FDA Knew COVID Vaccine Safety Monitoring System Was ‘Not Sufficient,’ Latest Pfizer Documents Confirm

The U.S. Food and Drug Administration (FDA) released its final batch of documents related to licensing Pfizer’s Comirnaty COVID-19 vaccine for ages 16 and up.

“Now, independent scientists and researchers can see everything FDA saw when it made its decision that this vaccine was ‘safe and effective,” according to a Dec. 4 press release by the Informed Consent Action Network (ICAN), a nonprofit that funded a lawsuit to get the files released.

This news comes more than two years after the agency on Aug. 23, 2021, approved Pfizer’s vaccine. ICAN said:

“With this final batch, the documents, presumably those relied upon by FDA to approve the vaccine, are finally in the hands of the public, where they belong, 800 days after approval!”