Lessons Relearned? H1N1, COVID-19, and Vaccination Planning.

Abstract

Just over 10 years ago, public health practitioners were fighting a different novel microbial foe: the global pandemic of influenza A virus subtype H1N1 (H1N1). Unlike the current pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, hereafter COVID-19), H1N1 was a new influenza virus, not a novel coronavirus. And, unlike COVID-19, public health and health care experts had an advantage with regard to H1N1 vaccine production and distribution, given years of global experience with influenza. Although the 2 viruses are different, we can learn a great deal from our national and global responses to H1N1 as we look toward ending the spread of COVID-19. Despite prior experience with influenza, the public health effort to develop and distribute a safe and effective H1N1 vaccination campaign was not without its challenges. These included public communication issues about H1N1 vaccine availability and who should get it, vaccine shortages, and concerns about H1N1 vaccine safety. These challenges eroded public trust in the H1N1 vaccination program: a November 2009 survey found that 54% of adults believed the federal government was doing a “poor” or “very poor” job at providing the country with an adequate supply of H1N1 vaccine.1 More than 10 years later, and with no COVID-19 vaccine yet authorized or approved for use by the Food and Drug Administration (FDA), only half of Americans surveyed in May 2020 (52%) had a “fair amount” (35%) or a “great deal” (17%) of confidence in the federal government's ability to deal with the COVID-19 outbreak.2 Public scrutiny of federal efforts, and by extension state, territorial, Tribal, and local efforts, to vaccinate the population will be high and pressure to build public trust extreme. In 2010, the Association of State and Territorial Health Officials (ASTHO) conducted scans of H1N1 in-progress reviews, after-action reports, expert meeting summaries, congressional testimony, and governmental and nongovernmental reports.3,4 The Table presents significant H1N1 vaccination policy issues and barriers reported in those scans that consumed countless hours of local, state, and federal officials' time; almost all are relevant issues in COVID-19 vaccine planning today. TABLE - Policy Barriers Identified in ASTHO Scan of H1N1 After Action Reviews, Government Publications, Expert Panel Meetings, and National Expert Conveningsa Policy Category Barriers Identified Vaccine Identification, Formulation, and Manufacture Comments and concerns were raised about the methods of vaccine production and the timing of vaccine development and availability. Vaccine Allocation and Prioritization Approaches A number of issues were identified related to vaccine allocation and prioritization, including equitable allocation of small quantities of vaccines; Advisory Committee on Immunization Practices (ACIP) recommendations and special populations; allocation of vaccine from the federal government; allocation of vaccine from state/local governments; the timing of vaccine availability; conflicting/changing messaging; and vaccine reallocation. Vaccine Distribution and Delivery It was noted that plans for rapid distribution and administration of vaccinations must be refined. Other issues were cited regarding the distribution and delivery of H1N1 vaccine, including vaccine shipping information and conditions; questions about the quality/necessity of ancillary supplies sent with vaccines; guidance on using remaining H1N1 vaccine; and vaccine disposal issues. Administering Vaccines States raised a variety of issues related the authority to administer vaccine. Strategies to increase the number of vaccinators included licensing modifications to allow a range of health professions to vaccinate; qualifying school nurses as public health employees to administer vaccines and report immunizations; and lowering patient age for vaccination. Other issues included questions about consent to vaccinate; authority to restrict vaccination recipients; and the use of school vaccination clinics. Sources addressing vaccine payment and reimbursement issues acknowledged that payment systems for vaccine administration must be improved and that state insurance laws do not mandate coverage of vaccines during declared public health emergencies. Vaccine Tracking, Coverage, Recall, and Adverse Events Reporting Issues related to using immunization registries to track vaccinations were identified. A number of issues were raised regarding vaccine coverage, including vaccine uptake and coverage rates; coverage among health care workers; uptake and coverage data/monitoring; and using school immunization data. It was also noted that vaccine tracking systems must be enhanced to monitor for adverse reactions. In addition, the different reporting requirements of the multiple federal vaccine injury compensation funds should be clarified. Vaccination Communications It was noted that vaccination outreach activities must include special efforts to encourage young adults, minorities, and other at-risk individuals get vaccinated. Vaccination Other Issues Other