The Lacuna Project

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Exhibit 021

FDA releases Pfizer from the placebo-controlled postmarketing study

Exhibit 021 ยท Regulatory action

FDA releases Pfizer from the placebo-controlled postmarketing study

FDA letter releasing Pfizer from postmarketing commitment 4 of the 2025 approval, 'a prospective, exploratory, placebo-controlled, randomized study to evaluate detection of circulating SARS-COV-2 spike antigen and self-reported symptoms of post-COVID-19 vaccination syndrome or Long COVID symptoms.' The letter replaces it with a nonclinical biodistribution study and a retrospective integrated analysis. It does not mention the commitment to a placebo-controlled study in adults aged 50 to 64.

Source
U.S. Food and Drug Administration, as reported
Date
September 2026
Grade
Reported
Document
https://www.fda.gov/media/194509/download
Accessed
2026-11-09
Cited by
Findings citing this exhibit
Note
The FDA letter is the primary document. Press reports of a halted adults 50-64 trial are separate and not part of this exhibit.

Cited by

Finding MED-3.9
Reported In 2025 Pfizer committed to FDA to run a randomized, double-blind, placebo-controlled study of its COVID-19 vaccine in healthy adults aged 50 to 64. In 2026 FDA released Pfizer from a different placebo-controlled commitment from the same approval, a study of post-vaccination syndrome and Long COVID symptoms, and replaced it with a biodistribution study and a retrospective analysis.