University of Miami Miller School of Medicine
1:10 P.M. EDT
DR. FORD: Mr. Vice President, Commissioner Hahn, Governor DeSantis, Lieutenant Governor Núñez, Congressman Díaz-Balart, and other distinguished guests: It is my distinct honor and pleasure to extend a heartfelt welcome to you, to the University of Miami’s Miller School of Medicine.
As a point of departure, I would like to thank each of you for the continuous support, partnership, and tireless effort as we navigate the impact of COVID-19 on our community, the university, and our health system.
Mr. Vice President, you could not have picked a better place to mark the start of the phrase three COVID-19 trials. The Miller School of Medicine was Florida’s very first medical school, and it is now home to South Florida’s first and only NCI-designated comprehensive cancer center.
The Gordon Center, where we sit today, is one of the crown jewels of the university. It is home to the first cardiopulmonary simulator, named “Harvey,” for medical education. Harvey has trained tens of thousands of learners worldwide, and we continue to do so every year.
As an institution whose overarching mission and singular focus is to be at the forefront of advances in clinical care, medical education, and translational medicine to improve the health of our nation, we are pleased to host your first visit to a phase three clinical trial site in the nation.
And before I send the mic to our governor, I would like to recognize my colleagues joining us today: Dr. Dipen Parekh, Chief Operating Office of the University of Miami Health System; Dr. Stephen Nimer, the Director of our NCI-designated Sylvester Comprehensive Cancer Center; and, of course, the reason we are all here today, Dr. Susanne Doblecki-Lewis, the Principal Investigator of the University of Miami arm of the Moderna COVID-19 vaccination trial.
And it is now my distinct pleasure to introduce our governor and a great friend of the University of Miami, Ron DeSantis.
GOVERNOR DESANTIS: Well, thank you so much, Dr. Ford, and thanks to the Vice President for being in Florida again and lending so much support for the state of Florida during these many months.
We here — you know, as we look at Florida and where we are, you know, I’m pleased to report that if you look at visits to the emergency room for COVID-like illness, they’re at the lowest levels that we’ve seen since the middle of June, here in the state of Florida. Admissions to hospitals for COVID patients is at its lowest that it’s been since June.
If you look at our test positivity rate, that is slowly but definitely declining. And our case fatality rate here in Florida is one of the lowest of anywhere in the country, particularly for a state of this size: about 1.3 percent. And I think part of the reason you have that — well, I think there’s two main reasons. One is Florida is laser-focused on protecting the most vulnerable, particularly seniors in long-term care facilities. But also, I think it’s because, you know, we’ve got a great medical system here in the state of Florida, particularly here in South Florida.
So when we reached out a few weeks ago, because the physicians wanted to have more of the drug remdesivir, you know, the administration responded very quickly. And we’ve had now multiple shipments of remdesivir to hospitals throughout the state of Florida. Those physicians are using that, and they are generating better patient outcomes now than was generated in March and April throughout the country. Part of that is just knowledge, but part of that is, I think, a testament to how hard people have worked here.
So even as we’ve seen, you know, the hospital census for COVID stabilize or decline in many parts of the state, that we recognize the great work that so many people have been doing, particularly here in Miami-Dade County, where we saw the most hospital admissions anywhere in the state.
But, you know, the system has worked. You know, there’s still capacity. Hopefully we’re not going to need more with the COVID patients in the next coming weeks. But people have been working very hard in this state. We’ve put in 150 folks just to Jackson System, and we’ve put in hundreds more to elsewhere throughout South Florida. So we’re here to help. We’re going to continue to do it.
Today is really special because I think that this, you know, comes on the heels of so much that you’ve done in Florida. But now with these clinical trials, we’re really, really looking forward to what the University of Miami can contribute to this very, very important thing.
So, Mr. Vice President, thank you for the continued support that you’ve given the state of Florida. The task force, the President, all the Cabinet Secretaries — any time we’ve called, y’all have sprung into action. And the people of Florida, I think, understand that. But I’m happy to remind them that and happy to be able to here — welcome you, yet again, here to the State of Florida.
