Stories Behind the Science: Preparing to Fight the Next Epidemic

Updated on Sep 9, 2025 | COVID-19, Featured, Research

Stories Behind the Science: Preparing to Fight the Next Epidemic

Kris White, PhD, Assistant Professor of Microbiology at the Icahn School of Medicine at Mount Sinai (right), and lab member Isidora Suazo, PhD, Postdoctoral Fellow (left), are part of a research network to discover new drugs for a viral epidemic preparedness initiative.

It was June 2022, and Peter White, a lawyer from Point Lookout, Long Island, was in Florida attending a work event. As he was waiting for his flight home, he started to feel sick.

“By the time I landed, I was very sick with a heavy pressure in my chest,” said Mr. White, 67. “Any time I had previously felt like this, it had always, at a minimum, developed into bronchitis or pneumonia.”

Mr. White was worried it was COVID-19, which could spell poor outcomes given his underlying respiratory condition. “When I get a cold, it has a tendency to morph into bronchitis and, at times, pneumonia. I’ve had walking pneumonia several times, as well as regular pneumonia,” he said. “I can’t count the number of times I have had bronchitis.”

His doctor advised him to go to the emergency room to seek treatment for COVID-19. Thankfully, just months prior—in December 2021—the antiviral medication Paxlovid (nirmatrelvir/ritonavir) from Pfizer had become available via emergency use authorization for the treatment of COVID-19.

“I did not feel better right away,” Mr. White recalled. “However, I did not get worse, which was huge given my prior history, and it was a comfort for me that the drug was working.”

“Thankfully, his bout with COVID-19 ended up being uneventful, because he was able to take Paxlovid quickly and clear it out of his system,” said Kris White, PhD, Assistant Professor of Microbiology at the Icahn School of Medicine at Mount Sinai and Mr. White’s son.

“The COVID-19 pandemic really taught us the value of having treatments ready to test and deploy quickly when an epidemic hits,” said Dr. White.

Mount Sinai has been working toward that goal, in part through its involvement in the Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern, established in 2022 by the National Institutes of Health (NIH). Dr. White’s lab is among several at Mount Sinai contributing research as part of the AViDD Centers, developing antiviral drugs to tackle future outbreaks.

Dr. White (second from right) with his father, Peter (second from left), with five of Dr. White’s children and two nieces. Peter caught COVID-19 in 2022, but with Paxlovid antiviral treatment, it did not develop into something severe, for which Mr. White was at high risk.

However, recent cuts to NIH funding have threatened to stall progress. “We were halfway to the finishing point,” said Dr. White. “With our funding cut, it is like we have half a drug—and that is of no good to anyone.”

Read about how antiviral research can help us navigate future epidemics, and challenges the AViDD Centers face.

‘It Could Have
Been A Very
Different Pandemic’

The issue with relying solely on pharmaceutical companies to develop drugs for an epidemic is that until the health crisis is at hand, there is no incentive for them to carry out such research, noted Dr. White.

That was the case with COVID-19—when it hit in early 2020, there were few if any drug candidates to test right away. Pharmaceutical companies and academic institutions scrambled to find new compounds, or repurpose old ones, that could treat the infection.

Pfizer had a lead, PF-07321332, which had potential for targeting SARS-CoV-2, the virus that causes COVID-19. It was developed in 2003 to address the severe acute respiratory syndrome (SARS) outbreak in 2002-2004. But before it could make it into human clinical trials, the outbreak was contained and development was discontinued.

Even promising compounds take time before they can be used on patients. It wasn’t until March 2021 that Pfizer announced it would test PF-07321332 in humans in a phase 1 trial. In June that year, a phase 2/3 trial was carried out to test its effectiveness, and in December, the compound, which had been named Paxlovid, received its emergency-use authorization.

“We’ve seen that given the will, we can quickly test the effectiveness and safety of treatments and make them available to the public,” said Dr. White. “Imagine if we had compounds ready to test right at the beginning, it could have been a very different pandemic.”

For Dr. White’s father, that difference was between life and death. “Paxlovid was a game changer for me,” said Mr. White. “Knowing that I was most likely going to suffer, but not die, from COVID-19 was good news. It would have been better if this drug was available sooner rather than later.”

