Fauci: Phase 1 Trial of a Coronavirus Vaccine Expected in ‘a Month or So’

By Melanie Arter | March 4, 2020 | 10:30am EST
(Photo by SAUL LOEB/AFP via Getty Images)
(Photo by SAUL LOEB/AFP via Getty Images)

(CNSNews.com) - The first phase in the trial of a potential coronavirus vaccine could be underway in “a month or so,”  Dr. Anthony Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases, said Tuesday.

President Donald Trump toured the NIH facility on Tuesday with Fauci and Health and Human Services Secretary Alex Azar. 



 

There, the president “got to hear from the actual bench scientists who, within three days -- within three days -- developed a potential vaccine for the novel coronavirus,” Azar said. “And they reported some really important news to the president that, yesterday, the Food and Drug Administration authorized the entry of that vaccine into phase one safety clinical trials.”

“So, what we did is we just had the opportunity to take the president and show him the actual individual researchers who are doing the things that we've been talking about,” Fauci told reporters on the White House lawn.

“And what they were referring to is that the actual scientists -- middle level, senior, junior -- were there and explained to the president what I have actually been explaining to the press, but showed it on graphics: how after the virus was identified, the sequence was taken and put into this platform called messenger RNA, and what happened is that, literally, within a period of a couple of days, we were able to stick it in,” he said.
 
“And now, as I said, we're going to go into a phase one trial in about three months from that day -- well, we're probably, you know, a month or so -- I mean, I don’t want to over promise.  I said a month and a half the other day. It may be about a month or so, and then very soon, we'll be sticking the first person with the vaccine,” Fauci said.

He cautioned, however, that this was just the first stage of development of the vaccine, because since the vaccine will be given to normal, healthy people, “safety is very important and you really need to know that it actually works.”

“That next phase is a phase two trial. We're not going to be able to start that for at least another three or four months after we go in. So the whole process is going to take a year, a year and a half at least,” Fauci said.

“The other thing that's interesting that we explained to the president - and the secretary already knew - is that the difference between testing the vaccine and testing therapy are almost qualitatively different, because with the therapy, you're going to give it to someone who is already ill and you compare it to standard of care. So, within a reasonable period of time, you're going to know if it works or not,” he said.
 
“So, right now, as of like today, there are two large trials going on in China that are comparing one of the drugs -- and there are several -- one called Remdesivir with the standard of care alone, and when we get those results -- which likely will be several months, because you're going to have to accumulate hundreds of patients to decide,” Fauci said.

He said there’s a trial going on right now at the University of Nebraska with some people infected with the virus.

“So once you get the result with the therapy -- unlike a vaccine, which takes quite a while -- once you get a result, you can start distributing the medication,” Fauci said.

“So, Dr. Fauci, just to be clear: You're saying three months away from treating people who already have coronavirus?” Trump asked.
 
“No, I didn’t say that. I said, if the drug works and you prove it works, you will treat them. I am not saying that three months from now we’re going to have a drug to treat people,” Fauci said.
 
“If it works,” Trump said. “So if it works, three months from now, it is possible --”
 
“No,. I didn’t say. I said you have to accumulate enough patients, when they get to 400 patients in each trial. That may take three months. That may take five months. I don’t know. When the trial is over and they evaluate the data, if the drug works, then you’ll be able to apply it,” Fauci said.
 


 

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