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- Title
Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration.
- Authors
Egilman, Alexander; Wallach, Joshua D.; Puthumana, Jeremy; Zhang, Audrey D.; Schwartz, Jason L.; Ross, Joseph S.
- Abstract
Nearly 90% of FDA-required postapproval trials were completed within 3 years after approval, a higher rate than observed for drug approvals.[5] However, only 3 of the 8 vaccines had benefit confirmed by a postapproval trial using clinical outcomes. Next, we identified postapproval trials FDA required for accelerated approval, including ClinicalTrials.gov registrations and corresponding publications on PubMed, and extracted trial characteristics and determined study status.
- Subjects
DRUG approval laws; COVID-19; VACCINES; MEDICAL research; VACCINE effectiveness; COVID-19 vaccines
- Publication
JGIM: Journal of General Internal Medicine, 2021, Vol 36, Issue 10, p3281
- ISSN
0884-8734
- Publication type
Letter
- DOI
10.1007/s11606-021-06943-x