Reassuring the Public and Clinical Community About the Scientific Review and Approval of a COVID-19 Vaccine
Howard Bauchner, Preeti Malani, Joshua M. Sharfstein
Abstract
Public perception of the review of medications and vaccines for coronavirus disease 2019 (COVID-19) has become enmeshed in politics.The pressure on the US Food and Drug Administration (FDA) and Commissioner Stephen Hahn, MD, to approve the broad use of a COVID-19 vaccine in the coming months will be immense.However, a lack of clarity about the agency's approachcoupled with a stream of announcements from various federal agencies and pharmaceutical companies-has led to confusion and concern.Greater clarity and transparency about the review process as well as the full engagement of the relevant federal advisory committees can inspire understanding and trust.
Topics & Concepts
MedicineCoronavirus disease 2019 (COVID-19)2019-20 coronavirus outbreakSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2)MEDLINEFamily medicineVirologyInfectious disease (medical specialty)PathologyLawOutbreakDiseasePolitical scienceEthics in Clinical ResearchVaccine Coverage and HesitancyHealth Systems, Economic Evaluations, Quality of Life