4

Conclusions and Recommendations

The committee was charged to evaluate the activities of the Immunization Safety Office (ISO) during the COVID public health emergency (PHE) and provide recommendations for the future (see the Statement of Task in Box 1-1). Chapter 2 provides the review of the vaccine risk monitoring and evaluation work and Chapter 3 the communications activities. As described in Chapter 1, vaccine safety experts from ISO were detailed to the Vaccine Task Force at the Centers for Disease Control and Prevention (CDC) during the PHE. For convenience, this report refers to these staff, the systems they used, and the analytic approaches as “ISO,” regardless of their organizational placement and reporting relationship at the time. Furthermore, the committee uses the phrase “vaccine risks” to indicate undesired, serious health outcomes. The use of “safety” indicates to some a complete lack of any negative outcomes and to some a balance between risks and benefits. ISO’s primary role is to conduct ongoing surveillance and monitoring of vaccine safety, though it may also support hypothesis-driven research when needed to inform evaluation. Thus, the committee describes ISO’s function as vaccine risk monitoring and evaluation.¹

The committee does not want its focus on the risks of vaccines to detract from the overwhelming evidence of their benefits. One way to

___________________

¹ During the committee’s deliberations, major changes were announced in the structure of CDC and its parent Department of Health and Human Services. To avoid possible confusion, the committee refers to ISO when describing the activities undertaken by that office before these reorganizations but to a federal vaccine risk monitoring and evaluation office for time periods after the start of those reorganizations.

increase use of vaccines when indicated, and therefore their benefits, is to increase understanding of and confidence in the studies of vaccine risks conducted by the federal government. The committee believes that ISO merits the nation’s trust and serves as a reliable and unbiased source of monitoring, evaluation, and communication about vaccine risks. It offers recommendations to enhance ISO’s capabilities.

As described briefly in Chapter 1, the committee identified five principles that ground its recommendations. A robust vaccine risk monitoring and evaluation office that merits the nation’s trust needs to be relevant, seen as highly credible, trusted with data, committed to continuous improvement and innovation, and scientifically independent. These will be described in more detail in a subsequent section.

The committee offers three conclusions about the functioning of ISO, focusing on evidence about its activities during the PHE. The committee then offers five recommendations, framed around the aforementioned principles. The committee ends this chapter and report with overarching thoughts on the value of the office and its work.

CONCLUSIONS

As documented in Chapter 2, ISO studies the risks of vaccines using standard pharmacoepidemiology, surveillance, and clinical research methods. The multiple systems for monitoring and evaluation are complementary, and the additional systems created during the PHE, such as V-safe, resulted in stronger monitoring and evaluation. Combined with vaccine safety evaluations as required by the Food and Drug Administration and the work of other federal agencies, such as the Veterans Health Administration and Centers for Medicare & Medicaid Services, and with regular communications

and collaboration with international vaccine safety researchers, ISO is central to generating new knowledge about vaccine risks.

During the PHE, ISO conducted a large amount of timely and rigorous monitoring and evaluation (see Appendix E). As shown in the case studies in Appendix D, it made frequent public presentations of the findings as they emerged, helping health professionals, policy makers, and the public understand the effects of these vaccines in real time.

However, as the committee heard from public comments (see Box 1-5) and has been documented in studies of vaccine hesitancy, ISO research is viewed skeptically by some because of the intermingling of information about vaccine risks and benefits. Clearance of ISO risk publications currently involves those in CDC responsible for studying vaccine benefits and fostering immunization. Technical content was not solely reviewed by the risk experts (see Appendix C). Additionally, during the PHE, understandably, communications were cleared at multiple levels (Jernigan, 2025).

RECOMMENDATIONS

The committee identified a set of principles well established over decades that have influenced the functioning of a variety of federal statistical agencies and offices, including an office long housed at CDC, the National Center for Health Statistics (CDC, 2024; NASEM, 2025). The mutually reinforcing, co-equal principles articulated in this series of reports by the National Academies have been incorporated in federal directives and stood the test of time as a goal post for offices entrusted with citizens’ data in service to the nation (NASEM, 2025).

