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— Clinical

Trials By Dire

UC San Diego Health was part of three of the first four clinical trials resulting in approved COVID-19 vaccines, and has conducted more than two dozen other investigations of potential drugs and therapies

On December 11, 2020, the U.S. Food and Drug Administration (FDA) gave emergency use authorization (EUA) to the Pfizer-BioNTech COVID-19 vaccine. Seven days later, it granted EUA to the Moderna vaccine. On February 27, 2021, an EUA was given to the Janssen/Johnson & Johnson vaccine. At this writing, clinical trials data for a fourth major vaccine — AstraZeneca — had not yet been submitted for FDA review.

One year earlier, none of these vaccines existed; all were the product of intense, accelerated development that included international clinical trials involving hundreds of thousands of participants and expedited review. In three of the four trials — Moderna, Janssen/Johnson & Johnson and Astra-Zeneca — UC San Diego Health and local residents played roles.

“It’s not really surprising,” said Gary Firestein, MD, Distinguished Professor of Medicine and director of the Altman Clinical and Translational Research Institute (ACTRI). “UC San Diego is an international research hub where thousands of clinical trials are conceived or conducted every year, for almost every human condition imaginable.

“The ability to combine a deep bench of experienced investigators with all of the necessary tools and resources makes UC San Diego a natural, go-to destination for clinical trials, and that means San Diegans often get first access to the latest advances in medical science.”

Gary Firestein, MD
Trial By Dire

Gary Firestein, MD (left) is Distinguished Professor of Medicine and director of the Altman Clinical and Translational Research Institute, with project scientist Deepa Hammaker, PhD.

“The ability to combine a deep bench of experienced investigators with all of the necessary tools and resources makes UC San Diego a natural, go-to destination for clinical trials, and that means San Diegans often get first access to the latest advances in medical science.”

And notably, Firestein added, ACTRI investigators were “extremely successful” in recruiting trial participants from underserved and underrepresented communities, a critical element in developing therapeutics that are reflective and effective across all demographics. In the Moderna study, for example, approximately 80 percent of participants in the second (and last) month of recruitment were Hispanic/Latinx.

The Pfizer and Moderna vaccines are based on messenger RNA (mRNA) technology. These vaccines provide cells with instructions to produce a harmless piece of the virus’ characteristic spike protein. The human immune system recognizes the spike protein as “foreign” and builds an immune response against it. Later, if vaccinated persons are exposed to the SARS-CoV-2 virus, their immune systems are already prepared to help prevent infection and illness.

The Astra-Zeneca and Janssen vaccines employ an older approach: An inactivated common cold virus is modified to carry SARS-CoV-2’s spike protein, which the virus uses to enter host cells, spurring the immune system to create neutralizing antibodies that essentially render subsequent exposures to the coronavirus as non-infectious.

Astra-Zeneca and Janssen are built on much-documented vaccine platforms that had worked well with other diseases, including HIV, Ebola and malaria, said Susan Little, MD, professor of medicine at UC San Diego School of Medicine and principal investigator for both UC San Diego trials.

MRNA vaccines are easier and faster to develop, but until the pandemic, the approach had never been approved for human use. “The world was facing an unprecedented crisis; millions infected, hundreds of thousands of people already dead,” said Stephen Spector, MD, Distinguished Professor of Pediatrics and principal investigator in San Diego for the Moderna trial. “A vaccine was desperately needed, as soon as possible.”

“The world was facing an unprecedented crisis, millions infected, hundreds of thousands of people already dead.”

Stephen Spector, MD.

All of the trials, both in San Diego and around the world, were accelerated efforts, conducted over the course of months, not the usual five to 10 years. That alacrity demanded spending billions of dollars and making some educated guesses.

For example, drug manufacturers said injections of the two-dose Pfizer and Moderna vaccines should be given 21 and 28 days apart, respectively, but those intervals were set, in part, to hasten data collection and speed review. Eventually, the Centers for Disease Control said dose intervals could be up to 42 days apart with no negative consequences, and longer intervals may actually produce a more robust immune response.

Initial clinical trial data indicated all of the EUA-granted vaccines were strongly effective against SARS-CoV-2. Concerns grew, however, that the vaccines were less effective against new virus variants emerging around the world, from the United Kingdom and South Africa to Brazil and India. Subsequent data suggests the vaccines remain effective, both preventing infection and dramatically reducing the risk of severe disease and hospitalization.

Davey Smith, MD, is a translational research virologist and head of Infectious Diseases and Global Public Health at UC San Diego School of Medicine. He works in both vaccine development and in studying viral variants.

“It’s the nature of SARS-CoV-2, like all viruses, to evolve, to adapt to any challenges that might threaten survival. COVID-19 vaccines will need to be modified and improved going forward. Every year, the flu shot is a different formulation. Something similar might be necessary with SARS-CoV-2 and future variants to keep the virus under control.”

Much effort now focuses on refining current vaccines, creating new options and developing boosters. One question still to be fully resolved is how long do current vaccines remain effective. One clinical trial involving UC San Diego will try to provide answers, comparing transmission and infection rates between two groups of students, one vaccinated, the other not.

Other clinical
trials

Vaccines were not the only target of COVID-19 trials at UC San Diego Health. More than two dozen have been launched, many assessing new or repurposed drugs and therapies.

For example, UC San Diego Health researchers have been involved in clinical trials assessing the antiviral drug remdesivir and the repurposed drugs tocilizumab, used to treat arthritis and other inflammatory diseases, and ramipril, used to treat hypertension.

