The paper discusses systems and data flow implications for vaccine allocation, distribution, administration, tracking, and reporting, including a visual depiction of the various information systems and roles of key entities.
Efforts to develop and manufacture COVID-19 vaccines are well underway with expectation that the U.S. Food and Drug Administration will authorize at least one vaccine candidate before the end of 2020. Once authorized, success will hinge on the ability to quickly distribute and administer the vaccine across the country. Processes for vaccine allocation, distribution, administration, tracking, and reporting will be complex and rely on effective use of data. All states have existing data systems and processes upon which to build and will need to navigate unique dynamics for COVID-19 vaccines, which may include enhancing, augmenting, and adapting existing infrastructure to allow for effective coordination with federal and local governments as well as providers and data intermediaries such as health information exchanges (HIEs). Please see Appendix A for additional information on new and existing information systems that will support vaccine distribution and administration and related considerations for COVID-19 vaccine planning.
There are numerous factors contributing to the complexity of data collection and information sharing for COVID-19 vaccine distribution and administration in the United States, including:
- New Systems and Processes. While the United States has extensive experience with vaccine distribution and administration, new systems and processes are being implemented to meet the unique demands of COVID-19. As such, states and other public health jurisdictions may choose to use new systems to augment current capabilities to meet federal requirements. The Centers for Disease Control and Prevention (CDC) outlined a number of immediate priorities for states related to data reporting in its COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations. Please see Appendix B for additional information on CDC’s data reporting priorities for states.
- Phased Rollout. Once authorized, vaccine supply will initially be limited until production capacity accelerates, necessitating a phased rollout of the vaccine. Initial recipients of the vaccine will include high priority populations. Data and technology will be essential to integrating a wide range of demographic, employment, and public health information to identify and locate priority populations and support decisions for allocating vaccine doses as part of a phased approach.
- Provider Enrollment and Onboarding. To facilitate timely, widespread, and equitable vaccination in the United States, states are actively enrolling providers to administer vaccines and targeting settings where COVID-19 vaccination services are accessible to the critical populations. Part of this process involves onboarding providers to the state’s Immunization Information System or other external system and training them on ordering, documentation, and other system functions.
- Ultra-Cold Storage Requirements. Each COVID-19 vaccine candidate in development has unique storage and handling requirements. At least one vaccine candidate in late-stage development is anticipated to have strict requirements regarding ultra-cold storage and transport, which will impact distribution processes and require strict adherence to tracking and reporting protocols to avoid waste.
- Multiple Vaccines and Doses. It is likely that more than one vaccine will be authorized for COVID-19 and all but one of the vaccine candidates in late-stage development requires administration of two doses separated by several weeks. The vaccine candidates are not interchangeable, both doses must be the same product. Data will need to be collected and shared to ensure that individuals receive each dose of the correct vaccine at the right time.
- Mass Vaccination Sites. Public health jurisdictions planning for satellite, temporary, or off-site vaccination locations should consider the additional technical tools and data elements required for CDC reporting as identified in the COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations. Mass Vaccination data elements are likely to require enhancements or a Mass Vaccination module for data collection and reporting.
The data flow in this paper depicts anticipated vaccine distribution and administration processes and associated information systems. The left side– Vaccine Distribution – depicts the processes and systems used to facilitate vaccine allocation, ordering, distribution to vaccine administration sites, inventory management, and tracking. The right side – Vaccine Administration – shows the processes and systems used to facilitate vaccine administration, including scheduling and reminders, and subsequent documentation and reporting. The data flow also differentiates roles and responsibilities at the federal level (blue), state/jurisdiction level (yellow), and administration site level (purple).
Depending on the specific strategy employed by a given state or jurisdiction, some of the steps in these processes may vary. For example, not all states are connected to the federal system for cross-state immunization record query and vaccine administration sites will have differing levels of sophistication to document and report information. Additional details on these considerations are outlined in Appendix A.
 To support the expanded functions for tracking, reporting, and administration at temporary sites, states will have to either 1) enhance the IIS platforms, 2) use CDC available options, or 3) identify 3rd party vendor solutions.
All NGA COVID-19 memos can be found here, or visit COVID-19: What You Need To Know for current information on actions States/Territories are taking to address the COVID-19 pandemic; as well as advocacy, policy, and guidance documents for protecting public health and the economy.