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.”

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.

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.

“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,” 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.”

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 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.”

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.”

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.

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.

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.

“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.

“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.”

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 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.’”

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.”