{"subscriber":false,"subscribedOffers":{}} COVID-19 Vaccine To Vaccination: Why Leaders Must Invest In Delivery Strategies Now | Health Affairs

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Analysis

COVID-19
Analysis

COVID-19 Vaccine To Vaccination: Why Leaders Must Invest In Delivery Strategies Now

Affiliations
  1. Rebecca L. Weintraub ([email protected]) is director of Better Evidence, Ariadne Labs, Harvard T. H. Chan School of Public Health and Brigham and Women’s Hospital, and an associate physician at Brigham and Women’s Hospital, all in Boston, Massachusetts.
  2. Laura Subramanian is a senior specialist at Ariadne Labs.
  3. Ami Karlage is a writing specialist at Ariadne Labs.
  4. Iman Ahmad is a research assistant at Better Evidence, Ariadne Labs.
  5. Julie Rosenberg is deputy director of Better Evidence, Ariadne Labs.
PUBLISHED:Free Accesshttps://doi.org/10.1377/hlthaff.2020.01523

Abstract

Worldwide, leaders are implementing nonpharmaceutical interventions to slow transmission of the novel coronavirus while pursuing vaccines that confer immunity to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. In this article we describe lessons learned from past pandemics and vaccine campaigns about the path to successful vaccine delivery. The historical record suggests that to have a widely immunized population, leaders must invest in evidence-based vaccine delivery strategies that generate demand, allocate and distribute vaccines, and verify coverage. To generate demand, there must be an understanding of the roots of vaccine hesitancy, involvement of trusted sources of authority in advocacy for vaccination, and commitment to longitudinal engagement with communities. To allocate vaccines, qualified organizations and expert coalitions must be allowed to determine evidence-based vaccination approaches and generate the political will to ensure the cooperation of local and national governments. To distribute vaccines, the people and organizations with expertise in manufacturing, supply chains, and last-mile distribution must be positioned to direct efforts. To verify vaccine coverage, vaccination tracking systems that are portable, interoperable, and secure must be identified. Lessons of past pandemics suggest that nations should invest in evidence-informed strategies to ensure that coronavirus disease 2019 (COVID-19) vaccines protect individuals, suppress transmission, and minimize disruption to health services and livelihoods.

TOPICS

Worldwide, public health leaders are recommending a combination of nonpharmaceutical interventions to slow transmission of the novel coronavirus. Scientists are clear, however, that nonpharmaceutical interventions alone will not end transmission of coronavirus disease 2019 (COVID-19). A safe and effective vaccine is a critical component for reducing COVID-19-related illnesses, hospitalizations, and deaths and for restoring the global economy.

To this end, governments and investors are earmarking unprecedented investments to prepare billions of doses of COVID-19 vaccines. Vaccine development for COVID-19 has progressed faster than for any other pathogen in history. The efficacy and long-term safety of these vaccines cannot be predicted yet, especially as several of the leading contenders are based on new technology platforms such as mRNA that lack proven track records. Pfizer/BioNTech and Moderna recently released promising results indicating that their vaccines are 94–95 percent effective,1,2 and AstraZeneca’s early results indicate an average vaccine efficacy of 70 percent.3 However, three critical areas remain to be demonstrated: robust evidence of efficacy and of safety with data from thousands of patients over longer periods of time, and vaccine doses manufactured consistently at the highest quality standards. The Food and Drug Administration (FDA) has stated that COVID-19 vaccines will be approved only if they are shown in large-scale clinical trials to reduce disease by at least 50 percent and to be safe.4 Experts recommend investing in a wider, more diversified portfolio of vaccines, as they predict that first-generation vaccines will not be effective enough to end the pandemic on their own.5 In addition, some models predict that it will probably take more than a year to produce enough vaccines just to inoculate the world’s fifty million medical staff and that it could be September 2023 before there are enough doses for the world.5 Assuming that safe and effective vaccines are developed, having a supply of vaccines is only the first step in ensuring that vaccines actually get delivered to populations.

To ensure that COVID-19 vaccines lead to widespread vaccination and that 60–70 percent of the population has immunity,6 governments and public health leaders need to prepare transparent, evidence-based strategies to promote COVID-19 vaccine acceptance and implement equitable and effective vaccine delivery. This will require four interconnected strategies: generating demand for the vaccine, allocating the vaccine, distributing the vaccine, and verifying coverage.

