A federal court last week granted the U.S. Food and Drug Administration’s (FDA) request to pause legal proceedings until April 2025 in a Freedom of Information Act (FOIA) lawsuit brought by Children’s Health Defense (CHD) against the agency.
CHD sued the FDA after the agency failed to respond to a FOIA request submitted in September 2022, seeking records relating to the agency’s active monitoring of large healthcare databases, including insurance claims databases, for analysis of some adverse events reported after the COVID-19 shots.
This is at least the third FOIA lawsuit seeking the FDA’s analysis of adverse events possibly linked to the COVID-19 shots where the FDA has asked the judge to pause proceedings until 2025, and the second, so far, where the judge has agreed.
The agency claims that given the hefty demands of the court-ordered release of FOIA documents related to the licensing of the Pfizer and Moderna shots — documents that it was legally required to make immediately available for public disclosure upon granting the licenses — it simply doesn’t have the “bandwidth” to address any other “complex” FOIA requests related to the COVID-19 vaccines until at least mid-2025.
Federal agencies typically have 20-30 business days to respond to FOIA requests.
“It is disappointing that a court again has agreed the FDA can circumvent its obligations to timely respond to FOIA requests, preventing CHD and U.S. citizens access to documents of critical importance to understanding the agency’s actions and inactions during the COVID-19 pandemic,” Kim Mack Rosenberg, acting general counsel for CHD, told The Defender.
“Allowing the FDA to dodge accountability lays the groundwork for similar secrecy in the future as FDA continues to hide the ball,” she added.
The other two lawsuits, filed by the Informed Consent Action Network (ICAN) and CHD, requested documentation related to the FDA and Centers for Disease Control and Prevention’s (CDC) analysis of reports made to the Vaccine Adverse Event Reporting System (VAERS).
A court granted the stay in ICAN’s case. A decision on the requested stay in CHD’s case is still pending.
The lawsuit in which the judge granted a stay last week seeks FDA analysis of a different dataset.
The FDA in early 2021 began an active-safety monitoring program to investigate possible causal links between the COVID-19 shots and certain symptoms or events called adverse events of special interest (AESI). AESIs are of “special interest” because they identify side effects the agency believes might be caused by the shots.
In addition to VAERS — a passive system where people report data that the agencies analyze — the FDA also proactively seeks out and analyzes millions of records contained in large healthcare data systems.
It analyzes that data to see if there are safety signals for AESIs, which allows it to verify safety issues identified elsewhere and detect additional signals it may not find in VAERS.
In FDA protocols established in February 2021, the agency underscored the importance of active monitoring:
“Active monitoring is essential because it allows us to assess potential associations between vaccine exposure and adverse events in near-real time, determine if more comprehensive analyses should be conducted, and provide timely information to support regulatory decision-making processes.”
CHD argued in its opposition memo that the FDA’s continuing failure to produce the requested records puts the public, which needs to know about problems with the shots to make informed decisions, at risk, writing:
“Information about FDA’s active investigation of possible causal links between COVID-19 injections and adverse events remains important for members of the public, who are still faced with decisions about whether to take COVID-19 shots and boosters, whether to vaccinate their children, and whether to politically support vaccine mandates.”
However, the court sided with the FDA, agreeing that it is entitled to an “Open America” stay, which can be granted to allow an agency time to process a FOIA in its existing backlog when the agency shows it is exercising “due diligence” to meet those demands and it faces “exceptional circumstances” that could not have been anticipated in which to do so.
CHD argued the FDA is not demonstrating due diligence and that the “exceptional circumstances” the FDA faces, where it is required to attend to an increased number of FOIA requests regarding the COVID-19 vaccine, were entirely predictable.
Brian Hooker, Ph.D., CHD’s senior director of science and research, told The Defender it is essential for scientists to have access to FDA and CDC data in order to do their own analysis of the real effects of the vaccines.
Hooker said:
“The gold standard of post-marketing surveillance of vaccine safety is CDC’s Vaccine Safety Datalink, which is safely tucked away at the CDC — like Fort Knox — from any independent scientists. This is despite the fact that it is supported by $30 million per year of taxpayer dollars.
“The only recourse for these scientists would be FOIAing the AESI data from FDA, which is much more comprehensive than the woefully under-reported, much maligned CDC VAERS database.
“If the federal government was interested in transparency in any way, shape, or form, they would execute this FOIA request in a timely fashion and open up the Vaccine Safety Datalink to independent scientists…
Children's Health Defense 
