An Overview Of Vaccine Development, Approval, And Regulation, With Implications For COVID-19

From Health Affairs

By Aaron S. Kesselheim, MD, JD, MPH; Jonathan J. Darrow, SJD, JD, MBA; Martin Kulldorff; Beatrice L. Brown; Mayookha Mitra-Majumdar; ChangWon C. Lee; Osman Moneer; Jerry Avorn, MD

SUMMARY: This Health Affairs article provides a systematic overview of the processes by which vaccines are developed, evaluated, approved, and regulated in the United States, with explicit attention to how these processes would apply to COVID-19 vaccines being developed under emergency conditions. The piece contextualizes the regulatory and scientific standards ordinarily required for vaccine approval and examines the implications of emergency use authorization and accelerated timelines. The team of authors — including Avorn and Kesselheim — draws on the history of vaccine regulation to evaluate the risks and opportunities presented by pandemic-era expedited development. (Note: Full text paywalled; summary reflects publicly available title, abstract description, and field context only.)

BACKGROUND: Vaccine development, approval, and regulation involve multi-phase clinical trials and established regulatory review processes. The COVID-19 pandemic created pressure to accelerate these timelines significantly.

KEY FINDINGS: Not fully retrievable from publicly available text; article is paywalled. The piece provides an overview of ordinary regulatory standards and their application to COVID-19 vaccine development and emergency use authorization.

IMPLICATIONS: Understanding the established regulatory framework for vaccines is essential for evaluating the tradeoffs inherent in expedited COVID-19 vaccine authorization.