The committee found the similarities in the functioning of federal statistical agencies to ISO compelling and, with a few changes in vocabulary to fit its specific task, uses those principles to frame recommendations for a robust vaccine risk monitoring and evaluation system that merits the nation’s trust. It offers one recommendation related to each of the five principles and includes recommended implementation steps to guide future activities. Details about the implementation reside with the administration.

Relevance

Vaccine risk monitoring, evaluation, and communications activities meaningfully address the needs of health professionals, policy makers,² and the public.

___________________

² The committee intends policy makers to include federal, state, and local public health agencies.

The committee anchors its recommendation in a strategic plan and the processes established to develop it to ensure the work of the vaccine risk monitoring and evaluation office is relevant to health professionals,

policy makers, and the public and that its mission is restricted to vaccine risk monitoring and evaluation and not promoting vaccine use. The office needs a simple, recognizable identity focused exclusively on vaccine risk monitoring and assessment. It can start by developing a mission statement, which the committee was unable to locate for ISO. A concise articulation of its focus on monitoring and evaluating the risks of vaccines could increase understanding of its work.

Any robust strategic plan is developed, reviewed, and revised on a regular basis and includes metrics for evaluation, timelines, and deadlines. It ought to include disclosure of the office’s resources, such as staffing and research contracts. Transparency about the sources of funding for its resources is paramount in helping demonstrate the relevance of the office’s work.

A key element of the plan is a scientific agenda. The committee is aware of an ISO research agenda published in 2011, developed in response to a recommendation by the Institute of Medicine (CDC, 2011; IOM, 2005) but none since. Outlining scientific priorities and reporting on progress is important for transparency and accountability. Soliciting input into the scientific agenda from health professionals and the public helps ensure it broadly represents the needs and interests of a range of interests. The input can take many forms—website, open comment sessions, and scientific workshops, for example. Articulating the strategy for decision making about what signals to pursue could assure health professionals, policy makers, and the public that issues of salience to them are not being ignored.

A board of scientific counselors can play an integral role in assuring credibility of the vaccine risk monitoring and evaluation office. The board would provide a locus for developing and reviewing the strategic plan, including the scientific agenda, serve as the conduit for communications with health professionals and the public, and support accountability. It would advise on the science and processes of vaccine risk monitoring, communications, and the independence of both of those functions, including that its products stay clear of policy and advocacy. The expertise of the board members ought to include, for example, an established track record in vaccinology, immunology, risk communication, vaccine safety, pharmacoepidemiology, and informatics. The office also should consider the merits of having a consumer or member of the public on the board. The head of the vaccine risk monitoring and evaluation office should have comparably deep and relevant expertise, in addition to skills as a communicator. Other roles for the board are articulated in subsequent sections.

Because vaccine risk monitoring and evaluation will follow compressed timelines and have unique scientific priorities during PHEs, the strategic plan ought to clearly indicate action steps to be taken to address the PHE and resource allocation, especially regarding personnel, and work that will

be modified to address the emergency and maintain the routine work of the vaccine risk monitoring and evaluation office. Communications with health professionals and agencies at the state and local level is particularly important during an emergency.

Credibility

Health professionals, policy makers, and the public can rely on scientifically sound information and data analysis about vaccine risks.

