Fauci On Remdesivir Trial: ‘Clearly Positive’ But ‘Modest’; A ‘First Step’ To ‘Better Drugs’

On Thursday, Director of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci appeared on “TODAY” to discuss several new developments in the fight against COVID-19.

First, anchor Savannah Guthrie asked Fauci about the reportedly successful trial of the drug remdesivir, which is manufactured by biopharmaceutical company Gilead Sciences.

“You said that remdesivir is not a knockout, this isn’t a miracle drug, but it sounds like it is a breakthrough,” Guthrie said. “Can you explain why?”

Fauci replied, stressing the importance of the trial process:

Well, it’s a really important proof of concept because this is the first very highly-powered – about 1,100 individuals, and it was a placebo controlled, randomized trial, which I’ve been talking about for some time now, which is really the gold standard of how you prove something is safe, and either works or doesn’t work.

Fauci was prudent in his assessment of the significance of the treatment.

“And although the results were clearly positive from a statistically significant standpoint, they were modest,” Fauci stated. “The improvement was 31% better chance of recovering and getting out of the hospital.”

That’s important, but it’s the first step in what we project will be better and better drugs coming along, either alone or in combination, drugs of this type and drugs addressing other targets of the virus. So, it’s good news, but I was very serious when I said this is not the total answer by any means – but it’s a very important first step.

Guthrie proceeded to ask Dr. Fauci about the Food and Drug Administration (FDA) granting “emergency usage” for remdesivir, and how quickly he anticipates the drug coming into mass use.

While Fauci said he expects it to be soon, he added that the FDA has reportedly not “made a final decision” just yet.

Guthrie pressed Fauci on whether or not it would be possible to push out remdesivir quickly “enough to make a difference,” as the drug is “intravenous” and reportedly “takes months and months to manufacture.”

Gilead is allegedly “committed to get it out as much as they can as quickly as they can,” according to Fauci.

“I’m pretty confident that that will be the case because I believe they’re committed to trying to get this out as quickly as possible,” Fauci added. “So, we’ll see, but I think it’s gonna happen.”

Guthrie and Fauci also discussed the timeline for a potential vaccine for COVID-19.

“The administration has confirmed that it has a program called Operation Warp Speed … with, according to reports, the goal to speed the timeline for a vaccine to develop hundreds of millions of doses to be ready by January,” Guthrie said. “Do you feel that’s in the realm of possibility?”

Fauci said that he believes it is indeed possible, and that they’re looking for a “safe” and “effective” vaccine, which if successful, could be scaled “rapidly.”

After noting that they’re in the process of a Phase 1 vaccine trial, Fauci said that as the next phase begins, they will determine as swiftly as possible if the vaccine is effective in order to begin early mass production “at risk.”

“In other words, you don’t wait until you get an answer before you start manufacturing. You, at risk, proactively start making it assuming it’s going to work, and if it does, then you could scale up and hopefully get to that timeline,” Fauci stated.

According to the Gilead Sciences official website:

Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity – it is not approved anywhere globally for any use. Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are also coronaviruses and are structurally similar to COVID-19. The limited preclinical data on remdesivir in MERS and SARS indicate that remdesivir may have potential activity against COVID-19.