As the 2020–2021 influenza season approaches in the US and the convergence of the seasonal influenza season and COVID-19 vaccination efforts appears likely, a range of unique considerations are emerging for a diverse group of stakeholders. Operation Warp Speed (OWS) and the Centers for Disease Control and Prevention (CDC) are preparing for possible COVID-19 vaccine authorization or licensure and dose distribution. It is important to evaluate the potential impact of COVID-19 vaccine distribution on seasonal influenza vaccine distribution.

The US government will oversee COVID-19 vaccine allocation, distribution, tracking, and linking between manufacturers, distributors, and providers. The unprecedented nature of distributing and tracking large volumes of a novel, potentially 2-dose COVID-19 vaccine, which may vary in target populations and storage requirements, will require new systems and levels of coordination across numerous stakeholders. In addition, should parts of the US seasonal influenza season overlap with a COVID-19 vaccine distribution effort, the concurrent distribution of multiple vaccines may put additional strain on available resources and infrastructure.

Vaccine Distribution

Drawing on lessons learned from the 2009 H1N1 influenza pandemic, OWS has positioned itself to oversee national distribution of a novel COVID-19 vaccine, leveraging the CDC’s existing vaccine distribution and information technology (IT) infrastructure. However, COVID-19 vaccine candidates raise several unique storage and handling considerations not previously experienced with H1N1 and routine immunizations. Several COVID-19 vaccine candidates require storage in ultra-cold temperature freezers. Distribution infrastructure and technical requirements aside, ensuring convenient access and educating the public on vaccine safety will be critical if distribution strategies are to drive vaccine uptake and administration.

Supply Chain Capacity

Distributing COVID-19 vaccine to the American population will require significant coordination between federal, state, and local distribution channels. Though the current supply chain is well positioned to distribute seasonal influenza vaccine, the CDC, along with state and regional localities, must now evolve existing infrastructure to simultaneously deliver both influenza vaccines and novel COVID-19 vaccines.

Although seasonal influenza vaccination requires a single annual dose, several COVID-19 vaccines could require that 2 doses be administered within several weeks. Further, while the Advisory Committee on Immunization Practices (ACIP) maintains a routine influenza vaccine recommendation for all persons above age 3, it is developing a separate allocation framework for COVID-19 vaccine. The ACIP is likely to include healthcare personnel in the first tier of distribution during an initial phase of limited supply. Although broader COVID-19 vaccine use is likely not to coincide with influenza vaccination until the 2021–2022 season and it is not yet known whether annual COVID-19 vaccination will be needed, the supply chain will need to rapidly expand to allow for the potential mass immunization of both. The need to concurrently distribute the seasonal influenza vaccine raises additional considerations, particularly the unique, outsized need for ancillary supplies (e.g., needles, syringes, alcohol prep pads) and sufficient staffing and training of vaccine administrators.

Vaccine Ordering and Tracking

OWS is constructing a new IT architecture that will integrate with existing state-based databases to support data exchange. The CDC has initiated work on improving the current data infrastructure to better track vaccine doses and administration. This tracking and monitoring are key as  the 2-dose vaccines produced by different manufacturers will likely not be interchangeable. COVID-19 vaccination providers enrolled by their jurisdictions will order both COVID-19 vaccine and ancillary supplies through their respective jurisdiction’s immunization program, most of which will place orders through the CDC’s Vaccine Tracking System (VTrckS), the primary system for vaccine ordering under the Vaccines for Children program and other publicly funded vaccine programs. Using the VTrckS for both COVID-19 and widespread influenza vaccine ordering has never been done before, so provider education will be especially important. Additionally, it is not yet clear how the new IT connections being built by the government will integrate or communicate with existing infrastructure, including the VTrckS.

While many realities associated with the influenza season overlapping with the COVID-19 pandemic remain unclear, increased investment, stakeholder coordination, data exchange, and education will be essential to ensure widespread, timely vaccine distribution and administration.

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