THE VICE PRESIDENT: Well, thank you, Governor DeSantis. And I know I speak on behalf of the President when I express our appreciation to you, to Lieutenant Governor Jeanette Núñez, and your entire administration for the strong and steady leadership that you’ve provided for the people of Florida over the past four months, but most especially over the challenging days through which Florida is recently passing.
And, Governor, I’ve said it on all of my visits here and in every conversation we’ve had, but I want to say again to you and to the people of Florida: We’re with you. We’re going to make sure that the state of Florida has the testing, resources, personal protective equipment for our extraordinary healthcare workers, and also plays that leading role in helping us to create the therapeutics and the new vaccines that someday will put this coronavirus in the past.
We are encouraged, Governor, by the favorable trends here in Florida, but just like you, I want the people of this state to know that we’re going to continue to make sure the resources are there to ensure that anyone in Florida impacted by the coronavirus will have the same level of care that any of us will want a family member of ours to have.
So, again, Governor, thank you for — thank you for your leadership, thank you for the partnership that you forged not just with our President and our task force, but with our entire administration.
I am pleased to be joined today by the Commissioner of the FDA. The FDA cleared the way today for what will be the first phase three clinical trial in the United States. Eighty-nine sites across America with up to 30,000 participants will begin the first phase three clinical trial on a vaccine for the coronavirus.
And let me just say the President and I are truly grateful for Dr. Hahn’s leadership at the FDA. It is remarkable to think that Moderna — that will be initiating this phase three clinical trial — actually entered phase one back in March. And if memory serves, we moved to the first — the first phase of this clinical trial in record time. It was literally just a matter of weeks after we received the genetic coding for the coronavirus that, because of the strong work at the FDA and the urgency that President Trump placed on this, that we began to develop a vaccine.
And from that point, we continue to work at what the President has called “warp speed” to make sure that we have a vaccine every bit as soon as it is safely possible to have for the American people.
With the strong support of Congress that’s well represented here by my friend of many years, Congressman Mario Díaz-Balart, we were able to secure funding for our vaccine project, $10 billion — billions of which have already been deployed to companies — because as you know, Governor, we’re not waiting to create the vaccine until it’s finally approved. With both Moderna and Pfizer and other companies, we’re actually having them create the vaccine now and to have it ready at the point at which we achieve the final approval from the FDA that any vaccine would be safe to deploy to the American people.
We have a goal of literally manufacturing hundreds of millions of doses by this fall and to have them available by next year. In fact, we’re also in the process of procuring over a billion needles and syringes to be able to deploy a vaccine to the American people.
The President called it “Operation Warp Speed,” and that’s — that’s the speed at which we’re moving to develop a vaccine. But to be here today, Governor, to be here in Florida, at a great university that has played such an important role, particularly in the midst of this pandemic.
And, Dean Ford, I want to thank you for the way the University of Miami and Miller School of Medicine have stepped forward. I know you actually created a separate COVID hospital here for COVID patients. And I want to agree strongly with — with Governor DeSantis that it’s been the level of care here in Miami, the University of Miami, and all across Florida that’s — that’s had the — had the effect of lowering the number of heartbreaking losses that have occurred. And so I want to commend you for that.
But I also wanted to say we thought there would be no better place among the 89 sites across America than to come here to University of Miami, where, in just a few short days, the first phase three clinical trial of a coronavirus vaccine will begin. And I hope — I hope you take it, and the whole team here takes it as a great compliment and a great statement of confidence in the professionalism of all of the great healthcare team here at the University of Miami.
We look forward to the results. And we thank you for the cooperation that’s brought us, really, to this — this historic day, a day when we begin in earnest, in phase three, down the path toward securing a vaccine for the American people.
So let me just — let me close — before I turn it over to Dr. Hahn, who will describe to you the process whereby we got here and what we’ll be looking to see in the days ahead — simply to say thank you. Thank you again to the University of Miami. Thank you to Moderna for the urgency and public spirit that this company has brought to this effort, as so many other companies have brought to the development of vaccines and therapeutics.
I want to thank Congressman Díaz-Balart and, frankly, members in both political parties who’ve made the resources available for us to meet this moment.
