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Equitable Scientific Collaborations, Partnerships, and Coordination Within the United States

The first session of the workshop delved more deeply into the successes and shortcomings of the COVID-19 response in the United States, particularly in terms of collaboration among groups in academia, industry, government, public health, civil society, and other stakeholders. The panel was moderated by Dan Barouch, William Bosworth Castle Professor of Medicine at Harvard Medical School, and Elizabeth Hermsen, global antimicrobial resistance and antimicrobial stewardship medical affairs lead at Pfizer. William Gruber, senior vice president of vaccine clinical research and development at Pfizer, provided an overview of the pharmaceutical industry’s pandemic response and the factors that enabled rapid vaccine development. Myron Cohen, Yeargan-Bate Professor of Medicine, Microbiology and Epidemiology and associate vice chancellor for medical affairs at the University of North Carolina (UNC), provided an academic clinical research perspective on pandemic response efforts. Barney Graham, senior advisor for global health equity at Morehouse School of Medicine, discussed the role of public-private partnerships and interagency collaboration in responding to COVID-19. Umair Shah, Secretary of Health at Washington State Department of Health (WADOH), outlined the public health strategies and partnerships that formed Washington’s pandemic response.

INDUSTRY PERSPECTIVE ON THE COVID-19 RESPONSE

Gruber outlined biomedical and scientific research aspects of the response to the COVID-19 pandemic, highlighting factors that increased the speed of development and promoted health equity. He described the

pandemic as a unique experience where government, academia, public health experts, and industry share the same urgent priority: developing an effective vaccine. The uncertainty surrounding the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus and its spread required Pfizer to continually shift its vaccine discovery and development approach. Gruber noted the unprecedented speed with which Pfizer and partner company BioNTech developed the messenger RNA (mRNA) COVID-19 vaccine. The vaccine was granted emergency use authorization only 10 months after the start of development efforts. Paxlovid, a viral protease inhibitor taken orally, obtained emergency use authorization within 17 months (FDA, 2021).

Multiple factors contributed to the swift development of a COVID-19 vaccine, said Gruber. He highlighted the role of extensive research by the National Institutes of Health (NIH) on the Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) prior to the COVID-19 pandemic. This foundational work included technical advancements in stabilizing and producing the spike protein that were translated and applied to vaccine development for SARS-CoV-2. Pfizer and BioNTech developed mRNA vaccines based on stabilized spike protein constructs. He surmised that vaccine development would likely have taken significantly longer without this research foundation. Gruber commended the invaluable contribution of roughly 45,000 volunteers who enrolled at more than 150 clinical trial sites in six countries, approximately 42 percent of whom were over age 55 (Polack et al., 2020). He also noted efforts to communicate vaccine development progress in order to build confidence in this scientific endeavor. These efforts included uploading early data from clinical trials to preprint servers and publishing the protocol for its phase III study on Pfizer’s website. Gruber emphasized that the urgent public health need fueled the actions to bring novel vaccines to market in less than 10 months. However, Gruber noted that public acceptance of vaccine interventions has been less successful, particularly in terms of the politicized perception of vaccination as a personal choice rather than as a communal responsibility.

Collaboration with Regulatory Authorities

Collaboration and communication with regulatory authorities were essential to the rapid COVID-19 vaccine development, Gruber emphasized. Pfizer strived for seamless advancement from preclinical trials to phase I (dose ranging safety and immune response studies) and to pivotal efficacy studies in phase III trials. Stages that historically lasted years were compressed into months; stages previously requiring months transpired within days. However, requirements for quality, safety, and immune response data were not compromised by shortening timelines. Speed was achieved via

the removal of transition time at each decision point. For example, Pfizer and BioNTech completed submission of phase II data to the U.S. Food and Drug Administration (FDA) on Friday, July 24, 2020. The agency worked continuously through the weekend to review the submission and authorized proceeding into phase III trials only 3 days later, on Monday, July 27. Regulatory authorities also accepted utilization of nimble, alternative approaches to data analysis, such as a Bayesian approach for interim analyses as new data and hypotheses emerged in lieu of a frequentist approach.¹

