Published: Oct 20, 2020 | PRESS RELEASE
Government officials hope to identify one or more safe and effective COVID-19 vaccines over the next few months as part of a multi-agency effort known as Operation Warp Speed. If and when they succeed, their focus will shift to making sure people across the country can access the vaccine.
A new issue brief lays out some of the key challenges with such a massive vaccination effort, which could require hundreds of millions of vaccine doses to be delivered across the country in a short period of time. The brief describes the leading vaccine candidates for the U.S. and what’s known about the federal government’s plans for distributing a successful vaccine or vaccines across the country and the challenges, including the potential need for billions of dollars in additional funding.
It also examines issues around supply, logistics and monitoring; the role of the federal, state and local governments; insurance coverage and out-of-pocket costs; racial and ethnic disparities; and building public confidence about the vaccine’s safety and effectiveness.
The brief is part of KFF’s broader portfolio examining the health and economic impacts of the COVID-19 pandemic, including original policy analysis, polling and journalism.
A COVID-19 vaccine or vaccines may become available in the United States in the next several months, at which point the process of actually delivering vaccines to most, if not all, of the population will begin. Although the U.S. has some experience with mass vaccine distribution, including during an outbreak, COVID-19 represents an unprecedented challenge that will require a scale not previously undertaken. Planning has already been underway, including the release of a federal distribution strategy and the federal government’s advance purchase of millions of doses of COVID-19 vaccine candidates. Even so, numerous outstanding questions and challenges remain regarding vaccine distribution, including:
- Funding for Vaccine Distribution. A critical and potentially limiting factor in the distribution of a COVID-19 vaccine is resource constraints faced by state and local health departments. Public health has long been underfunded in the U.S., and the health and economic impacts of the pandemic have further strained the public health infrastructure and reduced revenues. To date, just $200 million in federal emergency funds has been directed to state and local health departments for vaccine distribution.
- Supply, Logistics, and Monitoring. Distributing potentially hundreds of millions of doses of COVID-19 vaccines rapidly, effectively, and equitably represents a public health logistics effort on a scale not seen in the U.S. before. In addition to the challenges of the sheer number of doses likely to be needed, other logistical issues include identifying and vetting a broad network of sites for administration, ensuring cold chain requirements are met, monitoring delivery of multiple doses, and tracking vaccine safety.
- Federal, State, and Local Authority Over Vaccination Requirements. There remain outstanding issues concerning the relative roles and responsibilities of the federal, state and local governments in vaccine distribution in the context of a pandemic which crosses jurisdictional lines. A complicated patchwork of rules and regulations across jurisdictions could result in differential access to vaccines and varying levels of success in controlling COVID-19. Some policy considerations include whether or not vaccine mandates or changes in scope of practice regulations regarding who can administer a COVID-19 vaccine will be pursued.
- Insurance Coverage and Out-of-Pocket Costs. Ensuring that COVID-19 vaccines are covered by insurance and available at no-cost to individuals would greatly enhance access. Both the Administration and Congress have taken steps to address this issue, including advance purchase of millions of doses of COVID-19 vaccine candidates and legislative requirements to provide no-cost COVID-19 vaccines under private insurance, Medicaid, and Medicare, building on existing protections under the Affordable Care Act (ACA). Despite these measures, limitations and gaps remain and some individuals may still face cost and access barriers.
- Addressing Racial and Ethnic Disparities. COVID-19 has had a significant impact on communities of color in the U.S., and the pandemic threatens to further widen racial and ethnic disparities. People of color may face greater challenges in seeking and receiving Covid-19 vaccines due to cost and access issues and may be more reluctant to get a vaccine due to mistrust of the medical system. Taken together, these issues present formidable challenges not only to reaching people of color with a COVID-19 vaccine, but to the success of the overall national COVID-19 vaccine effort.
- Communication and Trust. Except when individuals may be subject to a vaccine mandate, receiving a COVID-19 vaccine will be voluntary, so high vaccination rates will depend on the public’s willingness to be vaccinated. People will have to trust the vaccine, the authorities overseeing distribution, and the provider administering the vaccine. All vaccines face issues of public confidence to one extent or another, yet there are indications that distrust of COVID-19 vaccines may be greater than other vaccines, and concerns about politicization of vaccine approval and distribution. Overcoming this trust deficit will likely require robust communication and trust-building efforts.
A vaccine or vaccines for COVID-19, the disease caused by the SARS-CoV-2 virus, may become available for use in the U.S. over the next several months. At that point, officials will begin the process of actually delivering vaccines to states and localities and overseeing their administration to individuals. It will be a historically complex challenge to ensure that enough vaccines are distributed in a rapid, effective, and equitable way. The U.S. has some experience with mass vaccine distribution to build on and has faced some of the challenges before, but delivering COVID-19 vaccines will need to be at a much greater scale than past efforts, and will also bring new and unique challenges.
While there are still many unknowns, it is likely that hundreds of millions of COVID-19 vaccine doses will have to be administered to people across the country to achieve an adequate level of protection. For example, by one estimate, 462 to 660 million doses of a vaccine could be needed for a two-dose regimen, and potentially more over time depending on the strength and duration of immunity and dosing requirements. While initial planning documents have been released, numerous outstanding questions and challenges remain. These range from questions regarding the respective roles of the federal, state, and local governments, to financing and coverage of a vaccine, addressing racial and ethnic disparities and communication and public trust. This brief outlines what is currently known about the U.S. COVID-19 vaccine distribution plan and discusses key issues and challenges as well as outstanding questions.
Jump to Key Policy Issue
COVID-19 Vaccine Candidates and Timeframe for Availability in the U.S.
The U.S. government, through a multi-agency, public-private partnership, known as Operation Warp Speed (OWS), which was publicly launched on May 15, has provided pharmaceutical companies with over $10 billion in funding to support research, development, manufacturing, and distribution of eight different candidate COVID-19 vaccines. Through these efforts, the federal government has already effectively purchased hundreds of millions of doses of these vaccines, from multiple manufacturers, even as clinical trials and federal regulatory review are ongoing (see Table 1).
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