The work of a federal vaccine risk monitoring and evaluation office needs to be credible if the public is to trust it to assist in personal decision making. The committee heard during public comment period that some people mistrust the information from ISO because its parent agency, CDC, also promotes vaccines (see Box 1-5), a long-standing issue (CDC, 2004, 2006). As described in Chapter 3, CDC communications about vaccine risks usually include information about benefits, to portray the full picture of the effects. However, the committee thinks having a web presence for the work of the vaccine risk monitoring and evaluation office that clearly identifies the risk information distinct from vaccine advocacy or use recommendations could help some members of the public increase their trust in it. It could include links to CDC sites with use recommendations, effectiveness

information, and general vaccine advocacy. The risk monitoring and evaluation experts ought to be consulted for technical accuracy, but other offices in CDC or HHS can use the risk information in policy determinations and communications

Two things that could help the public and health professionals trust information from this office are transparency and comprehensiveness. The public and those who promote and administer vaccines need to be able to understand the work of the office and trust what they see, knowing they are seeing the complete work. To facilitate public understanding of the work, the office ought to develop a suite of public-facing products, such as ones that explain the monitoring and evaluation systems used, including their strengths and limitations. The office should develop a process for explaining its decision making around studying risks of salience to the public. The board of scientific counselors can oversee this and provide advice.

An additional step toward transparency is to make the analysis protocols available (ISPE, 2015). The committee notes that some protocols from the Vaccine Safety Datalink (VSD) were made available during the PHE (CDC, 2023), but it has not been standard practice. Publishing research protocols is an integral part of clinical trials (NIH, 2025) and strongly recommended by pharmacoepidemiology experts (ISPE, 2025); the federal vaccine risk monitoring and evaluation office ought to adopt it as standard practice.

Because many people interested in vaccine risk evaluation do not have in-depth knowledge of epidemiology and statistics, this office ought to publish plain language summaries of every research publication and, where of broad national and public interest, unpublished findings that are made public, such as in public presentations. Additionally, where possible, to facilitate the public’s understanding, the office ought to adopt standardized risk reporting, including relevant subgroup analyses where available.

Data Stewardship

Vaccine risk monitoring, evaluation, and communication activities are conducted with respect for the individuals whose data are used by protecting their privacy, using their data properly to address important questions about vaccine risks, and sharing the results.

Federal agencies have an obligation to be good stewards of the citizen information used for research and policymaking. Vaccine risk research depends on participation by a wide variety of individuals and their trust that their protected personal information is kept confidential. Private medical information and contact information are important to collect for research but ought not be made public. Members of the public whose information is included in systems such as the Vaccine Adverse Event Reporting System or VSD deserve to know that their data are secure.

Honoring their participation means that the public knows that they participate for a good reason—that the monitoring and evaluation questions being asked are important, addressed with appropriate scientific expertise, and broadly reflect the interests of the scientific community, health professionals, the public, and policy makers. The public input components of the research agenda and strategic plan for this office outlined in Recommendation 1 can help assure this. The monitoring and evaluation office contributes as much as possible with its given resources to understanding the risks of vaccines, but it is not, cannot, and should not be the only entity researching vaccine risks. The validity of the scientific process and the confidence in the results could be bolstered if, under appropriate circumstances, data collected and used by the office were available to outside researchers. VAERS data are available for free by download (VAERS, n.d.), and some limited VSD data had been available to outside researchers (CDC, n.d.). The board of scientific counselors envisioned in Recommendation 1 could provide the guidance and oversight of efforts to review and revise, if necessary, public access programs.

Continuous Improvement and Innovation

Regular evaluation of vaccine risk monitoring, evaluation, and communication practices leads to adopting new methodologies and technologies with the capacity to address emerging questions about vaccine risks.

A well-functioning risk monitoring and evaluation office continuously improves and innovates. As with the first recommendation, metrics for evaluation ought to be developed that address innovation. The committee concluded that ISO has been important in performing and communicating about vaccine risk monitoring and evaluation and that during the PHE, its staff and the systems they used performed extremely well. Existing monitoring and evaluation systems ought to be continued and even enhanced and expanded as new information and new technologies become available. Implementing this and other recommendations will require resources, but the committee did not determine a specific level.

