Former Fred Hutch President and Director Dr. Larry Corey will head the Hutch-based operations center for the COVID-19 Prevention Network, a collaboration formed by Dr. Tony Fauci of the National Institute of Allergy and Infectious Diseases to manage multiple large-scale clinical trials of coronavirus vaccines.
Photo by Robert Hood / Fred Hutch News Service
When Dr. Tony Fauci, director of the National Institute of Allergy and Infectious Diseases, was tasked with developing a vaccine against COVID-19, Dr. Larry Corey knew that a call was coming.
The renowned virologist and former president and director of Fred Hutchinson Cancer Research Center has worked with Fauci since the 1980s on HIV drugs and vaccines. At Fauci’s urging, he co-founded in 1998 what became the HIV Vaccine Trials Network, the world’s largest publicly funded international collaboration conducting clinical trials of HIV vaccines.
Now, Fauci is pooling the expertise and infrastructure of HVTN and its sister organization, the HIV Prevention Trials Network, with the Atlanta-based Infectious Diseases Clinical Research Consortium in a national collaboration to speed the development of a vaccine to stop this coronavirus. It is called the COVID-19 Prevention Network, or CoVPN.
In a recent interview, Corey talked about the challenges and opportunities ahead.
(The interview has been shortened and edited for clarity.)
What role will Fred Hutch play in this COVID-19 Prevention Network?
We've been put together to optimize our ability to run these very large COVID vaccine trials that will each have 30,000 participants. The operations center for that is the Hutch. I am the head of the operations center. The laboratory that Dr. Julie McElrath directs is also a central resource for the country, and that they picked us to do this is a testament to the support HVTN has received over the years from Fred Hutch.
How many vaccine candidates will you be evaluating?
We’re probably going to look at five, six or seven.
How closely will you be working with Dr. Fauci?
Everything that has to do with the clinical trials is under the National Institute of Allergy and Infectious Diseases — all the operationalizing, the actual deciding of what trials are to be done, when they will be done, where they will be done, how that will be done. Dr. John Mascola (director of the NIAID Vaccine Research Center) and I work directly with Tony. John works for Tony, and I interact with Tony advising on overall strategy for the program. I meet with him three times a week and probably talk with him one or two times a day, usually when he’s coming to or from the White House.
You and Dr. Fauci stress often the importance of ‘harmonizing’ trials. What does that mean?
There is a need to have multiple vaccines. We can't make enough of one vaccine to cover 4.4 billion people. We need to ask a common set of questions and use a common set of measurements. Different vaccines have different side-effect profiles and often have differences and subtleties with respect to how well they work in different patient populations: kids, adults, the elderly, pregnant women. And the vaccines will be produced at different times, often in a different place. In clinical trials, you’ll actually know this vaccine worked at 60% efficacy, that vaccine worked 65% and another worked this or that.
Vaccinating the World: a free online webinar
Join Fred Hutch President and Director Dr. Tom Lynch in conversation with Drs. Larry Corey and John Mascola, director of the National Institute of Allergy and Infectious Diseases Vaccine Research Center, in "Vaccinating the World," a conversation about COVID-19 vaccine prospects.
Friday, June 5
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The system that we're talking about is allowing us to have some commonality, so that when we're done, there's the ability to not only compare the vaccine against placebo, but some relative sense of how one vaccine works versus the other. It's a way to interpret the data so you know whether they're all pretty similar, or if one is a little bit better than the other. What are the immune responses? What are the side effect profiles? Did they all work in 50-year-olds, or does only one work for those 70 years old or more?
You’ll need to conduct the trials in a way that antibody assays, immune assays [are] all done in the same lab. They're not done in each pharma company's own lab where you have no idea what’s comparable.
Dr. John Mascola is director of the Dale and Betty Bumpers Vaccine Research Center within the NIAID in Bethesda, Maryland.
Photo courtesy of NIAID
What lab would that be?
Well, labs that we have used in our HIV studies. So, when we measure T cells (infection-fighting blood cells), it would be Julie McElrath's lab here at the Hutch. When we measure antibodies, it'll be the labs at Duke or the laboratories under John Mascola’s direction at the National Institutes of Health. There's a new lab at the University of North Carolina. And when we measure levels of the virus, it's going to be at the University of Washington [virology] lab directed by the Hutch’s Dr. Keith Jerome.
CoVPN is a collaborative. Who else is involved?
The COVID-19 Prevention Network links together HVTN, HPTN and another infectious disease network called the Infectious Diseases Clinical Research Consortium based at Emory University. I'm one of the network leaders of the vaccine program along with Dr. Kathy Neuzil, director of the Center for Vaccine Development and Global Health at the University of Maryland; Dr. Mike Cohen, who is the principal investigator of the HPTN; as well as Dr. David Stephens of IDCRC in Atlanta.
Dr. Fauci said a vaccine might be ready for approval by year end. Normally, it can take 10 years. Is it really possible?
We'll still be doing three phased trials, and we're not cutting corners for safety. But we are doing it in a way that's very compressed. One phase can begin before the other is completed. We are going at lightning speed to reduce the transitions, which usually are months between the stages. In fact, manufacturing processes are also going ahead. They're actually manufacturing vaccines now and the U.S. government is buying them “at risk.” (Paying for them in anticipation they can be used). We hope they do work and distribute it, and we're doing everything we possibly can to make sure that the assessments are done.
The Gates Foundation may be helping to fund new vaccine factories, even if they never can be used. Are you working with them?
They have been very involved in the concept of manufacturing and building factories and working with companies for scale; and in even with some of the smaller companies to try and get them be factors in this game. It’s wonderful to see what the foundation is doing. Mr. Gates is a terrific human being, and very knowledgeable on this topic. But the foundation is not involved in our program at the moment.
What issues are facing you once you've got a candidate that you think is worth putting through?
Well, I think that's where the link to Operation Warp Speed is. Gen. Gustave Perna is part of this. He's the head of logistics for the Army and certainly has been talking about mobilizing logistics of the military and civilians to rapidly immunize people. That's being actively discussed. But that's not my job. My job is to be able to put him into motion.
NIAID is tapping HVTN expertise, built on decades of HIV research. What happens to HIV studies while your attention is on COVID?
We have a lot on our plate. We’ve had a hiatus because of COVID-19, but we’ve been working on the efficacy studies, and the teams in South Africa and operation centers have done an amazing job of continuing trials. And last week we've reactivated the Mosaico trial in South America with Johnson & Johnson. So, our HIV work is coming back.
How confident are you of success?
You’re never confident of anything, and if you are, that’s hubris. … That we are running 30,000-person trials under Operation Warp Speed is both a compliment and a challenge. What's wonderful is that the we now have 72 clinical trial sites in this combined effort with our partners, and we’ve worked together. We know each other. These are the most prominent infectious disease people. They've all been involved in the COVID epidemic in their own right. You know, it’s the strength of that mass of expertise that gives me the optimism to say that we’re going to do well.