It was more than a year ago when Kathleen Neuzil, MD, MPH, director of the Center for Vaccine Development and Global Health (CVD) at the University of Maryland School of Medicine (UMSOM), was gearing up for a spate of research into influenza so her team could work on developing a longer-lasting vaccine. This was coupled with multiple trips to several sites in Africa and Asia to manage a team of experts testing a typhoid vaccine on tens of thousands of children.
All of this happened as infectious disease experts around the world, including Neuzil, were remembering the 100th anniversary of the Spanish influenza pandemic, which swept across the world infecting 550 million at the end of World War I. And, while experts like Neuzil had warned repeatedly that another pandemic was possible — particularly in a globally connected world — what wasn’t known was that in a matter of weeks the world would be facing one of the most serious pandemics in modern history as a new coronavirus moved quickly across the globe.
“We’ve really been working around the clock. The days and nights have merged, and most people are working seven days a week,” said Neuzil, whose interdisciplinary research team is studying SARS-CoV-2, or COVID-19, testing therapies to treat those infected by the virus and conducting clinical trials for vaccines on hundreds of volunteers. “We’re working into the evenings, and it’s really not just here at CVD, it’s the medical and public health communities together that see the urgency of this pandemic.”
Neuzil, the Myron M. Levine, MD, DTPH, Professor in Vaccinology, has been at the center of the domestic and global responses to COVID-19. As the co-principal investigator of the Infectious Disease Clinical Research Consortium of the National Institutes of Health (NIH), she is part of the strategic team evaluating COVID-19 vaccines and therapeutics in the United States, and she is part of the study team that designed the first COVID-19 clinical vaccine trials in the U.S.
All of this research has been mobilized at an unprecedented pace.
Neuzil said that over the Christmas holiday, infectious disease experts around the world were first learning of this new pneumonia-like illness, but most initially thought it might be a localized illness in China, where it emerged. This was the case with the first severe acute respiratory syndrome (SARS) pandemic of the 21st century that took place in 2002.
“Over the holidays into the new year, we heard a little about what was happening in China, that there was this new disease. And at that point, we initially thought it was likely to be a localized outbreak,” she said.
But as cases started popping up across Asia, Europe, and then in the United States in a matter of weeks, it became quite a different story.
“I think by February, it became very clear that this was much more transmissible, that containing this coronavirus in small outbreaks was not going to be possible, and that really we needed to double our efforts with treatments and vaccines — it was very clear that this was a pandemic,” Neuzil said.
Since then, it has been a life-changing and personal experience for researchers at the CVD.
Five immediate family members of CVD staff members have died from COVID-19. They did not contract the disease because of the work at CVD, but Neuzil worries about the risk to her clinical trials staff and others who could be exposed.
“It’s been really tragic. This is very personal,” she said.
The days are long for her and her staff. Neuzil’s days sometimes start as early as 4 a.m. as she oversees several COVID-19-related research projects on campus and at other research sites across the country.
“I am usually here at work by 6 or 6:30 a.m., and that gives me maybe an hour or two to get some things done before the calls and the workday start,” Neuzil said. “I would say that the hours pass quickly, because we are doing some important work and that involves engaging conversations with energetic people with good ideas. To be honest, the people here at CVD inspire me to work harder.”
Neuzil, a respiratory illness expert, serves as co-director of the White House’s COVID-19 Prevention Network, the committee of experts that was quickly mobilized this year and is designing vaccine trials and a COVID-19 response at sites across the country. Neuzil also is an ad hoc member of the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization’s working group on SARS-CoV-2 vaccines, and as a member of the World Health Organization’s (WHO) Strategic Advisory Group of Experts on Immunology, she is advising WHO on the use of COVID-19 vaccines as data become available.
A typical day for Neuzil will start with meetings with researchers in Europe or from one of CVD’s sites in Africa or Asia, then her day merges into meetings with NIH officials and other collaborators across the country. In this midst of that, she will make the time to head across the street to greet volunteers in CVD’s clinical trials, talk to the nursing staff, and get an update from her investigators.
“Without our volunteers in our clinical trials, we will not have a vaccine. They are our most important partners in this effort,” Neuzil said.
All Hands on Deck
At CVD, several clinical trials for COVID-19 vaccines have been underway, including a Phase 1 vaccine trial for Pfizer, Inc., and a Phase 3 trial for a vaccine developed by Moderna, Inc. More trials are in the preparatory stages, and this could include a pediatric vaccine.
“It takes everybody pitching in,” Neuzil said.
Neuzil credits success at CVD to the bench-to-bedside approach to research. Experts are working in the lab to understand the virus, and many of the physicians on staff also are treating the sickest of patients in the COVID-19 ward at the University of Maryland Medical Center. She noted that early results for remdesivir, an antiviral therapy tested by CVD, and the Pfizer and Moderna vaccines are promising.
“What makes us unique is that we look at vaccine development from end-to-end, from basic science and antigen discovery, to the clinical trials, out to the modeling of the policy and the delivery of vaccines,” Neuzil said. “Our team works collaboratively in a multidisciplinary way to tackle infectious diseases.”
Reaching Populations Most Impacted by COVID-19
A key focus of CVD’s trials is reaching populations most impacted, including African Americans, members of the Latino community, elderly individuals, and those with underlying health risks such as obesity, diabetes, asthma, and heart disease.
“We have seen a lot of the health disparities in this country exposed. Minorities are certainly more likely to contract COVID-19, and we know that the minority populations in this country have more underlying conditions,” Neuzil said.
To address this issue, CVD has partnered with community organizations such as CASA de Maryland in Hyattsville to reach populations most impacted. For the first time ever, CVD is conducting its research with COVID-19 vaccines in the community. Researchers have set up a satellite site in Hyattsville, and they are vaccinating and screening individuals there at CASA headquarters. Participants in this community, a hotspot for COVID-19 and largely Latino, can participate in the CVD trial locally, without having to come to the Baltimore campus.
Karen Kotloff, MD, professor of pediatrics, head of the clinical trials unit within the CVD, and principal investigator for COVID-19 vaccine and therapy research, said that since the beginning of this year, COVID-19 has been the center of her life.
“It is all I do 16 hours a day, and I won’t stop until I know that there is a safe and effective vaccine that is available globally, and, most importantly, for the people in the U.S. and in Africa where I work who need it the most — those who are vulnerable, afraid, distrustful, or disenfranchised, who have less access to health care or are living in conditions or doing jobs that don’t allow them to fully protect themselves,” Kotloff said.
And while Neuzil and her team spend countless hours moving forward with COVID-19 research, weighing heavily on Neuzil’s mind is the health and stamina of her team. “When we talk about CVD and the way we are working to get to the finish line, I do worry about the morale. I worry about continuing to inspire people to take care of themselves a bit,” Neuzil said.