As they finish inoculating local volunteers for the Moderna COVID-19 vaccine trial and continue recruiting for a new vaccine trial, doctors at the University of Miami Leonard M. Miller School of Medicine are elated by early indications that the Moderna vaccine and another one are extremely effective in preventing the spread of COVID-19.
“It’s incredibly exciting,” said Dr. Susanne Doblecki-Lewis, clinical director for the Miller School’s Division of Infectious Diseases and the principal investigator of the Moderna trial. “This shows we can have vaccines for COVID-19 that are highly effective—and hopefully, we’ll have several because they will make an incredible difference in the course of the pandemic.”
Last week, Moderna announced that preliminary data shows its two-dose vaccine is 94.5 percent effective in the prevention of symptomatic COVID-19, the infectious disease caused by the novel coronavirus. Just days earlier, pharmaceutical giant Pfizer announced that its vaccine was more than 90 percent effective. Both companies are now in the process of mass producing the vaccines, although the vaccine trials continue to follow patients for two years after inoculation.
If it was not for the willing participants in Greater Miami and elsewhere, Doblecki-Lewis, an associate professor of clinical medicine, said the Moderna vaccine trials would not have generated positive results so quickly.
“Our participants should be really proud—without them we would not have this data, and I think we’ll need a lot more volunteers in the future because it’s important that we have multiple vaccine candidates that are tested,” she said. “At this time in the pandemic, volunteering is a really positive thing to do to make sure we have the best possible vaccine and enough of it.”
University doctors are now recruiting participants for a one-dose vaccine developed by Janssen, a subsidiary of Johnson & Johnson. They have just a few weeks to wrap up enrollment by the end of the year and hope to get close to 1,500 participants.
“At the moment, the trial is going very well, and the patients we have had so far have very few side effects,” said Dr. Dushyantha Jayaweera, principal investigator for the Janssen trial and a professor of medicine in the infectious disease research unit at the Miller School.
Jayaweera noted that both the Janssen study, as well as the Moderna one, are double-blind, placebo-controlled studies. This means that half of the participants get the vaccine, while the other half will not. But both the doctors and patients are unaware of who is getting the vaccine and who is getting a placebo.
So far, the Janssen study has garnered 110 participants in the first two weeks of recruitment, but Jayaweera, and one of his co-investigators, Dr. Olveen Carrasquillo, said they need many more, particularly minority candidates. Right now, he is happy to report that more than 60 percent of candidates are Black or Hispanic, but Jayaweera and Carrasquillo said that just last week they were on a conference call with Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases (NIAID), who emphasized the need for minority groups to participate in vaccine trials. That way the results will represent all of the people who are suffering from COVID-19. Data from the beginning of the pandemic has shown that Black, Hispanic, and Native American people are much more likely to be affected by COVID-19, and often face more dangerous outcomes.
“Everything, so far, suggests positive things. But we need brave people to make sure the vaccine is safe and effective for everyone,” said Carrasquillo, chief of the division of general internal medicine and a national expert on health disparities.
Physicians are optimistic about the vaccines being tested in upcoming trials because most share a critical element, Doblecki-Lewis said. All of the vaccines they are testing at the University so far—and most under clinical trials in the U.S.—operate by attacking the disease’s spike protein, which is how COVID-19 enters into the body’s cells and replicates. But until there were some results from these first two trials, no one knew if that was the right approach to provoke an immune response. A similar method is used to create synthetic monoclonal antibodies, which are present in the Regeneron treatment that is the subject of another clinical trial at the University, she added.
“When COVID-19 came about, many thought that the spike protein was the best target, but until now we weren’t sure that was the right focus,” Doblecki-Lewis explained. “It turns out that it was a good bet.”
The data released about the effectiveness of the Moderna and Pfizer vaccines was also encouraging because respiratory vaccines are often much less effective, Doblecki-Lewis added. In comparison, the flu shot—which she highly recommends—is only 70 percent effective.
Still, University physicians recognize that more than two vaccines will be needed to help immunize the nation and the world against COVID-19.
“We need more than 300 million vaccines for the U.S. alone, so even if the Moderna and Pfizer vaccines are ready, you need more than two,” Jayaweera said. “Even more important is that the public understands how rigorous we are testing these vaccines, so that they will hopefully get immunized after the trials are over. What’s the point of having all these vaccines if people do not use them?”
Toward that goal, there will likely be more COVID-19 vaccine trials coming to the University, Doblecki-Lewis said. That’s because the Miller School of Medicine is part of the National Institutes of Health COVID-19 Prevention Trials Network, which is spearheading the nation’s vaccine efforts. Since the Miller School was already a part of the HIV Vaccine Trials network, the existing partnership made it a logical place to test COVID-19 vaccines, according to Doblecki-Lewis.
At the same time, the University is also working to:
- Earn government approval for its own rapid COVID-19 test developed by Dr. Sylvia Daunert, in the Department of Biochemistry and Molecular Biology, and an oral rinse test developed by Dr. Elizabeth Franzmann, in the Department of Otolaryngology.
- Further advance a vaccine platform developed by Dr. Natasa Strbo, in the Department of Microbiology and Immunology.
- Test whether convalescent plasma treatments in COVID-19 patients—and in outpatients who may be exposed to COVID-19—are effective to fight off the disease or to prevent it entirely.
- Determine whether inhaled nitric oxide can help stabilize COVID-19 patients in need of oxygen support—a clinical trial that is being done by Dr. Roger Argelio Alvarez, an assistant professor of pulmonology.
All of these treatment efforts will help physicians continue to advocate for their patients during what will likely be a challenging winter, said Carrasquillo, who has treated many people suffering from COVID-19.
“Over the past several months, we learned a lot more about how to treat these patients. We had a lower mortality in July than we did in April, and every little bit helps,” he said. “But for prevention there was no hope, yet listening to the data from Pfizer and Moderna, I can see a light at the end of tunnel. A vaccine is not going to happen immediately—we are still months away—but I am hopeful that by next summer we will be in a different place than we are now.”
To participate in the Janssen vaccine trial, or any of the ongoing COVID-19 clinical trials at the University, visit https://umiamihealthresearch.org and click on the COVID-19 icon.