Researchers have previously documented the challenges of getting life-saving supplies or medications to populations and have identified the concept of “implementation bottlenecks” as a key cause of the failure to translate known interventions into robust delivery of services.7 We have studied implementation bottlenecks and strong delivery systems during the past decade.8 In this article we draw on the growing public health and social and behavioral science evidence base from previous epidemics and vaccine campaigns to describe the lessons learned about successful and less successful vaccine delivery. These lessons should aid leaders in designing COVID-19 vaccine delivery systems that lead to an immune population.

Generating Demand For A Vaccine

Humanity will fail to contain the COVID-19 pandemic if not enough people accept a vaccine. For a new vaccine developed with unparalleled speed, generating demand requires understanding people’s perceptions of vaccine safety and efficacy and implementing communication campaigns tailored to specific populations.

Because vaccination campaigns require healthy people to seek an intervention, such campaigns require generating demand. Vaccine confidence was already decreasing worldwide before the COVID-19 pandemic for cultural, political, and personal reasons.9 The Epidemic Intelligence Service in the US, which addresses public health emergencies, maintains that a pandemic is as much a communications emergency as a medical crisis.10 The World Health Organization’s (WHO’s) Increasing Vaccination Model acknowledges that people’s thoughts and feelings about vaccines, including their perceived risk, worry, confidence, trust, and safety concerns, can affect their motivation to get vaccinated.11 Vaccine hesitancy was cited in 2019 as one of the top ten threats to global health.11,12 As a consequence, nations must work proactively to mitigate global hesitancy for COVID-19 vaccines.

The complexity of generating demand for COVID-19 vaccines has increased with the rising tide of misinformation and vaccine hesitancy. One recent US survey found that only 60 percent of US adults are likely to accept a COVID-19 vaccine,13 with another survey indicating that reasons for hesitancies include vaccine-specific concerns, a need for more information, antivaccine attitudes or beliefs, and a lack of trust.14 Public trust in government approval processes has eroded as FDA Emergency Use Authorizations for hydroxychloroquine and convalescent plasma have been revoked (the former) or faced scrutiny (the latter).15

Influencers

Strategies to stimulate COVID-19 vaccine demand must be based on perceptions, attitudes, and public trust. In the past, celebrities and respected public figures have proved successful in improving public attitudes, trust, and uptake of health interventions, including vaccines.16 In 1956, for example, Elvis Presley got a polio vaccination on national television in hopes of motivating susceptible teenagers to get vaccinated, and vaccination rates increased during the next six months.17 In 1991 basketball icon Earvin “Magic” Johnson announced that he was HIV positive, which led to an increased level of knowledge and curiosity about the disease and increased HIV testing.18 Social scientists have studied how influencers—cultural and public health leaders—help shape knowledge, attitudes, behaviors, and outcomes. Influencers have been a powerful voice during the COVID-19 pandemic, with social media platforms serving as a primary source for health information.19 This power can be leveraged by engaging influencers in promoting COVID-19 vaccines through storytelling, information sharing, and other forms of public engagement—on social media and in other communication venues.

Health Care Workers

The health care workforce also has an important role to play in promoting vaccine acceptance. For example, a systematic review of shingles (herpes zoster) vaccine acceptance among older adults showed that primary care physician recommendations consistently played a significant role in generating high demand for the vaccine.20 Given the COVID-19 vulnerabilities for adults older than age sixty-five, the health care workforce could play a similar role in providing education and counsel and in building trust in the COVID-19 vaccine portfolio among vulnerable adults.

