FDA Refuses To Provide COVID-19 Vaccine Safety Data To US Senator

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

U.S. officers are refusing to offer COVID-19 vaccine security information to a U.S. senator.

Sen. Ron Johnson (R-Wis.) asked the U.S. Food and Drug Administration (FDA) for the outcomes of analyses on information from the Vaccine Adverse Event Reporting System in January. The request got here after the U.S. Centers for Disease Control and Prevention (CDC) stated not one of the security indicators it recognized for the COVID-19 vaccines had been “unexpected.”

The two businesses have run various kinds of analyses on the system’s experiences, that are primarily made by well being care professionals.

The CDC ran Proportional Reporting Ratio analyses, which contain evaluating the variety of reported opposed occasions to the variety of opposed occasions reported after vaccination with different vaccines.

The first time the company ran analyses utilizing the strategy for the COVID-19 vaccines, in 2022, a whole bunch of indicators had been triggered, recordsdata obtained by The Epoch Times show.

The FDA in 2021 began a special sort of research, referred to as Empirical Bayesian (EB) information mining.

The Proportional Reporting Ratio outcomes “had been usually in keeping with EB information mining, revealing no further surprising security indicators,” 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 FDA recently responded to Mr. Johnson, telling him that it cannot provide the information he seeks.

“FDA’s EB information mining analyses of opposed occasions contained in VAERS experiences for COVID-19 vaccines are presently the topic of pending FOIA [Freedom of Information Act] litigation. FDA is unable to touch upon pending litigation or present info or information that’s presently being thought-about in pending litigation,” the company advised the senator.

Mr. Johnson in a new letter advised FDA Commissioner Dr. Robert Califf that the declare was incorrect.

“As you’re effectively conscious, Congress has a proper to info contained at U.S. federal businesses because it conducts its constitutional oversight tasks,” Mr. Johnson said.

“It is outrageous that FDA would assert that pending litigation, and significantly FOIA litigation, would permit your company to hinder my congressional oversight,” he added. “Any pending litigation FDA could have regarding its EB information mining data has no bearing on its accountability to adjust to 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 agency, 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 declined to immediately provide a comment.

The company was sued in January over its refusal to offer the outcomes of the EB information 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 but that it has to do a “page-by-page, line-by-line overview” to determine whether any information on the pages should be withheld, or redacted. The agency said it is “dealing with 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 the Vaccine Adverse Event Reporting System. 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 as the agency has not 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 rating member of the Senate’s high investigative subcommittee, your company’s June 23, 2023 response is totally unacceptable and calls into query the veracity of the dedication you made earlier than the Senate throughout your affirmation listening to,” Mr. Johnson said. “I name on you to instantly revise HHS’s incomplete response and supply the requested info.“

HHS didn’t reply to a request for remark.