They are studying the immune response to SARS-CoV-2 in cancer patients and the likely outcomes of chronic kidney disease patients with COVID-19 infections. And they are evaluating viral transmission risk of persons fully inoculated with the Moderna vaccine and among asymptomatic children.

— Clinical

Trials By Dire

UC San Diego Health was part of three of the first four clinical trials resulting in approved COVID-19 vaccines, and has conducted more than two dozen other investigations of potential drugs and therapies

For most patients who succumbed to COVID-19, the ultimate cause of death was pneumonia, a condition in which inflammation and fluid buildup make it difficult to breathe. Severe pneumonia often requires lengthy hospital stays in intensive care units and assisted breathing from mechanical ventilators.

To quickly detect pneumonia — sometimes before a COVID-19 diagnosis — UC San Diego Health clinicians used artificial intelligence to augment lung-imaging analysis, part of a clinical research study.

“The world was facing an unprecedented crisis, millions infected, hundreds of thousands of people already dead.”

Stephen Spector, MD.
Trial By Dire

Gary Firestein, MD (left) is Distinguished Professor of Medicine and director of the Altman Clinical and Translational Research Institute, with project scientist Deepa Hammaker, PhD.

“Pneumonia can be subtle, especially if it’s not your average bacterial pneumonia. If we could identify those patients early, before you can even detect it with a stethoscope, we might be better positioned to treat those at highest risk for severe disease and death,” said Albert Hsiao, MD, PhD, associate professor of radiology at UC San Diego School of Medicine and a radiologist at UC San Diego Health.

Hsaio’s team developed a machine-learning algorithm that made earlier detection possible.

The images show chest X-rays from a patient with COVID-19 pneumonia. At top is the X-ray with the AI algorithm applied, indicating pneumonia. Below is the original X-ray. This particular patient also happened to have a pacemaker device and an enlarged heart, indicators that, while a subject may have significant underlying health issues, the algorithm was still able to do its job.

— Clinical

Trials By Dire

UC San Diego Health was part of three of the first four clinical trials resulting in approved COVID-19 vaccines, and has conducted more than two dozen other investigations of potential drugs and therapies

During the pandemic, Joe Bautista, a registered nurse at the UC San Diego Health COVID-19 Telemedicine Clinic, collected songs from his patients as part of a satirical “Nurse’s Fee,” in which Bautista would ask each patient to tell him which song best described 2020 for them.

As the pandemic spread and deepened in San Diego, Michele Ritter, MD, and other infectious disease specialists launched the COVID-19 Telemedicine Clinic, which was open to anyone in the community with a recent COVID-19 diagnosis. Through video visits and phone calls, nurses and physicians consulted with people who had mild to moderate symptoms.

Every week, Bautista called and checked in on his patients to ensure they were on their way to recovery at home. These song requests helped Bautista build relationships with his patients, which in turn furthered the healing process by providing a personal connection.

“The world was facing an unprecedented crisis, millions infected, hundreds of thousands of people already dead.”

Stephen Spector, MD.

Now, Bautista’s COVID-19 playlist has more than 500 songs. Popular titles include “I’m a Survivor” by Destiny’s Child, “House Arrest” by Sofi Tukker, and “You Can’t Always Get What You Want” by the Rolling Stones.

— Clinical

Trials By Dire

UC San Diego Health was part of three of the first four clinical trials resulting in approved COVID-19 vaccines, and has conducted more than two dozen other investigations of potential drugs and therapies

Q&A

  • Question

    When did you first become aware of COVID-19 outside of the United States?

    Answer:I happened to be in Switzerland at the time and was with friends with whom I had graduated from medical school. We were reading in the news what was happening in China and discussing whether the illness was a global threat, whether this could be the next SARS or the next epidemic.

  • Question

    Were you afraid in the early days?

    Answer:No. As a health care epidemiologist, you’re always thinking about what could be. Always in the back of your mind, you think, “What should I be worrying or thinking proactively about? Could this virus come to the U.S.? How should we prepare?” As epidemiologists, we are engineered to think ahead. It’s really a question of how do you detect or how do you prevent infection. For example, what PPE (personal protective equipment) should you use? What are the needed diagnostic tests? Ventilation systems? Etcetera.

  • Question

    When did you start to realize that a global threat was emerging?

    Answer:Toward mid-January 2020, we started hearing about something unusual going on in Italy. Within weeks, it was clear that the situation was remarkable and dangerous. Illnesses started appearing in the region of Bergamo in northern Italy. That was when my attention became very narrowly focused and I started thinking about San Diego and a need for a headquarters of local operations. Then, in late-January, we got the phone call that planes would be arriving from Wuhan. That was our unified call to action at UC San Diego.

  • Question

    What prepared you for the patients’ arrival from China?

    Answer:Every infectious disease that came before COVID-19 prepared us. In 2014, we prepared for Ebola and even designed and built an infectious disease unit to care for potential patients. Before that, there was SARS, H1N1, and avian flus. All of the lessons learned came into play. While there was no test for COVID-19 early on, we already had intense safety protocols to prevent disease transmission, plus the CDC team was onsite for consultation. We knew that this was a respiratory virus, so if we had good protection, and we knew how to doff (or remove) our PPE without contaminating ourselves. We would have appropriate layers of defense.

“The world was facing an unprecedented crisis, millions infected, hundreds of thousands of people already dead.”