Grassroots And Local Leadership

Engaging grassroots and local leadership is also essential for demand generation. Under Surgeon General David Satcher during the Clinton administration, thirty black churches partnered with the health care system to successfully increase immunization rates for all childhood vaccines among black children.21 During a recent measles outbreak among the Orthodox Jewish community in New York, a group of Orthodox Jewish nurses formed a nonprofit organization and became local ambassadors to educate the community, counter the misinformation published in antivaccination pamphlets, and shift the trend on vaccination.22 The nurses worked with health care providers and facilitated community discussions, including partnering with parents to demonstrate how to identify misinformation.22 The success of the initiative reinforced the importance of both preparing the local workforce and enhancing the skills of trusted, local community influencers. Similar efforts tailored to local community needs have proved essential in many countries. The Meningitis Vaccine Project’s communication efforts in sub-Saharan Africa included campaigns tailored to specific subpopulations, such as in Burkina Faso, where the project targeted adolescents via peer education, employed targeted social mobilization messages, gained the participation of celebrities, and organized vaccination lines for young boys only (who were particularly reluctant to accept vaccination), as well as vaccination campaigns in universities and schools.23

Industry Leaders

Vaccine industry leaders have already taken steps to promote confidence in COVID-19 vaccines. In September, amid mounting fears that the administration would fast-track the approval of COVID-19 vaccines, nine pharmaceutical leaders released a joint statement promising to uphold scientific integrity and to refuse to apply for approval of a COVID-19 vaccine until sufficient trial data could be aggregated.24 Selected companies have also released their clinical trial protocols in the interest of transparency and public trust.

Global Community

The global community is also coming together in a coordinated effort to promote COVID-19 vaccine acceptance. Experts in anthropology, communication, and other social sciences recently launched the Working Group on Readying Populations for COVID-19 Vaccines, which developed recommendations on how to integrate evidence from behavioral and communication sciences, timely data, and empirically based advice to support vaccine delivery. They suggest further investment in research, integration of user-centric approaches such as speaking to patients’ own values, and research-practitioner partnerships that engage community-based groups in the design and monitoring of vaccine delivery. The working group’s report also highlights the central role of human factors—including identity, worldview, understandings of disease, perceptions of risk, and social factors affecting access—in vaccine uptake. The report highlights the role of involving trusted community spokespeople to convey salient messages.25

The evidence base is robust: To generate demand for COVID-19 vaccines, investment needs to be made in multifaceted, longitudinal engagement with communities, and engagement strategies must be adapted to change attitudes and beliefs over time.24 Urgent and ongoing study of public concerns regarding the vaccine portfolio’s efficacy, safety, benefits, and initial scarcity will be essential to tailor communication efforts around COVID-19 vaccination and ensure that the vaccine leads to vaccination.26

Vaccine Allocation In A Pandemic

Assuming that demand can be generated for COVID-19 vaccines, the question remains about who should be first in line to receive them. Unfortunately, scarce resources too often go to the most privileged. Decisions about how to allocate the limited initial supply of COVID-19 vaccine doses should leverage the expertise of the biological and social sciences with the goals of interrupting transmission of the pathogen, minimizing disease burden, and maximizing societal functioning. Epidemiologists are scouring an array of disparate data sources and generating models to inform COVID-19 vaccine prioritization,27 with the assumption that many vaccine candidates will require a two-dose course. Further investment is needed to bolster and aggregate global data so that leaders can understand and compare the various scenarios and plan for COVID-19 vaccines.

Global Efforts

At the global level, the WHO and other stakeholders have formed the ACT (Access to COVID-19 Tools) Accelerator, a global collaboration to augment equitable access to COVID-19 tests, treatments, and vaccines.28 COVAX—led by the WHO; Gavi, the Vaccine Alliance; and the Coalition for Epidemic Preparedness and Innovations—is a global mechanism under the ACT Accelerator to accelerate the development and manufacturing of COVID-19 vaccines and to guarantee fair and equitable global access to these vaccines.29 Under COVAX, participating countries will receive COVID-19 vaccine doses as follows: In phase 1, allocation is proportional to countries’ populations, covering up to 20 percent of the population including most of the at-risk groups. In phase 2, allocation is based on risk assessments of each country’s COVID-19 threat and health system or population vulnerability.30 This allocation strategy is supported by a model indicating that an 80 percent effective COVID-19 vaccine distributed in proportion to population could prevent 61 percent of global deaths; if it were distributed to high-income countries first, it could prevent only 33 percent of deaths.31

To reduce mortality and protect health care workers, the WHO also released a Global Allocation Framework for COVID-19 products recommending that health care workers, elderly adults, and other high-risk groups be the highest priorities for vaccination. This global framework acknowledges the need for ongoing flexibility because of the evolving pandemic trajectory and portfolio of products available, and it recommends a global access mechanism that meets the needs of all countries.32

