Login
A federal court on Thursday ordered the U.S. Food and Drug Administration (FDA) to respond to a series of questions, as part of an ongoing lawsuit Children’s Health Defense (CHD) filed against the agency to obtain documents related to reports on COVID-19 vaccine injuries in the Vaccine Adverse Event Reporting System (VAERS) database.
CHD sued the FDA in January 2023 for records of the data-mining analysis the agency conducted to identify safety signals in VAERS that might indicate links between the COVID-19 shots and adverse events.
CHD originally requested the information as part of a Freedom of Information Act (FOIA) request filed in July 2022, and denied by the FDA in October 2022.
The lawsuit alleged the FDA violated provisions of the FOIA by refusing to provide key analysis of reports in VAERS.
The FDA claimed the records are fully exempt from disclosure under FOIA. The agency later claimed it was overwhelmed by a high number of COVID-19 vaccine-related FOIA requests.
The FDA filed a motion in September 2023 requesting a stay of the lawsuit’s proceedings for 18 months. In January, the court granted a six-month stay, which CHD disputed in its June joint status report.
In Thursday’s order, delivered via email to CHD and FDA attorneys, Judge Randolph D. Moss of the U.S. District Court for the District of Columbia ordered the FDA to file a status report by Aug. 9, providing information including whether an overlap exists between the documents CHD requested and documents requested in other FOIA requests the FDA is processing.
Moss also ordered the FDA to provide its best estimate of when it can begin processing CHD’s FOIA request, and to outline the steps it has taken “to seek redress regarding the burdens” the agency faces due to the FOIA requests it is responding to, including the hiring of new employees for this purpose.
Thursday’s order came after a hearing July 8 during which Moss posed a similar set of questions to the FDA’s legal counsel. The FDA repeated its claim that the agency is overwhelmed with other FOIA requests, but said “the processing of FOIA requests has not stopped” despite this.
Attorneys for CHD, in turn, pointed to “a lack of due diligence” on the part of the FDA.
CHD will have 10 days after the FDA files its status report to respond, after which the court will decide whether to renew the existing stay or to order the FDA to begin processing CHD’s FOIA request.
Ray Flores, senior outside counsel for CHD, told The Defender he is “pleased to see the court put it upon the FDA to develop or at least explain its plan, since endless delays appear to be no longer acceptable.”
Flores added:
“The FDA’s response to vaccine-related FOIA requests has essentially remained at a standstill. The court took CHD’s arguments to heart that a proactive solution must be found to end this gridlock.
“By issuing this order the court sent a message that the public has a right to access such information and that an agency’s workload cannot stop the free flow of that information to the public.”
FDA slow-walking release of FOIA documents, claiming it is overwhelmed by requests
As part of its July 2022 FOIA request, CHD also requested records of any FDA review of Serious Adverse Events of Special Interest, records of the FDA’s communications with VAERS staff and the Centers for Disease Control and Prevention (CDC) about the CDC’s own COVID-19 vaccine safety monitoring, and records of follow-up investigations of safety signals.
In October 2022, the FDA claimed the records CHD sought were fully exempt from disclosure under FOIA laws because they contained “opinions, recommendations and policy discussions” protected by law and attorney-client privilege.
CHD appealed the FDA’s decision in November 2022 and sued the agency after the FDA said that it needed six months to a year — a period far exceeding the time limit specified by FOIA — to respond to the appeal.
In status reports jointly filed by CHD and the FDA in May and June 2023, the FDA said it had located 150 records related to the data mining and was still working on locating records related to the rest of the request.
Instead of providing these records or processing the rest of CHD’s request, the FDA stated in the August 2023 status report that it planned to seek a stay of proceedings, known as an “Open America” stay.
This led to the FDA’s September 2023 motion for an 18-month stay of the proceedings in the lawsuit.
In that motion, which CHD opposed, the FDA did not dispute that CHD’s request was legally entitled to processing or indicate any problem with the request.
The FDA did not commit to fulfilling CHD’s request after the 18-month stay. Instead, the agency said it would let the court know “whether it needs additional time before proceeding with this case.”
In October 2023, the FDA claimed it could not fulfill CHD’s FOIA request because it was overwhelmed by an increased number of vaccine-related FOIA requests since 2019, and in particular, by demands to meet the hefty production schedule for disclosing documents related to the Public Health and Medical Professionals for Transparency (PHMPT) lawsuits.
Those lawsuits require the FDA to release all documents related to licensing of the Pfizer-Comirnaty COVID-19 vaccine, and have led to the release of what are widely known as the “Pfizer documents.”
The FDA, which previously claimed, unsuccessfully, that it needed 75 years to process the documents requested by PHMPT, claimed in October 2023 that the processing of those documents was placing a heavy burden on the agency, as it was compelled to release at least 35,000-55,000 pages per month.
CHD responded that any problem managing its workload “is a problem of the FDA’s own making” in not assigning necessary personnel to the FOIA division of the Center for Biologics Evaluation and Research division that regulates vaccines for human use.
CHD asked the court to require the FDA to process CHD’s request in accordance with the law.
In Thursday’s ruling, the court ordered the FDA to specify “how many FDA employees are dedicated to responding to FOIA requests unrelated to the PHMPT II litigation” and “what steps, if any, has the agency taken to seek redress regarding the burdens imposed by [the PHMPT] litigation.”
This article was funded by critical thinkers like you.
The Defender is 100% reader-supported. No corporate sponsors. No paywalls. Our writers and editors rely on you to fund stories like this that mainstream media won’t write.
Documents may shed light on safety signals, investigations into adverse events
If and when they are released, the documents CHD requested may shed light on some statistical safety signals, regarding certain types of serious adverse events related to the COVID-19 shots.
The documents are also expected to provide key insights into follow-up investigations, if any, that the FDA should be conducting in collaboration with the CDC on the potential safety signals and reports of serious adverse events.
More than 1.6 million adverse events following COVID-19 vaccination have been reported to VAERS in the less than four years since the first shots were made available in mid-December 2020.
However, VAERS is likely undercounting the total number of adverse events and deaths following COVID-19 vaccination.
Last month, analyst Albert Benavides presented evidence indicating that numerous deaths following COVID-19 vaccination are “hidden” within VAERS and are not part of the official tally.
In November 2023, Benavides presented similar evidence related to VAERS figures regarding serious adverse events following COVID-19 vaccination.
A 2010 Harvard study found that less than 1% of all adverse events following vaccination are reported to VAERS.
The CDC considers VAERS to be a key “early warning system” for detecting unusual or unexpected patterns of adverse event reporting that can signal safety problems with a vaccine, which they are then meant to further investigate.