Stephen Spector, MD.
  • Question

    What did you see in the patients’ faces when you entered their rooms?

    Answer:For me, one thing that struck me about the patients from China was the fear. The fear of being targeted because of the perception of bringing a disease into a new country? The racism, the inherent fear of being targeted, the abrupt separation from family all became factors. All of the patients had a connection to the U.S and so were allowed to get on that plane, but their fear was real. When I saw them, I observed how isolated they were. I felt the pure humanity of it all. Very few of the patients actually tested positive. One happened to be a grandmother and nurse bringing her grandson to the U.S. She had to be separated from him to be hospitalized and how heart-wrenching that was to see. In the grandmother, in all the patients, was this fear of rejection, and this feeling of guilt. Survivor’s guilt. But at the same time, a lot of gratitude towards us, who were willing to take care of them, and welcome them.

  • Question

    What was the game-changer in altering the course of the pandemic?

    Answer:One of the things I greatly appreciated was a leadership team deeply grounded in reality. They were very keen on learning from a wide variety of experts and polling them on a regular basis to guide the health system forward. They made hard decisions to protect the integrity and the survival of the health care ecosystem, especially our CEO. It was gutsy to stop all surgeries because we wanted a safe environment for all employees and patients, knowing that there would be economic consequences. Our C-suite was among the heroes in this community. We took in the first patients, launched the first clinical trials and vaccinated the first community members. None of this would have been possible with leaders who were not nimble and present every single day.

  • Question

    What traits about UC San Diego Health helped us survive the pandemic?

    Answer:One of the things I greatly appreciated was a leadership team deeply grounded in reality. They were very keen on learning from a wide variety of experts and polling them on a regular basis to guide the health system forward. They made hard decisions to protect the integrity and the survival of the health care ecosystem, especially our CEO. It was gutsy to stop all surgeries because we wanted a safe environment for all employees and patients, knowing that there would be economic consequences. Our C-suite was among the heroes in this community. We took in the first patients, launched the first clinical trials and vaccinated the first community members. None of this would have been possible with leaders who were not nimble and present every single day.

— Clinical

Trials By Dire

UC San Diego Health was part of three of the first four clinical trials resulting in approved COVID-19 vaccines, and has conducted more than two dozen other investigations of potential drugs and therapies

“You don’t look like the doctor,” the patient’s husband says. “I bet I wouldn’t catch you running around in the street, would I.”

The resident stops short, but isn’t surprised. As a Black man, he has confronted such comments many times. This particular comment is prompted, in part, by the recent death of Ahmaud Arbery, a 25-year-old Black man pursued and fatally shot by white community members while he was jogging through his South Georgia neighborhood on February 23, 2020. At the time, no arrests were made.

The resident feels powerless. He turns to leave the room, believing that no matter how he responds, any reply might jeopardize his career — and wouldn’t change anything.

Three months following the death of Arbery, George Floyd dies after a Minneapolis police officer kneels on his neck for nine minutes and 29 seconds. This time, more than 30 medical students and residents in the School of Medicine speak up, penning a pair of letters to school leadership demanding change.

“We had been meeting with medical students from underrepresented communities in the field of medicine for some time in order to address the need for equity, diversity and inclusion in medicine.”

Steven Garfin MD

“We had been meeting with medical students from underrepresented communities in the field of medicine for some time in order to address the need for equity, diversity and inclusion in medicine,” said Steven Garfin, MD, interim dean, UC San Diego School of Medicine. “But we realized in this situation with our resident, and after receiving the two letters, a more urgent response was necessary to ensure policies and procedures, as well as education and training, were put in place for medical professionals — and patients.”

And so the Anti-Racism Framework for UC San Diego Health Sciences was established, along with multiple work streams tasked with addressing specific issues and demands raised in the letters.

The five main categories of work are organized by Education; Organizational Training and Enrichment; Recruitment, Retention and Representation; Health Care Policies; and Health Disparities. Each group seeks to improve equity, diversity and inclusion efforts where we all learn, work, teach and receive care.

Invitations to join a work group were sent to all faculty, staff, students and residents; nearly 400 individuals expressed their interest in helping.

In Fall 2020, the work groups began meeting regularly to address issues affecting not just residents, nurses and medical professionals, but hospital support staff, such as environmental services and food and nutrition as well.

“First and foremost, we listened, and it was very painful to hear the stories,” said Garfin. “We thought we understood and empathized, but we can’t do this right unless we’re put in the shoes of others. We opened our eyes to what had to be done because we can’t continue to relive centuries of this systemic racism.”

“We thought we understood and empathized, but we can’t do this right unless we’re put in the shoes of others. We opened our eyes to what had to be done because we can’t continue to relive centuries of this systemic racism.”

Steven Garfin MD

Immediate actions included leadership recruitment and new positions, such as a Chief Administrative Officer for Health Equity, Diversity and Inclusion at UC San Diego Health and an Assistant Vice Chancellor for Health Equity, Diversity and Inclusion for UC San Diego Health Sciences.

New clinical policies were created to protect staff and set expectations for patients on what is acceptable behavior while receiving care. “We needed to be clear that we will not tolerate racist behavior at UC San Diego Health. These policies are critical because they affect everyone,” said Thomas Savides, MD, chief experience officer at UC San Diego Health and chair of the Health Care Policies work group.

“Specifically, we’ve created two policies on anti-racism that would promote an inclusive work environment for our staff and also help mitigate racist encounters with patients.” For team members, the policies provide guidance on how to manage racist events involving patients. Each event will be managed by a team to evaluate the situation, escalate for additional action, review the event and track patterns.