The board of scientific counselors described could oversee efforts by the office to incorporate advances in vaccinology, epidemiology and statistics, and informatics. Other federal partners can also provide input and collaborations, which are vital to scientifically robust monitoring and evaluation office. Additionally, as discussed in Chapter 3, the robust field of research on public health communication and risk communication could be leveraged to improve communication about vaccine risk monitoring and evaluation efforts by not only shaping communications but also evaluating them. It is important to assess how the messages are received by the intended audiences, particularly for helping the public understand uncertainty around emerging risks.

Independence

Vaccine risk monitoring, evaluation, and communication are free from undue internal or external influence.

Because the committee believes that vaccines have been demonstrated to provide enormous benefit to individuals and populations over the last century, it focuses on the scientific independence of risk monitoring and evaluation as a way to assure individuals and health professionals that the results are free from internal and external influence. The committee bases this not on evidence that the results have been tainted by association with vaccine promotion but because of the persistent perception that this is true (CDC, 2004, 2006). Unlike the preceding recommendations, this recommendation is directed to CDC; the risk monitoring and evaluation office cannot assure its own independence.

During its public comment session, the committee heard, as has been true for decades, that some fear the safety of vaccines because of the perception that risk research and communications are often inextricably linked to and biased by the CDC to increase vaccination (CDC, 2004) (see Box 1-5). While clinical use recommendations for vaccines, as with drugs, include considerations of benefits and risks and are clearly in the purview of the National Center for Immunization and Respiratory Diseases, ACIP, and other governmental offices, the risk information ought to be generated and communicated independently of efforts to increase immunization if it is to be trusted by those who do not currently. The committee notes, as described in Chapter 1, that annual funding for ISO has come from not only its parent center, but also NCIRD.³

___________________

³ Personal communication, J. Gee, Centers for Disease Control and Prevention, August 5, 2025.

That office ought to remain, as ISO is, organizationally and administratively separated from those parts of the department that study vaccine benefits and work to increase vaccinations. The committee is aware of suggestions for alternative placements (Salmon et al., 2004) but did not evaluate these options, as that is outside of its remit. The office should have a web presence that is distinct from vaccine promotion efforts, clearly identifying the office from which the monitoring and evaluation data originated. The site could contain links to data related to the benefits of vaccines to support user-friendly navigation.

Scientific independence from other parts of CDC and other relevant government agencies, such as FDA, need not isolate the staff of the vaccine risk monitoring and evaluation office from needed scientific expertise. Consultation and collaboration ought to be fostered, but the final decision making about monitoring and evaluation of vaccine risk information and the scientific content of risk communications needs to remain with this office.

Adhering to the principles behind the other recommendations in this report would support the prompt publication of all risk evaluation information, including null or uncertain findings. While the committee understands the need for quality assurance of research data and peer review, it heard in public comments (see Box 1-5) and key informant interviews (see Appendix C) that publication is sometimes delayed due to burdens of review and CDC clearance. It is important for engendering trust in the safety of vaccines that research results are not perceived as being constrained or hidden. The vaccine risk monitoring and evaluation efforts during the COVID PHE demonstrated that frequent, complete, and timely communications (Gee, 2024; Jernigan, 2025) can occur, and the committee thinks speed, completeness, and transparency ought to govern those about vaccine risks. As per this recommendation, CDC should assure that the technical content of these communications is under the purview of the vaccine risk scientists and that clearance of the technical information by offices that promote vaccination ought to be limited to “notification only.”

PUBLIC HEALTH EMERGENCIES

The need for relevant vaccine risk information is heightened during a PHE, and it is imperative that health professionals, policy makers, and the public believe the information provided to them. Federal staff doing vaccine risk monitoring, evaluation, and communications can continue to be guided by the principles of relevance, credibility, data stewardship, continual improvement and innovation, and scientific independence detailed earlier, regardless of temporary or situational placement within a whole of government response.

