Sen. Johnson Points Out Conflicting CDC Statements on Surveillance of COVID-19 Vaccine Adverse Events

WASHINGTON – On Monday, U.S. Sen. Ron Johnson sent a follow-up letter to Rochelle Walensky, Director of the Centers for Disease Control and Prevention (CDC), demanding clarity on whether the agency performed sufficient surveillance of COVID-19 vaccine adverse events. Recent conflicting statements by CDC officials about monitoring adverse events called into question CDC’s integrity and transparency.

In a June 2022 letter to the CDC, Sen. Johnson outlined the CDC’s Standard Operating Procedures (SOP) document dated January 29, 2021, in which the agency claimed it would “perform routine [Vaccine Adverse Event Reporting System (VAERS)] surveillance to identify potential new safety concerns for COVID-19 vaccines.”  The SOP also stated that the “CDC will perform Proportional Reporting Ratio (PRR) analysis . . . to identify [adverse events]” and “perform PRR data mining on a weekly basis or as needed.”

However, in response to a May 9, 2022 Freedom of Information Act (FOIA) request, the CDC wrote, “no PRRs were conducted.”

Dr. John Su, a CDC official on the agency’s Vaccine Safety Team, recently said the opposite to a media outlet claiming that the “CDC has been performing PRRs since Feb 2021, and continues to do so to date.”

The senator wrote, “CDC’s assertion and Dr. Su’s statement cannot both be true.”

“The American people deserve the truth and you have not been providing it. That is why I, together with millions of Americans, have completely lost faith in the CDC and other federal health agencies. It is time to start regaining their confidence and your agency’s integrity by coming clean, being transparent, and telling the truth,” the senator added.

Read more about the letter in the Washington Examiner.

The full text of the letter can be found here and below.

 

July 25, 2022

Rochelle P. Walensky, MD, MPH

Director

Centers for Disease Control and Prevention

 

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).[1]  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.”[2]  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.[3]

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].”[4]  The SOP also stated that, “CDC will perform PRR data mining on a weekly basis or as needed.”[5]  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.”[6]

                The validity of this assertion has recently been called into question.  Although CDC claimed that “no PRRs were conducted,” Dr. John Su, a CDC official that works on the Vaccine Safety Team, reportedly told a media outlet that “CDC has been performing PRRs since Feb 2021, and continues to do so to date.”[7]  CDC’s assertion and Dr. Su’s statement cannot both be true.

                The American people deserve the truth and you have not been providing it. That is why I, together with millions of Americans, have completely lost faith in the CDC and other federal health agencies.  It is time to start regaining their confidence and your agency’s integrity by coming clean, being transparent, and telling the truth.

                Accordingly, please provide an immediate and complete response to my June 23, 2022 letter and the following information by no later than July 29, 2022:

  1. Is Dr. Su’s statement that “CDC has been performing PRRs since Feb 2021, and continues to do so to date” true?[8]
    1. If so, why did CDC claim that “no PRRs were conducted” in response to a May 9, 2022 FOIA request?[9]
    2. If Dr. Su’s statement is true, please provide all of the PRRs performed since February 2021.
  2. Please make Dr. Su available for an interview with my office to discuss the types of surveillance CDC has performed regarding COVID-19 vaccine adverse events and the data CDC has generated based on its surveillance.

Thank you for your attention to this important matter.

Sincerely,

###



[1] Letter from Senator Ron Johnson, to Rochelle Walensky, Director, Centers for Disease Control and Prevention, June 23, 2022, https://www.ronjohnson.senate.gov/services/files/9914278B-A73B-4434-8349-91091138E18B.

[2] Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19, Centers for Disease Control and Prevention, Jan. 29, 2021, https://www.cdc.gov/vaccinesafety/pdf/VAERS-v2-SOP.pdf at 3.

[3] Josh Guetzkow, New FOIA Release Shows CDC Lied About Its VAERS Safety Monitoring Efforts, Substack, June 16, 2022, https://jackanapes.substack.com/p/new-foia-release-shows-cdc-lied-about.

[4] Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19, Centers for Disease Control and Prevention, Jan. 29, 2021, https://www.cdc.gov/vaccinesafety/pdf/VAERS-v2-SOP.pdf at 11.

[5] Id. at 16.

[6] Letter from Roger Andoh, FOIA Officer, Centers for Disease Control and Prevention, to Divyanshi Dwivedi, Children’s Health Defense, June 16, 2022, https://jackanapes.substack.com/api/v1/file/afc9ad6a-9330-4a80-a2c2-5f3bde28422e.pdf.

[7] Zachary Stieber, EXCLUSIVE: CDC Says It Performed Vaccine Safety Data Mining After Saying It Didn’t, Epoch Times, July 23, 2022, https://www.theepochtimes.com/exclusive-cdc-says-it-performed-vaccine-safety-data-mining-after-saying-it-didnt_4617563.html; John Su, Advisory Committee on Immunization Practices, Vaccine Safety Team, Centers for Disease Control and Prevention, Jan. 5, 2022, https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-01-05/02-covid-su-508.pdf.

[8] Zachary Stieber, EXCLUSIVE: CDC Says It Performed Vaccine Safety Data Mining After Saying It Didn’t, Epoch Times, July 23, 2022, https://www.theepochtimes.com/exclusive-cdc-says-it-performed-vaccine-safety-data-mining-after-saying-it-didnt_4617563.html.

[9] Letter from Roger Andoh, FOIA Officer, Centers for Disease Control and Prevention, to Divyanshi Dwivedi, Children’s Health Defense, June 16, 2022, https://jackanapes.substack.com/api/v1/file/afc9ad6a-9330-4a80-a2c2-5f3bde28422e.pdf.