This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage is available here.
NIH Director Francis S. Collins said he expects at least one of the vaccines against COVID-19 to be proven safe and effective by the end of 2020.
“I think, along with my good colleague, [National Institute of Allergy and Infectious Diseases Director] Tony Fauci—I would say I’m cautiously optimistic that by the end of 2020—one or more of these vaccines will have been proven to be safe and effective,” Collins said during the Sept. 16 virtual Rally for Medical Research.
Six vaccines for COVID-19 are either in phase III trials or about to enter phase III trials, Collins said during the virtual rally.
The rally was organized by American Association for Cancer Research.
“Each of those [are] planning to enroll or [are] already enrolling 30,000 participants—half of them getting placebo, half getting vaccine,” Collins said. “We’re watching closely, of course, then, to see what is the way in which this vaccine works in the real world. Does it, in fact, show the appropriate safety? And that’s going to be a very high bar indeed. And is it effective? Does it prevent people from getting sick with SARS-CoV-2 infections?”
The Centers for Disease Control and Prevention Director Robert Redfield Sept. 16 said that vaccinations against COVID-19 will not be widely available until the middle of next year.
“Of course, if a vaccine turns out not to be successful, we’ll have to throw those away. But it is a good investment, given the timetable we’re up against,” Collins said. “Although we knew pandemics were around the corner, this one is really quite a striking example of the kind of thing we hoped would not happen. But science is our best hope for pushing that back.”
Collins listed the initiatives the government has launched to fight the virus:
ACTIV—(Accelerating Coronavirus Therapeutic Interventions Vaccines), a government and industry collaboration to develop a research strategy for prioritizing and speeding development of the most promising COVID-19 treatments and vaccines.
RADx, an initiative to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing.
Operation Warp Speed, a government vaccine development initiative that aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021.
During the virtual rally, Collins said Congress and NIH are acting quickly on COVID-19.
“I’ve got to say, as somebody who’s been part of NIH now for 27 years, seeing all of this come together this year is truly breathtaking,” Collins said. “Nobody’s worried about who’s going to get the credit. We’ve just got to get this done because people are dying and time is passing.
“I’m really pleased to see the way in which our community, and that’s all of you and the Congress, we’ve all gotten together to do this thing of using science to address this—and science is our best hope right now.”
The text of Collins’s talk follows:
I’m delighted to have a chance to speak to you, although I would have preferred, and I know you would, too, if we could all have been together in person, as we have done for several years now, but it’s been a pretty tough year and I am proud of the community.
And that’s all of you, who have done everything you can to support medical research, even in the midst of some serious challenges called COVID-19.
I want to thank the American Association for Cancer Research for their hosting, and many other advocacy organizations that have joined together here on Rally Day. I particularly want to thank the members of Congress for their steadfast championship for biomedical research—both parties, both houses, making medical research a very high priority, and recognizing that this is something that the government can do that otherwise wouldn’t happen.
The consistent funding increases for NIH over the course of the last several years have put us in a very strong position to respond to challenges.
And goodness knows, we’ve had a challenge with COVID-19. And on top of that, Congress has found it possible in the midst of everything else, to recognize that we could go even faster, with some additional resources, and an additional $3.5 billion have been put into the research engine, to allow us to do things with COVID-19 we otherwise would not have been able to do.
My goodness, what a remarkable series of advances have been happening in record time.
It was only Jan. 10, where that sequence of the virus SARS-CoV-2 was first posted. Within a couple of days, the scientists at the Vaccine Research Center had designed a vaccine based upon the messenger RNA approach, a relatively novel approach that was actually developed, in part, based upon what we learned about Ebola, and now it could be brought forward for this new really serious challenge.
Sixty-three days later, the first patient was being injected in the phase I trial, blowing away by many months, the record previously held for going from that kind of recognition of a pathogen to having a trial started.
That pace has continued, as you know. Here we are now, with six vaccines that are either already in phase III trials, or will be soon in the next couple of months—three different technologies, which is good. You want to have this diversity of approaches.
Each of those [are] planning to enroll or [are] already enrolling 30,000 participants—half of them getting placebo, half getting vaccine.
We’re watching closely, of course, then, to see what is the way in which this vaccine works in the real world. Does it, in fact, show the appropriate safety? And that’s going to be a very high bar indeed. And is it effective? Does it prevent people from getting sick with SARS-CoV-2 infections?