Having treatments available early on not only reduces transmission, disease severity, and mortality rates, but also has an impact on health policy.

“Having such an antiviral could even have mitigated the need for severe lockdowns, or even vaccine mandates,” said Dr. White. For people who might be ineligible for vaccines, or were resistant to such mandates, having a treatment available would have provided options for health providers and policymakers, he explained.

March 2020

The World Health Organization declares COVID-19 a pandemic.
September 2020

Pfizer completes pharmacokinetic study of PF-07321332 in rats.
March 2021

PF-07321332 tested in a first-in-human phase 1 trial.
June 2021

Phase 2/3 trial for PF-07321332 begins.
December 2021

PF-07321332 receives emergency-use authorization from the FDA, is named Paxlovid.

Kickstarting the Process

Dr. White, seen dressed in protective clothing, works with Biosafety Level 2 and Biosafety Level 3 viruses as part of his work. His lab’s research includes drug discovery of new antivirals and building up animal models of viral infection.

Following the authorization of Paxlovid, the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, realized the benefits of having promising drug candidates ready to be tested at the onset of an outbreak.

“Academic institutions like Mount Sinai were perfectly suited for kickstarting that discovery work,” said Dr. White, whose lab studies viral-host interactions, develops cell culture and animal models of viral infection, and performs other antiviral drug discovery work.

Members of Dr. White’s lab, from left to right: Briana McGovern, BS, Senior Research Associate; Meg Gordon, BA, Research Associate; Dr. White; Dr. Suazo; Jared Benjamin, MS, Research Associate.

“Historically, drug discovery was a process that took billions of dollars, and was usually undertaken by pharmaceutical companies,” said Dr. White. “Now, with technological advances and artificial intelligence, the cost of that process has been brought down to millions of dollars, which is a realm that the federal government can provide funding for.”

NIAID awarded a total of $577 million in 2022 toward the creation of nine AViDD Centers, which collectively work to discover better treatments for SARS-CoV-2 and other coronaviruses, as well as six other pathogen families of concern, which include Ebola, Zika, and other cold-causing viruses. Mount Sinai researchers received a total of $16 million and are involved in four of the nine centers.

Progress
Cut Short

Dr. White handling cell cultures stored in a cold storage unit in his lab.

The AViDD Centers were conceived as a five-year project. However, in March 2025—three years into the Centers’ inception—the Centers for Disease Control and Prevention canceled more than $11 billion in funding earmarked for pandemic response.

This included funding for the AViDD Centers, where researchers had the remainder of their unspent budget terminated immediately, pulling out the rug from under several projects.

“I’ve had to let people go from my lab, and we’re currently working in an unfunded state for the AViDD project,” said Dr. White. “We’re only continuing because we had prepaid for certain things before the funding cutoff.”

The most advanced drug developed thus far was basically a better Paxlovid for targeting coronaviruses, but without the need for the ritonavir component, said Dr. White. This is critical because the ritonavir component severely limits the use of Paxlovid in some patients due to drug interactions with other drugs. That compound is more or less ready for a pharmaceutical company to take over for clinical trial testing, with its patents remaining open access, as directed by the NIH.

“We have an excellent coronavirus drug ready to go to clinical trials, but every other drug for the other viruses—paramyxovirus, filovirus, flavivirus, and more—none of them are even close,” he said.

At best, work on the other viruses are close to getting their animal model efficacy data, which is crucial for moving the drugs into human models, said Dr. White. “Getting animal model data is hard enough in five years. Without funding for the remaining two years, getting that data in just three years is almost impossible.”

The drug dispensing robotics system, operated by research associate Mr. Benjamin in this photo, is part of the workflow in which the lab tests new antiviral compounds, said Dr. White. The equipment functions similar to an inkjet printer, and is able to print drugs into a plate format.
Dr. White’s lab had been working on animal models of coronaviruses, flaviviruses, and enteroviruses, and with funding for AViDD Centers abrupted halted, cultures remain in cold storage, waiting for work to resume.
Mr. Benjamin is monitoring the high throughput liquid handler system, which increases the number of samples that can be tested. Throughput is what drives drug discovery, and the lab was able install the equipment thanks to AViDD Centers funding, said Dr. White.

