Children's Health Defense By
The Centers for Disease Control and Prevention (CDC) told Children’s Health Defense (CHD) the agency has no records of certain internal email communications about the agency’s follow-up investigation of safety signals associated with COVID-19 vaccines.
In its response to CHD’s Freedom of Information Act (FOIA) request seeking key communications records associated with the agency’s analysis of safety signals in its Vaccine Adverse Event Reporting System (VAERS), the CDC said that “after a careful search of program emails,” it didn’t uncover any relevant documents.
“If the CDC carried out the follow-up investigations on safety signals detected in VAERS as described in the Standing Operating Procedures document for COVID-19, the agency should be able to provide CHD with the requested email communications and response plans,” Risa Evans, the CHD staff attorney who submitted the FOIA request told The Defender.
“The public would certainly benefit if the CDC and the FDA [U.S. Food and Drug Administration] made records of all their vaccine safety-monitoring activities fully available — regularly, and as a matter of course,” Evans said. “Unfortunately, even though the Freedom of Information Act requires transparency with respect to many of these records, actually obtaining them from the agencies is a challenge.”
CHD last week appealed the CDC’s response, alleging that the agency’s initial search was insufficient, and it should check again.
“If the activities occurred, then the records exist, and the CDC should conduct the searches necessary to locate these records, which are clearly identified in the original FOIA request,” the appeal letter said.
In its appeal, CHD asked the CDC to conduct another thorough search within 20 days and provide a list of search terms and the accounts or domains searched.
According to the CDC and FDA protocols established in January 2021 as part of the VAERS Standing Operating Procedures, the agency should have been monitoring the database for safety signals and investigating those signals when they emerged.
The procedures document outlines the CDC’s VAERS surveillance protocols for the COVID-19 shots, including data processing, coding and follow-up, signal detection, and signal assessment.
As part of those protocols, the agency indicated that when it identified a safety signal warranting further investigation, the CDC’s VAERS team would notify leadership at the Immunization Safety Office (ISO), the FDA and other relevant agencies and develop a coordinated response plan.
It also said the ISO would notify the Vaccine Task Force and the leadership at the National Center for Immunization and Respiratory Diseases, a subagency of the CDC, about any follow-up investigation after a signal was detected.
CHD asked the agency to search all locations, departments and systems likely to have records related to some of these communications. It requested the relevant notifications from the VAERs teams to the ISO leadership and all coordinated response plans and notifications from ISO leadership to the other entities.
In the original FOIA request, CHD also asked for VAERS data review summaries that the procedures document says the CDC will provide to relevant stakeholders. In response, the CDC sent a list of presentations made to the CDC’s vaccine advisory committee since 2021. The response also included a list of publications on COVID-19 vaccine safety monitoring.
This information was already publicly available…
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