Reflections On Governance, Communication, And Equity: Challenges And Opportunities In COVID-19 Vaccination

Developing and producing vaccines within a year of the discovery of a viral pathogen is an achievement beyond previous imagination. Molecular, genomic, immunologic, and technical advances have overcome what would have been an impossible consideration just a few years ago. Unparalleled investments and collaborations included an advance market commitment, enabling millions of doses to be produced for each vaccine candidate in anticipation that the vaccine would be safe and effective and enabling distribution of the vaccine for use immediately following regulatory review and authorization. These hopes have already come to fruition: Two vaccine products to protect against coronavirus disease 2019 (COVID-19) received Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) in December 2020 based on evidence of their safety profile and efficacy of greater than 90 percent.^1,2 Several other candidates are on the horizon.

Operation Warp Speed may be successful in its principal purpose and objective: “ensuring that every American who wants to receive a COVID-19 vaccine can receive one, by delivering safe and effective vaccine doses to the American people beginning January 2021.”³ However, COVID-19 vaccines may have a limited impact on controlling the pandemic and returning to normal social and economic life because vaccination, not vaccines themselves, saves lives. An estimated 70 percent of the population or more must have immunity to COVID-19 to effectively control disease through herd or community immunity.⁴ These estimates assume homogeneous uptake of the vaccine, however; there is ample evidence that clustering of unvaccinated people can lead to disease outbreaks such as recently seen with measles, even when vaccine coverage at the state or national level is very high.⁵ Disease-induced immunity comes at a heavy price and likely wanes over time. Vaccine-induced immunity is very straightforward to calculate: vaccine effectiveness multiplied by vaccine uptake. Operation Warp Speed seems to be based on the principle that if we build it, they will come. In this article we characterize public perceptions during the rollout of the vaccine and the impact on vaccine-informed decision making, the potential for vaccine equity to help address underlying health disparities, vulnerabilities of the vaccine program, and the role of health care providers and science to impact vaccine decision making and communications.

Vaccine Rollout Environment

Public polling data demonstrate that COVID-19 vaccine rollout will occur in an environment that is not prepared to widely accept the vaccine. We may build it, but many might not come.

US adults may underestimate COVID-19. Polls from early in the pandemic found that nearly two-thirds underestimated the overall risk of death from COVID-19 and that more than half severely underestimated their own susceptibility to death.⁶ The percentage of US adults intending to vaccinate against COVID-19 decreased substantially from more than 70 percent in late spring to only about half in September, before rebounding to above 60 percent by late fall. Although the exact starting and ending points varied, this U-shaped pattern was generally seen regardless of race/ethnicity, political affiliation, gender, age, and education. Common concerns among those not intending to vaccinate were safety, efficacy, and the perceived rushed timeline for development.^7–10 Factors consistently associated with lower intention to vaccinate include Black race, younger age (less than age sixty), lower education, and conservative political ideology.^6–11 Having more fear of COVID-19 and receiving a provider recommendation were both associated with greater intention to vaccinate.¹¹

The immense investments in and achievements of the development of these vaccines will result in suboptimal public health benefit without a systematic approach to providing interpretable, context- and culture-specific, accurate, and trusted information about the vaccines that promotes vaccine confidence. A one-size-fits-all vaccine information and “demand creation” effort will not succeed, given the size of the US and the wide range of cultural beliefs, political leanings, scientific understanding, levels of trust in government leaders and agencies, and perceived motives of pharmaceutical companies. There is also the influence of antivaccine campaigns and the rapid spread of misinformation through a variety of electronic media to contend with. As described by the World Health Organization (WHO) in the context of vaccine messaging broadly, “Messages need to be tailored for the specific target group, because messaging that too strongly advocates vaccination may be counterproductive, reinforcing the hesitancy of those already hesitant.”¹² The importance of tailored messaging is especially important in the COVID-19 context given wide variability in perceptions of disease susceptibility and severity, range of vaccine safety concerns, and underlying distrust of the vaccine program and government response to the pandemic.

