Tuesday, November 14, 2023

Feds keep hidden books on vaccine injury reports, barely follow up: investigation - Greg Piper

 

​ by Greg Piper

Pfizer has about 1,000 more full-time employees than CDC doing "vaccine surveillance," British Medical Journal estimates. House COVID subcommittee expresses concern.

 

Federal public health agencies are reportedly withholding the most accurate and up-to-date reports of vaccine injury from the public, allegedly to protect privacy. Patients don't necessarily see it that way, and it's not clear the feds told Congress.

The Vaccine Adverse Events Reporting System, jointly managed by the CDC and FDA, has a secret "back end" privy only to regulators, an FDA official told advocates of VAERS reform nearly a year ago, according to a British Medical Journal investigation published Friday.

"Anything derived from medical records by law" cannot be included in the "front end system" accessible to the public, Narayan Nair, director of the Division of Pharmacovigilance, allegedly told advocates.

The public can see initial reports but not corrections or updates, such as "a formal diagnosis, recovery, or death," and those who filed reports cannot update them through VAERS, journalist Jennifer Block wrote for BMJ.

She also wrote the journal's investigation of cross-ideological concerns about so-called gender affirming care.

Patients would have to file Freedom of Information Act requests to see the "full record of their report," a Food and Drug Administration spokesperson told BMJ, whose investigation of "data integrity" issues in Pfizer's COVID-19 vaccine trial article was throttled by Facebook. University of Maryland pharmacy professor Peter Doshi is a senior editor.

While the Centers for Disease Control and Prevention told the journal the omissions were justified in the interest of "protecting patient confidentiality," BMJ noted the FDA maintains drug adverse-event and medical-device reporting systems that, unlike VAERS, provide the public access to updated reports.

 

The journal also estimated that Pfizer has about 1,000 more full-time employees than the CDC tasked with "vaccine surveillance," citing FOIA requests it had viewed and Pfizer's last public accounting of its adverse-event hiring plans from February 2021. 

The CDC declined to give BMJ current staff numbers, just a range of "several dozen to hundreds" tasked with vaccine surveillance depending on "the needs of" the Immunization Safety Office, whose last specific figure of 70-80 workers is a year old.

As a passively monitored system open to public reports, VAERS appears to give regulators an excuse to brush off politically inconvenient "safety signals" even though vaccine makers and healthcare providers – required by law to report potential injuries – file most of the reports in the system.

CDC researchers minimized their own findings in March 2022 that 1.3% of VAERS reports cited death followed mRNA COVID vaccination.

 

 

The House Oversight Committee's Select Subcommittee on the Coronavirus Pandemic "is committed to investigating all COVID-19 failures," a spokesperson told Just the News when asked whether panel members knew of the two-tiered VAERS system and alleged staffing shortages.

"At our hearing with former CDC Director Rochelle Walensky in June, she assured SSCP members that the CDC will 'review all of the things that come into the Vaccine Adverse Event Reporting System,'" the spokesperson wrote in an email. "If staffing shortages are preventing the CDC from reviewing VAERS data and sharing accurate information with Americans, the CDC must be held accountable."

A spokesperson for House Energy and Commerce Committee Chairwoman Cathy McMorris Rodgers, R-Wash., referred Just the News to a colleague who did not respond. 

The committee oversees the public health agencies and threatened to subpoena the FDA last week for withholding documents "regarding experiments involving virus manipulation, which the FDA has acknowledged occurred in some of its research studies."

 

 

A fuller public accounting of vaccine injuries could be instrumental in litigation that is already ramping up.

The Justice Department is accepting applications through Nov. 30 for eight new trial attorneys to represent the Department of Health and Human Services in National Childhood Vaccine Injury Act lawsuits in the U.S. Court of Federal Claims.

A federal lawsuit alleges the Countermeasures Injury Compensation System violates the Fifth and Seventh amendments by depriving alleged COVID vaccine victims of "basic due process protections, transparency, and judicial oversight."

The eight plaintiffs and vaccine injury support group React19 want "the right to review evidence, obtain discovery, present expert witnesses and appeal adverse decisions," Reuters reported last month.

UCLA researcher Patrick Whelan told BMJ that his VAERS report on a 7-year-old, who was initially hospitalized for cardiac arrest after COVID vaccination, was not updated to reflect the boy's death.

"I made the false assumption" that my half-hour conversation with the FDA's Nair and a "press officer," six weeks after I complained about the lack of followup to his initial report, "would result in an adjustment in the publicly reported case," Whelan told Block.

 

The BMJ investigation rang true to vaccine injury advocate Renée Capo.

After sending "all my medical records & proof of my #vaccineinjuries with diagnosis’s my original report is all that you can see on the VAERS website!" Capo wrote on X, formerly Twitter. "You have only a very small amount of time & it was my 5th or 6th attempt" trying to file the original report before the system timed out, she wrote.

The frequency of system timeouts is one reason why initial reports may be short on detail.

Robert Sullivan, a 49-year-old Maryland ski buff, told Block about his similar race to successfully file a report about collapsing on the treadmill three weeks after his second COVID vaccine dose.

Sullivan said he didn't hear back from the feds for a year, a situation repeated by interviewees including James Gill, the chief medical examiner for Connecticut, who has appointments at Yale and the University of Connecticut.

The CDC's first response to Gill's first-ever VAERS report, about a 15-year-old boy who died of "stress cardiomyopathy" days after his second Pfizer dose, came in a letter to the editor of the Archives of Pathology & Laboratory Medicine contesting Gill's case reports, according to BMJ.

OpenVAERS, a private anonymous entity that takes public VAERS data and makes it "more user friendly," said it flagged the signs of VAERS omissions starting more than a year before BMJ.

 

 

While it could tell the exported files were "pushed from a larger and more complete Database," OpenVAERS said in August 2022 it didn't realize the extent until a whistleblower provided screenshots that showed the missing data, including race, ethnicity and pregnancy status. The CDC even referred to race data in a December 2021 VAERS presentation.

Publishing full race data could reveal that black Americans have higher-than-average vaccine injury rates, OpenVAERS speculated, citing similar numbers of VAERS reports by blacks and Asians in the CDC presentation but a much lower vaccination rate among the former.

OpenVAERS' April 2023 update noted that a CDC vendor contract, obtained under FOIA and covering services from 2014-2018, showed the government had received nearly 33,000 more reports since VAERS' creation than were actually reflected in VAERS as the public could see it. 

The contract explicitly requires the vendor to "clearly" segregate information at followup from the original VAERS report, a provision that "makes it impossible for independent researchers to accurately assess vaccine safety in this country," OpenVAERS said.

The FDA acknowledged a Just the News query but did not answer questions. The CDC didn't respond.

 

Greg Piper

Source: https://justthenews.com/government/federal-agencies/feds-keep-hidden-books-vaccine-injury-reports-barely-follow

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