For patients, certain expectations, rights and responsibilities are expressly outlined, explaining that racism exhibited by patients, family members or anyone visiting the health system will not be tolerated. The updated policy will be provided to patients upon admission.

“It’s gratifying to know that we’re making changes now that will be in place for decades to come.”

Thomas Savides, MD

“It’s been a coordinated effort instead of a lot of people working in silos,” said Savides. “It’s gratifying to know that we’re making changes now that will be in place for decades to come.”

Systemic racism has been public health crisis for centuries. Numerous high-profile deaths, often involving police, fueled an explosion of outrage and grief in 2020, which soon spread to not only include disproportionate violence, but also health disparities and the impact of COVID-19 on communities of color.

“Our CEO Patty Maysent sent out a call to action for physicians and nurse leaders: Stand up and contribute to ensure patients have more equitable health outcomes,” said Amy Sitapati, MD, chief medical information officer of Population Health at UC San Diego Health and chair of the Health Disparities work group. “We were tasked with finding a way to become a cohesive unit of change and the most important thing we needed to do first was allow for open and transparent conversations.”

“The world was facing an unprecedented crisis, millions infected, hundreds of thousands of people already dead.”

Stephen Spector, MD.

Sitapati’s work group focused initial efforts on listening to staff who were personally affected by health care inequities, experienced racism in the workplace, and who had witnessed inequities in patients they cared for. Collectively, they were moved by how the pandemic dramatically impacted Latinos in San Diego.

“During the surge, half of my inpatients with COVID-19 only spoke Spanish. We also noticed our Spanish-speaking Latinx population were developing severe cases,” said Sitapati. “Our goal as a work group was to be strategic and personal to ensure we were more inclusive to all patients and staff.”

The work consisted of adapting communications for frontline staff — including nonclinical departments such as food and nutrition and environmental services — to be more linguistically inclusive and at an appropriate literacy level. Translations for staff town halls were provided to ensure staff received leadership updates in the language they best understood.

For patients, the team understood the underlying importance that structural barriers and social determinants were impacting patients at risk for severe COVID-19.

“We were able to load in the social deprivation index for every person, based on their census block provided by the California Healthy Places Index (HPI),” said Sitapati. “Just by knowing where a patient lived, we could determine their HPI and prioritize care for patients with the highest risk.”

Not only did this apply in the clinical setting, but it also assisted the work group in determining where to focus COVID-19 vaccination efforts as UC San Diego Health ramped up its mobile vaccine clinic, which delivers vaccines directly to communities in the greatest need.

Since the Anti-Racism Framework was established, Sitapati has noticed a culture shift at UC San Diego Health that she believes is a result of the collective efforts of all involved.

“The timing of these two extremely emergent events — COVID-19 and the social injustice experienced by persons of color — truly highlighted the severity of health disparities among certain communities and really emphasized the critical need for change,” said Garfin. “Which is why it’s so important for those in medicine to understand how racist sentiments and biases affect a person’s overall health. As educators, this training will become the norm as we mentor the next generation of doctors and work with our current doctors actively providing health care.”

— Clinical

Trials By Dire

UC San Diego Health was part of three of the first four clinical trials resulting in approved COVID-19 vaccines, and has conducted more than two dozen other investigations of potential drugs and therapies

“It’s here!” Nancy Yam, PharmD, was chatting with colleagues outside her office at UC San Diego Medical Center in Hillcrest early in the morning of December 15, 2020 when her smart watch pinged with the message they had all been waiting for.

The group darted for the stairs leading to the shipping and receiving area. Yam glanced at another message on her watch. “No, it’s already been taken up!” The giddy group reversed course and a few moments later, they burst through the back door to the hospital’s pharmacy.

There, two cardboard boxes sat on a cart. The boxes might have contained anything, but Yam and her co-workers knew exactly what lay within. They had been waiting for this shipment and this moment for months, along with the entire country. The first COVID-19 vaccines were in the house.

Word spread and within minutes people from neighboring work areas arrived to take pictures of the boxes and to text families and friends.

It was a historic moment, but Yam, associate chief pharmacy officer at UC San Diego Health, and her team could not pause to appreciate its significance. They needed to get work. Carefully following instructions from Pfizer and the Food and Drug Administration (FDA), they moved the vaccine into supercool freezers in the “Freezer Pharm.” They collaborated with team members from Facilities and Emergency Management to coordinate delivery of doses and ancillary items, such as needles, syringes and vaccine cards, to Jacobs Medical Center in La Jolla. They consulted with physicians and nurses to determine how and when the vials would be thawed and reconstituted, and how nurses would administer doses.

On December 16, the following day, doctors, nurses and staff lined the hallway and cheered as the first employees were called in to receive their vaccinations. Within four weeks, more than 10,000 UC San Diego Health employees had been vaccinated, an effort led by Shira Abeles, MD; Marlene Millen, MD; and others.

“Before the vaccines became available, we were working around the clock to prepare for surges of patients with COVID-19, to make sure that we could provide them, as well as our other patients, with outstanding care and to make sure we weren’t going to run short of medications — all with so many unknowns and things changing daily,” Yam said. “ “At the same time, many people were dealing with so much loss, anxiety, weddings delayed and kids out of school.

“That’s why it was so meaningful to be able to play a part in equitable distribution of the vaccine, starting with our own health care heroes. It was a day of pride, and hope.”

