Court Pauses CHD Lawsuit, Gives FDA Until April 2025 to Hand Over Analysis of COVID Vaccine Injuries
The Freedom of Information Act lawsuit brought by Childrenâs Health Defense seeks records relating to the U.S. Food and Drug Administrationâs analysis of adverse events related to COVID-19 vaccines, based on the agencyâs active monitoring of large healthcare databases.

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A federal court last week granted the U.S. Food and Drug Administrationâs (FDA) request to pause legal proceedings until April 2025 in a Freedom of Information Act (FOIA) lawsuit brought by Childrenâs 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 agencyâs 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 FDAâs 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 â documents that it was legally required to make immediately available for public disclosure upon granting the licensesâ it simply doesnât have the âbandwidthâ to address any other âcomplexâ 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.
âIt 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 agencyâs actions and inactions during the COVID-19 pandemic,â Kim Mack Rosenberg, acting general counsel for CHD, told The Defender.
âAllowing the FDA to dodge accountability lays the groundwork for similar secrecy in the future as FDA continues to hide the ball,â 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 Preventionâs (CDC) analysis of reports made to the Vaccine Adverse Event Reporting System (VAERS).
A court granted the stay in ICANâs case. A decision on the requested stay in CHDâs case is still pending.
The lawsuit in which the judge granted a staylast 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 âspecial interestâ because they identify side effects the agency believes might be caused by the shots.
In addition to VAERS â a passive system where people report data that the agencies analyze â 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:
âActive 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.â
CHD argued in its opposition memo that the FDAâs 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:
âInformation about FDAâs 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.â
However, the court sided with the FDA, agreeing that it is entitled to an âOpen Americaâ 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 âdue diligenceâ to meet those demands and it faces âexceptional circumstancesâ that could not have been anticipated in which to do so.
CHD argued the FDA is not demonstrating due diligence and that the âexceptional circumstancesâ 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., CHDâs 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:
âThe gold standard of post-marketing surveillance of vaccine safety is CDCâs Vaccine Safety Datalink, which is safely tucked away at the CDC â like Fort Knox â from any independent scientists. This is despite the fact that it is supported by $30 million per year of taxpayer dollars.
âThe 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.
âIf 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.
âWhat is it that theyâre actually hiding?â
âA problem of the FDAâs own makingâ
In early 2021, the FDA began an active safety-monitoring program to investigate possible causal links between COVID-19 shots and certain AESIs.
In September 2022, CHD submitted a FOIA requesting the FDAâs records related to that investigation, but the FDA never provided the records.
Shortly after CHD submitted its request, the FDA said it may not be able to respond within the 20-30 day time limit allowed under FOIA and it also denied CHDâs expedited processing request.
FDA failed to respond to several follow-up inquiries, although it did indicate CHDâs request was clear and didnât need any further clarification. It also informed CHD the request had been assigned to its ââcomplexâ queueâ and wouldnât be assigned for processing for at least 24 months.
In August, CHD filed a lawsuit seeking to compel FDA to process the request.
Today, CHDâs request is stuck in the FDAâs âcomplex processing queue,â which the complaint says is one of six queues maintained by the Access Litigation and Freedom of Information Branch (ALFOI).
ALFOI is the FOIA-processing subdivision of the Center for Biologics Evaluation and Research (CBER), the center in the FDA that regulates vaccines.
The FDA alleges that ALFOI is struggling to meet its current FOIA obligations because it has received a substantially higher number of requests since 2019 and in particular, the burden of meeting the Public Health and Medical Professionals for Transparency(PHMPT) FOIA lawsuits â mandating the FDA release the Pfizer documents and the Pfizer and Moderna documents regarding licensure of Comirnity and Spikevax shots â were placing a heavy burden on the agency, which was compelled to release at least 35,000-55,000 pages per month.
CHD argued, in opposition, that âthe challenge ALFOI faces in managing its current workload is a problem of the FDAâs own making,â and it does not exempt the FDA from its responsibility to produce documents requested under FOIA âpromptly.â
The agency is responsible for delegating the work in such a way as to meet those requests, CHD wrote.
CHDâs request is âlocked in cold storageâ at FDA
The FDA claimed it is exercising âdue diligenceâ to respond to CHDâs request, but is struggling under the weight of increased caseloads and lawsuits.
However, attorneys for CHD said a closer look at agency-wide FOIA metrics since 2014 paints a different picture.
First, the average number of FOIAs has not increased steadily but rather has gone up and down.
The FDA increased the number of staff dedicated to processing FOIAs from approximately 120 full-time people in 2014 to 163 in 2022. Spending on FOIA requests by the FDA has dropped sevenfold since 2014 and the average time of response has increased.
Since 2021, the backlog for requests and the number of administrative appeals to compel compliance have increased.
When the FDA receives a FOIA request, the agency assigns it to the subdivision that maintains the records sought â in this case, the request went to ALFOI at CBER, where all vaccine-related requests go.
Only the number and complexity of requests to CBERâs ALFOI division have increased continually since early 2020, but the FDA did not begin adding more staff there until 2022.
When ALFOI receives requests, it places them in one of six different processing queues based on the volume, complexity or subject matter. CHDâs request was placed in the âcomplexâ line, which contains requests that the FDA deems will require extensive time to process.
By the end of fiscal year 2022, according to the FDA, ALFOI had a backlog of 532 requests in total and 370 of them were in the âcomplex processing queue.â
âThat isâ CHD wrote, âthe complex processing queue contained at least 70% of the total backlog for all six ALFOI queues, and 9% of the FDAâs entire FOIA backlog.â
The FDA claimed it is exercising âdue diligence,â but the demands are simply too high.
