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What federal health agencies aren't disclosing about COVID-19 vaccines

WND 

[Editor's note: This story originally was published by The Daily Signal.] By Fred Lucas The Daily Signal For more than two years, Sen. Ron Johnson, R-Wis., has pushed federal health agencies for more information about adverse reactions to the COVID-19 vaccines—and about the agencies’ efforts to censor criticism. Johnson said it was “beyond despicable,” for…

The post What federal health agencies aren't disclosing about COVID-19 vaccines appeared first on WND.

[Editor's note: This story originally was published by The Daily Signal.]

By Fred Lucas
The Daily Signal

For more than two years, Sen. Ron Johnson, R-Wis., has pushed federal health agencies for more information about adverse reactions to the COVID-19 vaccines—and about the agencies’ efforts to censor criticism.

Johnson said it was “beyond despicable,” for example, that the U.S. Food and Drug Administration could be “actively hiding information about vaccine safety signals from Congress and the American people.”

In one case, the FDA replied that Johnson couldn’t have the requested information because of pending litigation. In other cases, the Wisconsin Republican got vague answers. In most, though, he got no response at all.

So, Johnson will hold a forum Monday with a provocative title: “What Are Federal Health Agencies and the COVID Cartel Hiding?” The event will begin at 9 a.m. in the Senate Russell Office Building on Capitol Hill.

“The COVID pandemic has opened many eyes to the failure and corruption of the global elite and their institutions, including government,” Johnson, ranking member of the Senate Homeland Security Committee’s permanent subcommittee on investigations, told The Daily Signal in a written statement. “Unfortunately, many eyes remain closed and the global elite will use all of their power to keep them closed.”

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The bulk of Johnson’s requests to the Department of Health and Human Services, the Centers for Disease Control and Prevention, and the Food and Drug Administration pertained to what is called the Vaccine Adverse Event Reporting System. Also known as VAERS, the system includes data on injuries, deaths, and other complications reported after someone gets a shot with one of the COVID-19 vaccines.

Back on June 23, 2022, Johnson wrote to then-CDC Director Dr. Rochelle Walensky about tracking adverse events springing from the COVID-19 vaccines.

Johnson referenced standard operating procedures for the CDC and the FDA on these adverse events. Those procedures say each agency would perform “surveillance to identify potential new safety concerns for COVID-19 vaccines.”

That surveillance was to include “generating tables summarizing automated data from fields on the VAERS form for persons who received COVID-19 vaccines.”

Johnson said the Centers for Disease Control and Prevention failed to produce these tables.

Johnson referred to a May 2022 response from the CDC to a Freedom of Information Act request asserting that “no PRRs were conducted” and that “data mining is outside of th [sic] agency’s purview.”

PRR refers to a proportional reporting ratio for adverse events. CDC’s standard operating procedures say the agency “will perform PRR data mining on a weekly basis or as needed.”

Just two days later, Johnson wrote again to Walensky, CDC’s director, referring to a story in The Epoch Times that contradicted the agency’s initial claims.

“Although CDC claimed that ‘no PRRs were conducted,’ Dr. John Su, a CDC official that works on the Vaccine Safety Team, reportedly told a media outlet that ‘CDC has been performing PRRs since Feb 2021, and continues to do so to date,’” Johnson wrote Walensky. “CDC’s assertion and Dr. Su’s statement cannot both be true.”

The Wisconsin Republican’s June 25 letter asks: “Is Dr. Su’s statement that ‘CDC has been performing PRRs since Feb 2021, and continues to do so to date’ true?” It also states: “Please make Dr. Su available for an interview with my office to discuss the types of surveillance CDC has performed regarding COVID-19 vaccine adverse events and the data CDC has generated based on its surveillance.”

In September, Walensky responded to Johnson’s two June letters, saying the Centers for Disease Control and Prevention relies on a new metric, the Empirical Bayes method, rather than proportional reporting ratios.