“At the same time, many people were dealing with so much loss, anxiety, weddings delayed and kids out of school.”

Nancy Yam, PharmD

Left to right, the Padres’ Friar mascot; Lydia Ikeda, senior director of COVID operations at UC San Diego Health; and Nathan Fletcher, chair of the San Diego County Board of Supervisors, celebrating the 100,000th dose delivered at Petco. More than 225,000 doses would be administered before the site closed.

25,000 community members signed up to volunteer at UC San Diego Health’s vaccination superstations.

California Governor Gavin Newsom tours the Vaccination Super Station at Petco Park with UC San Diego Health CEO Patricia Maysent.

Thousands of UC San Diego and local community members received their COVID-19 vaccination at the Recreation, Intramural and Athletic Complex (RIMAC) superstation on UC San Diego’s La Jolla campus.

Hidden
Figures

From setting up surge tents and testing sites to launching vaccination super stations to establishing that fire and life safety protocols were in place in clinical spaces, the facilities and engineering team helped make it possible for staff to provide the highest level of care for patients during the pandemic. “If our clinical staff can come in to work every day and are able to do their job of taking care of patients in their greatest time of need, then we’re doing our job and it’s an honor,” said Tim Rielly, director of facilities engineering at UC San Diego Health. “We’re always here, working behind the scenes, and our goal is to keep everyone safe.”

Partnering
to expand

A few weeks later, UC San Diego Health CEO Patricia Maysent was on the phone, strategizing with San Diego County and other UC San Diego Health leaders about how best to quickly and safely vaccinate all of the remaining health care workers in the region. “That was a Wednesday, and I asked ‘What would it take to get 5,000 vaccines in arms a day starting Monday?’” Maysent said. “’What would that take? Can you do it?’”

Everyone was eager, but one of the limiting factors was the need for a space large enough to accommodate thousands of people. Maysent thought of the San Diego Padres, with whom she had worked closely for several years. (UC San Diego Health is the Official Health Care Provider of the San Diego Padres, the region’s Major League Baseball team.) Five days later, the state’s first drive-through Vaccination Super Station opened in the Tailgate Lot next to Petco Park, the Padres’ stadium.

“The rapid buildout and staffing of the COVID-19 vaccine hub at Petco Park was a massive undertaking, and it would not have been possible without our partners at the county, city and the Padres,” Maysent said. “We are extremely proud of San Diego for coming together during this crisis, leveraging the innovation and collaboration for which our region is known, to support the health and safety of the entire community.”

“The rapid buildout and staffing of the COVID-19 vaccine hub at Petco Park was a massive undertaking, and it would not have been possible without our partners at the county, city and the Padres”

Patricia Maysent

The massive undertaking, led by Lydia Ikeda, senior director of COVID-19 operations; Will Ford, director of project management; and others, involved 42,000 square feet of tenting, 5,700 feet of power cable, 85 laptop computers on wheels, wireless internet provided by the Padres, and a self-scheduling website integrated with UC San Diego Health’s electronic health record system. The site was run by 300 clinical and administrative staff and volunteers per day. Yam’s pharmacy team and their Storehouse colleagues prepared and delivered the doses and ancillary items daily, and remained on call, ready to drop everything and drive downtown with more doses if the team was able to open up more appointments.

“After all that work, on the first day, when we had the first patient enter the site, the feelings I had were awe, inspiration and hope,” Ikeda said. “It felt like the first step in a long journey, and amazing that we accomplished it in such short order.”

The Vaccination Super Station administered approximately 5,000 vaccines per day, 12 hours per day, seven days a week.

The community’s response to the superstation was overwhelmingly positive, including an outpouring on social media to express gratitude and pride in the San Diego region for being able to rapidly collaborate to scale-up and streamline vaccine distribution at a time when most regions were struggling to implement the basic infrastructure. More than 25,000 people signed up to volunteer.

The site was visited by many elected officials, including California Governor Gavin Newsom and representatives from other health systems. Petco site leaders were asked to present to national organizations and were interviewed frequently by local and national media. Petco even received a shout-out during a White House news conference.

“What I’m probably most proud of is that the Petco site served as a model for other similar mass vaccination centers in the state, and around the country,” Maysent said.

Staff and volunteers were treated to donated meals and treats, visits from Padres alumni, high-fives from the Padres mascot, an impromptu concert from an opera singer during her post-vaccination observation period and thank-you cards from kids grateful that their grandparents had been vaccinated.

The Petco site operated for 68 days, administering more than 225,000 vaccine doses. It permanently closed March 20, 2021 with the advent of the Major League Baseball season. As the County began to open up vaccine eligibility to additional occupations and age groups, UC San Diego opened a second super site at the Recreation, Intramural and Athletic Complex (RIMAC) on the La Jolla campus. The site served UC San Diego employees, students and patients, as well as members of the community. In the almost four months it operated, more than 195,000 doses were administered at the RIMAC site.

“One of the things I’ll never forget is how grateful people were to get their vaccines, how they thanked us for saving their lives, even if they’d been waiting in traffic for hours to get there,” Ikeda said. “It was a privilege to be able to help our community this way, and we, in turn, were buoyed by them. It was exactly what we needed after months of being ‘COVID-weary.’”

“It was a privilege to be able to help our community this way, and we, in turn, were buoyed by them. It was exactly what we needed after months of being ‘COVID-weary.’”

