loading animation

— 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

Fetaulaiga Ala: At a Crossroads

I was in our Hospital Command Center in early February 2020 when we got that first call that U.S. Marshals would be transporting people who were sick and might be infected with a novel coronavirus — evacuees from Wuhan, China being held in federal quarantine at the nearby Marine Corps air base — to our hospital in Hillcrest. Our Incident Commander turned me and said, “Liz, what’s our plan?”

My first thought was “Holy s***, this is real. This is really happening.” Until then, it was all talk, just something we heard about in the news. We’d been through this before. With Ebola, we had prepared, we created a dedicated unit, but the virus never came. It occurred to me in that moment that this time would be different.

“I didn’t know what my plan was, but we obviously needed one — quick.”

It was one patient from Wuhan that day. Then another. Then another. The first thing we needed to do was figure out how to clear and secure the path of patient transport from ambulance to the rooms that had been readied for them. For the first few weeks, we worked closely with the Marshals. Everything was tightly controlled. Then one day the Marshals left, and it was up to us to determine who could go where and when.

Then it all snowballed from there.

After the Wuhan evacuees were released, we were at, well, “fetaulaiga ala.” (That’s “crossroads” in Samoan, which my parents spoke at home while I was growing up in Hawaii and California, and the language in which words still first come to me sometimes.) That’s when our leaders turned to me and said, “Liz, we need to secure every entrance. No one in except staff and patients. No visitors.”

We needed a new plan.

Seemingly overnight we set up a system to screen each person entering our hospitals, and only those with an employee badge or appointment could enter. Those early days were the hardest — processes and requirements were changing every day with the fluid situation. Sometimes mistakes were made simply because a person could show up to work following yesterday’s new protocols, not knowing they had already changed again.

It quickly became clear that our agents couldn’t possibly staff every entrance station, so we worked closely with the health system’s labor pool — a system for re-deploying staff from other units to an area of greatest need. Suddenly, agents weren’t just responsible for themselves, but became team leaders and subject matter experts in a way they never were before.



“At the same time, many of us were worried about our own families. We may have been a little resentful at first of all the people who could do their work from home when we couldn’t.”

I had to show up to work every day, as did my husband, a San Diego Police Department detective. And of course we worried that we could be bringing this mysterious virus home to our family. I’m grateful those fears never materialized and we fortunately have not been affected personally by COVID-19. As we learned more about the virus, and with the tremendous support of UC San Diego Health’s experts and leaders, we were able to take all the right precautions to work comfortably and safely on the front lines.

I cannot tell you how proud I am of my amazingly adaptive team. Whenever the need seemed impossible, we just dug in our heels and said “How can we help?” even if that meant working double-shifts (16-hour days) for seven days straight when we had to. Even when the worst happened — we lost a member of our team to COVID-19 — we came together, and we stepped up our efforts to get everyone vaccinated.

In January 2020, the Security team was again called upon to help make the impossible possible: Work with the County, the City, the San Diego Padres and San Diego Police Department to open the state’s first drive-through Vaccination Super Station at Petco Park. Oh, and do it all in just five days from idea to open gates. Everyone jumped in. It was hard at first, making adjustments every day to traffic flow and maintaining a safe environment for our hundreds of staff and volunteers, as well as the thousands driving in each day to be vaccinated, all in a parking lot downtown. Several days of wild winter storms didn’t make it any easier.

At times the Petco site felt like an episode of M*A*S*H — it was like a medical drama and I found myself in the middle of patient care in a way that I normally don’t. Each day a “doc of the day” was in charge of overseeing medical care, should patients need extra observation for rare allergic reactions after vaccination. I’ll never forget this one day when I was talking to the doc-of-the-day at our onsite command center when a call came through by walkie-talkie for a medic. I basically threw the doctor into a golf cart and drove him to the medical tent. He jumped out and started calling out commands before I’d even rolled to a stop. I’d never seen anything like it before.

I’ll also never forget the gratitude of the people coming in to be vaccinated — even if they had waited for hours, they were thanking us. That was worth all the hours of walking, talking, planning. After the Petco superstation, launching and managing additional vaccination locations was easy by comparison!

Before COVID-19, one of the main things my Security team was focused on was managing workplace violence. Most people would probably be surprised to hear it, but violence is a major issue in health care environments everywhere. So for many years we’ve been developing threat assessments and implementing data-driven programs for conflict management and weapons screening.

