Sen. Johnson: CDC Must Immediately Provide Complete and Reliable Information about COVID-19 Vaccine Adverse Events

WASHINGTON – On Tuesday, U.S. Sen. Ron Johnson (R-Wis.) sent a letter to Dr. Rochelle Walensky, Director of the Centers for Disease Control and Prevention (CDC), regarding CDC’s repeated failure to provide complete data about the agency’s surveillance of COVID-19 vaccine adverse events and demanding further explanation of recently released information.

Sen. Johnson previously sent letters to the CDC on June 23, 2022, July 25, 2022 and September 12, 2022 seeking clarity about whether the agency is sufficiently monitoring COVID-19 vaccine adverse events. In June 2022, the CDC provided an incomplete response to a Freedom of Information Act (FOIA) request and claimed they did not conduct a Proportional Reporting Ratio (PRR) analysis, which was meant to identify vaccine adverse events. In July 2022, a CDC official on the agency’s Vaccine Safety Team 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.” 

On January 3, 2023, the Epoch Times published multiple PRR tables that contained data relevant to Sen. Johnson’s previous information requests that the CDC has refused to provide.

“These PRR tables appear to be responsive to my previous letters, and yet, the CDC continues to hide this and other information from my office and ultimately, the American people,” said Sen. Johnson.

In September 2022, the CDC responded to Sen. Johnson’s previous letter by claiming their PRR analysis revealed “no additional unexpected safety signals.”

“Given the ‘hundreds of adverse events’ listed in the published PRR tables, the CDC must explain how it determined what is and is not an ‘unexpected safety signal,’” Sen. Johnson wrote.

Read more about the letter in the Epoch Times.

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

January 10, 2023

 

Rochelle P. Walensky, MD, MPH

Director

Centers for Disease Control and Prevention

Dear Director Walensky:

 

              Since June 2022, despite multiple requests for information, the Centers for Disease Control and Prevention (CDC) has repeatedly failed to provide my office with complete data regarding its surveillance of COVID-19 vaccine adverse events.[1] 

My requests have included all Proportional Reporting Ratio (PRR) analyses since February 2021 that, according to CDC’s January 29, 2021 Standard Operating Procedures (SOP), is meant to “identify [adverse events] that are disproportionately reported relative to other [adverse events].”[2]  CDC has also failed to provide all Bayesian data mining described in 2.3.2 of the January 2021 SOP.[3]  As I noted in my September 12, 2022 letter to you, the only response CDC has provided to date—on September 6, 2022—ignored nearly all of my previous data requests and failed to explain why CDC made inconsistent statements about the data it generates to track COVID-19 vaccine adverse events.[4]

On January 3, 2023, the Epoch Times published multiple PRR tables that it reportedly obtained through a Freedom of Information Act (FOIA) request.[5]  According to the news outlet, the PRR analyses appear to show “hundreds of adverse events” potentially linked to the Moderna and Pfizer COVID-19 vaccines.[6]  These PRR tables appear to be responsive to my previous letters, and yet, CDC continues to hide this and other information from my office and ultimately, the American people.

In your September 6, 2022 response to my previous letters you wrote that the “results from PRR analysis were generally consistent with [Empirical Bayesian] data mining, revealing no additional unexpected safety signals.”[7]  Given the “hundreds of adverse events” listed in the published PRR tables, CDC must explain how it determined what is and is not an “unexpected safety signal.”[8]

The American people have a right to know the extent to which your agency was aware of and tracked COVID-19 vaccine adverse events.  Your lack of transparency is unacceptable.  Without immediately providing complete and reliable information about COVID-19 vaccine adverse events, you are obstructing Congressional oversight and leaving the public in the dark.  I expect you to provide a full response to this letter and to the requests in my June 23, July 25, and September 12, 2022 letters by no later than January 17, 2023.

Sincerely,

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[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

(enclosed); Letter from Senator Ron Johnson, to Rochelle Walensky, Director, Centers for Disease Control and Prevention, July 25, 2022, https://www.ronjohnson.senate.gov/services/files/D48FBED6-BDF3-4FB7-8B24-D52A2EDCE39E (enclosed), Letter from Senator Ron Johnson, to Rochelle Walensky, Director, Centers for Disease Control and Prevention, Sept. 12, 2022, https://www.ronjohnson.senate.gov/services/files/0CBE044E-4F2C-47F2-8272-4DB4F14D3359 (enclosed).

[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 11; see also Letter from Senator Ron Johnson, to Rochelle Walensky, Director, Centers for Disease Control and Prevention, July 25, 2022, https://www.ronjohnson.senate.gov/services/files/D48FBED6-BDF3-4FB7-8B24-D52A2EDCE39E at 2.

[3] 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 at 3.

[4] The CDC’s response is dated September 2, 2022, but the agency did not send it to my office until September 6, 2022.  Letter from Senator Ron Johnson, to Rochelle Walensky, Director, Centers for Disease Control and Prevention, Sept. 12, 2022, https://www.ronjohnson.senate.gov/services/files/0CBE044E-4F2C-47F2-8272-4DB4F14D3359.

[5] Zachary Stieber, EXCLUSIVE: CDC Finds Hundreds of Safety Signals for Pfizer and Moderna COVID-19 Vaccines, Epoch Times, Jan. 3, 2023, https://www.theepochtimes.com/health/exclusive-cdc-finds-hundreds-of-safety-signals-for-pfizer-and-moderna-covid-19-vaccines_4956733.html.

[6] Id.

[7] Letter from Rochelle Walensky, Director, Centers for Disease Control and Prevention, to Senator Ron Johnson, Sept. 2, 2022 (enclosed).

[8] Id.; Zachary Stieber, EXCLUSIVE: CDC Finds Hundreds of Safety Signals for Pfizer and Moderna COVID-19 Vaccines, Epoch Times, Jan. 3, 2023, https://www.theepochtimes.com/health/exclusive-cdc-finds-hundreds-of-safety-signals-for-pfizer-and-moderna-covid-19-vaccines_4956733.html.