Vice President Mike Pence visited the University of Miami Miller School of Medicine along with Florida Gov. Ron DeSantis to thank the University for its leadership in launching the first Phase 3 clinical trial of a COVID-19 vaccine.
“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 3 clinical site in the nation,” said Henri R. Ford, M.D., M.H.A., dean and chief academic officer of the Miller School, in welcoming the vice president and the governor on July 27.
“Today is a historic day,” Vice President Pence said. “Today at the University of Miami we will begin the first Phase 3 trial for a coronavirus vaccine in the United States – 89 sites all across America with more than 30,000 participants will be part of this. I want to thank the University of Miami not just for being the site of the clinical trial, but just as much, Dean Ford, for everything you’ve done throughout this pandemic.
“It is a tribute to the innovation of all the doctors, nurses and health care workers.”
Governor DeSantis thanked the vice president for his support and pointed out that despite the ravages of the coronavirus, some numbers in Florida are improving. Visits to emergency departments for COVID-like illness are lower than they were in mid-June, hospital admissions are lower, and the COVID test positivity rate is “slowly but definitely declining.”
“It’s because we have a great medical system in the state of Florida, particularly here in South Florida,” DeSantis said. “I want to thank the folks here at UHealth who have been doing a great job saving lives and producing good patient outcomes.”
The vice president expressed deep gratitude for UHealth’s contributions throughout the pandemic. “It’s been the level of care, here at the University of Miami and all across Florida, that’s had the effect of lowering the number of heartbreaking losses that have occurred,” Pence said. “I want to commend you for that, but I also want to say that we thought there would be no better place among the 89 sites across America than to come here to the University of Miami, where in just a few short days the first Phase 3 clinical trial of a coronavirus vaccine will begin.
“I hope the whole team takes it as a great compliment and a great statement of confidence in the professionalism of all the great health care team at the University of Miami.”
Susanne Doblecki-Lewis, M.D., M.S.P.H., associate professor of clinical medicine, is leading UM’s participation in the clinical trial, part of the National Institutes of Health COVID-19 Prevention Trials Network. The trial will test a vaccine developed by scientists at the NIH’s National Institute of Allergy and Infectious Diseases and collaborators at biotechnology company Moderna, Inc.
“We’re incredibly excited to begin this process here at the University of Miami, and we are really amazed and humbled by the number of volunteers who have already stepped forward to be a part of this trial,” Dr. Doblecki-Lewis said at the news conference. The Miller School plans to enroll 1,000 patients in the trial, making sure to represent the diversity of South Florida and patients most at risk because of medical conditions.
Stephen Hahn, M.D., commissioner of the Food and Drug Administration, also spoke of the participants in the clinical trial as “heroes” for helping the research move forward so quickly. “It’s a true sign of the great American biomedical research enterprise that we find ourselves here today,” he said. “Normally this process would take months and years. Although we have gone at great speed, our solemn promise is that we will judge results based on the data, and on the gold standard we have at the FDA regarding the safety and efficacy of a vaccine.”
Those at the news briefing attended a roundtable discussion with the vice president and the governor at the Gordon Center for Research in Medical Education that included Lt. Gov. Jeanette Nunez; U.S. Rep. Mario Diaz-Balart; Dipen J. Parekh, M.D., chief operating officer of the University of Miami Health System; Stephen Nimer, M.D., director of Sylvester Comprehensive Cancer Center; and Howard Schwartz, M.D., principal investigator of Research Centers for America.
Vice President Pence joined in the praise for clinical trial participants and encouraged everyone who might be interested in participating to visit clinicaltrials.gov. He reminded his audience that “all of us have a role to play, practicing good hygiene, washing our hands, wearing a mask.”
“Today is a day of hope,” Pence concluded. “Today is a day of promise. If all of us continue to do all we can, we’re going to reach the day when we put this coronavirus behind us.”