A silver lining of the pandemic has been that now, with staff at each hospital entrance to screen for COVID-19 symptoms and compliance with masking and visitor requirements, hospitals everywhere are more secure than they ever have been before. It’s long kept me awake at night that, just by its nature, the hospital is completely open to the public. There wasn’t a way to know who was in the hospital at any given time — who they are, why they are there, where they are going. But now calls to Security to manage unauthorized people, custody and domestic violence issues, vandalism and theft have gone down to practically zero. I can tell you how many people are in the hospital at any given time, and that’s huge from a safety perspective, including in the case of fire. I hope we can keep it that way going forward.

Through all of this, we realized that we are more capable than we ever thought possible — we really can implement totally new systems very quickly when we need to. If you had told us before we’d have to do the things we did, we’d laugh and say we couldn’t do it. But we did it, and we improved every day along the way. I’m grateful to the team for not becoming overwhelmed, but instead realizing that UC San Diego Health, where we are blessed with incredible support and resources, is the best place to be.

— Clinical

In Short, Long COVID is Complicated

But with each patient, doctors learn more about ways to make the disease go away forever

In March of 2020, just a couple of weeks into the pandemic, the Division of Infectious Diseases at UC San Diego Health launched a COVID-19 Telemedicine Clinic. The goal was to provide patients recovering at home with direct access to an infectious disease specialist and a nursing team that could communicate with them daily or as needed about symptoms and concerns.

It was a mutually beneficial relationship. Patients were able to speak directly with a doctor who could give them advice. Physicians were able to see and study the clinical course of COVID-19 firsthand.

Quickly, we learned that the clinical course of COVID-19 varies greatly. Duration and severity of symptoms were often unpredictable. Some patients had very mild cases, perhaps no symptoms at all, while others suffered greatly, sometimes worsening to the point of emergency department visits or hospitalization. There were few telltale indicators of disease progression, and when patients asked if or when they would feel better, there often was not a conclusive answer.

We also learned that the psychological trauma from COVID-19 was significant. For the first time in many patients’ lives, they confronted the specter of their own mortality. They grappled with the stigma, sometimes the guilt, of having the disease, perhaps unknowingly exposing family or loves ones. They struggled with necessary isolation during their illness and literal distance from their support network.

All of this was on top of the immense stress and trauma gripping society. In time, we noticed that some patients who had seemingly recovered from their initial COVID-19 illness began complaining that some symptoms returned or persisted. They asked to return to our clinic for evaluations. As infectious disease physicians, we are aware that post-viral syndromes can occur in a small subset of patients following an initial illness, such as influenza or mononucleosis. But with COVID-19, the number of patients with recurring or ongoing symptoms appeared alarmingly high.

“Persistent symptoms included severe fatigue, shortness of breath, cough and anxiety.”

They reported that simple activities, such as doing laundry, would become so exhausting they would need to go to bed to recover. Many patients were so sick they could not return to work or struggled to manage household duties or care for their children.

Many complained of “brain fog,” reporting that their thinking had become sluggish, fuzzy, or just not as sharp as it once was. One patient described getting into her car, closing the door and then forgetting how to roll down the window. Others experienced speech impairments or difficulty articulating certain words.

These cognitive/psychological symptoms, which also included insomnia and depression, ran concurrent with physical woes: chest discomfort, rapid heart rate, reflux and joint pain. In trying to treat them, we were learning everything we knew about chronic COVID from our patients themselves. (The term “Long COVID” comes from patients who referred to themselves as “long haulers” in online chat forums.) We began to hear similar tales at other health systems across the country, though published, peer-reviewed medical literature and clinical guidelines were scant.

“Early on, we created the Long COVID Interdisciplinary Working Group to bring together specialists across UC San Diego Health to share insights about evolving problems and treatments.”

The working group included colleagues from pulmonology, neurology and cardiology, among others. Psychiatry and spiritual care were integrated into the group, and both have been instrumental in supporting patients through their recovery.

Over the last year, we have gained a much greater understanding of “Long COVID,” or more technically, “post-acute sequelae SARS-CoV-2 infection.” We know now that Long COVID may affect up to one-quarter of patients who experience a COVID-19 infection. The severity and symptoms of the initial infection are not directly related to development of Long COVID. Indeed, the majority of Long COVID sufferers were never hospitalized or in need of intensive care.

Symptoms vary among Long COVID patients. The disease course remains hard to predict, which makes it difficult to help patients manage expectations about recovery. We still just don’t know with certainty when, or even if, they will have a full recovery.