Alterations to the Research and Development Process

Gruber described how research and development for COVID-19 diagnostics and therapeutics changed from pre-pandemic operations to accelerate the process. Pfizer utilized a “light speed paradigm” that included, among other elements, parallel testing and at-risk investment (Anderson, 2022). Instead of testing different vaccine designs sequentially, Pfizer conducted parallel testing in which four vaccine constructs were evaluated at the same time during the phase I study. Experienced physician scientists were involved in analyzing the benefit-risk profile to determine the strongest vaccine candidate, he noted. Pfizer’s existing clinical trials network was leveraged to establish trial sites in response to the rapid evolution of the virus.² Real-time modeling was used to predict geographic spread and intensification of the pandemic so that participant enrollment could then be targeted to those locations in an effort to more quickly assess the vaccine efficacy. He noted that Pfizer began clinical work and large-scale manufacturing as early as possible; this at-risk investment ensured that vaccine product would be available immediately if the efficacy results were favorable and the vaccine received emergency use authorization. Gruber added hundreds of millions to billions of dollars were invested before data on tolerability of the vaccine, safety, immune response, or efficacy in humans were obtained.³

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¹ Bayesian analysis is a method of statistical inference that combines known information about a population parameter with observed data. In the case of clinical trials, a Bayesian approach utilizes predictive probability to specify conditions under which clinical trial results might be considered as sufficiently convincing in order to stop the trials early.

² The Pfizer-BioNTech vaccine candidate was tested through Pfizer’s privately funded clinical trials and trial network; it did not participate in the COVID-19 Prevention Network (CoVPN) trials. For more information on CoVPN and COVID-19 trials, see https://doi.org/10.1001/jamanetworkopen.2022.51974 (accessed June 10, 2023).

³ Although details were not specified during the speaker’s remarks, at-risk investments taken by vaccine developers during the COVID-19 pandemic included preparing clinical grade drug material and reagents necessary for the vaccines and repurposing or redirecting manufacturing facilities from their existing operations to prepare for these vaccines. See https://www.mckinsey.com/industries/life-sciences/our-insights/fast-forward-will-the-speed-of-covid-19-vaccine-development-reset-industry-norms (accessed June 10, 2023).

Health Equity Practices

Gruber described Pfizer’s commitment to and efforts toward creating equitable and affordable access to a safe and effective vaccine that can help end the pandemic. Individual responses to any given medicine vary. Therefore, determining real-world efficacy and acceptance of a vaccine necessitates a diverse trial population. In its phase III trial, Pfizer enrolled 45,000 participants—from countries including Argentina, Brazil, Germany, South Africa, Turkey, and the United States—and used epidemiology modeling data to establish new trial sites based on infection rates to accrue study cases as quickly as possible. More than 4.2 billion Pfizer-BioNTech COVID-19 vaccines had been shipped worldwide as of November 2022, he reported, yet disparities in vaccine access persist. The COVID-19 Vaccines Global Access (COVAX) Facility, the vaccine pillar under the Access to COVID-19 Tools Accelerator, was established to promote equitable COVID-19 vaccine access.⁴ To contribute to this initiative, Pfizer and BioNTech agreed to provide 1 billion doses of vaccine at the not-for-profit price for the U.S. government to donate to 92 low- and middle-income countries that are eligible for access via COVAX’s advanced market commitment. In 2021, COVAX supplied 200 million vaccine doses supported by this agreement. Gruber added that vaccines are only effective if administered, which requires efforts to ensure vaccine use via public and private partnerships, effective communications, and utilization of social and behavioral research to convey the positive public health benefits of vaccines against COVID-19 and other diseases.

ACADEMIC PERSPECTIVE ON THE COVID-19 RESPONSE

Cohen discussed his experience with successful efforts and shortfalls within the academic community’s response to the COVID-19 pandemic. Noting the suddenness with which a previously unknown pathogen compromised the entire human species, he outlined priorities that immediately surfaced within the academic community. These included understanding the transmission and pathogenesis—particularly in terms of the high mortality attributed to contracting the virus—and learning how to prevent, treat, and cure the disease. He added that the long-acting presentation of COVID-19 known as post-acute sequelae SARS-CoV-2 infection (i.e., PASC or “long COVID”) became apparent to the research community at a later point in time.