issues related to vaccine and vaccinations identified were international vaccination efforts; and vaccine research and development needs. aFrom ASTHO.3,4 As public health officials and their teams ready for the national effort to vaccinate against COVID-19, what some have called the “greatest public health effort of our generation,”5 public health and health care experts, policy makers, and the public will benefit from examining the experience of H1N1 and other previous public health responses requiring mass vaccination campaigns. The strength and success of the upcoming COVID-19 campaign will be influenced, in large part, by public health leaders and partners proactively applying these lessons learned to COVID-19 mass vaccination planning immediately. Focus Equally on Vaccine Development and Vaccination Uptake There is tremendous media attention and public interest in the science of vaccine development and production: effective vaccines are often viewed as “silver bullets” to prevent devastating illnesses such as polio, measles, and pertussis. H1N1 vaccine research and development began days after the infectious agent was identified as an influenza virus and drew upon years of experience with developing vaccines for other influenza strains.6 While interesting, the science of vaccine development is only half the story: once a vaccine is developed, it has to become a vaccination. Administering a population-wide vaccination campaign in a country as large and diverse as the United States is no small task. The US Department of Health and Human Services' (HHS) $6 billion “Operation Warp Speed” (OWS) has been tasked with procuring 300 million doses of a safe, effective COVID-19 vaccine, with the initial doses available by January 2021, an admirable goal especially for a novel virus that has proven worldwide that it will follow its own timeline, not ours.7 We suggest that a complementary “Warp Speed”-like federal investment made to support the significant logistical, communications, and public outreach efforts to get people vaccinated, to monitor for any adverse outcomes, and to evaluate COVID-19 vaccination programs at all levels of government is needed. Getting the individuals responsible for carrying out vaccination efforts “in the room” with federal planners overseeing vaccine development is an urgent priority and a lesson learned from the H1N1 experience. Intentional, structured, and collaborative federal, state, territorial, Tribal, and local public health planning for COVID-19 vaccination will proactively address the communication and coordination problems that we can anticipate will be present in a large-scale, national vaccination effort. As one federal official commented on call with state and territorial health officials about COVID-19 vaccination planning efforts soon after the efforts began in earnest in September 2020, “I feel behind already.” States, territorial, Tribal, and local health officials are similarly playing catch-up with federal officials who are coordinating among OWS, the White House, the HHS, and its operating divisions including the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services, the FDA, the Health Resources and Services Administration, the Indian Health Service, and several other HHS staff offices and other federal agencies, including the military, that are involved in the vaccine response. Develop a Shared “Operating Picture” With Public Health and Health Care Leaders A major finding of the H1N1 experience was the vital need for the development and use of a common operating picture among federal-, state-, and local-level governmental leaders and private and public stakeholders. In H1N1, there were significant supply and distribution issues, raising questions in the public's mind about vaccine availability and prioritization. ASTHO's H1N1 scan noted: ...There was a need to create a “common operating picture” as a means to more effectively share standardized data and information between the different levels of government. Specifically, federal, state, and local health departments should share lessons, innovations, and resources.... Finally, coordination with national public health partner organizations is an important part of the public health system's emergency response efforts.4(p11) To date, the national COVID-19 response, most specifically the national COVID-19 testing effort, has been criticized by many for lacking a robust, common operating picture. The COVID-19 vaccination planning effort provides an opportunity to reset the existing approach, with explicit attention to local, state, territorial, Tribal, and federal collaboration, information collection and sharing, and timely communication, and, to date, federal leaders have engaged these governmental partners on vaccine allocation, distribution, and administration planning. These joint planning efforts are very positive steps as is the CDC's COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations.8 An OWS pilot test on vaccination planning launched in August 2020 in 4 state health departments (North Dakota, Florida, California, and Minnesota) and 1 city-county health department (Philadelphia, Pennsylvania) informed the development of the Playbook. This effort provided insight into some of what is needed to promote clarity in operations across the public health system and identified significant challenges to COVID-19 vaccination including the data and IT systems needed to track vaccine distribution and uptake, challenges with reminders for 2-dose vaccines, cold-chain/ultra-cold-chain storage issues involved with vaccine shipments and storage, public-private collaboration in vaccine administration including how to promote engagement of pharmacies and chain drug stores in the effort, challenges with distribution in rural areas, and many others. The OWS pilot effort also gleaned that focused, intentional mechanisms to coordinate local, state, federal, Tribal, territorial, and public and private assets are needed. To help meet this need, for example, beginning in September 2020, ASTHO and the American Pharmacists Association began co-convening a national COVID-19 Vaccination Partnership group comprising leaders from approximately 20 national associations in the public health, pharmacy, health care, and health care materials distribution sectors to strategize, discuss, exchange, and work toward solving some of the challenges organizational members will be and are facing in implementing the CDC COVID-19 vaccination playbook at the state and territorial levels. The coalition's work will complement the efforts of the CDC, HHS, and OWS and support efforts at the state and territorial levels. Communicate Frequently and Effectively About Vaccine Safety The increase in measles outbreaks in the United States in 2018 and 2019 highlighted the contentious nature of vaccine mandates in many states and amplified the questions that some parents have about the safety and timing of childhood vaccinations. While less of an issue in 2009 than in 2020, confidence in the safety and efficacy of vaccinations was in question, especially as aspects of the H1N1 vaccination program were reminiscent of the US swine flu “fiasco” in 1976.9 In the case of swine flu, a rushed vaccine was potentially associated with several deaths and adverse outcomes including Guillain-Barré syndrome, which led some states to suspend their swine flu vaccination programs, and has eroded public confidence in vaccines ever since. During the H1N1 response, communication about vaccine safety and efficacy was key. The challenge of communicating both the rapid nature of vaccine development and the safety of the new vaccine is summarized in this comment from an H1N1 after-action report that stresses the need to avoid any appearance of going around established FDA processes and the need to assure the public about vaccine safety: Given the very high level of skepticism in the U.S. (and around the world) about vaccines in general and some of the concerns about the pandemic vaccine in particular, it has been critical for federal officials to reassure the public that this is the very same vaccine manufacturing process that hundreds of millions of Americans have taken safely to protect themselves against seasonal flu. Clinical trials for this pandemic vaccine were thorough and efficient, providing additional reassurance to the American people. Approval of cell-based vaccines against a novel influenza virus, when not currently approved for the seasonal virus, would have been considered experimental by many Americans. There may have been a misperception that the vaccine had not gone through the usual rigorous FDA approval process. This would have complicated efforts to encourage all Americans, especially those at highest risk, to receive a vaccination against the H1N1 virus.4(p81) While FDA officials have stated a commitment to “unwavering regulatory safeguards for COVID-19 vaccines,”10 there must also be a concerted effort to share information about safety and efficacy, transparently present research findings from the trials, and address public concerns with vaccine safety over the course of COVID-19 vaccine development. With the “Warp Speed” timeline for vaccine development comes the public concern that the vaccine may be rushed and perhaps not safe. Indeed, President Trump stated publicly in an August 6, 2020, interview, “I am rushing it. I am. I am pushing everyone.”11 While FDA Commissioner Hahn has publicly stated that any Emergency Use Authorization to permit the use of a COVID-19 vaccine will be almost as stringent as full approval, the agency's proposed strict guidance has not yet been approved by the White House and President Trump suggested he could “veto” it.12 Commenting on Russia's approval of a COVID-19 vaccine product still in development, HHS Secretary Azar reassuringly stated: “The point is not to be first with a vaccine, the point is to have a vaccine that is safe and effective for the American people and the people of the world.”13 Several state health officials, including Pennsylvania's Secretary of Health and ASTHO's President Dr Rachel Levine, have addressed the issue of speed and safety stating: “You can't set a date on science.”14 There are mixed federal signals in communicating the need for speed and importance