Operating costs for AViDD projects are on a larger scale because they involve high-throughput structural biology and biochemistry that run millions of dollars per year, noted Dr. White. Researchers are reaching out for patchwork funding to keep operations going, including from the Department of Defense, NIH, not-for-profit organizations such as the Drugs for Neglected Diseases initiative, and philanthropy.

Getting continued funding is crucial because viral outbreaks do not take breaks.

“At our labs, we’ve been focusing on Zika virus disease and dengue fever, and these are viral infections we’ve already seen on our shores but still have no treatments for,” said Dr. White.

“At the end of the day, I want to be able to keep my dad and many other people like him safe when—and not if—the next viral outbreak occurs,” said Dr. White. “We were already caught by surprise once with COVID-19. Let’s not have history repeat itself again.”

A Message Board of COVID-19 Reflections

Updated on Jun 17, 2025 | COVID-19 Reflections

Five years have passed since the height of the COVID-19 pandemic in New York City, and the Mount Sinai Health System marked the occasion by preparing ways to reflect on lessons learned during the health crisis, and to memorialize the challenges faced.

During the period in which the message board was open to Mount Sinai staff for posting, many shared their experiences of going through the height of the pandemic, such as this post from Sean Liu, MD, PhD, Medical Director of the COVID Clinical Trials Unit.

One such effort was creating a message board and inviting staff across Mount Sinai to share their thoughts. From March through June 2025, doctors, nurses, volunteers, and even researchers posted about their experiences on navigating the pandemic.

“Many of us look back at the COVID-19 pandemic like a time of war,” wrote Sean Liu, MD, PhD, Medical Director of the COVID Clinical Trials Unit, on the message board. “Our loved ones were sheltered away at home while we marched into the hospital every day to face uncertainty and witness the horror and devastation of an invisible enemy.”

Some shared memorials for lives lost to COVID-19. Some put up pictures about the camaraderie and courage shown by members on the front line. One poster, in particular, shared how he tried to lighten mood for his team with a comically sized fake mustache on his mask.

The message board is now closed for any new posts, but you may still view it to see what Mount Sinai staff shared.

Check out the message board here

Archiving COVID-19 Memories: Capturing All Voices of a Pandemic’s Impact

Updated on May 16, 2025 | COVID-19, COVID-19 Reflections, Infectious Diseases

From left to right, Erik Blutinger, MD, Assistant Professor of Emergency Medicine; Karen Wish, Vice President and Chief Marketing Officer; and Khalid Islam, Safety and Training Manager for Emergency Medical Services at Mount Sinai, contributed oral histories about their experiences during the pandemic.

When the COVID-19 pandemic hit New York City in March 2020, all manner of operations at the Mount Sinai Health System were disrupted. Clinicians and nurses, regardless of specialization, were suddenly caring for COVID-19 patients, in-person work had to cease and be shifted to remote, and staff across all departments had to handle the stresses of a new reality.

During that time, The Arthur H. Aufses, Jr. MD Archives, which houses historical collections from the Health System and the Icahn School of Medicine at Mount Sinai, were documenting how staff members were dealing with the pandemic by recording oral history interviews.

“It was critical to speak with our staff during the start of the pandemic so that their initial experiences could be saved as they had just happened,” said Molly Seegers, Director of the Archives. “This was to recognize and honor what they were experiencing and to ensure that their stories would be preserved for future generations to learn from how we responded and prepare for another pandemic.”

From July through October 2020, the Archives team conducted interviews with doctors, nurses, students, researchers, medical responders, and administrative staff to get the full story of COVID-19’s impact. It was important that the team capture not just the voices of hospital leaders, who spoke frequently at town hall meetings, but all facets of Mount Sinai, said Ms. Seegers.

“People in positions of authority are often the ones whose opinions and decisions are most broadcast. Oral history interviews allow for people who may be left out of the historical record to contribute their experience and have the human experience be more accurately represented,” she said.

The Archives team gathered the “COVID Memories” oral history collection—containing 26 video and audio interviews with transcripts—of challenges, memorable events, and emotional moments.