Commending the success of Operation Warp Speed (OWS), Cohen spotlighted the unprecedented level of federal spending applied to vaccine devel-

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⁴ Launched in April 2020, COVAX was coordinated by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations, and the World Health Organization. See https://www.gavi.org/vaccineswork/covax-explained (accessed June 10, 2023).

opment and the exceptional extent to which federal employees connected with researchers. A large public-private partnership was also established to forge collaboration between academia and industry. Early in the pandemic, a decision was made to redeploy the HIV research community and infrastructure to study COVID-19. Cohen acknowledged that an opportunity cost to HIV research was inherent in this decision. In early 2020, he—along with other HIV researchers including Lawrence Corey (Fred Hutchinson Cancer Center), Kathleen Neuzil (University of Maryland School of Medicine), and David Stephens (Emory University Woodruff Health Sciences Center)—was asked to establish the COVID-19 Prevention Network (CoVPN). Under the network structure, East Coast researchers focused on developing monoclonal antibodies and West Coast scientists focused on vaccines. Cohen noted that antiviral therapeutics were not available at that time.

COVID-19 Mitigation

Early in the pandemic, it seemed improbable to HIV researchers that a COVID-19 vaccine would be developed in under 1 year, because there is no effective vaccine for HIV even after four decades of research, said Cohen. Therefore, researchers and decision makers prioritized behavior changes to mitigate virus transmission, with mixed success. Face masks received particular attention, both because masking was a primary mitigation method and because they generated controversy due to the U.S. population’s unfamiliarity with wearing them (Escandón et al., 2021). In the first months of the pandemic, the belief that COVID-19 was primarily transmissible via surfaces fueled a supply shortage of hand sanitizer. Cohen noted that some places have been slow to adopt the shift in understanding that transmission of the pathogen occurs via respiration and is unlikely to be transmitted via other mechanisms. Similarly, the realization that outdoor spaces have much lower transmission risk than indoor spaces required time to take root in public understanding.

Disproportionate Effect on Older Adults

Cohen emphasized that rarely has a disease increased the mortality rate of people over age 65 to the extent that COVID-19 does. In May 2020, residents and workers in long-term care (LTC) facilities accounted for 35 percent of COVID-19-related deaths (Yourish et al., 2020). As CoVPN began work on monoclonal antibodies and vaccines, Cohen was asked to focus on two populations with high incidence rates of COVID-19: LTC facilities and the meatpacking industry. He noted that in some LTC facilities, as many as half of residents died from the virus. The pharmaceutical industry committed significant resources to address this challenge

as part of its pandemic response efforts. For example, Eli Lilly created a fleet of seven vans that traveled throughout the United States to deliver monoclonal antibodies to LTC facilities as part of a randomized controlled trial of bebtelovimab.

Successes of the COVID-19 Response

Many factors contributed to achievements within the pandemic response, including the energy that the research community dedicated to the COVID-19 response to drive progress and development, said Cohen. He noted that this energy was exerted despite the pandemic-related stressors that researchers faced in their daily lives, like the rest of the public. Several hundred investigators joined twice-weekly phone calls to discuss their research progress. Decades of prior research on HIV, respiratory syncytial virus (RSV), and other pathogens provided a foundation of expertise that underlie the pandemic response. Cohen also noted that the high incidence of COVID-19 cases enabled the expeditious conduct of randomized controlled trials, and that the decreasing incidence will affect trial timelines for pharmaceutical development. Public-private partnerships occurred at an unprecedented level, Cohen said, noting that the rapid development of COVID-19 vaccines was a crowning achievement. CoVPN and pharmaceutical companies made notable contributions to this process. Importantly, he credited the altruism of volunteers—who were willing to receive these new protein or mRNA vaccines despite misinformation circulating in the general public—as the cornerstone that enabled the rapid development of the vaccines. As many as 200,000 volunteers participated in CoVPN’s vaccine program, and approximately 400,000 people completed online registrations to volunteer, Cohen recalled. He emphasized the importance of federal funding in enabling rapid research efforts. The level of federal funding provided through the Biomedical Advanced Research Development Authority (BARDA), the Administration for Strategic Preparedness and Response (ASPR), and other agencies and organizations enabled researchers to proceed without the typical delays in writing grant applications and waiting for the grant rewards.

Shortfalls of the COVID-19 Response

Although federal funding played a substantial role in facilitating vaccine development, lack of funding for other research areas was one factor contributing to shortfalls within the COVID-19 response, said Cohen. The resources and research funds available for vaccine development were insufficient to support the efforts needed to fully understand transmission and other aspects of viral pathogenesis. Vaccines decreased the number of

people requiring hospitalization, but many other patient needs and questions could not be fully addressed. Cohen maintained that funding was withdrawn precipitously, and that funds are currently inadequate to answer critical questions about COVID-19. He cautioned that the copious funding provided early in the pandemic enabled rapid scientific developments, but withdrawal of funding decelerates the development process and reinstates the delays due to fundraising activities.

