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The U.S. Food and Drug Administration (FDA) is asking a federal judge to let it wait at least 18 more months before providing key analyses, conducted in 2021 and 2022, of the Vaccine Adverse Event Reporting System (VAERS) database.
Children’s Health Defense (CHD) on Wednesday filed a memo opposing the FDA’s request, which the agency made in response to a Freedom of Information Act (FOIA) lawsuit CHD filed in January.
Kim Mack Rosenberg, CHD acting general counsel, told The Defender:
“These records CHD is requesting are extremely important to the public because they are the only complete record of what the public health agencies have done to use VAERS the way that they say it is supposed to be used, which is as an early warning system for vaccine injuries.
“For them to continue to attempt to wriggle out of substantively responding to legitimate requests like CHD’s further erodes public confidence in these agencies — confidence that is already dropping among Americans, regardless of vaccination status.”
CHD first 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 Adverse Events of Special Interest, along with records of the FDA’s communications with VAERS staff and the Centers for Disease Control and Prevention (CDC) regarding that agency’s 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 “opinions, recommendations and policy discussions” protected by law.
CHD appealed that decision in November 2022, then followed up with a lawsuit after the FDA responded that it would take six months to a year — which far exceeds the time limit set under FOIA — to respond to the appeal.
Both parties issued joint updates, or “status reports” to the court in May and June on the FOIA process, in which the FDA indicated it had located 150 records related to the data mining and was still in the process of working on locating records related to the rest of the request.
However, instead of providing the 150 records or continuing to process the rest of the request, in an August update, the FDA told the court it planned to seek a stay of proceedings, known as an “Open America” stay.
The agency filed a motion on Sept. 14 to stay the proceedings for 18 months. The FDA did not dispute that CHD’s 14-month-old request is legally entitled to processing or indicate there was any problem with the request.
Instead, the FDA indicated it could not fulfill CHD’s 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.
The FDA did not commit to fulfilling CHD’s request after the proposed 18-month pause in proceedings. Instead, it said at that time it would let the court know “whether it needs additional time before proceeding with this case.”
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 (CBER) division that regulates vaccines for human use.
According to CHD, an increase in vaccine-related FOIA obligations was “entirely predictable given the FDA’s rapid grant of Emergency Use Authorization … and then full licensure to some COVID-19 injections, the safety concerns surrounding the shots from the outset, and the FDA’s own regulations, which make vaccine licensing information immediately available for public disclosure when a full license is granted.”
CHD asked the court to require the FDA to process the organization’s request in accordance with the law.
No ‘additional unexpected’ safety signals?
The FDA and the CDC promised to vigilantly monitor the safety of COVID-19 injections and to this day, the agencies’ message to the public is that the vaccines are “safe and effective.”
The two agencies jointly administer the VAERS database that allows healthcare professionals and others to file reports about vaccine-related injuries.
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.
More than 1.5 million adverse events following COVID-19 vaccination have been reported to VAERS in the less than three years since the first of the shots were made available in mid-December 2020.
The VAERS “Standard Operating Procedures for COVID-19,” published in January 2021, indicated the CDC and the FDA would coordinate monitoring for “potential new safety concerns for COVID-19 vaccines” by performing routine VAERS surveillance — “on a weekly basis or as needed.”
Each agency would use a different standard approach to data mining to screen for potential safety signals.
The CDC would run Proportional Reporting Ratio (PRR) data mining on a weekly basis, or as needed. The FDA would conduct a bi-weekly thorough manual review of serious adverse events and through empirical Bayesian data mining, which uses a statistical method to compare adverse events related to the COVID-19 vaccine with those related to non-COVID-19 vaccines in order to identify safety signals.
CHD and The Epoch Times both obtained the results of the CDC’s PRR data mining analysis through FOIA requests. The CDC analyzed adverse events reported from Dec. 14, 2020, to July 29, 2022.
The CDC issued multiple false statements on the data mining, before ultimately admitting it didn’t start performing the analysis until 2022 — more than one year after the Pfizer and Moderna vaccines were authorized.
The CDC’s analysis identified signals for hundreds of conditions, such as blood clotting in the lungs, intermenstrual bleeding, a lack of oxygen to the heart and even death.
According to emails sent by a CDC spokesperson to The Epoch Times, the CDC results “were generally consistent with [FDA’s] EB data mining, revealing no additional unexpected safety signals.”
It is the FDA’s analysis of the empirical Bayesian data that CHD wants the court to compel the FDA to release, along with communications about these findings.
The FDA’s limited ‘bandwidth’
The FDA is asking the court to halt the processing of CHD’s request until April 2025 at the earliest.
Its justification is that its Access Litigation and Freedom of Information Branch (ALFOI), the FOIA processing unit within CBER, is struggling to shoulder its current FOIA workload and it doesn’t have the “bandwidth” to process CHD’s request, according to Suzann Burk, director of the Division of Disclosure and Oversight Management within CBER.
Since 2019 and particularly in 2021, FOIA requests to ALFOI have increased, “exacerbated by requests for records related to the COVID-19 pandemic. Moreover, in fiscal year 2020, FOIA litigation cases also began to add significantly to ALFOI’s workload,” Burk said.
The FDA pointed specifically to the fact that the PHMPT lawsuits — mandating the FDA release the Pfizer documents and the Pfizer and Moderna documents regarding licensure of Comirnity and Spikevax for children ages 12-15 — were placing a heavy burden on the agency, which was compelled to release at least 35,000-55,000 pages per month.
Although it is doing its “due diligence” to fulfill CHD’s requests, it said, the FDA faces “exceptional circumstances” and therefore cannot do so for at least 18 months, if not more.
CHD pointed out that in fact FOIA requests to the FDA overall have actually decreased over the last three years.
Only requests to CBER’s ALFOI division have increased. Although the number of FOIA requests has been increasing since 2019, ALFOI did not begin adding more staff until 2022.
CHD also noted that the U.S. government has spent billions of dollars to promote the vaccine and that the FDA itself has an $8.4 billion budget and over 19,000 employees.
But rather than re-allocating its ample resources to support FDA’s legal responsibility to comply with FOIA by producing documents “promptly,” CHD wrote:
“FDA now seeks carte blanche to ignore the FOIA altogether: an eighteen-month stay with an unconditional option to renew and no mandate to take any steps towards processing CHD’s request in the meantime.”
Its own decision not to allocate sufficient resources to its work, wrote CHD, “does not entitle it to such extraordinary and unprecedented relief.”
Not doing so, CHD wrote, harms the public, which has an important interest in understanding how the FDA determines the safety of the COVID-19 vaccines, especially given that the number of adverse events submitted to VAERS has continued to grow since CHD submitted its request.
The FDA has received (and denied) at least two other FOIA requests for the EB mining records — one from the Informed Consent Action Network, and one from The Epoch Times — according to CHD’s memo, which have also gone unfulfilled.
And last month the agency refused to provide Sen. Ron Johnson (R-Wis.) with the EB mining data after he requested the analysis in January, The Epoch Times reported.
“FDA’s 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,” the agency told the Senator.
“FDA is unable to comment on pending litigation or provide information or data that is currently being considered in pending litigation,” it added.
Johnson told FDA Commissioner Robert Califf in a letter that the FDA could not withhold that information from him.
“As you are well aware, Congress has a right to information contained at U.S. federal agencies as it conducts its constitutional oversight responsibilities,” Johnson told The Epoch Times.
“It is outrageous that FDA would assert that pending litigation, and particularly FOIA litigation, would allow your agency to obstruct my congressional oversight,” he added.