In this slideshow, excerpts from three different interviewees have been selected. To watch the full interview and others in the collection, click on the button to access the archives.

"COVID Memories" oral history collection on the Arthur H. Aufses, Jr., MD Archives

Working on the Front Lines During the Early Days of the Pandemic Helped Her Commit to a Career in Clinical Research

Updated on Apr 25, 2025 | COVID-19 Reflections, Featured, Research

Nicole Simons, MA, right, with Katherine Keller, Clinical Research Coordinator

When the first of several waves of COVID-19 cases hit New York City, Nicole Simons, MA, had just landed her first big job out of school as a research coordinator at the Icahn School of Medicine at Mount Sinai. In a matter of days, her dream job was eliminated, along with the jobs of several colleagues.

Then came the call from Human Resources: Could she take on a front-line job that would expose her to this unknown virus and clinics filled with COVID-19 patients? Her answer was a resounding yes.

In a moment of instant serendipity, she was reassigned to work for Alexander Charney, MD, PhD, a noted researcher in the field of schizophrenia, a disease that had first captured her attention in college.

Working closely with clinicians on the front lines during the pandemic would turn out to be a lifechanging experience. She visited hospital wards to collect samples, helped out staff when she could, and even served as a second author of a paper in Nature Medicine that described the team’s work. Now she is the Program Manager of the Jeff and Lisa Blau Adolescent Consultation Center for Resilience and Treatment and is a PhD student in the Clinical Research Program at the Icahn School of Medicine, with plans to continue research into the genetics of schizophrenia. “Working with clinical colleagues on the frontlines really got me thinking about how to narrow the gap between research and clinical care. I plan to use the lessons I’ve learned to keep building research programs that move us closer to becoming a true learning health care system.”

It’s a long way from those early days of the pandemic in 2020. Dr. Charney, Associate Professor, Psychiatry, and Genetics and Genomic Sciences, had been asked by hospital leadership to rapidly build up a COVID-19 Biobank that would collect hundreds of blood samples from patients hospitalized with COIVD-19. It would ultimately serve as a backbone for ongoing research into the virus and the human immune response.

Nicole Simons, MA

Dr. Charney’s team consisted of 100 volunteers who, like Ms. Simons, had seen their research projects paused but were given a chance to come help. The team quickly designed a sample-collection protocol, and once this was in place, the cadre of volunteers organized itself into six teams, with Ms. Simons assigned to the “Running Team.” This team was responsible for transporting collection kits to every location within the hospital, and then bringing those kits back.

What might sound like a simple and straightforward assignment involved a major hurdle. How to gain access to clinics where new hospital rules would not even allow families to enter, even when patients were seriously ill?  Ms. Simons would have to find a way in.

“Entering those clinics was like entering a fog of war environment. The strain on the nurses and doctors was palpable; we needed to visit their clinics without creating additional work for them” she says. They had to figure out a way to make easy for them to know if they should allow the researchers on the floor.

“I came up with this idea of making our research team stand apart so we’d be instantly recognizable.” Her solution: hot pink everything. “We wanted to stand out, so we wore hot pink scrubs, gloves, hairnets. Even our labels were pink,” she says. She and her teammates quickly developed a rapport with the nurses managing the floors they’d visit at all hours of the day and night.

“I felt like we were on the outside looking in, that we were somehow protected bystanders while they provided round-the-clock, unconditional care for their patients. To say thank you and support them, we brought them candy and other treats,” she says. They heard that nurses working in the tents constructed in Central Park needed clean, dry socks, so they asked for sock donations, and the response was instantaneous.

Lending help to the clinicians working in the hardest of circumstances also perpetuated for her a sense of shared purpose with staff and faculty at Mount Sinai. Among the volunteers at the Biobank, she found strength.

During the pandemic, Nicole Simons, MA, left, and a team collected hundreds of blood samples from patients hospitalized with COIVD-19, working with MIriam Merad, MD, PhD, center, Dean for Translational Research and Therapeutic Innovation, and Alexander Charney, MD, PhD,

“We all shared this common goal to collect those samples, no matter the hurdles.  When the hours were long, and the days were hard, we had this shared humanity that pulled us through,” she says.