Diagnosis of Long COVID can be challenging. It requires a long interview with the patient to learn the details of their disease course and symptoms. Treatment includes drugs to address specific symptoms, such as heart medication for tachycardia, as well as comprehensive physical and cognitive therapy, plus emotional support.

Many Long COVID patients have significant recovery times, approximately three to six months, but a subset continue to experience severe symptoms longer. As we continue to care for Long COVID patients, we also glean new insights into the pathophysiology of the illness and learn new lessons that will allow us to better care for all COVID-19 patients in the future.

— Clinical

Dose of Reality

Creating vaccines was the first step; getting them into arms required the often unseen efforts of pharmacists

On December 11, 2020, the U.S. Food and Drug Administration FDA granted emergency use authorization (EUA) for the first COVID-19 vaccine (Pfizer), with the Moderna vaccine given EUA just a week later.

Those approvals were the breathmaking result of medical science working at breathtaking speed — developing, testing and approving new vaccines in less than a year when the typical process can require a decade or more. But for all of the celebrating that vaccines were finally available — the only true way to mitigate and end the pandemic — the moment also marked the beginning of an unprecedented time of effort and innovation, of fear, worry and sleepless nights for myself and my colleagues.

As a pharmacist, my fundamental job is to ensure that medicines are delivered, dispensed and used correctly, to help ensure that whatever treatment is prescribed, it works as safely and effectively as possible.

“The approved COVID-19 vaccines represented a monumental challenge at every level.”

They were brand new. Clinical trials aside, a lot remained unknown about how well they would work, what effects and results might be seen, short- or long-term. The vaccines were simple to use — an injection into the muscle of the upper arm, just like a flu shot — but they were complicated to store and distribute, with different refrigeration needs and shelf lives.

Both the Pfizer and Moderna vaccines rely upon mRNA molecules, which are very fragile. To keep them intact, the molecules are encased in tiny droplets of fat, which must be stored at very low temperatures to maintain their shape and shield the mRNA. For the Pfizer vaccine, that meant transporting and storing it at -70 degrees Celsius. (-94 degrees Fahrenheit). For the Moderna vaccine, it was a slightly more balmy -20 degrees C (-4 degrees F).

(The third vaccine, Johnson & Johnson, uses a different approach and can be stored at normal refrigerator temperatures.)

UC San Diego Health has multiple specialized, ultra cold freezers capable of keeping the vaccines appropriately frigid. Still, we fretted about unpredictable power outages or unforeseen temperature deviations. We prepared for every contingency and, on the day after FDA authorization, we received our first allocation of the Pfizer vaccine.

There was huge anticipation. We knew the day of arrival (by FedEx), but not when or in what exact form the vaccines would appear. They came in a single box, which I remember expecting to be much larger. Still, there was so much excitement, hope and worry. This box would start everything! We had reviewed advance instructions on how to remove the vaccine vials from the box, but we read them again and again. We weren’t taking any chances. There were three trays in the box, totaling 2,925 doses. We put one tray in each of three different freezers, just in case one went down.

Our job was to reconstitute and distribute vaccine doses where needed. Initially, vaccines went to health care workers and then over time more broadly to patients and the public. We began delivering first to vaccination sites within the hospitals, carefully calculating the number of doses that could be dispensed during operating hours. We didn’t want to waste a single dose.

When vaccination eligibility expanded and we launched our super stations, everything got more complicated. We were preparing thousands of doses a day to sites indoors and outdoors, across the county. We didn’t sleep. I drank more black coffee than I care to admit. Everybody on the team went all out, and I worried about their physical and mental health. It was hard, but I believed we were making a difference.

I got certified to help vaccinate people; anything to help. My first inoculation was a fellow pharmacist at the RIMAC super station. He said it didn’t hurt, so that was an accomplishment.

“Later, I was asked if I would like to throw out the ceremonial first pitch at the Padres’ “reopening day” game June 17, 2021 at Petco Park. I would be representing UC San Diego Health and all health care workers.”

My kids were so proud. My daughter asked if I would be only throwing out the first pitch or pitching the entire game. I told her it was likely the manager would pull me after my no-hitter (and no-batter). Pregame instructions said there would be no autographs. My children said it was a shame the players couldn’t get mine.

I have been asked what I will remember about the pandemic. I will remember everything as much as I’m sure many would like to forget. Although I wish this didn’t happen, there were good things that came from this pandemic. I will remember the time, effort and energy that my team put in; I am so proud of them and so grateful to be a part of this amazing group of people. There was so much teamwork, not only from the pharmacy team but also in collaboration with people I may not have worked with otherwise.