“CDC and the Food and Drug Administration (FDA) chose to rely on Empirical Bayesian (EB) data mining—a more robust technique used to analyze disproportionate reporting—rather than PRR calculations to mitigate potential false signals,” Walensky replied to Johnson in her letter.

“CDC consistently performs extensive data collection and analysis to direct potential adverse events and safety signals and then communicates this information to the public,” Walensky added later.

Johnson wrote back Sept. 12 about what he called the CDC director’s “inadequate and unacceptable response,” saying she didn’t explain the “inconsistent statements about the data.”

“This data should be made public immediately to better inform the American people about risks of specific adverse events relating to the COVID-19 vaccines,” Johnson wrote. “Your lack of clarity calls into question whether CDC has and continues to sufficiently monitor COVID-19 vaccine adverse events.”

On Jan. 10, 2023, Johnson again reached out to Walensky, noting in a letter that the Centers for Disease Control and Prevention “repeatedly failed to provide my office with complete data regarding its surveillance of COVID-19 vaccine adverse events.”

He also inquired about the metric, writing:

You wrote that the ‘results from PRR analysis were generally consistent with [Empirical Bayesian] data mining, revealing no additional unexpected safety signals.’ Given the ‘hundreds of adverse events’ listed in the published PRR tables, CDC must explain how it determined what is and is not an ‘unexpected safety signal.’

On March 14, 2023, Jeff Reczek, director of CDC’s Washington office, wrote to Johnson that “EB data mining [is] performed by FDA” and that the senator should “direct future inquiries regarding EB data mining to FDA.”

Afterward, Johnson’s staff emailed the Food and Drug Administration to inquire about the same information. About three months later, on June 15, 2023, an FDA staffer responded.

That message, cited in Johnson’s email, said:

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. FDA is unable to comment on pending litigation or provide information or data that is currently being considered in pending litigation.

In a letter dated Sept. 5, 2023, Johnson told FDA Commissioner Robert Califf that the “notion that FDA is actively hiding information about vaccine safety signals from Congress and the American people is beyond despicable.”

“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 wrote Califf.

“It is outrageous that FDA would assert that pending litigation, and particularly FOIA litigation, would allow your agency to obstruct my congressional oversight,” Johnson added. “Any pending litigation FDA may have relating to its EB data mining records has no bearing on its responsibility to comply with a congressional request.”

Johnson’s event Monday will include Dr. Robert Malone, a molecular biologist and mRNA expert, as well as journalist Lara Logan, a former CBS News and Fox News correspondent.

As of Sept. 1, Johnson said, 1.5 million adverse events and 36,080 deaths in the U.S. have been associated with the COVID-19 vaccines.

Johnson noted that Germany’s public health agency had logged 333,492 adverse reactions to the vaccines as of Oct. 31, 2022, and Danish officials said 13,635 individuals had reported 43,496 suspected adverse events. The European Medicines Agency, using health data for the European Union, reported about “1.7 million spontaneous reports of suspected side effects” related to COVID-19 vaccines in the three years from December 2020 to December 2023.

In October 2023, Johnson wrote what he called the “60th public letter I have sent to government agencies concerning various aspects of the COVID-19 pandemic.” He addressed it to the Centers for Disease Control and Prevention, the Food and Drug Administration, the Department of Health and Human Services, and the National Institutes of Health.

In the letter, Johnson’s questions included: “Do FDA and CDC agree that parents should have complete awareness of all potential adverse health outcomes associated with the COVID-19 ‘vaccines’ before deciding whether to get their child ‘vaccinated?’”

He also asked:  “Given the findings of the Oct. 15, 2023, FDA-funded study that revealed specific adverse health outcomes for children following COVID-19 ‘vaccination,’ does CDC stand by its Sept. 12, 2023, recommendation that ‘everyone 6 months and older get an updated COVID-19 vaccine’?”

The Wisconsin Republican did get a reply from HHS.