When the team reached its goal of 500 samples, they pushed on, ultimately sampling more than 700 participants in 49 days, amounting to more than 10,000 vacutainers portioned into 50,000 smaller samples. A high level of organization was critical to success.

“But strong morale, in the darkest of times, was what really got us through those long days,” she says.  “At such a difficult time, it felt like a huge stroke of luck to be working for Dr. Charney, a psychiatrist, leading the Biobank team. His commitment to resilience and mental health was non-stop. He created a safety net for us, with regular weekly check-ins and the option for one-on-one counseling with him any time.”

In July 2020, she served as second author of a paper published in Nature Medicine describing the Biobank’s unique 49- day deep dive to uncover the pathogenicity of the virus. The authors would describe their journey as “not necessarily a model to follow, but rather a live-and-learn memoir of our actions and mistakes under uniquely strenuous circumstances.”

“The team was working intensely in a very high stress, high stakes environment, without much preparation for what we would all come to realize was a once in a lifetime experience,” says Dr. Charney, now Director of The Charles Bronfman Institute for Personalized Medicine and Vice Chair of the Windreich Department of AI and Human Health. “Their mental health was front and center for me. What pulled them through, I believe, was their strong purpose and being part of the group that didn’t have to stay home.”

A Homecoming for a Mount Sinai Nurse and COVID-19 Patient

Updated on Apr 3, 2025 | COVID-19 Reflections, Featured, Nursing

A Homecoming for a Mount Sinai Nurse and COVID-19 Patient

For retired nurse Theresa Francisco, 69, the cardiac intensive care unit at The Mount Sinai Hospital means many things: it had been her workplace for nearly four decades, but also a place where she was cared for when she became critically ill with COVID-19 in 2020.

On Thursday, March 27, 2025, Ms. Francisco returned to the unit for the first time to reunite with the staff who saved her life. Accompanying her were her brother and sister-in-law—both of whom were also admitted to Mount Sinai for the treatment of COVID-19—and Cynthia Enrile, another Mount Sinai retired nurse who cared for Ms. Francisco during her hospitalization.

“I can still remember everything—being a nurse and being a patient,” said Ms. Francisco. When she was initially admitted to the unit, which had been converted to a COVID-19 response unit, she thought she would be discharged after a couple of days. Ms. Francisco ended up spending 42 days in the hospital, and was intubated for 10 of them.

Listen to Ms. Francisco recall her story, and read more about how she went from a Mount Sinai retired nurse to COVID-19 patient in a slideshow of her reunion at the intense care unit.

Theresa Francisco, retired Mount Sinai nurse, shares thoughts on visiting the same unit that treated her when she was hospitalized for COVID-19

Theresa Francisco, 69, who lives in Far Rockaway, Queens, had been a critical care nurse at The Mount Sinai Hospital for 38 years. She retired in January 2020.
On March 27, 2020, Ms. Francisco was hospitalized for COVID-19. She was admitted to the cardiac critical care unit—which was converted to a COVID-19 response unit during the pandemic—at The Mount Sinai Hospital, where she used to work.
Shortly after Ms. Francisco (center) was admitted, so were her brother (left) and sister-in-law (right), also for COVID-19.
Her sister-in-law was discharged after a week, and her brother was discharged after two weeks. Ms. Francisco spent 42 days in the hospital, and was intubated for 10 of them.
Francisco’s friend Cynthia Enrile (left) was a fellow nurse at the critical care unit and cared for Ms. Francisco (right) during her time there. Ms. Enrile retired in May 2020, after working at Mount Sinai since 1986.
On Easter Sunday, 2020, Ms. Francisco’s intubation tube was removed.
After her discharge, Ms. Francisco faced months of grueling recovery. She required high-flow oxygen for months and couldn’t walk.
Today, five years after being hospitalized for COVID-19, Ms. Francisco (left) is still feeling the aftereffects of the disease. She is living with cardiomyopathy and sees a Mount Sinai pulmonologist every six months for follow-up. Pulmonologist E Neil Schachter, MD (right), was part of her care team.
Reuniting with the Mount Sinai staff who saved her life was an emotional but grateful moment, said Ms. Francisco (right). Her tour was guided by Umesh Gidwani, MD (left), chief of the cardiac critical care unit and who cared for her during her hospitalization.

