FDA Review of Novavax’s COVID-19 Vaccine—Regulatory Integrity and Deviations From Standard Practice

This Viewpoint notes that the review and communication processes for the Novavax COVID-19 vaccine deviated from standard practice and raises concerns if this is the “new normal” for the FDA.

Authors

Patricia J. Zettler (ORCID: https://orcid.org/0000-0001-9114-0735)
Peter Lurie (ORCID: https://orcid.org/0000-0001-7867-4951)
Sarah Despres
Stephen Cha

Institutions

Center for Science in the Public Interest (United States) (US)

Publication Details

Journal: JAMA
Published: 2025-06-09
DOI: https://doi.org/10.1001/jama.2025.9898
Citations: 5
Primary Topic: Vaccine Coverage and Hesitancy
Type: article
Field-Weighted Citation Impact: 10.84

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article

FDA Review of Novavax’s COVID-19 Vaccine—Regulatory Integrity and Deviations From Standard Practice

Patricia J. Zettler, Peter Lurie, Sarah Despres, Stephen Cha

Jun 9, 2025

5 citations

JAMA

Vaccine Coverage and Hesitancy

10.84

article

FDA Review of Novavax’s COVID-19 Vaccine—Regulatory Integrity and Deviations From Standard Practice

Patricia J. Zettler, Peter Lurie, Sarah Despres, Stephen Cha

June 9, 2025article en

5 citations

Abstract

This Viewpoint notes that the review and communication processes for the Novavax COVID-19 vaccine deviated from standard practice and raises concerns if this is the “new normal” for the FDA.

JAMAVol. 334(6)

Center for Science in the Public Interest (United States) (US)

Openalex Percentile: Top 2%

Vaccine Coverage and Hesitancy

10.84

DOI Source OpenAlex

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FDA Review of Novavax’s COVID-19 Vaccine—Regulatory Integrity and Deviations From Standard Practice — Patricia J. Zettler, Peter Lurie, et al. · JAMA (2025) | TGRS Research Map | TGRS