Lydia Ikeda

Moving the needle: Mobile and pop-up clinics were created to boost access to vaccines in hard-hit communities and across the border. 

Other clinical
trials

While the supersites were exceptional at vaccinating huge numbers of people, they often weren’t accessible to those who needed them most. In March 2021, with support from philanthropists John and Sally Hood, UC San Diego Health, led by Abeles, Ikeda and others, began collaborating with trusted community-based organizations to expand outreach and support widespread deployment of vaccines to San Diego County communities affected by the greatest number of COVID-19 cases and highest rates of hospitalizations and deaths. These mobile vaccine clinics were designed to reach more patients more effectively, and help ease barriers, such as lack of transportation to vaccine appointment sites and distrust in health care providers outside of local communities.

One of the first stops was a complex of warehouses and trucking services in Otay Mesa, where a team vaccinated approximately 1,200 people who deliver food and goods throughout San Diego County and the nation. In following weeks and months, the team administered vaccines in churches, high schools and work places.

“No virus, especially one as infectious as COVID-19, recognizes borders,” said Abeles, dubbed the “vaccine czar” in a February 2021 Science article. “As a leading advocate and provider for health care across our region, UC San Diego Health quickly recognized the public health benefit in joining our binational community in expanding outreach and supporting the widespread deployment of COVID-19 vaccines to help end this pandemic.”

In May, UC San Diego Health set up a mobile clinic at the Mexican border in San Ysidro, where a team vaccinated 10,000 maquiladora workers employed by United States subsidiary companies over seven days. The clinic was made possible through the efforts of the Consulate General of Mexico and County of San Diego.

“Our ability to vaccinate a quarter of San Diegans, and save so many lives, it was historic,” Ikeda said. “We’ll be telling these stories to our grandkids the way our grandparents talk about the polio vaccine.”

“The world was facing an unprecedented crisis, millions infected, hundreds of thousands of people already dead.”

Stephen Spector, MD.

Vaccines by the Numbers*

— Clinical

Trials By Dire

UC San Diego Health was part of three of the first four clinical trials resulting in approved COVID-19 vaccines, and has conducted more than two dozen other investigations of potential drugs and therapies

In the early days of the pandemic, scientists and physicians struggled just to understand the scope and scale of the looming public health threat. Who was infected? How many? Where?

Answers were scarce, in large part because testing was equally so, and without comprehensive testing data, no one really knew what was happening.

In late-February, the Food and Drug Administration (FDA) debuted guidance permitting university-based hospital labs to develop SARS-CoV-2 diagnostic tests. Steve Gonias, MD, PhD, chief of pathology services for UC San Diego Health and chair of the Department of Pathology at UC San Diego School of Medicine, headed a committee to coordinate lab efforts among the five UC medical centers and later represented those labs in UC’s broader response to the pandemic.

In late March, UC San Diego Health announced it was partnering with five leading in vitro diagnostics manufacturers — Thermo Fischer Scientific, Roche Diagnostics, GenMark Diagnostics, Abbott Diagnostics and Luminex Corporation (the last being a test developed at UC San Diego) — to expand testing capacity. Each manufacturer produced its own testing platform, but none alone could meet UC San Diego’s overall need. In combination, however, they might help weather the coming storm.

Trial By Dire

Gary Firestein, MD (left) is Distinguished Professor of Medicine and director of the Altman Clinical and Translational Research Institute, with project scientist Deepa Hammaker, PhD.

Ordinarily, said David Pride, MD, PhD, an infectious disease specialist and director of microbiology at the Center for Advanced Laboratory Medicine (CALM) at UC San Diego Health, a single testing platform would be used for sake of consistency.

“We took a diversified approach to meet our patient care needs. Having different platforms means we are able to maintain testing supply, even when one or more manufacturers can’t meet our testing needs,” Pride said.

The goal was to boost testing capacity to 1,000 to 1,500 tests per day within two to three weeks, up from the then-current rate of just a couple dozen tests per day. That ambition was quickly reached. Within six months, CALM had expanded capacity to 6,000 COVID-19 tests daily. Typical turnaround time was reduced to approximately 16 hours.

“In my 17 years as chair of the Department of Pathology, this is perhaps the best example of our pathology lab directors and hospital leaders coming together to accept a challenge on behalf of our entire state and country,” said Gonias. “We succeeded at a high level.”

In April 2020, UC San Diego Health launched serological testing, which looks for the presence of antibodies to the novel coronavirus, evidence that a person has been previously infected, even if they never experienced tell-tale symptoms.

“This is part of the next wave of testing,” said Ronald W. McLawhon, MD, PhD, director of CALM and UC San Diego Clinical Laboratories and chief of the Division of Laboratory and Genomic Medicine. “It’s intended to answer those growing questions about who has been infected and who might still be vulnerable to exposure.”

“We took a diversified approach to meet our patient care needs. Having different platforms means we are able to maintain testing supply…”

David Pride, MD, PhD

Serological testing was conducted most often in the early months of the pandemic, but less so as vaccination rates increased, with more and more persons possessing antibodies through inoculation.

In May, UC San Diego went live with its own university-based, FDA-approved COVID-19 diagnostic test.

Other UC labs soon followed. On August 31, 2021, UC San Diego Health crossed a milestone, performing its millionth COVID-19 test.

Return
to Learn

A major component to bringing students back to campus and the resumption of in-person instruction was widespread testing, which began with the official launch of the Return to Learn (RTL) program in May 2020.