Racing to Stop a Pandemic: The Critical Role of Clinical Trials

Updated on Apr 1, 2025 | COVID-19 Reflections, Featured, Research

A group photo of the COVID-19 Clinical Trial Unit, part of the Mount Sinai Infectious Diseases Clinical and Translational Research Center.

When the COVID-19 pandemic ramped up in New York City in March 2020, the disease was so novel there was no approved treatment for it.

“We saw people come to the hospital with COVID-19, and without specialized treatments, many died,” said Sean Liu, MD, PhD, Associate Professor of Medicine (Infectious Diseases) at the Icahn School of Medicine at Mount Sinai. “I remember feeling helpless, and helplessness is probably the worst feeling that a doctor could experience, because people come to you for help but there is only so much you can do or give.”

With a dire need to discover treatments for patients, the Mount Sinai Infectious Diseases Clinical and Translational Research Center (CTRC) formed the COVID-19 Clinical Trial Unit (COVID CTU) in June 2020 to find ways to stop the disease.

“We already had experts beginning the effort, and with the support of Dennis S. Charney, MD, Anne and Joel Ehrenkranz Dean of the Icahn School of Medicine, and under the leadership of Judith Aberg, MD, Director of the CTRC, we were able to form the COVID CTU and go all in to stop COVID-19,” said Dr. Liu, who was tapped as Medical Director of the research unit.

The COVID CTU conducted interventional studies in all aspects of tackling COVID-19, including several drugs that were ultimately approved by the U.S. Food and Drug Administration (FDA). These include Regeneron’s monoclonal antibody therapies, Gilead Sciences’ remdesivir, and two COVID-19 vaccines.

Judith Aberg, MD, Director of the Mount Sinai Infectious Diseases Clinical and Translational Research Center (left) and Sean Liu, MD, PhD, Medical Director of the COVID-19 Clinical Trials Unit (right).

In this Q&A, Dr. Liu and Dr. Aberg share their experience of how the COVID CTU worked tirelessly throughout the pandemic, and where it is headed in the future.

How did the COVID CTU come to be formed?

Dr. Aberg: We were able to build upon the infrastructure that was created for HIV clinical trials, along with the support of many, to immediately start two different drug trials for COVID-19. One drug aimed at the SARS-CoV-2 virus and the other was a potent anti-inflammatory. And I must say, our prompt efforts paid off. We were able to give remdesivir, an antiviral drug, via a compassionate use application on March 9—within two days of the admission of our first patient at Mount Sinai West.

Dr. Liu: When the pandemic first hit, I was working as a hospitalist—someone who cares for admitted patients—at Mount Sinai Queens, and Dr. Aberg asked me to help with clinical trials at The Mount Sinai Hospital.

As pharmaceutical companies started developing more candidates for COVID-19 treatment, the team working on the initial studies started taking on more studies, supported by the CTRC, the Infectious Diseases Division, and the Medicine Clinical Trials Office at the Icahn School of Medicine. When we realized we sorely needed to expand and formalize a team for COVID-19-related trials, Dean Charney provided seed funding, and during the summer of 2020, we were able to hire more staff needed to run the trials.

How big was the COVID CTU then, and how has it grown since?

Dr. Liu: It started with 11 people, including six from the CTRC. By 2021, we had 25 staff.

What was it like fielding a clinical trials team during the pandemic?

Dr. Liu: Dr. Aberg already had a research unit working with HIV before the pandemic, and we pooled together a staff of clinical researchers, project managers, research nurses, coordinators, and regulatory staff. It was incredible seeing so many people come together quickly to tackle one of the biggest challenges we’ve faced in health care.

In addition to assessing the effectiveness of industry-developed treatments, the unit became a translational springboard where basic science researchers could come to us with their ideas, and we could help apply them in a phase 1 study, creating a bridge between preclinical and in-human studies.

What were some of the COVID-19 trials done at Mount Sinai?