Cohen commented that inequities within medical research also need improvement. Some trials were stopped and forced to make urgent corrections because of insufficient enrollment of participants from minority populations. Finally, Cohen believed that the largest mistake made by academia in its response to the pandemic was a lack of communication with the public. In retrospect, he wondered whether creating opportunities to directly communicate with the public—perhaps via weekly press conferences—could have fostered public understanding of the developments that were taking place. Such communications could have explained the function and expected efficacy of vaccines and monoclonal antibodies. He clarified that the lack of communication was not driven by a desire for secrecy, but because researchers were focusing all of their efforts on developing vaccines and treatments and did not understand the value of dedicating time to public communication.

The need for communication became apparent with the unanticipated politization of vaccination, noted Cohen. The research community anticipated a public willingness to get vaccinated for their own benefit and for the benefit of others. Appreciation of the social forces that compromised prevention efforts was slow to develop, which delayed recognition of the economic, social, and familial implications of these forces. Vaccines, monoclonal antibodies, and therapeutics do not exist in a bubble, shielded from social dynamics. COVID-19 highlighted the fragility of the human population, and lessons learned from this pandemic should be incorporated into pandemic preparedness efforts, Cohen reflected.

RESEARCH AND PARTNERSHIP IN COVID-19 VACCINE DEVELOPMENT

Graham discussed the importance of supporting and investing in basic research and of proactively preparing for pandemics—in terms of not only biological understanding, but also planning for collaborations between academic and industry groups. He shared his desire to use his position as senior health advisor for global health equity to focus on vaccine uptake and access, two areas in which adequate solutions have yet to be developed.

Foundation of Research for COVID-19 Vaccine and Monoclonal Antibodies Development

Graham reviewed the timeline for the rapid development of COVID-19 vaccines. On January 10, 2020, the sequences for the novel virus were published. Within weeks, researchers were producing proteins, solving structures, and developing immunological assays. Immunogenicity of prototype vaccines was confirmed in laboratory mice on February 18, 2020. Within 65 days of the sequence publication, an mRNA vaccine entered clinical trials. Prior planning and research contributed to the speed of vaccine development, he reiterated. Most of the technologies applied to the coronavirus vaccines originated through four decades of HIV research. In addition, 8 years of research on coronavirus spike protein structure, the mapping of antigenic epitopes, and how neutralizing antibodies work had been conducted before the pandemic began. He added that COVID-19 vaccine development was also informed by prior research on RSV structure-based vaccine design, as well as the use of platform manufacturing technology as a method for strengthening pandemic preparedness.

The foundation of prior research and collaboration that enabled rapid vaccine development also applied to making monoclonal antibodies. Graham noted that an existing relationship between the National Institute of Allergy and Infectious Diseases (NIAID) and AbCellera Biologics facilitated creation of molecular probes and acquisition of convalescent peripheral blood mononuclear cells from COVID-19 survivors in the United States. This partnership involved 3 years of prior research on cross-reactive coronavirus antibodies that provided a system able to generate hundreds of sequences. Antibodies were then created and examined for neutralized activity. AbCellera and Eli Lilly arranged the clinical development program. COVID-19 vaccines were in phase III trials after 6 months, and therapeutic antibodies were in phase III trials after 5 months. Bamlanivimab was the first therapeutic antibody created, followed by bebtelovimab. These products are no longer in use because they are not effective against new variants, but many other antibodies have been developed that could replace them. Graham suggested considering the use of these other antibodies to develop new therapeutics.

Preexisting Partnerships in COVID-19 Response

Experience with structure-based design, antibody discovery, pandemic preparedness, and responding to public health emergencies of international concern contributed to readiness to respond to COVID-19 (Graham et al., 2018; Graham and Sullivan, 2018). Preexisting academic and public-private partnerships played an important role in pandemic response efforts, said

Graham. In 2017, the NIAID Vaccine Research Center (VRC) partnered with Moderna in response to growing awareness of the potency of mRNA vaccines and a failure to respond quickly enough to Zika. VRC assisted Moderna with Zika testing, and the entities agreed to develop a pandemic preparedness demonstration project to leverage Moderna’s work on mRNA constructs and VRC’s research on designing antigens. In addition, VRC had a formal research collaboration with AbCellera on antibody discovery. Five years prior to the COVID-19 pandemic, VRC partnered with a consortium of academic groups on developing an improved MERS vaccine using structure-based design and mRNA. This partnership included work with the University of Texas at Austin on structural biology, UNC on animal models and molecular biology, and Vanderbilt University on coronavirus biology, particularly in terms of viral replication and evolution. Other partners included Eli Lilly and Medigen Vaccines Biologics Corporation, a Taiwanese company that worked with VRC on making a subunit vaccine authorized for use in Taiwan. Extramural divisions of NIAID and the U.S. Department of Defense developed a coronavirus prevention program that enabled vaccine development to move from the lab into large-scale clinical trials with more than 200,000 enrolled volunteers within 6 months.