Testing formally began with on-campus locations providing self-administered, nasal swab-based COVID-19 tests to the approximately 5,000 undergraduate and graduate students who continued to reside on campus, with plans to expand to monthly testing of all 65,000 students, staff and faculty in the fall.

“Asymptomatic testing is important because most of the transmission of the virus is done by people who aren’t having symptoms”

Robert Schooley, MD

“Asymptomatic testing is important because most of the transmission of the virus is done by people who aren’t having symptoms,” said Robert Schooley, MD, an infectious disease specialist, professor of medicine and one of RTL’s leaders.

“People who do develop symptoms begin to shed virus from the nasopharynx two or three days before those symptoms appear. These individuals feel fine, yet they are shedding larger amounts of the virus at this stage of the illness than after they become ill. This happens because in the beginning stages, the virus turns off the ‘first response’ elements of the immune system. These responses are responsible for the flu-like symptoms we experience in most viral infections. The virus grows unimpeded and leaves us unaware of our infection. This phase of the illness is known as the “pre-symptomatic phase.”

In October 2020, more than 6,000 students moved into dorms, which had been reorganized to incorporate pandemic mitigation measures, such as single-resident rooms. Those numbers expanded with the winter semester and continued to grow, along with the percentage of courses offered in-person.

Throughout, testing has continued unabated, fueled by easy-to-use vending machines that dispense COVID-19 tests, the involvement of the Expedited COVID IdenTification Environment (EXCITE) lab (which in tandem with CALM doubled testing capacity) and other monitoring measures. The tests are free and available to students, staff and faculty.

On September 20, the 2021 Fall Quarter began, with total enrollment exceeding 40,000 students. Of the nearly 12,000 undergraduate students who had moved into campus housing, only 13 tested positive for COVID-19.

Beyond
campus

With time, the ability and capacity of UC San Diego clinicians and scientists to test for COVID-19 expanded dramatically. It was offered in drive-through settings, to persons requiring testing before travel and to other public institutions, such as local schools via the EXCITE lab, who needed an early detection system in order to reopen their own classrooms.

— Clinical

Trials By Dire

UC San Diego Health was part of three of the first four clinical trials resulting in approved COVID-19 vaccines, and has conducted more than two dozen other investigations of potential drugs and therapies

When you enter the conference room on the first floor of UC San Diego Medical Center in Hillcrest, it looks like most spaces where meetings are held: A 12-foot-long, walnut-colored table takes up the middle of the room. Chairs and mostly blank walls surround it.

But in emergencies, that room becomes a sort of crisis control center, where experts, highly skilled at operating clinical and non-clinical areas and aspects of the hospital system, convene to sort out issues, make decisions and find remedies. When that happens, phones on the table start ringing constantly. The walls start to fill with pinned notes and broad sheets of butcher paper covered with names, numbers and data. A large, flat-screen TV at one end of the room is turned to local news or video feeds around the hospital. Doctors, nurses, administrators and staff hustle in and out.

The room is transformed. It is now a Hospital Command Center (HCC), a designation activated by events ranging from local wildfires or major power outages to internal issues that might temporarily and significantly disrupt services. It’s a carefully structured operation with specific roles, such as Incident Commander, Safety Officer, Logistics Officer and Public Information Officer, each with its own set of responsibilities.

“We all hung on their every last word, afraid to miss a vital piece of information and hungering to learn more about the novel coronavirus.”

Yadira Galindo

On February 5, 2020, the HCC was activated for what would become the COVID-19 global pandemic.

Staff across all areas of the hospital system were alerted by their pagers suddenly and loudly pinging. It was their cue to head toward the HCC ASAP, and take their seat at the table.

“What has never ceased to amaze me in the 12 years I’ve had the privilege and honor to be a part of the organization, is that people always come in willing to help, even if they are nervous to step out of their comfort zone,” said Monique Imroth, director of Emergency Management and Business Continuity and Telecom Operator Services at UC San Diego Health.

Carrying the communications pager and on-call, Yadira Galindo, then-senior communications and media relations manager at UC San Diego Health, was among the first staffers to arrive at the HCC that February day.

“There was a frenzy of requests to develop internal and external communications, yet the command center became unnervingly quiet when a member of the infectious disease team gave an update,” said Galindo. “We all hung on their every last word, afraid to miss a vital piece of information and hungering to learn more about the novel coronavirus.” Soon, Galindo was joined by colleague Jeanna Vazquez, who had only joined the communications team a few weeks prior.

“I often found myself going to work and coming home in the dark,” said Vazquez. “The energy walking into that room every day was palpable. We were surrounded by such incredible minds that wanted to help and prepare our staff for this crisis as best as possible.”

“The world was facing an unprecedented crisis, millions infected, hundreds of thousands of people already dead.”

Stephen Spector, MD.

As the hours turned to days, weeks, months and now more than a year, the pandemic has become the longest HCC activation in UC San Diego Health history at more than 650 days, and counting.

“The longest HCC activation prior to the pandemic was seven days during the 2007 San Diego wildfires,” said Imroth.

In the beginning, the HCC was open seven days a week, with some staff members putting in 70- to 90-hour weeks. Daily topics ranged from proper PPE protocols, staffing and training for the COVID-19 units to communicating with Chinese patients airlifted from Wuhan and how to best submit COVID-19 tests to the Centers for Disease Control in Atlanta for processing.

People who had never been part of an HCC were tapped. “We were using our collective knowledge, skills, abilities, talents, desires and efforts to synergize and band together,” said Imroth.

