by Brenda Baletti, Ph.D., Childrens Health Defense:
Children’s Health Defense on Wednesday filed a memo opposing the U.S. Food and Drug Administration’s request that a federal judge give the agency at least 18 more months to provide key analyses, conducted in 2021 and 2022, of the Vaccine Adverse Event Reporting System, or VAERS, database.
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.
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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.
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