In a five-page letter to Johnson dated Dec. 2, Melanie Anne Egorin, the HHS assistant secretary for legislation, contended that much of the information from the Vaccine Adverse Event Reporting System is incomplete.

“Some reports of serious illnesses or deaths among people who have been recently vaccinated are not directly due to the vaccine itself,” Egorin wrote. “Limitations of VAERS include the lack of a control group (e.g., an unvaccinated control group) and that reports to VAERS may contain inaccurate or incomplete data.”

“For example,” she wrote, “VAERS reports can lack laboratory results that help establish (or rule out) a diagnosis. Thus, VAERS is not designed to assess causality.”

Egorin told Johnson that physicians at the CDC and FDA continuously screen and analyze adverse event data related to the COVID-19 vaccines.

“During these reviews, FDA and CDC have found that many reports do not represent adverse events caused by the vaccine,” she wrote.

Egorin later added: “In summary, FDA-approved and FDA-authorized COVID-19 vaccines have met FDA’s regulatory and scientific standards for safety and effectiveness. Hundreds of millions of people in the United States have received COVID-19 vaccines under the most intense safety monitoring in U.S. history.”

On Dec. 21, Johnson wrote to the heads of the HHS, CDC, and FDA about a study in the journal Nature by Dr. Thomas Mulroney finding that Pfizer’s COVID-19 vaccines may produce “off-target” or incorrect proteins.

Johnson again called on the federal health agencies to produce proportional reporting ratio data analyses and Empirical Bayesian data by Jan. 18 of this year.

On Jan. 12, he sent another letter to the FDA and CDC chiefs referring to troubling data obtained by the Informed Consent Action Network. It was analyzed by researchers at the OpenVAERS Project, a private organization founded in 1990 that tracks and analyzes HHS data on the adverse effects of any vaccine.

“As a former manufacturer, this data provides strong evidence that the vaccine manufacturing process was not in control,” Johnson wrote. “If these data analyses are accurate, then your agencies have kept this vital information hidden from Congress and the American people for years, despite my requests for this data beginning in December 2021.”

FDA spokesperson Cherie DuvallJones said the FDA and CDC “place a high priority on vaccine safety and are committed to our vaccine safety monitoring program.”

“The VAERS website is transparent about the system’s limitations. When any member of the public opens the website, the user must then acknowledge reading and understanding specific information that includes among other important details, ‘VAERS data available to the public include only the initial report data to VAERS. Updated data which contains data from medical records and corrections reported during follow up are used by the government for analysis. However, for numerous reasons including data consistency, these amended data are not available to the public,’ DuvallJones told The Daily Signal in a statement.

The Wisconsin Republican sought answers about reports that  government agencies were coercing or encouraging private companies to censor information about the vaccines.

In January 2022, Twitter censored a tweet that referenced adverse event data on COVID-19 vaccines.

Well over a year later, in May 2023, the social media giant’s successor, X, told Johnson’s office that “throughout 2021, executive branch officials, particularly from the Center [sic] for Disease Control (CDC) within the Department of Health & Human Services (HHS), communicated with social media companies, including Twitter, about ‘COVID Vaccine Misinformation.’”

And, X told Johnson’s office, “CDC identified ‘misleading information about VAERS reports’ as a specific subset of ‘COVID Vaccine Misinformation’ which they encouraged social media companies to address.”

In an August 2023 letter, Johnson told CDC Director Mandy Johnson, Walensky’s successor,  that “CDC’s campaign to encourage social media companies to suppress CDC’s own data appears to be a blatant attempt to mislead the public about adverse events associated with the COVID-19 vaccines.”

The Daily Signal sought comment Thursday and Friday from spokespersons for the HHS, CDC, FDA, and NIH, but none of them responded to questions by publication time.

[Editor's note: This story originally was published by The Daily Signal.]

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The post What federal health agencies aren't disclosing about COVID-19 vaccines appeared first on WND.

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