The Lacuna Project

lacuna (n.) a gap in a record where something should be

Independent research. Not affiliated with any government, agency, or company.

Exhibit 020

FDA approval letter for Comirnaty, 2025, listing Pfizer's postmarketing commitments

Exhibit 020 ยท Regulatory action

FDA approval letter for Comirnaty, 2025, listing Pfizer's postmarketing commitments

FDA's 2025 approval letter for Pfizer's COVID-19 vaccine acknowledges Pfizer's written commitments of 26 August 2025, including a randomized, double-blind, placebo-controlled study in healthy adults aged 50 to 64. The letter's postmarketing requirements (PMR 1 and 3, from a 15 August 2025 letter) were pediatric studies.

Source
U.S. Food and Drug Administration, reported by Managed Healthcare Executive
Date
2025
Grade
Reported
Document
https://www.fda.gov/media/188439/download
Accessed
2026-11-09
Cited by
Findings citing 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.