There was also a fear factor. “The command center sits in the hospital setting. People were wondering if they were going to catch the virus and bring it home to their families.

“Part of my job is to connect with everyone in that room and let them know I am there for them. If I found out someone in the HCC liked peanut M&Ms or had a dietary requirement or drink preference, we made sure to provide those comforts. If I knew someone was feeling uneasy, I shared my own feelings with them. I am a fan of candid conversation, and sometimes humor, to eliminate anxiety and let others know they are not alone. And during that time, we all needed to know we were not alone.”

As more was learned about the novel coronavirus and COVID-19, and guidelines emerged and evolved regarding masking, physical distancing and reducing transmission risks, HCC operations settled into a sort of routine. After seven months working around that conference room table, and realizing that the pandemic was not going to end any time soon, the decision was made to go remote. It had never been done before for a major crisis event.

“We transitioned to a virtual command center slowly. It was similar to the physical command center in that we still had a plethora of meetings and briefings. We just did them over Zoom instead of from across a table,” said Imroth. “As things changed with the pandemic, we adapted too.”

The virtual HCC continues, with weekly briefings for key leaders and occasional sessions as needed. Hundreds of all-staff emails have been sent, updating employees to the situation and needs.

Recalling 2020, Imroth said some lessons carry forward.
“I think what we found out is that we need each other.
We need each other to get through these difficult times.
We need each other as cheerleaders.
We need each other as support teams.
We need each other to laugh with.
We need each other to cry with.
We need each other to rant with.
We need each other.”

Happy Orange

On the morning of February 5, 2020, with the first potential COVID-19 patients en route to UC San Diego Medical Center in Hillcrest from quarantine at Marine Corps Air Station (MCAS), a Code Orange was called.

— Clinical

Trials By Dire

UC San Diego Health was part of three of the first four clinical trials resulting in approved COVID-19 vaccines, and has conducted more than two dozen other investigations of potential drugs and therapies

For refugees living in San Diego, the challenges caused by a global pandemic were magnified in a city they had just begun to call home. In response, the UC San Diego Refugee Health Unit shifted its focus to supporting members of communities experiencing systemic inequities exacerbated by the public health crisis. Work began with a survey of the San Diego refugee community, the first in more than 15 years.

Surveyors learned that nearly one-third of families had canceled or missed health appointments during the pandemic. In more than 40 percent of surveyed families, at least one member had lost their job; 60 percent of families couldn’t pay rent and feared they would be evicted.

“For us, our work is more about looking at the issue of systemic racism and tackling that,” said Amina Sheik Mohamed, founding director of the Refugee Health Unit.

“The world was facing an unprecedented crisis, millions infected, hundreds of thousands of people already dead.”

Stephen Spector, MD.

“Right now we’re figuring out where the gaps are to meet the community where they are. With our approach, we collect information on what is needed, how to get these resources to the community and then we go to the next problem. We’re climbing the ladder together. It’s not one group, but all of us, and it’s something to be proud of.”

After the survey, the Refugee Health Unit served as a conduit between the refugee community and the County of San Diego by holding meetings with community health care workers and local government officials.

“We received weekly updates from the county on the pandemic, including vaccine eligibility and tier restrictions, and then took those updates back to our community health care workers who disseminated the information to refugee community members,” said Reem Zubaidi, manager of the Refugee Health Unit. “This was essential to the whole process. We can’t understate how important it is to provide this information in a person’s primary language from someone who they can relate to and converse with in their preferred communications method. It’s not just translation, it’s cultural.”

— Clinical

Trials By Dire

UC San Diego Health was part of three of the first four clinical trials resulting in approved COVID-19 vaccines, and has conducted more than two dozen other investigations of potential drugs and therapies

In 2020, Brenda Tanoi lost one or two family members or friends each month to COVID-19. In December 2020, the 68-year-old Logan Heights resident and retired educator from American Samoa was infected herself with the virus.

On the day in mid-April 2021 when these photos were taken, Tanoi was at home, still recovering from her bout with COVID-19 and awaiting her second shot of the Moderna vaccine and a dose of hope from a nurse practitioner with UC San Diego Health’s Population Health Services Organization (PHSO).

“The world was facing an unprecedented crisis, millions infected, hundreds of thousands of people already dead.”

Stephen Spector, MD.
Trial By Dire

Gary Firestein, MD (left) is Distinguished Professor of Medicine and director of the Altman Clinical and Translational Research Institute, with project scientist Deepa Hammaker, PhD.

Early in the pandemic, PHSO brought together staff in social work, nursing and pharmacy to anticipate the physical and emotional needs of high-risk seniors, those age 65 and older. The effort included a call center where staff answered questions, triaged needs, provided vaccine education and sometimes just offered a compassionate ear. Ten team members work the phones, handling approximately 10 to 15 calls each, daily.

PHSO’s at-home service took center stage during COVID-19 vaccinations. Staff could reach out to senior patients whose health prevented them from traveling to a vaccination site. As of May 2021, there have been more than 1,000 home visits. “We try to make doing the right thing the easy thing for our elderly patients, helping them get through this marathon,” said Ming Tai-Seale, PhD, director of research and learning at PHSO.

In her visit, Tanoi gratefully and joyfully welcomed visiting nurse practitioner Janet Davis. “I am honored to tell everyone I am fully vaccinated,” Tanoi said. “I want to stop going to memorial services. I want to enjoy many more birthdays and holidays with my family, for as long as I can.”