Abstract

The Public Can Trust the FDA's Vaccine Review Process.

Highlights

  • With the upcoming November election and calls by President Trump for 1 or more vaccines for coronavirus disease 2019 (COVID-19) to be ready before the end of the year, if not by the election, many have started to wonder whether the US Food and Drug Administration (FDA) can withstand this type of political pressure

  • Noting the FDA’s historically robust review process and decades of experience with regulatory flexibility in multiple product areas, the answer is an unqualified vote of support for the FDA

  • The public should be reassured that vaccines approved by the FDA will have been subject to the same strenuous reviews that have characterized the agency’s previous reviews

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Summary

Introduction

With the upcoming November election and calls by President Trump for 1 or more vaccines for coronavirus disease 2019 (COVID-19) to be ready before the end of the year, if not by the election, many have started to wonder whether the US Food and Drug Administration (FDA) can withstand this type of political pressure. The Public Can Trust the FDA’s Vaccine Review Process Noting the FDA’s historically robust review process and decades of experience with regulatory flexibility in multiple product areas, the answer is an unqualified vote of support for the FDA.

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