The strategic plan, discussed in relation to Recommendation 1, should include a section on operations during a PHE and plans for an intensive vaccine risk evaluation apparatus, such as the VaST used during the COVID PHE or the processes established during the H1N1 pandemic in 2009 (Markowitz et al., 2024; Yih et al., 2012). A continuity of operations plan would define what routine vaccine risk monitoring, evaluation, and communication work will continue and what will pause, what resources will be shifted to address the emergency, and how risk information will be shared. The emergency plan ought to also include steps for the vaccine risk monitoring and evaluation office to rapidly return to its pre-emergency administrative placement, research agenda, and scientific independence, as soon as possible (Markowitz et al., 2024; Yih et al., 2012).

CONCLUDING THOUGHTS

The committee has concluded that ISO functions well and merits the nation’s trust; however, federal vaccine risk monitoring, evaluation, and communication could be enhanced by adhering to the offered set of five recommendations. Implementing these will require resources but also the commitment of the CDC director to protect the office in order to significantly enhance the capability to deliver timely, trustworthy, and scientifically robust vaccine risk information. This, in turn, supports increased public confidence in vaccination programs, ultimately contributing to stronger public health outcomes and preparedness for future public health emergencies.

REFERENCES

Gee, J. 2024. CDC response to vaccine safety needs for the U.S. COVID-19 vaccination program—an overview of vaccine safety systems. Presentation to the Committee to Review the Centers for Disease Control and Prevention’s COVID-19 Vaccine Safety Research and Communications, Washington, DC, August 7.

IOM (Institute of Medicine). 2005. Vaccine safety research, data access, and public trust. Washington, DC: The National Academies Press.

ISPE (International Society for Pharmacoepidemiology). 2015. Guidelines for Good Pharmacoepidemiology Practices (GPP). https://www.pharmacoepi.org/resources/policies/guidelines-08027/ (accessed June 5, 2025).

ISPE. 2025. Author Guidelines. https://onlinelibrary.wiley.com/page/journal/10991557/homepage/forauthors.html (accessed June 5, 2025).

Jernigan, D. 2025. CDC COVID-19 vaccine safety risk communications. Presentation to the Committee to Review the Centers for Disease Control and Prevention’s COVID-19 Vaccine Safety Research and Communications, Washington, DC, January 10, 2025.

Markowitz, L. E., R. H. Hopkins Jr, K. R. Broder, G. M. Lee, K. M. Edwards, M. F. Daley, L. A. Jackson, J. C. Nelson, L. E. Riley, and V. V. McNally. 2024. COVID-19 Vaccine Safety Technical (VaST) Work Group: Enhancing vaccine safety monitoring during the pandemic. Vaccine 42:125549. https://doi.org/10.1016/j.vaccine.2023.12.059.

NASEM (National Academies of Sciences, Engineering, and Medicine). 2025. Principles and practices for a federal statistical agency: Eighth edition. Washington, DC: The National Academies Press.

NIH (National Institutes of Health). 2025. Protocol Registration Data Element Definitions for Interventional and Observational Studies. https://clinicaltrials.gov/policy/protocol-definitions#intro (accessed July 9, 2025).

Salmon, D. A., L. H. Moulton, and N. A. Halsey. 2004. Enhancing public confidence in vaccines through independent oversight of postlicensure vaccine safety. American Journal of Public Health 94(6):947–950. https://doi.org/10.2105/AJPH.94.6.947.

VAERS (Vaccine Adverse Event Reporting System). n.d. VAERS Data. https://vaers.hhs.gov/data.html (accessed June 5, 2025).

Yih, W. K., G. M. Lee, T. A. Lieu, R. Ball, M. Kulldorff, M. Rett, P. M. Wahl, C. N. McMahill-Walraven, R. Platt, and D. A. Salmon. 2012. Surveillance for adverse events following receipt of pandemic 2009 H1N1 vaccine in the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) system, 2009–2010. American Journal of Epidemiology 175(11):1120–1128. https://doi.org/10.1093/aje/kws197.

This page intentionally left blank.