FDA Refuses to Provide COVID-19 Vaccine Safety Data to Who?

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U.S. officials are refusing to provide a U.S. senator with COVID-19 vaccine safety data.

Sen. Ron Johnson (R-Wis.) asked the U.S. Food and Drug Administration (FDA) for the results of analyses on data from the Vaccine Adverse Event Reporting System (VAERS) in January, after the U.S. Centers for Disease Control and Prevention (CDC) stated that none of the safety signals it identified for the COVID-19 vaccines were "unexpected."
The two agencies have run different types of analyses on the system's reports, which are primarily made by health care professionals.

The CDC ran Proportional Reporting Ratio analyses, which involve comparing the number of reported adverse events to the number of adverse events reported after vaccination with other vaccines.

The first time the agency ran analyses using the method for the COVID-19 vaccines, in 2022, hundreds of signals were triggered, files obtained by The Epoch Times show.
The FDA in 2021 started a different type of analysis, called Empirical Bayesian (EB) data mining.

The Proportional Reporting Ratio results “were generally consistent with EB data mining, revealing no additional unexpected safety signals," Dr. Rochelle Walensky, the CDC's director at the time, told Mr. Johnson previously.

Mr. Johnson demanded answers on that claim, prompting the CDC to point him to the FDA. The agency recently responded to Mr. Johnson, telling him that it can't provide the information he seeks.

"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," the agency told the senator.

Mr. Johnson, in a new letter, told FDA Commissioner Dr. Robert Califf that the claim was wrong.
"As you are well aware, Congress has a right to information contained at U.S. federal agencies as it conducts its constitutional oversight responsibilities," Mr. Johnson said.

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OPEN
VACCINES & SAFETY
EXCLUSIVE: FDA Refuses to Provide COVID-19 Vaccine Safety Data to US Senator
EXCLUSIVE: FDA Refuses to Provide COVID-19 Vaccine Safety Data to US Senator
The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. (Madalina Vasiliu/The Epoch Times)
Zachary Stieber
By Zachary Stieber
9/7/2023
Updated:
9/8/2023

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U.S. officials are refusing to provide a U.S. senator with COVID-19 vaccine safety data.

Sen. Ron Johnson (R-Wis.) asked the U.S. Food and Drug Administration (FDA) for the results of analyses on data from the Vaccine Adverse Event Reporting System (VAERS) in January, after the U.S. Centers for Disease Control and Prevention (CDC) stated that none of the safety signals it identified for the COVID-19 vaccines were "unexpected."
The two agencies have run different types of analyses on the system's reports, which are primarily made by health care professionals.

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The CDC ran Proportional Reporting Ratio analyses, which involve comparing the number of reported adverse events to the number of adverse events reported after vaccination with other vaccines.

The first time the agency ran analyses using the method for the COVID-19 vaccines, in 2022, hundreds of signals were triggered, files obtained by The Epoch Times show.
The FDA in 2021 started a different type of analysis, called Empirical Bayesian (EB) data mining.

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The Proportional Reporting Ratio results “were generally consistent with EB data mining, revealing no additional unexpected safety signals," Dr. Rochelle Walensky, the CDC's director at the time, told Mr. Johnson previously.

Mr. Johnson demanded answers on that claim, prompting the CDC to point him to the FDA. The agency recently responded to Mr. Johnson, telling him that it can't provide the information he seeks.

"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," the agency told the senator.

Mr. Johnson, in a new letter, told FDA Commissioner Dr. Robert Califf that the claim was wrong.
"As you are well aware, Congress has a right to information contained at U.S. federal agencies as it conducts its constitutional oversight responsibilities," Mr. Johnson said.

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"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. "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."

Mr. Johnson said in the past he's repeatedly received from the government documents subject to litigation, including from the FDA's parent department, the U.S. Department of Health and Human Services (HHS).

He urged the FDA to produce the EB data mining analyses by Sept. 20.

"The FDA has received the letter and will respond directly to the senator," an FDA spokesperson told The Epoch Times via email.

The agency was sued in January over its refusal to provide the results of the EB data mining to The Epoch Times and the nonprofit Children's Health Defense, citing exemptions in the FOIA.
Children's Health Defense, the litigant, said that the refusal to provide the records was illegal.

In the last update in the case, the FDA said it has 150 responsive pages but that it has to do a "page-by-page, line-by-line review" to determine whether any information on the pages should be withheld, or redacted. The agency said it is "facing an unprecedented FOIA workload" stemming from federal courts ordering it to release information it had said would be made public on the COVID-19 vaccines from Pfizer and Moderna.

Ignored Questions
In another new letter, Mr. Johnson pressed the HHS on the program it administers to provide compensation to people injured by the COVID-19 shots.
Despite injections starting in December 2020, and more than 1.5 million reports being lodged with VAERS, HHS has compensated just four people, paying $8,592 in total.

Others have been approved for compensation but the money is still pending.

Mr. Johnson in April asked for more details on the program, since the agency hasn't been forthcoming, including whether there are caps on the amount of money an injured person can receive and whether the government has advertised the program.

Mr. Johnson also demanded communications between HHS and COVID-19 vaccine manufacturers regarding compensation claims.

In a recent letter, HHS declined to answer many of the questions.
Mr. Johnson on Sept. 5 urged HHS Secretary Xavier Becerra to provide answers to all of his questions.
He pointed to how Mr. Becerra, when being vetted by the Senate, told senators that he would commit to providing a prompt response to any questions addressed by Senate Finance Committee members.

"As a member of the Senate Finance Committee and as ranking member of the Senate’s top investigative subcommittee, your agency’s June 23, 2023, response is completely unacceptable and calls into question the veracity of the commitment you made before the Senate during your confirmation hearing," Mr. Johnson said.

"I call on you to immediately revise HHS's incomplete response and provide the requested information."

HHS didn't respond to a request for comment.