FDA Admits Inability to Assess Safety Monitoring of Pfizer's BNT162b2 Vaccine for Myocarditis and Pericarditis in Access to Information Request
An access to information request reveals that the FDA has acknowledged its safety monitoring system's inability to "assess the serious risks of myocarditis and pericarditis" during the post evaluation of Pfizer's BNT162b2 COVID-19 vaccine for individuals aged 16 and older.
A non-profit organization, ICAN, has obtained nearly 52,000 pages of documents related to the COVID-19 vaccines and the FDA approval process. Among these documents is a CBER Sentinel Program Sufficiency Assessment, a program within the FDA that assesses postlicensure safety surveillance of vaccines and other biologics.
On the last page of the 7-page document, it states,
"The CBER Sentinel Program is NOT sufficient to assess the serious risks of myocarditis and pericarditis, and subclinical myocarditis associated with COMIRNATY (BNT162b2) in lieu of PMR safety studies under FDAAA. At the time of BLA approval, the data sources in the CBER Sentinel Program are not sufficient to identify the outcomes due to a lack of sufficient power to assess the magnitude of risk in patients 12-30 years of age. In addition, the CBER Sentinel Program is not sufficient to follow up on cases for recovery status and long-term sequelae, or for the identification and characterization of subclinical myocarditis cases."
You can read the post safety assessment report at the link below.