Dr. Fauci says he will back FDA's decision on coronavirus vaccine
ATLANTA - Dr. Anthony Fauci, one of President Trump's top coronavirus advisors, told an Emory University roundtable Thursday there are checks and balances in place to make sure the coronavirus vaccine is being thoroughly vetted before it is approved.
There are 4 candidate vaccines in phase III clinical trials in the US, and a fifth company is planning to begin a large-scale study of its vaccine in October.
Dr. Fauci told the panel each vaccine trial is tracked by an independent data and safety monitoring board made up of experts, he says, who are beholden to no one.
"So, if all of a sudden I woke up tomorrow and said, 'Gee, I'm curious. Let me look at the data..." Nah, I can't do that,” Fauci says.
He described the race for a vaccine as a carefully-engineered process of protocols designed to ensure the vaccine is safe and effective before it is approved.
"If it works the way it works, the way it should work, we should be able to say with confidence that this is a safe and effective vaccine," Dr. Fauci says. "I don't think many people appreciate how many fail safes there are in that process."
Once the large-scale clinical trials are complete, Emory's Dr. Carlos del Rio says, there will be a phase IV study that will continue to monitor millions of vaccine recipients for negative side effects.
"You keep looking at safety over time, because there are many side effects that may only happen after a million doses, after 10 million doses," Dr. del Rio says. "So, in fact, looking at safety never really ends when you have a biological like a vaccine."
Most Americans will need two injections of the vaccine, given about a month apart.
Earlier this week, Fauci told Congressional lawmakers the first 50 million doses of the vaccine could be ready as soon as November.
CDC Director Dr. Robert Redfield testified it may be late spring or summer before the vaccine is widely available.
President Trump has hinted a vaccine could be approved by November 3, 2020, Election Day.
But, Fauci says. if the FDA doesn't have full confidence in a vaccine, he will back the agency.
"I would rely very heavily on the decades of experience of the FDA scientists, who say we should do this. Therefore, I would have to lean heavily on their side and support them. So, if they come out and say, 'This is the way we should do it,' I've got your back on that."