These preexisting partnerships informed a pandemic preparedness demonstration project that was drafted in 2015, said Graham. Anthony Fauci, then-director of NIAID, approved a plan for Nipah vaccine development in 2018. In fall 2019, NIH and Moderna held meetings and toured Moderna’s manufacturing facility to ensure that its operations complied with applicable requirements. The demonstration project began during the first quarter of 2020. Although originally focused on Nipah, the project pivoted to coronavirus. Thus, testing for this coronavirus demonstration project began before the World Health Organization (WHO) officially declared COVID-19 a pandemic on March 11, 2020. All of the requisite elements were in place at the time when they were needed, thus Graham suggested replicating this collaborative process with a different pathogen.

Coordination and collaboration among government agencies also contributed to the COVID-19 response. Since the establishment of VRC in 2000, NIAID has responded to SARS, West Nile virus, avian influenza, swine influenza, chikungunya, MERS, Ebola, Zika, and SARS-CoV-2. After the avian influenza outbreak in 2005, the U.S. Department of Health and Human Services (HHS) established ASPR and BARDA. When Ebola broke out in 2014, vaccine prototypes were already available for development, and these were deployed into phase III trials within 1 year. Nonetheless, the speed of this process was insufficient, said Graham. When Zika emerged in 2016, John Mascola, then-director of VRC, insisted that government agencies coordinate response efforts to epidemics. Mascola pushed for NIAID and ASPR to form a joint leadership group that met biweekly to plan for

immediate, intermediate, and long-term responses to Zika. Graham stated that this group served as a foundation for the later development of OWS. He described the federal government’s response as being made feasible by (1) prior events and experience and (2) having people in place who could motivate leadership to respond. In order to foster ongoing coordination, HHS has created the HHS Coordination Operations and Response Element (i.e., H-CORE), an entity within ASPR intended to ensure the synchronization of medical countermeasure efforts across the federal government. However, whether this group will have the power and positioning to act when a crisis occurs remains to be seen, said Graham.

WASHINGTON STATE GOVERNMENT COVID-19 RESPONSE

Shah discussed the innovative public health strategies that WADOH used in its response to COVID-19 and the partnerships that made these strategies feasible. Public health is “what we as a society do collectively to assure the conditions in which people can be healthy” (Institute of Medicine Committee on Assuring the Health of the Public in the 21st Century, 2002). Shah emphasized the collective nature of public health and its mission to keep people safe, protected, and well. Shah highlighted the geographic and demographic diversity of the state served by local health jurisdictions in 39 counties intertwined with WADOH. Washington was the first U.S. state to report a case of COVID-19, to experience an outbreak, and to have a patient die from the virus. Thus, practitioners across the country looked to Washington’s response to inform their own response efforts. Staff at WADOH went to great lengths to serve the public, and this work extended into later stages of the pandemic response and included vaccination efforts. Shah shared a thank you note from an 80-year-old man who contacted the call center for help when he could not obtain COVID-19 vaccination. The call center customer representative not only secured a vaccination appointment but also arranged transportation to take him to the appointment. Shah maintained that equity, innovation, and engagement are cornerstone values that WADOH integrates into all activities, including the pandemic response.

Reimagined Health Service Provision

Responding to the COVID-19 pandemic involved reimagining service provision, said Shah. He shared some of the innovative programs developed by WADOH. For the first time, WADOH deployed Care-A-Van mobile units into local communities to provide on-site vaccinations at community events. The innovative Vaccine Action Command and Coordination System was designed to foster public-private partnership between WADOH and

