Measuring the Success of the US COVID-19 Vaccine Campaign—It’s Time to Invest in and Strengthen Immunization Information Systems

With the recent US Food and Drug Administration approval of the Pfizer-BioNTech and Moderna SARS-CoV-2 vaccines, the United States has begun COVID-19 vaccine dissemination. The vaccination program is historic in its massive scope and complexity. It requires accurate, real-time estimates of vaccine coverage to assess progress toward achieving herd immunity. Under Operation Warp Speed, the US Centers for Disease Control and Prevention (CDC) has constructed a federal database, or “data lake,” to monitor vaccine coverage nationwide and ensure that recipients receive both of the necessary doses. The data lake will be managed separately from existing state and local immunization information systems (IISs), which house vaccine data in all 50 states, five cities, the District of Columbia, and eight territories. In an open letter to the Director of the CDC in late 2020, four organizations representing immunization managers and public health officials expressed concerns about the plan to include vaccine recipients’ personal identifier information in the data lake.¹ They also urged stronger coordination with IISs.

We wholeheartedly agree with both points. While some IISs have limitations, including incomplete data and poor linkage with electronic health records (EHRs), they also have a track record of success, as during the 2009 H1N1 influenza pandemic.^2,3 The current moment demands that IISs be strengthened. With enhanced IIS data quality, we can reduce health inequities and conduct more rigorous evaluations of vaccine campaigns. Given the current limitations of IISs, the planned data lake may be a necessary stopgap for the COVID-19 vaccine program. However, the pandemic has radically increased public awareness about the value of the public health enterprise. We must seize this unprecedented opportunity to achieve long-standing goals to increase funding and streamline policies for IISs.

THE COVID-19 DATA LAKE

Operation Warp Speed’s data lake is managed federally, but it relies on state and local IISs to collect data. IISs, on the other hand, are managed by the very people who are responsible for administering vaccines and have thus established relationships with vaccine providers. Perhaps the most controversial aspect of the data lake is the plan for inclusion of identifiers (name, sex, date of birth, address, and race/ethnicity) of vaccine recipients. Identifiers are typically stored in IISs and are not reported to federal organizations. Trump Administration officials stated that identifiers are required to coordinate the administration of multidose vaccines, estimate vaccination coverage, and monitor adverse reactions, but these are standard functions of IISs. Concerns about how identifiers may be used by the federal government (e.g., to deport people) could undermine public trust and threaten the vaccine program’s success. The Biden Administration’s 200-page national strategy for COVID-19 response includes a goal to modernize data collection and reporting to guide pandemic response, but it does not explicitly mention IISs.

HOW TO STRENGTHEN IIS

According to the Advisory Committee on Immunization Practices (ACIP), IISs have the potential to ensure proper vaccination dosage, generate reminders about upcoming vaccinations, minimize vaccine waste, reduce time spent locating vaccination records, and evaluate vaccine campaigns. We believe there are three key improvements that, if undertaken, will unlock this potential.

First, IISs must receive all vaccination records, including those of older children and adults. A 2012 study estimated that 42% of states and localities operating IISs lacked a reporting mandate for vaccine providers.³ Without reporting mandates, data are typically incomplete, and IISs cannot reliably evaluate vaccination campaigns. While reporting to IISs is high for young children’s vaccination records (96% in 2019), it is lower for older children and adults (82% for 11–17 years and 60% for ≥ 19 years in 2019).⁴ The pandemic response effort will require immunization data for all ages, especially older adults, who are more vulnerable to COVID-19.

Second, IISs require more complete demographic information. Race/ethnicity, occupation, and residence type (e.g., long-term care) data are needed to facilitate prioritized SARS-CoV-2 vaccine administration. Occupation and residence type are not included in the CDC’s recommended core IIS data elements, although the CDC’s pandemic plans prioritize risk groups by occupation. Race/ethnicity data are included but are incomplete in some IISs, preventing the examination of vaccination disparities based on these variables.⁵ Vaccine hesitancy is greater in Black populations, and minorities have been disproportionately impacted by the pandemic.⁶ Identifying gaps in vaccination coverage by race/ethnicity is essential to reducing such inequities.

Third, increased linkage between IISs and EHRs is needed to support more rigorous evaluations, thereby increasing vaccine campaign effectiveness. If linked with EHR data, IIS data could be used to help assess SARS-CoV-2 vaccine effectiveness and safety within age and race/ethnicity subgroups. The unprecedented speed of SARS-CoV-2 vaccine development makes postlicensure evaluation especially important. Such data linkage would also benefit evaluations of school-based influenza and human papillomavirus vaccination programs, among others. However, interoperability between IISs and EHRs is often limited because of conflicting regulations governing IISs and patient privacy.³

POLICY REFORM AND INCREASED FUNDING

The solutions for strengthening IISs are clear: policy reform and increased funding. IISs are governed by over 984 federal, state, and local policies in 13 areas of law.² This often overlapping and contradictory hodgepodge of regulations creates confusion and hampers IIS effectiveness. The CDC, ACIP, and National Vaccine Advisory Committee provide best practices and guidance for IIS managers, but we need to reform laws to make them clear and uniform across all IISs in the following ways.

First, policies to protect patient privacy must be standardized to reduce confusion. Currently, patient privacy protections are specified not only by state and local IIS-specific regulations but also federal laws, such as the Health Insurance Portability and Accountability Act, resulting in confusion. Vaccine providers’ liability concerns contribute to inadequate reporting to IISs.² Streamlining these policies could thus increase reporting to IISs and protect privacy and public health.

Second, all states need policies authorizing and facilitating data transfers between IISs. Vaccine administration increasingly occurs across multiple localities and states. To accurately capture vaccination in different locations, IISs need to share data across city and state lines, but only about half do so.² In some states, IISs do not have the legal authority to share data with other IISs³; in others, data exchange agreements are needed to share data, which can slow or prevent data sharing.

Third, policies must encourage rather than hinder IIS innovation. There is no shortage of technological innovations to increase reporting to IISs (e.g., the integration of smartphone apps with IISs, as is done in Canada); however, the complexity of current policies relating to vaccine data privacy and transfer hampers innovation.

Improvements to IISs will require additional funding to support IIS computing infrastructure and staff time. Historically, IISs have been funded by federal, state, and local governments and foundations. Since 2014, the annual federal budget appropriation for immunization programs under Section 317 of the Public Health Service Act has remained the same at approximately $611 000.⁷ This pales in comparison with the billions of dollars of federal funding devoted to SARS-CoV-2 vaccine development. The March 2020 Coronavirus Preparedness and Response Supplemental Appropriations Act provided the CDC with $500 million to modernize public health data systems, and the December 2020 coronavirus stimulus bill included $8.75 billion in CDC funding to support COVID-19 vaccine dissemination and measurement of vaccination coverage. However, public CDC documents do not indicate whether any of these funds will be allocated specifically to strengthen IISs. Without increased and sustained funding, IISs will not realize their full potential, even if the policy reforms outlined above are achieved.

CONCLUSIONS

The public health departments that run IISs cannot lobby legislatures responsible for IIS policy. However, physicians, epidemiologists, and public health professionals can use their voices to express the importance of IISs, particularly during the COVID-19 pandemic, to advocate for policy reform and increased funding.

The recommendations to make IISs more effective are not new,^2,3 but the opportunity to achieve them is. We must capitalize on this moment to strengthen our public health systems so that we may save more lives in a more equitable manner in the current pandemic and beyond.