Informed Decision Making And Vaccine Acceptance

As a first step, there must be recognition that decision making in a crisis is different and complicated by the fact that the pandemic’s “waves” create heightened moments of crisis. The US population is not uniformly experiencing the pandemic: Some communities are disproportionately affected through increased exposure or severity of outcomes. Having the option to telework, living in households with multiple generations, relying on public transportation, having savings, and many other factors affect how the pandemic may affect people’s interest in being and eagerness to be vaccinated. Layer on historical and cultural experience with experimental medical research for some communities (for example, Black, Native American, and Latinx), either in the US¹³ or in countries they’ve recently migrated from,¹⁴ and the result is a complex set of lenses through which a pandemic and vaccination may be considered.

Building, implementing, and adapting effective community engagement for bidirectional communication and dialogue are essential to the success of a COVID-19 vaccination program. Partnering with community-based organizations that serve different geographic, racial/ethnic, age, religious/faith, and political belief groups can ultimately help reduce the disproportionate burden of illness from COVID-19 on particular communities and increase vaccine acceptance. Community engagement activities need to be ongoing and responsive to the evolution of knowledge regarding COVID-19 and advances in vaccine development and vaccine rollout.

Misperceptions around the severity of illness from COVID-19 must be addressed to create an environment receptive to vaccination.

In particular, misperceptions around the severity of illness from COVID-19 must be addressed to create an environment receptive to vaccination. Although there are indeed treatment options that are effective at reducing COVID-19 morbidity and mortality, a substantial proportion of the population believes that COVID-19 is not a serious disease.⁶ Frequent (and inaccurate) statements such as “the flu is worse than COVID-19,” “increasing incidence is a result of improved testing,” and “mortality data are inflated to increase the profits of clinicians” can contribute to people’s misperceptions of the severity of COVID-19 disease and hinder vaccine demand. Narratives that prioritize personal autonomy without considering community benefit as well as inconsistent messaging around mask wearing and social distancing further complicate receptivity to vaccination. Correcting misperceptions is important to inform people’s views as they develop instead of changing people’s minds, especially with regard to vaccines.¹⁵ Public health must change the perception of COVID-19 severity to facilitate the acceptance of vaccines as well as other disease control efforts.

The name “Operation Warp Speed” reflects the endeavor’s mission and focus; however, many perceived that the rush led to shortcuts around vaccine safety. To date, this is not the case. Phase III clinical trials have been adequately powered for determining whether the benefits outweigh the risks in the populations studied. The EUA process, though requiring less safety and efficacy data than are required for formal approval of vaccines through the standard Biological License Application process, included the Vaccine Related Biological Product Advisory Committee (VRBPAC) in its authorization process to share detailed clinical trial data; allow public review of all data; and include independent, nongovernmental experts in determinations of whether the available evidence of COVID-19 vaccine safety and efficacy justified its emergency use. The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC), comprising independent, nongovernmental experts, also provided vaccine recommendations regarding who should get which vaccines through public deliberations. The transparency of these processes may assist in overcoming perceptions that the vaccine has been rushed to market. However, transparency might not be enough. There should be focused efforts to engage the public regarding the rigorous approach to vaccine development, evaluation, authorization for use, and post-rollout safety surveillance and how it provides assurance that the benefits of the vaccine outweigh the risks, and, if adverse reactions result from the vaccine, how people will be compensated. Engagement and messaging need to be developed and evaluated for subpopulations that likely vary in information needs and credible sources for such information.

Assurance of safety goes beyond clinical trials and authorization for use. Adverse reactions that are uncommon, have delayed onset, or occur in subpopulations excluded from clinical trials or subpopulations included in inadequately powered trials require study after vaccines are deployed. Postauthorization safety evaluation to detect real adverse reactions is particularly important for COVID-19 vaccines, given that many are using novel technologies. Examples of real adverse reactions caused by vaccines but not identified until widely used in the population include Guillain-Barré Syndrome following the 1976 swine flu vaccine,¹⁶ narcolepsy following ASO3 adjuvanted pandemic 2009 H1N1 vaccine (Pandemrix),¹⁷ and enhanced disease following Dengue vaccine.¹⁸