private-sector entities including Starbucks, Costco, Alaska Air, Microsoft, Amazon, Google, and others to generate solutions for efficient and effective vaccine distribution. For example, Starbucks team members translated their knowledge of maximizing efficiency in filling coffee orders into maximizing efficiency at mass vaccination sites. Shah encouraged the public sector to leverage private-sector expertise to improve response activities, even during times of non-emergency. The Vaccine Implementation Collaborative was developed to convene 700 organizations and entities across Washington working to achieve equity in vaccine access by integrating the voices of communities often excluded into response efforts. Shah also noted that Washington leveraged its capabilities in innovation to become one of the few states to use smartphone applications for individual COVID-19–related notifications. The smartphone application WA Notify was developed in partnership with the private sector to alert users to potential COVID-19 exposures. Further, WA Verify was developed as a digital COVID-19 vaccine verification system to instantly provide users with digital copies of their vaccine records. The Power of Providers initiative combined the efforts of around 70,000 health care providers across Washington to leverage their relationships with patients to maximize vaccination rates. The Say Yes! COVID Test initiative enables Washington residents to order COVID-19 tests with next-day home delivery via a partnership with Amazon and CareEvolution. Millions of COVID-19 tests have been distributed free of charge through this program. Data management evolved over the course of the COVID-19 pandemic. Microsoft partnered with WADOH staff to address data modernization needs, particularly in relation to creating data dashboards, data visualization, assessment, and verification.

Underinvestment, Politization, and Invisibility in Public Health

Shah remarked that the public health sector’s response to COVID-19 was successful, even though society has failed the sector over decades by not investing adequate funds to build the necessary capacity to discharge its responsibilities. He has worked in public health in the politically conservative state of Texas and in the liberal state of Washington, and, in his experience, underinvestment in public health is an issue in both states. In addition to funding issues, politization of public health efforts has affected its efficacy. Development and provision of vaccines will be ineffective if people are unwilling to be vaccinated. Shah emphasized that public health concerns are ongoing and involve many fronts. For instance, public health is currently contending with infant formula shortages, mpox, and the “triple-demic” of RSV, influenza, and COVID-19. Investment in capacity building is needed to translate scientific developments into widespread practices to strengthen public health, he maintained.

In a New York Times article published during the pandemic, Shah likened public health to the offensive linemen of a football team in that their job done well attracts little attention, in contrast to quarterbacks—similar to the health care system—who draw public focus (Interlandi, 2020). Emphasizing the importance of investing in this offensive line is critical, said Shah, particularly in the current age of misinformation and disinformation that has challenged trust and transparency across the system. He described public health as facing an invisibility crisis. Fighting this crisis involves raising visibility, which engenders value, and value, in turn, validates pro-health resources and pro-health policies. Should investment continue to focus on the health care system in lieu of public health, then critical responses to crises such as a pandemic will be affected, Shah contended.

Transformational Health Plan

Ending the ongoing COVID-19 pandemic will require a shift from transactional health to transformational health, said Shah. Transactional health is time-limited and reactive, whereas transformational health addresses needs by intentionally and collectively transforming the health system. In August 2022, WADOH launched its transformational plan “A Vision for Health in Washington State,” which features five pillars: health and wellness, health systems and workforce transformation, environmental health, emergency response and resilience, and global and One Health.⁵ The plan hopes to support transformations built on a platform of equity, innovation, and engagement. Each pillar is supported by six key strategies, amounting to 30 strategies to move toward a transformational health system. In particular, Shah emphasized the importance of the public health workforce and the need to increase investment in it.

Shah described a collaborative approach as being able to move “farther together” than siloed approaches. Researching and sharing strategies for emergency response efforts can have a deep societal impact, he added, and incorporating partners can optimize preparedness for future responses. This approach involves bringing together partners to share research and practices on both a domestic and global level. Cornerstone values of equity, innovation, and engagement should be embedded into readiness planning in order to shift transactional systems into transformational ones, said Shah. He closed with remarks that smart, strategic, scalable, and sustained invest-

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⁵ WADOH is the first state health agency in the United States to make global and One Health one of the pillars in its transformational plan. More information about the WADOH Transformational Plan is available at https://doh.wa.gov/about-us/transformational-plan (accessed January 20, 2023).

ments are needed to advance U.S. public health systems, and the time for proactive investments in public health is now.

DISCUSSION

Broadening Stakeholders

Noting a theme of collaborative partnerships throughout the presentations, Hermsen asked each panelist whether any stakeholders were missing in the pandemic response that should be included.

Central Leadership

Shah stated that the United States’ federated system creates challenges in addressing federal recommendations and strategies across 50 states, territories, and approximately 3,000 local health jurisdictions. He noted that lack of strong leadership at the federal level translates to increased inconsistency across jurisdictions. For instance, some locations participate in private partnerships and emphasize equity partners, while others do not. The COVID-19 pandemic spanned a tapestry of responses across the country, a dynamic that eroded trust as the public compared the different ways in which different communities and states were responding. This system also impedes cross-border and cross-jurisdictional communication and strategies, said Shah.

