Democrat President Joe Biden’s Food and Drug Administration (FDA) is refusing a request from Senator Ron Johnson (R-WI) to hand over safety data regarding Covid mRNA shots.
Johnson has asked the FDA to provide the results of analyses conducted in January on data from the U.S. Centers for Disease Control and Prevention’s (CDC) Vaccine Adverse Event Reporting System (VAERS).
The Republican senator requested the data after the CDC said none of the safety signals it identified for the Covid vaccines were “unexpected.”
The CDC and FDA have both run different types of analyses on the system’s reports.
The reports submitted to VAERS are primarily made by healthcare professionals.
The CDC ran Proportional Reporting Ratio (PRR) analyses on the VAERS data.
These PRR analyses 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.
In 2021, the FDA conducted a different type of analysis called Empirical Bayesian (EB) data mining.
Dr. Rochelle Walensky, the CDC’s director at the time, previously told Johnson that the PRR results “were generally consistent with EB data mining, revealing no additional unexpected safety signals.”
Johnson demanded answers to support Walensky’s claim.
However, rather than provide the information, the CDC pointed Johnson to the FDA.
The FDA recently responded to Johnson by refusing to 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,” 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.”
In a new letter to the FDA, Johnson told 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,” Johnson wrote.
“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.”
Johnson said in the past he’s repeatedly received from the government documents subject to litigation, including from the FDA’s parent agency, the U.S. Department of Health and Human Services (HHS).
He urged the FDA to produce the EB data mining analyses by September 20.
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 Freedom of Information Act (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.
However, the federal agency says 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.”
The FOIA requests stem from federal courts ordering the FDA to release information it had said would be made public on Pfizer and Moderna’s Covid shots.
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 the public rollout of the shots beginning in December 2020, and more than 1.5 million reports being lodged with the VAERS, the HHS has compensated just four people.
Victims have received a total of just $8,592 in compensation payouts from the HHS.
Others have been approved for compensation but the money is still pending.
In April, Johnson asked for more details on the program as the agency has not been forthcoming.
The information requested includes whether there are caps on the amount of money an injured person can receive and whether the government has advertised the program.
Johnson also demanded communications between HHS and Big Pharma Covid vaccine manufacturers regarding compensation claims.
The HHS declined to answer many of the questions in a recent letter.
On September 5, Johnson urged HHS Secretary Xavier Becerra to provide answers to all of his questions.
He pointed to how 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,” Johnson said.
“I call on you to immediately revise HHS’s incomplete response and provide the requested information.”
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