Dr Anthony Fauci
The new coronavirus vaccine touted by Russia this week hasn't completed late-stage clinical testing, which has cast a shadow of doubt on whether the vaccine is safe and effective, according to National Geographic.
Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, expressed his concerns about the vaccine as part of an interview for Stopping Pandemics, a virtual event that National Geographic will air on Thursday.
"I hope that the Russians have actually definitively proven that the vaccine is safe and effective," he told Deborah Roberts, the event moderator and an ABC News correspondent. "I seriously doubt that they've done that."
Sputnik V, named after Russia's satellite that was launched in 1960, is still in phase 3 of the three-phase clinical trial process that checks for safety, efficacy and the best dosage of a vaccine. In May, researchers in Moscow said they began testing the vaccine on themselves, and a month later, the first phase of human clinical trials included 76 patients. So far, the scientists haven't published results — either from human trials or preclinical trials that include animals or experiments on cells.
But on Tuesday, President Vladimir Putin said Russia's health ministry approved the vaccine, and production will begin at two sites in Russia. The vaccine will be "gradually" introduced to the public, starting with medical workers who interact with coronavirus patients.
"We have to be grateful to those who have taken this first, very important step, very important for Russia and for the entire world," Putin said in a statement.
Phase 3 trials are still ongoing, according to the Associated Press, which has caused alarm among scientists within Russia and in other countries.
"Fast-tracked approval will not make Russia the leader in the race, it will just expose consumers of the vaccine to unnecessary danger," according to Russia's Association of Clinical Trials Organizations. The group urged officials to postpone vaccine approval until advanced trials are complete, the AP reported.
Three vaccine candidates are in late-stage clinical trials in the U.S., with a fourth on the way. The FDA has stated that it will only approve a vaccine with at least 50% efficacy, Fauci said.
"We have half a dozen or more vaccines," he said. "So if we wanted to take the chance of hurting a lot of people or giving them something that doesn't work, we could start doing this, you know, next week if we wanted to. But that's not the way it works."
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Cite this: Fauci Expresses Doubts About Russia's COVID-19 Vaccine - Medscape - Aug 12, 2020.
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