COVID-19 vaccines and treatments have been important tools in the prevention of infections, hospitalizations, and deaths. Availability of these vaccines and treatments has relied in part on the Food and Drug Administration (FDA)’s Emergency Use Authorizations (EUAs), with the US Government (USG) making purchasing commitments conditional on FDA approval or authorization. To date, the USG has generally covered both the administration and ingredient costs of COVID-19 vaccines and treatments available under EUAs without individual cost-sharing, regardless of insurance status. In the near future, COVID-19 vaccines and treatments will need to transition to more established regulatory pathways of approval and payment by public and private payers (a process we refer to as “commercialization”). This reflects both the likely exhaustion of funds for direct government purchase of these products and the need for planning as we move beyond the acute phase of the pandemic. During the COVID-19 pandemic, it has taken 5 to 18 months from EUA issuance to FDA approval of COVID-19 vaccines and treatments; the timing depends on many factors, including activity against currently circulating variants and continued data collection. Coverage and payment considerations and policies needed to transition to commercialization vary by payer and the product in question. One key approach that may prevent potential gaps in coverage is for payers to expedite and begin coverage and payment decision-making well before the USG-provided supply runs out, potentially concurrently with FDA regulatory review. Coverage of COVID-19 vaccines and treatments could lead to savings to payers by reducing hospitalization costs. Our estimates indicate that COVID-19 vaccines result in large savings in direct health care costs. The savings from the initial vaccination series far exceed the costs of the vaccines. Savings from vaccine boosters essentially cover the full cost for older adults. COVID-19 treatments also generate savings by lowering hospitalization costs, and these savings partially offset the costs of these treatments. These estimated health care savings are in addition to the lives saved and health improved by these vaccines and treatments, which are their most important benefits.
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