FDA Releases First Set of Pfizer COVID-19 Shot Safety Data

FDA Releases First Set of Pfizer COVID-19 Shot Safety Data
A vial of Pfizer-BioNTech COVID-19 vaccine in Los Angeles, Calif., on Aug. 23, 2021. Robyn Beck/AFP via Getty Images
Updated:

By the end of February 2021, there had been 1,291 reports of adverse events as a result of Pfizer/BioNTech’s experimental messenger RNA (mRNA) BNT162b2 biologic (also known as “Comirnaty”). The long list of adverse events associated with receipt of BNT162b2 shots were listed as an appendix to a 38-page report reluctantly released by the U.S. Food and Drug Administration (FDA) and Pfizer on Mar. 1, 2022.

Pfizer was forced to release documents from their clinical trials of the BNT162b2 biologic to the public after a group of scientists and researchers sued the FDA under the Freedom of Information Act (FOIA). The FDA requested that data related to the licensing of BNT162b2 be kept under seal for 75 years and not released until the year 2096.

Carolyn Hendler
Carolyn Hendler
Author
Carolyn Hendler, J.D., Director of Legal Affairs and Public Outreach, National Vaccine Information Center
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