of safety that have to be addressed immediately lest vaccine uptake fail from a nationwide crisis of confidence in the vaccine. The CDC's pre-COVID-19 Vaccinate with Confidence campaign is a recent effort to address the long-standing problem of vaccine hesitancy among parents. This effort should be expanded to address concerns with the safety of a new COVID-19 vaccine. The operative word here is confidence: confidence that the vaccine is safe and effective, confidence that it has been studied sufficiently to address any potential side effects or adverse events proactively, and confidence that the development of the vaccine was free of political or corporate influence. As several COVID-19 vaccine candidates enter phase 3 trials, constant communication about the development process, what is being tested and studied, and how issues such as safety are being addressed needs to take place. Addressing concerns from specific groups of Americans, including racial and ethnic groups that have different levels of trust in government, has to be included in such communication efforts. Presenting scientific findings and data is not enough: understanding specific concerns with empathy and compassion is what will be needed for the various communities that may be hesitant to or refuse to be vaccinated.15 Questions about the federal approval process and COVID-19 vaccine safety have led 2 governors (Newsom of California and Cuomo of New York) and the National Medical Association, a medical society of African American physicians, to publicly state they will form their own vaccine review committees prior to recommending the vaccine to residents of their state or to their patients because they lack trust in the FDA and the Warp Speed effort.16–18 Include the Community in Vaccine Distribution Planning and Implementation The experience of H1N1 vaccination prioritization suggests the immediate need for far more attention to subgroups than the “special” or “vulnerable” populations that were part of H1N1 vaccine planning. In H1N1, public health officials stressed the need for planning to include individuals with chronic medical conditions at a greater risk for complications from H1N1 infection, undocumented individuals who may not want to obtain a vaccination, and how to provide vaccination to the uninsured.3,4 In the 10 years since H1N1, attention to race and ethnic disparities in health has increased dramatically, amplifying the need for public health practitioners to anticipate how different communities may respond to local efforts to promote vaccination. As we have seen with COVID-19, those with preexisting conditions and those who are un- or underinsured have a greater risk of complications from the disease for many reasons. CDC analysis suggests that American Indians/Alaska Natives, Black or African Americans, and Hispanic or Latino persons have a higher rate of morbidity and mortality from COVID-19 than White, non-Hispanic persons.19,20 This makes it all the more important that individuals from the diverse racial and ethnic communities that comprise our nation are part of vaccination planning to help create and tailor nationwide efforts to local context. Recent efforts to advance local and state COVID-19 contact tracing activities in many American communities have been met with distrust and fear in the same communities that will be priority groups for the COVID-19 vaccine. This distrust and fear can be mitigated by engaging community leaders and trusted community members early in vaccination planning efforts in addition to frequent communication and transparency throughout the campaign. These differences need to be accounted for in vaccination planning efforts including how to prioritize access to vaccine for these groups when indicated and how to build trust with public health officials to help mitigate vaccine hesitancy and refusal. National advisory groups, including the CDC's Advisory Committee on Immunization Practices and the National Academies for Science, Engineering, and Medicine, are working on exactly that at a pace unseen in prior pandemics. Summary Myriad challenges are presented by COVID-19 vaccination planning. While COVID-19 and H1N1 are different viruses, many of the issues in H1N1 vaccination are applicable to COVID-19. Leaders and policy makers should apply what was learned from H1N1 to current COVID-19 planning, including a genuine and committed effort to support vaccination operations and logistics that fully engage at both the pre- and postdecisional levels, local, state, territorial, and Tribal health authorities, developing a shared information exchange pathway and common operating picture to guide efforts at all levels of government, a robust communications campaign to promote vaccine uptake especially in communities we can anticipate will be hesitant or refuse vaccination, and engage community stakeholders in planning efforts as true and trusted partners. There is tremendous pressure on public health officials to safely and efficiently deliver an effective COVID-19 vaccine. Let's not relearn the lessons of H1N1 again; let's apply them to our COVID-19 vaccination planning now.