Through it all, there was fear, frustration and exhaustion, but also excitement, hope, appreciation, gratefulness and love that came from so many directions. You don’t forget such things.

— Clinical

Doctors Without Borders

As the pandemic worsened, UC San Diego Health physicians and staff widened their work, offering experience and help to hard-pressed colleagues in Tijuana

In the spring of 2020, fear was in the air. The COVID-19 pandemic had arrived. Cases in San Diego County were growing: On March 3, there was one documented daily case; by April 3, there were hundreds of reported cases daily and, in time, there would be thousands.

Local hospitals were struggling to accommodate the growing numbers of patients with an infectious disease scarcely understood. There were acute shortages of personal protective equipment (PPE): N-95 respirators and surgical masks, gowns, gloves, eye protection. Ventilators — machines that mechanically pump oxygen into patients who cannot adequately breathe on their own — were limited. Physicians faced prospects of needing to choose who might get a ventilator and who might not, the latter effectively a death sentence.

As a pulmonologist (a specialist in the respiratory system, from windpipe to lungs) at UC San Diego Health, all things COVID-19 consumed my world at the time.

“I saw dozens of patients daily. I lived and breathed the disease metaphorically while my patients did so literally.”

Colleagues convened constantly to consider options. Hospital leadership held virtual town halls to update UC San Diego staff on the situation. In one of them, we discussed what was happening less than 15 miles to the south in Tijuana, Mexico. The pandemic seemed worse there: rising numbers of cases and deaths, but even fewer resources. I wondered aloud if anything could be done.

Over the next few days, I received calls and emails from peers asking how they could support my mission to Tijuana. What? I had no experience with medicine outside of the United States. I had never been to Tijuana General Hospital, the largest in the region and the eventual focal point of our efforts. It did not matter. I realized I needed to step up, to try to make something happen.

I reached out to San Diego County health officials to help me get in touch with others who might be able to assist. Andres Smith, an emergency medicine physician, medical director of emergency services at Sharp Chula Vista Medical Center and president of the board of directors for Cruz Roja de Tijuana, which manages the city’s ambulance services, joined the effort and connected us with officials at Tijuana General, who invited colleagues and myself to visit. It became a large-scale team effort. It needed to be to have a chance at success.

We did not go as medical saviors. We had no plans to take over, to treat the hospital’s patients. We went to see for ourselves what was happening and share what we knew, what we were learning every day in our own increasingly crowded intensive care units. We went to learn.

“We expected to find a hospital at the breaking point. It wasn’t, at least not in spirit and determination. “

There were critical shortages of people, equipment and technological support, but there was a strong desire among everyone to help as many as possible. Tijuana General had become a COVID-19 hospital, entirely turned over to the care and treatment of infected patients. One had to wear full PPE all day, every day. It was exhausting. Medical personnel were doing their best. They were smart and motivated, but there weren’t enough of them. Many doctors and nurses had already died of the disease. Deemed at high-risk, physicians over the age of 60 were not permitted to treat COVID-19 patients, leaving that duty to younger, less experienced colleagues pulled in from elsewhere. Almost no one possessed specialized training or extensive experience in pulmonary issues and respiratory disease.

For the next month or so, in May and June, volunteer teams of UC San Diego Health medical staff visited the Tijuana hospital daily. We couldn’t treat patients, but we could advise and consult with the doctors and nurses who were providing direct care. We proposed ways to optimize ventilator settings, when specific interventions might be implemented, how to deploy bedside ultrasound to decrease complication rates and myriad other observations learned from our own practices and patients.

It proved an unimpeded give-and-take of knowledge and compassion. We invited staff from Tijuana General to visit UC San Diego Health to see how we were set up and how we did things. I remember discussing the case of a COVID-19 patient with rheumatoid arthritis with one of our Mexican colleagues. He was a trained rheumatologist and thrilled to talk — at least in that moment — about a disease he knew a lot about and who had had minimal opportunity to treat in the preceding months.

Groups gave money in support. The San Diego Rotary Club donated $25,000 to purchase oximeters, a tool critical to monitoring patients’ blood oxygen levels. Other funding bought ventilator humidifiers, a necessity for patients being mechanically ventilated for long periods.

While we couldn’t address every need, other people, groups and institutions also rose to the challenge. We focused on what we could do with the greatest benefit. Most of all, we gave of ourselves — our time, presence, expertise and training — and it helped.

“And that was the goal: to help.”