Communications Needs

Cohen remarked that the parties working on vaccines and monoclonal antibodies focused primarily on research and development and clinical trial enrollment, without directly addressing communications—for instance, they did not engage social scientists and communications experts in their efforts. He added that the people communicating about these matters on network television were often provocative and were rarely professionals involved in the clinical trials. Communication issues were often ignored during the ongoing regular meetings of researchers focused on vaccine development, which, in retrospect, was a mistake, said Cohen. Instead, researchers could have clarified with the public that the endpoint was stopping disease and hospitalization—not ending transmission or acquisition of infection—and could have provided updates about the trials, particularly in terms of the numbers of people enrolled. However, the need for such communications was not anticipated, he said.

Barouch stated that physicians and scientists were largely unprepared for the communications challenges that ensued as lifesaving products

became available. The strength of discord was more intense than many of these professionals anticipated. Inclusion of social scientists and communications experts at the earliest phases of research and development could foster connection with the public, he suggested. Partnering with the community could increase acceptance of public health initiatives and thereby improve their efficacy. Enthusiastic to develop biomedical products at astonishing speed, the field overlooked the need to engage social scientists and communications experts.

Gruber added that understanding the most effective source of advocacy was a challenge. Appropriate senior figures in public health discussed pandemic-related matters with the public, but advocacy is generated by grassroots mechanisms to some extent, and grassroots anti-vaccine sentiment was difficult to address. Discussions of about countering opposition to vaccines generated ideas such as enlisting notable sports figures as advocates to promote vaccination and enrollment in clinical trials. Gruber remarked that biomedical science experts’ opinions about the effectiveness of such an approach varied. He added that during meetings of the Vaccines and Related Biological Products Advisory Committee and the Advisory Committee on Immunization Practices, advocates both for and against vaccination spoke in public sessions. To emphasize the power of grassroots voices, he recounted an advisory committee discussion of the recommendation for meningococcal quadrivalent vaccine use in adolescents. Initially, the vote looked likely to fail; however, the vote ultimately pivoted after advocates spoke about losing their limbs or loved ones to meningococcal disease. Messaging from leaders and public health authorities is important, but grassroots advocacy is also needed, said Gruber. He echoed an earlier suggestion on engaging behavioral and social science researchers to recommend effective messaging strategies.

Communication and Trust Building

Participants discussed approaches to increase mutual trust between health practitioners and the public. Shah believed that health and public health practitioners can connect with communities by integrating personal stories into their messaging. He shared that when asked as Secretary of Health whether he supported COVID-19 vaccinations for children, he answered with a personal story about his and his wife’s daily concern about the health and well-being of their three school-aged children. Shah acknowledged that this approach runs counter to the medical training that many professionals receive, which discourages the sharing of personal accounts. Shah’s aunt died of stage 4 breast cancer when he was a child, and he has often thought of her when treating women with the disease. However, his training has prevented him from sharing this personal

account with patients. After two decades of practice, he has realized that this approach can be problematic—within certain parameters, sharing personal accounts can be helpful. If health practitioners connect with patients only as physicians or scientists, trust can be lost. He maintained that more research is needed to understand the factors that foster patients’ trust in health practitioners. These factors may include inadequate connection, communication, and engagement strategies, as well as practitioners’ lack of skill sets in these areas.

Shah noted consequences from an erosion of trust between public health and the general public during the COVID-19 pandemic. Public health practitioners have been vilified, harassed, and subject to discrimination; he suggested that female practitioners may be more prone to these negative experiences. Asian American practitioners have been particularly vulnerable to discrimination because of associations with the first known outbreak having occurred in China. The negative characterization and caricatures of the public health field have spurred efforts to protect the field. The tools, training, and people communicating with communities are not always appropriate for building trust and in some cases have undermined trust. He stated that building trust between the public and public health is essential to effectively move forward.

