said.
US vaccines are now in phase three trials, having cleared phase one and phase two studies, being tested on hundreds, or in some cases a couple of hundred patients, which is about where Russia is right now, according to Gottlieb.
The amount of people who the Russian vaccine has been tested in means that it has cleared the equivalent of a phase one trial, but still needs to be evaluated in a large-scale clinical trial, Gottlieb said.
He said it was unclear to him what it meant for Russia to start giving some kind of preliminary approval to start vaccinating people outside of a clinical trial. Gottlieb added they might be trying to do a registry, where volunteers who take the vaccine outside of a trial who are then followed, but it’s not really cleared for general use in the market.
“There might be a little bit of semantics going on in terms of how they’re treating this from a regulatory standpoint,” Gottlieb said. “So, they’re claiming that it’s fully approved, but it’s not really fully approved.”
However, they are not ahead of the US, he said.
“They’re certainly not ahead of us, and we certainly wouldn’t allow a vaccine to be used for mass distribution at this point based on the data that we have in hand. We just don’t know that the vaccines are safe and effective at this point,” Gottlieb said.