The Role Of Global Cooperation

Despite this evidence-based guidance, COVID-19 pandemic preparedness has been thwarted for months by politics—including vaccine nationalism—as some countries are procuring vast quantities of doses even before the completion of clinical trials.33 As of December 2020 the WHO and nearly 190 countries had put their diplomatic weight behind the COVAX initiative to pool investment and promote global vaccine access.34 However, the United States and Russia have opted out of the plan.35

This nation-first strategy is not new. Soon after the WHO declared H1N1 a pandemic in 2009, high-income countries—specifically Australia, Canada, and the United States—purchased initially scarce vaccine supplies for their own citizens, leaving little vaccine supply for low- and middle-income countries that also needed it.36 The WHO responded by implementing a formal global process for vaccine allocation involving, among other tactics, the donation of up to 10 percent of high-income countries’ vaccine supplies to low- and middle-income countries.37 However, the WHO faced formidable barriers to ensuring equitable global vaccine allocation—most notably the lack of a global regulatory framework to enforce it.36 Thus, high-income countries only made donations to low- and middle-income countries once their own vaccine needs were satisfied, leaving the latter with a vaccine shortage.36 Because pandemics exacerbate existing inequalities, a vaccine must be allocated on the basis of what it will take to stop transmission and protect everyone (not just those who can pay for vaccines), to maximize impact.

Efforts In The United States

These goals for allocation are relevant at the national and state level as well as at the global level. The National Academies of Sciences, Engineering, and Medicine have published recommendations about who should have priority in the US for vaccines.38 They recommend that Operation Warp Speed (the Trump administration’s public-private effort to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics) allocate vaccine doses proportionally to states based on population and that states then hold 10 percent for hot spots and adopt a phased approach to allocation.38 The Centers for Disease Control and Prevention (CDC) has also released a prioritization framework in its COVID-19 vaccination program interim playbook,39 and the Advisory Committee on Immunization Practices (ACIP) recently released ethical principles for COVID-19 vaccine allocation,40 along with initial recommendations to prioritize health care workers and long-term care facility residents for the first doses.41 Meanwhile, US states are submitting COVID-19 vaccination plans to the CDC that include phased allocation strategies.42 For example, Maryland’s plan prioritizes first responders, health care workers, nursing home residents and staff, and other essential workers.43 States can use a COVID-19 vaccine allocation planning tool to assist with operationalizing their plans.44

These recommendations are similar to allocation procedures for the 2009 H1N1 pandemic, in which each US state received population-based allocations of H1N1 vaccine supply and local governments were then tasked with allocating vaccine supplies within communities based on priority group recommendations from ACIP.45 The ACIP priority groups for vaccination (health care workers, pregnant women, and children) were identified with the goals of minimizing the burden of illness, protecting health care system functions, and targeting key groups responsible for large amounts of disease transmission.46 Although the ACIP recommendations had the benefit of standardizing allocation at multiple levels, local variation in applying these recommendations led to some confusion among the public about eligibility for H1N1 vaccines, which can interfere with demand.47

Potential Bottlenecks

The example of H1N1 highlights the potential bottlenecks in implementing allocation strategies at the global, national, and local levels, as well as the need for careful planning and coordination to ensure consistency of allocation strategies at every level. With the early, limited supplies of H1N1 vaccines purchased by high-income countries instead of being allocated to all countries that had high rates of transmission, vaccine delivery failed to end the global pandemic precipitously, as vaccines helped contain the H1N1 epidemics in high-income countries but did not reach developing countries until several months later. Avoiding a similar situation for COVID-19 vaccines will require global coordination and political will.

Political Will

Political will is essential to implementing allocation guidelines. As an example, in the Meningitis Vaccine Project, key multilateral, nongovernmental organization, and public-sector stakeholders worked together, including hosting a high-profile vaccine launch ceremony attended by key African political leaders and partners. News of the launch was covered around the globe and generated interest in rolling out the MenAfriVac vaccine in sub-Saharan Africa.21 The Global Polio Eradication Initiative also benefited from strong political will: Rotary International and the United Nations Children’s Fund engaged heads of state and political bodies,48 which translated into powerful efforts to procure and allocate the polio vaccine where it was most needed.