Equity and Community Engagement

Meghan McGinty, senior executive for health emergency preparedness and response at Tetra Tech, described working at the New York City Municipal Health Care Center and trying to convince patients and coworkers alike to get vaccinated. She noted that although equity, collaboration, and communication are workshop topics, community members are not represented on the agenda. She asked the panel members how they intend to incorporate the community and local public health representatives in their work moving forward. Shah replied that the collaborations that were created to respond to COVID-19 remain useful. For example, in the midst of the recent mpox outbreak, WADOH leveraged its established partnerships to engage the LGBTQ+ community. He acknowledged that continuing partnerships will be challenging now that COVID-19–related funding is drying up, and work is needed to convince policymakers of the importance of building long-term capacity through prospective, broad-spectrum funding. Shah emphasized the value of including the voices and perspectives of people who are often not represented in decision-making bodies.

Graham shared that Morehouse School of Medicine’s focus on health equity was one reason he joined that institution. Health equity is part of the school’s mission statement and is integrated into all aspects of pro-

gramming. He maintained that trust cannot be rebuilt during a crisis, nor can it be rebuilt quickly; it must be built via an ongoing process during inter-crisis periods. Highlighting the need for efforts in this area, he noted that licensing for RSV vaccines will likely take place in the summer 2023. Several trials have been successful, yet a community engagement group has not been established to promote RSV vaccine preparedness. Graham raised the example of the March of Dimes, a grassroots organization that fostered the success of polio vaccination. Community groups, education, and other efforts are needed during inter-crises periods, said Graham. In particular, the younger generation (e.g., under age 25) can be involved in these activities to help counter the problematic dynamics around vaccines on social media.

Considerations for Older Adults

Theresa Bernardo, IDEXX Chair in Emerging Technologies and Preventive Healthcare at the University of Guelph, commented that a missed opportunity to limit COVID-19 virus transmission, cases, and deaths in LTC facilities occurred early in the pandemic. Noting use of personal protective equipment and guidance for reducing transmission of disease within LTC facilities as examples, she asked about other potential steps to ensure that the vulnerable population of older adults is not neglected in future health crises. Cohen remarked that the novel nature of the virus created gaps in understanding that hindered the establishment of steps to reduce transmission. In retrospect, transporting infected people from LTC facilities to hospitals where they in turn infected health care workers was a mistake, said Cohen.

Gruber recounted that the Seattle institution that reported the first COVID-19 cases provided his father with rehabilitative care after a stroke several years earlier. He shared the poignant realization that had his father been at that institution as the pandemic spread, he would not have been able to visit him. Now, with a better understanding of the virus, restricting access between residents in LTC facilities and their loved ones does not appear to be the best approach to response. Instead, focus should be placed on protecting LTC personnel and supporting institutions in reducing viral transmission, said Gruber. Regarding medical interventions, vaccination efforts did pivot to prioritize immunizing the older-adult population once safety information on mRNA vaccines was obtained. Recognizing that older individuals might not respond as well to the vaccine compared with younger people, researchers also spent additional time to optimize the vaccine dosage for the older population. Shah remarked that community engagement efforts should include older adults, and that the heterogeneity of this subpopulation should be reflected in strategies that protect those residing in LTC facilities and those living independently.

Proactive Investment

Hermsen asked about strategies to shift from reactive to proactive responses while maintaining fiscal responsibility. Shah remarked that the United States provides funding to communities in a reactive manner, as was the case with H1N1, Ebola, and Zika. In fact, he added, the funding to address Zika was not awarded received until the mosquito season was ending. Proactive investment and capacity building are more effective, efficient, and methodologically sound than the current pattern of reactive spending, said Shah. Cohen replied that the academic community contributes evidence that can be used to streamline response processes. For example, regulatory hurdles can slow response times to health crises, and academics can help regulatory agencies develop methods to act more swiftly. He opined that the European Medicines Agency (EMA) is more nimble in its regulatory processes compared with the FDA. For instance, EMA has made the short-acting version of the RSV monoclonal antibody universally available to all infants, a step that the United States has not yet taken even though infections are surging.

Graham addressed the fiscal aspect by highlighting that global losses in gross domestic product early in the pandemic amounted to billions of dollars per hour. Some of those losses could have been prevented by investing billions of dollars in laboratory preparedness and in rebuilding the public health infrastructure. He stated that proactive spending on pandemic preparedness will never be fiscally irresponsible because of the magnitude of economic losses that pandemics can cause. Gruber remarked that a proposal is before Congress to allocate unused funds from the American Rescue Plan Act of 2021 to BARDA, NIH, the Centers for Disease Control and Prevention, and other stakeholders to use in preparedness efforts. He added that after the 1918 influenza pandemic, the necessary work to address pandemic preparedness did not occur; rather than repeating that mistake, preparedness efforts should be championed.

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