Have health agencies conducted sufficient surveillance for COVI…

WASHINGTON – Last week, U.S. Sen. Ron Johnson (R-Wis.) sent a letter to Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, asking for information on whether the agency was doing enough surveillance side effects of the COVID-19 vaccine. A recent article noted that the CDC had not compiled all of the data on the adverse effects of the vaccines that it originally announced.

According to the CDC’s standard operating procedures (SOP) document dated January 29, 2021, the agency asserted that it would “perform [Vaccine Adverse Event Reporting System (VAERS)] monitoring to identify potential new safety issues for COVID-19 vaccines. Specifically, monitoring would include “the generation of tables summarizing automated data from VAERS form fields for individuals who received COVID-19 vaccines (e.g. age of vaccinee, type of COVID-19 vaccine, ‘adverse event)’.

The CDC reportedly failed to provide these charts and other monitoring data in response to a Freedom of Information Act (FOIA) request. The CDC said “no information was withheld [the FOIA] Release.”

The senator wrote“This raises questions about whether the CDC ever collected the vaccine safety information it originally claimed in the January 2021 SOP.”

Since the CDC did not generate the surveillance data it initially claimed, the senator called on the CDC to “explain why and detail who made the decision not to follow the SOP and when that decision was made.” socket”.

The full text of the letter is available here and below.

June 23, 2022

Rochelle P. Walensky, MD, MPH

Director

Centers for Disaster Control and Prevention

Dear Director Walensky:

I am writing about the Centers for Disease Control and Prevention (CDC) COVID-19 vaccine adverse event tracking. According to a recent article, the CDC did not provide documents responding to a Freedom of Information Act (FOIA) request regarding the CDC’s Standard Operating Procedures (SOP) document dated January 29, 2021.[1]

This SOP identified how the CDC and the Food and Drug Administration (FDA) would “perform [Vaccine Adverse Event Reporting System (VAERS)] monitoring to identify potential new safety issues for COVID-19 vaccines.[2] Specifically, monitoring would include “the generation of tables summarizing automated data from VAERS form fields for individuals who received COVID-19 vaccines (e.g. age of vaccinee, type of COVID-19 vaccine, ‘adverse event)’.[3] The FOIA request asked the CDC to provide these tables, but the agency did not.

For example, the CDC failed to produce all of the “weekly VAERS tables” listed in the January 29, 2021 SOP.[4] According to the SOP, these VAERS tables would consist of at least eight different tables, including “all reports [of adverse events] following COVID-19 vaccines by severity and selected brand name/manufacturer” and the “top 25 most frequently reported vaccines [adverse events].”[5] The CDC said these tables would be assembled “weekly” and “available every Monday.”[6] In response to the May 9, 2022 FOIA request, the CDC did not provide all of the requested tables and information.[7] The CDC, however, claimed that “no information was withheld from publication.” [8] This raises questions about whether the CDC ever collected the vaccine safety information it originally claimed in the January 2021 SOP.

In addition to the CDC’s inability to produce the full set of “weekly VAERS tables,” the CDC failed to provide other detailed data reports and assessments in the SOP. For example, the SOP stated that “the CDC will perform a proportional reporting ratio (PRR) analysis. . . to identify [adverse events] reported disproportionately compared to others [adverse events].”[9] The SOP also noted that “the CDC will perform PRR data mining on a weekly basis or as needed.”[10] However, in response to the May 9, 2022 FOIA request for these records, the CDC stated, “No PRRs were performed.[.]”[11]

The ability of public health agencies to track and warn the public about potential adverse events related to COVID-19 vaccines depends on these agencies performing routine and thorough data analysis. As discussed during the Oct. 22, 2020, Vaccine Surveillance Systems teleconference, a CDC official noted that the CDC and FDA plan to use VAERS to conduct “data mining.” . . every one to two weeks.[12] This official praised VAERS saying that it can “quickly detect safety signals and detect rare adverse events.”[13] Indeed, as of June 10, 2022, VAERS has reported 28,859 deaths worldwide following COVID-19 vaccination, with 7,890 or 27% of these deaths occurring on day 0, 1 or 2 post-COVID vaccination. -19.[14] Given the effectiveness of VAERS in “detecting safety signals”, it is unclear why the CDC did not generate all of the tables using VAERS and other surveillance data on adverse events from the COVID-19 vaccine, even though it had initially indicated that it would perform such tests.

In order to better understand the VAERS data produced by the CDC and its apparent decision not to compile certain data detailed in the SOP of January 29, 2021, please provide the following information:

  1. All documents requested in the May 9, 2022 FOIA request, #22-01479-FOIA, which included the following based on the January 29, 2021 SOP:[15]
    1. Copies of all “VAERS weekly tables” described in section 2.2.2 from February 1, 2021 to September 30, 2021 inclusive. These are described in the SOP document as follows: “Data tables demonstrating frequency, reporting reports and general characteristics will be generated automatically using predefined variables populated with VAERS data.”
    2. Copies of all tables, analyses, and reports generated as part of the “signal detection analyses” described in sections 2.3 of the SOP document (including PRRs described in section 2.3.1; Bayesian data mining described in section 2.3.2; the gross reporting reports described in section 2.3.3) from February 1, 2021 to September 30, 2021 inclusive.
    3. All tables, analyzes and reports generated as part of the “signal assessment” described in section 2.5 of the SOP document from February 1, 2021 to September 30, 2021 inclusive.
  2. If the CDC has not collected any of the above information, please explain why and detail who made the decision not to follow the SOP and when that decision was made.

Please provide this information as soon as possible, but no later than July 7, 2022. Thank you for your attention to this matter.

Sincerely,

###



[1] 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.

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

[4] 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; Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19, Centers for Disease Control and Prevention, January 29, 2021, https://www.cdc.gov/vaccinesafety/pdf/VAERS-v2 -SOP.pdf at 15.

[5] Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19, Centers for Disease Control and Prevention, January 29, 2021, https://www.cdc.gov/vaccinesafety/pdf/VAERS-v2 -SOP.pdf at 15.

[7] 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.

[8] Letter from Roger Andow, FOIA Agent, 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.

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

[11] Letter from Roger Andow, FOIA Agent, 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.

[12] Tom Shimabukuro, Presentation before the Vaccines and Related Biological Products Advisory (October 22, 2020), transcript available at https://www.fda.gov/media/143982/download, (See pages 95).

[14] United States Department of Health and Human Services (DHHS), Public Health Service (PHS), Centers for Disease Control (CDC) / Food and Drug Administration (FDA), Vaccine Adverse Event Reporting System (VAERS) 1990 – 06/10/2022 , CDC WONDER Online Database. Retrieved from http://wonder.cdc.gov/vaers.html on June 17, 2022 at 4:16:13 PM.

[15] FOIA request, May 9, 2022, https://jackanapes.substack.com/api/v1/file/44421d00-9c02-4fc9-9471-65fcdb24152c.pdf.