CHD countered that the U.S. attorney generalâs own FOIA guidelines state that âTimely disclosure of records is ⊠essential to the core purpose of FOIA.â It added that the Open America lawsuit the FDA cites as grounds for delaying the lawsuit itself stated âexcessive delay by the agency in its response is often tantamount to denial.â
CHD alleged the problem lies in how the FDA organizes its work to process the requests, not in the number of requests. Decisions made at the FDA demonstrate a lack of due diligence that leaves FOIA requests within ALFOIâs complex processing queue unattended.
It wrote:
âThe [FDAâs] declaration does not address the question of how many individuals within ALFOIâs limited workforce the FDA has dedicated to processing the backlog, but the answer appears to be straightforward: not enough.
âIndeed, given the 24-plus-month wait before requests in the complex queue are even assigned for processing, âprocessing queueâ is a misnomer; âlocked in cold storageâ more aptly describes the status of ALFOIâs complex requests.
âThe fact that ALFOI assigns incoming requests to one of six processing queues does not show due diligence, where one of the queues is virtually at a standstill.â
âFDAâs excuses ring hollowâ
To justify an Open America stay, the FDA must show it faces âexceptional circumstancesâ â which means it has experienced a âdelugeâ of requests that exceeds what would have been anticipated and that its existing resources are inadequate to deal with such a volume.
Congress was specific in making this definition narrow â it does not apply to a predictable agency workload of requests. The agency must show the number of requests is âtruly unforeseen and remarkable,â according to CHDâs memo.
But, CHD alleged, given that the number of average requests has decreased annually, the workforce has grown and the costs have gone down, the FDA canât reasonably argue overall that it faces exceptional circumstances.
Further, the current workload was not âunforeseen.â
âFor over three and a half years, the FDA has been aware of the publicâs keen interest in the agencyâs pandemic-related activities and of CBERâs activities in particular, and aware of the need to obtain and allocate sufficient resources,â CHD wrote.
The production levels associated with the PHMPT litigation â the primary basis for the FDAâs claim â is also not a surprise, it said, because the FDAâs own regulations say that when the FDA approves a vaccine, licensing information must be immediately available for public disclosure.
The FDA has known from the outset that when it licensed the COVID-19 vaccines, it would have to disclose records regarding safety and effectiveness data, study protocols, and adverse reaction reports publicly and also that requests for licensing records would go to CBER, where ALFOI would face that work, CHD wrote.
The need for greater staff became even more obvious, CHD alleged, when PHMPT submitted a FOIA requesting those records on Aug. 27, 2021, and ultimately on Jan. 6, 2022, when the court denied the FDAâs request for 75 years to produce the records.
Similar requests and lawsuits, CHD argued, should not have come as a surprise to the FDA, nor should the need for more staff within ALFOI.
CHD added that the FDAâs $8.4 billion budget â a $54 million increase over 2022 â FDA didnât lack resources to meet the request or time to redirect resources toward meeting ALFOI FOIA demands.
âOpen America does not give the agency license to shift the cost of its mistakes to CHD,â the complaint said.
Rosenberg said CHDâs request was a straightforward one and the courtâs decision was concerning.
âCHD did not ask the court to micromanage the FDA but simply asked the court to appropriately apply well-established legal standards concerning federal agenciesâ obligations under FOIA,â she said. âFDAâs excuses ring hollow and the court having accepted them and not requiring transparency from FDA is deeply concerning,â she added.
FDA also seeking âOpen Americaâ stay in CHDâs FOIA lawsuit for VAERS analysis
CHD is still waiting for the judgeâs decision in another pending FOIA lawsuit against FDA. In that case, the FDA is again asking a federal judge to let it wait at least 18 more monthsbefore providing key analyses, conducted in 2021 and 2022, of the VAERS database.
In that case, CHD filed a FOIA request in July 2022, asking the FDA 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 also requested records of any FDA review of serious AESIs, along with records of the FDAâs communications with VAERS staff and the CDC regarding that agencyâs own COVID-19 vaccine safety monitoring, and records of follow-up investigations of safety signals.
In October 2022, the FDA told CHD it would not provide any of the information, claiming the information was exempt because it contained âopinions, recommendations and policy discussionsâ protected by law.
CHD appealed that decision in November 2022 and then followed up with a lawsuit. FDA is also seeking an Open America stay in that case.
The FDA has received (and denied) at least two other FOIA requests for the Empirical Bayesian (EB) data mining records â one from ICAN, and one from The Epoch Times â according to CHDâs memo in that case, which have also gone unfulfilled.
And the agency in September refused to provide Sen. Ron Johnson (R-Wis.) with the data-mining analysis after he requested it in January, The Epoch Times reported.
âFDAâs EB data mining analyses of adverse events contained in VAERS reports for COVID-19 vaccines are currently the subject of pending FOIA [Freedom of Information Act] litigation,â the agency told the Senator.
âFDA is unable to comment on pending litigation or provide information or data that is currently being considered in pending litigation,â it added.
Johnson told FDA Commissioner Robert Califf in a letter that the FDA could not withhold that information from him.
âAs you are well aware, Congress has a right to information contained at U.S. federal agencies as it conducts its constitutional oversight responsibilities,â Johnson told The Epoch Times.
âIt is outrageous that FDA would assert that pending litigation, and particularly FOIA litigation, would allow your agency to obstruct my congressional oversight,â he added.
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