COVID vaccine study with 30,000 volunteers launched with Vice President Pence touting UM’s role in Miami

MIAMI — In the race to stop the spread of COVID-19, Vice President Mike Pence arrived at the University of Miami on Monday to kick off the first large-scale clinical trial of a potential vaccine in the United States.

The University of Miami is one of 89 sites in the country that will enroll volunteers for the 30,000-person study, which will look at the safety and effectiveness of a vaccine manufactured by Moderna.

“This is a statement of confidence in the professionalism of the great healthcare team at the University of Miami,” he said during a roundtable at the University of Miami Miller School of Medicine that included politicians and researchers. “Today is a historic day. It’s a day of hope, a day of promise.”

Pence announced the potential vaccine is moving through its phases at “warp speed” as promised by President Donald Trump.

“It is remarkable to think that Moderna entered phase one back in March in a matter of weeks after we received the genetic coding for the coronavirus,” Pence said.

He said the goal is for federal funding to go towards manufacturing hundreds of millions of doses by fall — even before the trials are complete — to and have them available by next year. “We have already begun procuring a billion needles and syringes to be able to deploy the vaccine to the American people,” he said.

Food and Drug Administration Commissioner Stephen Hahn, in Miami for the kickoff of the first potential vaccine to enter large-scale trial, said, “The heroes are the volunteers.”

Hahn assured the public that scientists at the FDA will not cut corners to validate a vaccine. “A vaccine will be judged based on data. We will be looking at the safety and efficacy of the vaccine,” he said.

Hahn said that more than 100 vaccines are in various stages and two in addition to the Moderna vaccine will start trials in the next several weeks.

Earlier this month, UM researchers announced they were scouting for volunteers in South Florida to participate in the clinical trial in which they will inject 1,000 people with the potential COVID-19 vaccine. The vaccine, developed by the National Institutes of Health and Moderna, trains the immune system to recognize COVID-19 and mount a defense.

Although other teams around the world are working on a vaccine, Moderna’s is considered to be the world’s largest study.

Rather than using the whole virus, UM researchers are using the COVID-19 spike proteins and mimicking the infection in such a way that they teach the immune system to recognize the virus and attack it.

Infectious disease expert and associate professor of clinical medicine Dr. Susanne Doblecki-Lewis is leading UM’s research team during the trials, alongside co-investigator Dr. Maria Alcaide. Doblecki-Lewis said Monday that the university is making a concerted effort to ensure diversity in the trial participants. “We are aware of the need to diversify our enrollment and we take that mandate seriously,” she said. As part of the trial, 500 volunteers will get the vaccine and 500 will get a placebo.

The Moderna vaccine performed well in a much smaller study of only 45 participants whose results were published in the New England Journal of Medicine in mid-July. The study showed that the vaccine, given at three different doses, triggered an immune response in the people who received it (the higher the dose, the higher the immune response). However, because there were only 15 healthy volunteers in each of the three vaccine dose groups, the work is still a preliminary achievement. And some of the participants did develop side effects such headache, fever, malaise and muscle pain.

Researchers will be looking at whether the vaccine protects the recipient completely from falling ill, whether it provides lasting immunity, and whether it lessens the severity of symptoms if someone does get sick from the virus.

Dr. Anthony Fauci, the nation’s top infectious disease expert, has expressed optimism that a vaccine could be available in the United States by the end of this year. Experts, however, warn there are risks with proceeding quickly.

Those who participate in UM’s vaccine trial will receive a shot in the arm and receive a second injection 28 days later. Researchers will follow trial participants for two years.

On Monday, Bill Gates announced a COVID-19 vaccine he is backing by the South Korean pharmaceutical company, SK Bioscience, may be capable of producing 200 million kits by next June. Besides working on its own vaccine candidates, the company also is a manufacturer for AstraZeneca which is working on a vaccine with Oxford University that will soon be in the final stages of testing.

Pence said it’s too early to know for certain how the vaccine will be distributed once approved by the FDA, but likely will initially be given to the most vulnerable population, which is the elderly and immuno-compromised.

Cindy Krischer Goodman is the health reporter for the Sun Sentinel. Connect with her at [email protected] or on Twitter @cindykgoodman