Additionally, vaccination of large numbers of people will be coincidentally related to health outcomes (for example, heart attacks, strokes, and illness from COVID-19) that would have happened anyway. Mass vaccination programs that rapidly vaccinate large numbers of people are at high risk of being undermined by coincidental adverse events following immunization, such as recently occurred in South Korea, where several deaths following a mass influenza vaccination campaign largely brought the program to a halt.¹⁹ Rapid and rigorous science is needed to determine whether adverse events following immunization are causally related to vaccination, are more likely in some individuals or subpopulations, or are simply coincidental. The process for separating real adverse reactions from coincidental events must be credible, and communication programs must be prepared to respond to real or coincidental vaccine safety scares that arise domestically or are imported from other countries.

Vaccine Equity

There are disproportionate risks for COVID-19-associated illness, hospitalization, and death among people whose exposure to the virus is increased because of their living and working environments and transportation requirements. The increased risks of COVID-19 are linked to systemic social injustices and underlying medical conditions. An equitable COVID-19 immunization program prioritizes these populations to receive a vaccine in order to mitigate health inequities.

Failure to gain acceptance of vaccines and achieve equitable access and use will represent a tragic public health failure.

It must be acknowledged, however, that many communities at disproportionate risk for COVID-19 might also not accept immunization. Some individuals within these communities are unlikely to trust an immunization program brought along at warp speed by the government and large corporations. To realize the goal of a COVID-19 immunization program to mitigate health inequities, it is essential for it to include engagement that facilitates trust, provides accurate and interpretable information, and honors and incorporates their values and lived experience. Failure to gain acceptance of vaccines and achieve equitable access and use will represent a tragic public health failure.

Mounting an effective vaccine program will require understanding and responding to the concerns and values of different groups. We can anticipate that the communication challenges will become more complex as additional vaccines are authorized. Health communication principles shown to improve trust should be emphasized, such as transparency, tailoring, and trusted messengers.^20,21

The Role Of Health Care Providers

Health care providers will play a critical role in any COVID-19 vaccination strategy. Health care providers have been consistently cited by parents and patients as a trusted source of vaccine information.^12,22 This mirrors recent national survey data in which over 90 percent of US adults reported “some” or “a lot” of trust in doctors and other health care professionals,²³ a trustworthiness that has persisted during the COVID-19 pandemic.^24,25 One of the most consistent predictors of acceptance among patients and parents of routine vaccinations is a health care provider recommendation.^26–28 Similarly, parents who have their vaccine concerns addressed or are given reassurance by their child’s health care provider have accepted vaccines after initially being hesitant.²⁹

Health care provider communication practices regarding a COVID-19 vaccine, however, will be contingent upon health care providers themselves being confident in the safety and effectiveness of any approved vaccine. Historically, this confidence has been achieved through trust in the processes and systems to develop, approve, and monitor the safety of vaccines. For COVID-19 vaccines, this trust has been damaged by the politicization of these processes and systems. The effect on vaccine uptake could be equally damaging if this loss of trust translates into health care providers giving only a weak recommendation to patients for an approved COVID-19 vaccine, or no recommendation at all.

Also complicating health care providers’ communication regarding a COVID-19 vaccine are unique communication challenges. One prominent challenge is that COVID-19 vaccines are currently available to the public through an EUA, an event that is wholly unprecedented for vaccines outside of only one other instance in which anthrax vaccine was made available to high-risk groups.³⁰ This poses a challenge because not only is there confusion among the public about what an EUA means,³¹ but also the use of an EUA to make a vaccine available has been associated with a decrease in vaccine acceptability.³²

Some evidence-based provider vaccine communication strategies may also be problematic in the context of COVID-19 vaccine discussion while the vaccine is only available through an EUA. One such strategy is clinician use of a presumptive format to initiate the vaccine discussion with a patient. This format linguistically presupposes that the patient or parent will vaccinate, such as, “So, we’ll do vaccines today.” Though use of this format has been shown to improve vaccine acceptance among parents,^33,34 the appropriateness of this strategy is dependent on the presence of a comprehensively studied, highly beneficial, low-burden, minimally invasive intervention for which simple consent is justifiable. Unlike routine vaccinations, a COVID-19 vaccine authorized for emergency use does not yet qualify as this type of intervention. Therefore, nonpresumptive formats that facilitate a discussion with patients and parents that approximates full informed consent are more appropriate with a COVID-19 vaccine authorized for emergency use.