Drs. Aberg and Liu recall some of the studies done by the COVID CTU:

  • Remdesivir: The antiviral drug is currently approved by the FDA to treat patients hospitalized for COVID-19. We initially opened trials for this drug via an emergency investigational new drug application at seven hospitals. In less than a month, we opened the Gilead-sponsored studies at four hospitals.
  • Monoclonal antibodies (mAbs): We were involved in Regeneron’s mAb studies in many different settings. These included an outpatient treatment study, an outpatient post-exposure prophylaxis study, and a pre-exposure prophylaxis study. One of Regeneron’s mAb that we did a study on was sarilumab, a potent IL-6 inhibitor. While this study did not demonstrate the robust findings of another IL-6 inhibitor we had worked on, Roche’s tocilizumab, it was the first study that paved the way for potent immune-modulating therapies to treat COVID-19 as we do currently.
  • mRNA vaccine: We were heavily engaged in the Pfizer/BioNTech COVID-19 vaccine trial, enrolling hundreds of participants from diverse backgrounds. Mount Sinai was recognized for enrolling the 40,000th participant in the initial phase 3 trial.
  • NDV-HXP-S: Mount Sinai developed its own COVID-19 vaccine, which can be delivered via injection or the nose. The technology was developed by our Microbiology Department, and the COVID CTU helped run the phase 1 trial. With our data, the vaccine went on to be developed further in other countries and has gone on to be approved as booster shots in Mexico and Thailand.
  • Hyperimmune immunoglobulin: This was a blood product-derived treatment using extracted antibodies from a pool of convalescent plasma donors who had recovered from COVID-19. With hyperimmune immunoglobulin, the patient is receiving a known purified amount of antibody from the donor. Studies are ongoing to identify who would benefit the most as well as timing in relation to onset of symptoms.

The COVID Clinical Trials Unit team received a letter of recognition for enrolling 280 participants—as well as the 40,000th participant—in the Pfizer/BioNTech COVID-19 vaccine trial.

What were some lessons learned on running clinical trials to address the pandemic?

Dr. Liu: There were so many studies to undertake, but we had to learn to focus. A part of it was trial and error, but as we gained experience, we became better at identifying what studies were likely to yield promising results. Some clinical trials might sound great on paper, but given limited resources, we had to weigh what factors went into them—such as enrollment opportunity or viral targets—and choose our trials accordingly or make adjustments.

Dr. Aberg: Decisive action can help change the trajectory of a pandemic. When Regeneron finalized its protocol for sarilumab trials, within seven days we opened a randomized, placebo-controlled trial of the drug. Its interim results, along with our remdesivir clinical trials and observational use of tocilizumab, helped advise us of the narrow window where these types of drugs may be effective to prevent patients from developing respiratory failure, requiring them to go on a ventilator, and even death.

What’s next for the COVID CTU?

Dr. Aberg: The COVID CTU no longer needed to be distinct from the CTRC. However, we are still involved in COVID-19 studies. One such trial is RECOVER-VITAL, a National Institutes of Health (NIH)-funded study to explore whether Pfizer’s Paxlovid™ treatment can be used to treat the chronic disease state commonly referred to as long COVID.

We are also in the NIH-funded Strategies and Treatments for Respiratory Infections and Viral Emergencies (STRIVE) consortium. A COVID-19 study we are involved in as part of the network is STRIVE-1, exploring whether the antiviral medication ensitrelvir can reduce symptoms and duration of hospitalization in persons with moderate to severe COVID-19. Another STRIVE COVID-19 study is exploring the additional use of immunomodulating agents for hospitalized patients.

Beyond COVID-19, we completed enrollment for a few other studies, including an mRNA shingles vaccine study by Pfizer and an exciting novel dual-affinity retargeting molecule for HIV. There are other studies we anticipate opening in 2025, including a C. difficile vaccine, as well as several HIV prevention and treatment studies.

Dr. Liu: We will never forget how the COVID-19 pandemic changed our lives. Thanks to tested vaccines and treatments, we are able to return to a normal life of packed movie theaters and lecture halls. Some of our team of skilled and knowledgeable research staff are being transferred to other areas where groundbreaking research is occurring throughout the Mount Sinai Health System. We are forever grateful for the contributions of the COVID CTU in reducing the morbidity and mortality from the COVID-19 pandemic.

Click here for more information about the CTRC or signing up for clinical trials

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