Equitable COVID-19 vaccine allocation will require global institutions to generate enough political will within nations to implement and monitor allocation guidelines. As all nations will face an initially scarce vaccine supply, a global allocation mechanism will be vital to efficiently and effectively decreasing transmission.

Distributing Vaccine Where It Is Needed

Gavi currently estimates that billions of doses of vaccines will be needed to establish herd immunity to COVID-19.49 Ensuring that high-quality vaccine doses can be manufactured and efficiently transported to priority populations will require responsive systems keeping pace with changes in transmission. During the past two decades Gavi has supported 496 vaccination programs in the world’s 73 poorest countries and helped vaccinate more than 760 million children through routine immunization programs plus 960 million through vaccine campaigns.50 Although Gavi’s central focus is expanding access to new and underused vaccines for vulnerable children, it has supported countries in providing vaccines for people of all ages for epidemic-causing diseases such as yellow fever and meningitis.

The supply-chain challenges facing the COVID-19 vaccine are hardly new.51 For example, the WHO process for managing the tens of millions of donated smallpox vaccine doses was long and complicated early in the smallpox eradication efforts. WHO was responsible for receiving samples of all dose batches, sending them for extensive testing at a single laboratory, and then coordinating with the producer to have those vaccine batches delivered to recipient countries.51

In 1967 the WHO established the Intensified Smallpox Eradication Programme and made several changes to the testing and distribution system. These included creating regional reference laboratories, requiring periodic sampling instead of universal testing, creating a central donated vaccine processing and storage facility in Geneva for rapid dispatch, and encouraging local vaccine production in endemic countries.51 Even with all of these measures in place, stocks of donated vaccines frequently ran low; however, by 1980 this novel distribution model enabled the eradication of smallpox from the world.51

Vaccine distribution must be responsive and efficient to successfully interrupt a pandemic. This means putting the vaccine and the necessary data into the hands of people who can make distribution happen. With smallpox, that meant making the WHO a centralized distributor. For COVID-19, it will require leveraging the know-how of manufacturing and supply-chain experts; organizations well versed in overcoming “last-mile distribution” challenges; and others with relevant experience to design, activate, and improve our distribution systems for vaccines.

For a COVID-19 vaccine, the supply-chain challenges will be complicated by and must be responsive to allocation decisions.

For a COVID-19 vaccine, the supply-chain challenges—getting the right product at the right temperature to the right person at the right time—will be complicated by and must be responsive to allocation decisions. Experts have stated that there will likely be an insufficient supply of vials, stoppers, and other necessary products to package and transport the vaccine.52 Supply-chain and distribution strategies must be upgraded now with digital advances to plan, track, and monitor vaccine delivery.

Verification Of Immunization

Verifying vaccine coverage—that the appropriate people and populations have received a COVID-19 vaccine—will be critical in tracking global progress toward herd immunity, informing allocation, and tailoring strategies to generate demand among the appropriate people and populations. When vaccine supplies are scarce, giving one person an extra dose of vaccine means denying it to another; similarly, misdirected vaccine represents a missed opportunity to interrupt virus transmission and protect at-risk populations. It will require a dedicated investment to build and implement a functional verification system for COVID-19 vaccines.

The identities of individuals receiving a product or service are at the foundation of any verification system.53 However, personal health information, including vaccination records with personal identifiers, is typically harder for the US government to access and manage because of privacy laws, state authority, and system interoperability challenges.54

The Role Of Registries

Immunization information systems (IIS) or centralized registries can play an important role in vaccine coverage verification for the pandemic response. During the 2009 H1N1 pandemic, states used their IIS to track inventory at provider sites, to communicate with providers (sending reminders for a second dose for certain population groups or alerts of recalled vaccines), and to aid with dosing regimens (determining who was eligible for one dose or two doses).55

Reporting to IIS, however, is uneven and not always mandatory. States and projects reporting to IIS suggest that there are issues with data quality related to patient identification in the absence of unique patient identifiers. These include variations in a patient’s name or missing addresses, which lead to duplication issues or inappropriately merged records.56 In September 2020 the Trump administration issued emergency guidance to allow pharmacists and pharmacy interns to order and administer COVID-19 vaccinations, which could add to the challenge of tracking vaccinations given, as not all states require pharmacies to participate in IIS.57

