Dear Director Walensky,
On June 23, 2022, I wrote to you about whether the Centers for Disease Control and Prevention (CDC) performed sufficient surveillance of covid-19 vaccine adverse events (enclosed).
To date, the CDC has failed to provide a response to that letter. In that letter, I described the CDC and the Food and Drug Administration’s Standard Operating Procedures (SOP) document dated January 29, 2021, which declared that the agencies would “perform routine [Vaccine Adverse Event Reporting System (VAERS)] surveillance to identify potential new safety concerns for covid-19 vaccines.”
Yet, in response to a Freedom of Information Act (FOIA) request for these surveillance records, CDC failed to provide data it originally claimed it would generate. As I noted in my letter, the SOP stated that “CDC will perform Proportional Reporting Ratio (PRR) analysis . . . to identify [adverse events] that are disproportionately reported relative to other [adverse events].” The SOP also stated that, “CDC will perform PRR data mining on a weekly basis or as needed.” However, in response to the May 9, 2022 FOIA request for these records, CDC wrote, “no PRRs were conducted” and that “data mining is outside of th [sic] agency’s purview.” The validity of this assertion has recently been called into question.