And I also want to — I want to say thank you to two other folks. First is to Governor Ron DeSantis for that steady leadership you’ve provided for the people of the state of Florida. You and your whole team have been — have been there for the people of this state. I want to especially commend you for your efforts to come alongside people in long-term care and in nursing homes. It was here in Florida that we saw early efforts to make sure that we had the testing, that we had the supplies to see to our seniors.
I want to thank you — thank you for those early efforts; they were truly an example to the nation and we know — we know saved lives and will continue to.
And lastly, I just simply want to say — I want to say thank you to all the Americans who have volunteered to participate in this phase three clinical trial. All of us have a role to play: wash our hands, practice personal hygiene, wear a mask every time that it’s indicated or where social distancing is not possible.
But as we sit here today, 30,000 Americans have stepped forward all across the country to participate in the vaccine trial, and we also have clinical trials that are taking place in therapeutics and in other vaccines. And so to each and every American who has volunteered to participate in these and other trials, on behalf of the President and on behalf of the grateful nation, we say: Thank you.
But let me urge anyone that would like to participate in this clinical trial here in Miami or anywhere across the country, you can go to ClinicalTrials.gov — that’s ClinicalTrials.gov — and find out a way that you can do more than your part to help us reach that day that we put the coronavirus in the past.
So with that, I’ll turn it over to Dr. Stephen Hahn, the Commissioner of the FDA. And I very much look forward to our conversation with all the great healthcare leaders. And thank you, Governor, again for hosting us today.
DR. HAHN: Thank you, Mr. Vice President.
THE VICE PRESIDENT: Stephen?
DR. HAHN: Thank you, Governor DeSantis and Dean Ford. Really appreciate the warm welcome. And my medical colleagues here, who are on the frontlines taking care of patients, very much appreciate it. And thank you for what you’re doing to help us get a vaccine to the American people and folks around the world.
I want to second what the Vice President said in terms of the heroes here are the folks who are volunteering to be participants in the clinical trial. And they will help us get to the point where the data are available to assess the efficacy and safety of a vaccine. It’s a true sign of the great American biomedical research enterprise that we’re at this point, at this time, after the introduction of COVID-19 and the pandemic that we’ve been through.
So, again, just terrific work, I think, by — by all Americans. And, Mr. Vice President, you’re right, we all have a role to play, and you have done more than your share, that’s for sure.
At FDA, we are doing all we can to support vaccine and other therapeutic development. As you know, we have issued guidance to outline the data that we’ll need to see, because we have great scientists, doctors, pharmacists, nurses at FDA, who will be looking at the data when they’re available for the vaccine to determine its safety and effectiveness.
I think it’s really important some of the components of that one is we’ve specified how many people should be in the trial, because we’re looking at a floor in terms of the efficacy of a vaccine. We specified that participants from all walks of life, from all groups, particularly those who are typically underrepresented in clinical trials, should participate in this trial, so we have a sense of these results being generalizable.
FDA scientists in our Center for Biologics Evaluation and Research will not cut corners. Let me just stress that: Will not cut corners in order to evaluate a vaccine. And although we have gone at significant speed to get to this point, our job at FDA, and our solemn promise to the American people, is that we will judge based upon the data and upon the gold standard that we have an FDA regarding the safety and efficacy of a vaccine.
The FDA scientists who call the balls and strikes, they do this every day. That’s what they’ve been doing for years. They’re aware of the information that we need. And I know that the great teams, University of Miami and elsewhere around the country, will be providing those data to the FDA.
And then finally, we have a really robust pipeline of therapeutics and vaccines in the United States and around the world. We’re fortunate — I think, Governor DeSantis and Dean Ford, you mentioned the fact that we’re in a fundamentally different place than we have been years — in the last couple of months with respect to therapeutics but also the great care that’s being provided. And there are more than 100 vaccines that are being looked at around the world in various stages of development. And, of course, we are — have a number of them in house at FDA, and we expect at least two additional to be in phase three trials within the next several weeks.
So it’s terrific to be here. I can assure you that FDA is on the job and that we will make the appropriate adjudication with respect to safety and efficacy.
Thank you, Mr. Vice President.
THE VICE PRESIDENT: Great. Thank you, Doctor. Thank you all.
1:27 P.M. EDT