Addressing Privacy Concerns

It is possible to do vaccine verification well, but it will require investment in systems engineering to address the technical complexities (adequate data storage, interoperability of data systems) and to ensure privacy. Concern about the handling and sharing of health-related data is legitimate and warranted. Privacy concerns surrounding the sharing of personal medical histories in the US are, for the most part, still governed by the Health Insurance Portability and Accountability Act (HIPAA) of 1996. However, in March 2020 the Centers for Medicare and Medicaid Services announced the adoption of the Interoperability and Patient Access final rule, which sets technical standards and will allow app developers to connect digitally with health facilities in order to pull data.58

If properly designed and integrated, biometric vaccine registries that can record vaccine receipt (for COVID-19 and routine vaccines) and function as a health record could be interoperable, portable, and secure. There is work ahead to set interoperability and privacy standards to ensure that these systems can connect to foundational identification programs as coverage expands during the next decade.

‘Immunity Passports’

Policy makers are also discussing the idea of COVID-19 “immunity passports”—documents verifying proof of immunity that allow a person to move freely through society. Although vaccination certificates incentivize vaccination only, immunity passports that can be attained after illness or vaccination can incentivize infection.59,60 The WHO does not currently recommend immunity passports for COVID-19, given the lack of evidence about what level of antibodies confers immunity and for how long. However, some countries are already exploring the use of immunity passports; the pros and cons should be considered carefully.

Vaccination Mandates

Another option that could facilitate verification is the policy lever of vaccination mandates.61 Although it is unlikely that public health emergency laws would be used to require populationwide vaccination (no US jurisdiction did this during the H1N1 pandemic), some US health care employers did implement 2009-H1N1 vaccination mandates for their workforces,62 and many commonly mandate seasonal influenza vaccination.63 A mandated vaccination approach requires health care employers to verify that their employees have received the influenza vaccine—for example, by administering vaccines directly to their staff or by requiring employees to document that they received the vaccine elsewhere. There is work ahead to ensure that vaccine verification will not impinge on equity but instead will ensure that vulnerable populations have access to the vaccine and that it will serve as a means to learn and to adapt and improve delivery systems.

Global stakeholders must convene, collaborate, and collectively tackle the problem of verifying vaccine coverage. Investing in global standards and modular, secure, biometrically supported digital health technologies that can not only deliver COVID-19 vaccines but also serve as longitudinal tracking systems for routine immunizations is a valuable step that will pay dividends long after the world’s attention has shifted.

Conclusion

Considering the speed of COVID-19 vaccine development, it is likely that there are only months left to plan for the rollout of COVID-19 vaccination programs. Previous pandemics remind us that the inability to expeditiously vaccinate at-risk populations and end transmission was a result of implementation bottlenecks.

Global cooperation around COVID-19 vaccines is already being thwarted by nationalistic tendencies. If this continues, ineffective vaccine delivery strategies will play out, much like those still being experienced in the distribution of personal protective equipment, testing, and COVID-19 treatments.

The COVID-19 vaccine portfolio requires urgent, unprecedented investment in the delivery strategies and systems needed to generate vaccine demand and facilitate vaccine allocation, distribution, and verification of coverage. Nations, states, and municipalities will need tools to build actionable—and equitable—plans for vaccine distribution. This will ensure that the vaccine protects individuals, suppresses transmission, and minimizes disruption to health services and livelihoods. The aims of existing health care delivery systems must be aligned to protect worldwide populations against a common threat—the virus—and leverage responsive data systems across borders.

ACKNOWLEDGMENTS

Rebecca Weintraub is a managing director of the Draper Richards Kaplan Foundation. The authors acknowledge and thank David Jones, Atul Gawande, Marc Lipstich, and Prashant Yadav for their review and advice. The authors also thank Liz McGovern and Vilas Dhar for their ongoing encouragement. An unedited version of this article was published online November 19, 2020, as a Fast Track Ahead Of Print article. That version is available in the online appendix. To access the appendix, click on the Details tab of the article online.

NOTES

   
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