This is going to be a very important few months as everyone knows. I think, along with my good colleague, [National Institute of Allergy and Infectious Diseases Director] Tony Fauci—I would say I’m cautiously optimistic that by the end of 2020—one or more of these vaccines will have been proven to be safe and effective.
And we are already, because of Operation Warp Speed, planning for success by spending hundreds of millions of dollars to prepare doses of each of these vaccines to be distributed to those highest risk individuals.
Of course, if a vaccine turns out not to be successful, we’ll have to throw those away. But it is a good investment given the timetable we’re up against, and the fact that at the time I’m speaking to you, almost 200,000 people have died from this disease.
We want to put an end to all of the death and suffering from this as fast as we can, and the vaccine is the best way to get there. But of course, we also need to work on therapeutics.
In that regard, a partnership that has been set up and has been operating with remarkable speed just since April—the partnership called ACTIV—Accelerating Coronavirus Therapeutic Interventions Vaccines—has been one of the more gratifying things that I’ve been part of in my 11 years as your NIH director, bringing together 20 pharmaceutical companies, the FDA, the CDC, multiple NIH institutes, the Veterans Administration, the Department of Defense, BARDA—all of this managed by the Foundation for NIH—and everybody, basically 24/7, determined to figure out how to prioritize the most promising therapeutics, and get them into rigorous clinical trials as soon as possible.
We are now in the midst of figuring out which of those things can work. For antibodies, do they need to be working in an inpatient, or would you rather start in an outpatient?
What about anticoagulants—are there ways that we can do a better job of helping people who get very sick, where we know blood clotting is a problem?
All those things underway in a record-speed-setting kind of protocol—and doing this with master protocols—where we have really clear ideas about what the endpoints are going to be, and how to assess them.
I’ve got to say, as somebody who’s been part of NIH now for 27 years, seeing all of this come together this year is truly breathtaking. And nobody’s worried about who’s going to get the credit. We’ve just got to get this done, because people are dying and time is passing.
I might also say another area that the Congress has helped us do is to get into the diagnostic areas. With that regard, something called RADx, rapid acceleration of diagnostics, has made it possible just in a few short weeks, since this started in late April—to find a total now of 16 new technologies that started out in small businesses or academic labs, and are now scaling up to be able to deliver, potentially a couple of million tests a day, that are point of care, that are rapid, that are reasonably cost effective.
That can range everywhere from a CRISPR based effort, to the usual RT-PCR to viral antigen test.
We need, of course, that kind of capacity, in order to find out who’s infected and to quickly respond. And all of that’s also part of our research agenda.
I’ve got to say, some of those technologies, I have to look at with a little bit of a sense of pride, because they depend on things we learned in the Human Genome Project about how to work with nucleic acid.
Because, of course, COVID-19, as an RNA virus, has a nucleic acid that is our best opportunity for diagnostics using technologies that originally came out of the Genome Project.
That’s one of the reasons we can do this as quickly as we can. And it is now 30 years, or it will be in a couple of weeks, since the original start of the Genome project in 1990—and who would have thought that it would have all of these spin-offs 30 years later, including tackling this unprecedented global pandemic. But we need everybody engaged.
I’m really pleased to see the way in which our community, and that’s all of you and the Congress, we’ve all gotten together to do this thing of using science to address this—and science is our best hope right now.
So, who knew, when we gathered a year ago, having a lovely time there, face-to-face, that this was looming out there just a couple months later, and it would change everything for the way in which we lead our lives, and how we plan our research, and all the things that are currently around us that give us a great sense of concern.
I think there’s no question that all of us will look back on 2020 as a memorable year and not in necessarily a good way. It was a dark year in terms of the havoc created by this unexpected coronavirus and its rapid spread, and its ability to be passed from person to person with such ease. Nothing like this was quite anticipated.
Although we knew pandemics were around the corner, this one is really quite a striking example of the kind of thing we hoped would not happen. But science is our best hope for pushing that back.
NIH will continue to strive to be that city on a hill that’s supported by this Congress, and lighted up by the brilliance and the determination of our bold, innovative, dedicated, and tireless scientists. So, thank you, all of you for what you were doing to keep those fires of ingenuity burning. Science is truly our best hope to get through this, and we will get through this.