Motivational interviewing—a patient-centered framework for behavior change that helps leverage inherent motivation for behavior—may be especially relevant here regarding how providers pursue a patient’s reluctance to vaccinate. Motivational interviewing can deepen rapport, broaden understanding of patient motivations, communicate support, and improve receptivity to information being shared. Furthermore, it has been shown to be effective at improving acceptance among those who initially voice vaccine concerns or resistance.^10,35

Science Rather Than Politics Driving The Process

The US response to COVID-19 has been plagued with politics, which has driven public health and messaging. Throughout the pandemic, then-President Donald Trump downplayed the seriousness of the disease, and as late as October 2020, as a major surge of disease was starting as predicted by many scientists, President Trump announced: “It’s going to disappear. It is disappearing.” He acknowledged that his approach was intentional.^36,37 In addition to downplaying the course of the pandemic, often attributed to increased testing, the FDA came under scrutiny that politics affected their decision to grant an EUA for hydroxychloroquine and later convalescent plasma.³⁸ The CDC, which normally would lead efforts around pandemic response and related communications, was largely sidelined in the response to COVID-19 with widespread accounts of political officials interfering with CDC COVID-19 reports.³⁹ The effect has been devastating. These messages misinformed the public and resulted in false beliefs about the seriousness of and projections on the pandemic and led to poor compliance with mask wearing and other recommended prevention methods. Moreover, the impact of politics on public health agencies undermined their credibility. These very same agencies must now authorize use, make vaccine recommendations, and launch a massive immunization program.

Shortly after retiring as CDC director in 2002, Jeffrey Koplan wrote a timely and timeless article titled “Plagues, Public Health, and Politics,” warning of the potential for politics to undermine public health and science.⁴⁰ Koplan argued that science must drive public health, which, in turn, must drive policy. He provided many successful examples that have followed this pathway from science to public health to policy (for example, vaccination, family planning, and the control of infectious diseases). Aspects of the early US response to HIV/AIDS exemplifies the perils when this pathway is reversed. Public perceptions that politics has driven public health, which has in turn affected science, have undermined the credibility of these agencies that the US now must rely on in order for COVID-19 vaccines to effectively control the pandemic.

Fortunately, preliminary Phase III trial data from Pfizer/BioNTech⁴¹ and Moderna⁴² of their respective COVID-19 vaccines was reported weeks after, and not before, the presidential election in November 2020. These data were subsequently reviewed by the FDA’s VRBPAC and the CDC’s ACIP in a transparent manner by independent scientists. This transparent process of science driving public health and then driving policy will hopefully help overcome public concerns that have plagued other aspects of the US COVID-19 response but likely will not be enough on its own without a prompt and thorough communication and engagement plan.

Conclusion

Elevating science over politics provides the opportunity to realize the potential of COVID-19 vaccines.

The potential for vaccines to control a pandemic, affecting everyday life and demonstrating the value of vaccination and public health, has never been greater than this moment with COVID-19. Despite multiple vaccines with extremely high efficacy and reasonably good safety profiles, the success of COVID-19 vaccines to accomplish this tremendous potential is not assured. Public health has the tools to understand and engage the public, with particular attention to subpopulations at increased risk of COVID-19 or immunization refusal, to improve vaccine-informed decision making, vaccine acceptance, and disease control. Health care providers have a very important role and can use well-validated approaches to inform their patients and assist them with their vaccine decisions. Elevating science over politics provides the opportunity to realize the potential of COVID-19 vaccines.

ACKNOWLEDGMENTS

An unedited version of this article was published online February 4, 2021, 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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