President Joe Biden’s Food and Drug Administration (FDA) has declined Senator Ron Johnson’s (R-WI) request for safety data related to Covid mRNA vaccines. Senator Johnson had sought 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).
Senator Johnson made this request after the CDC stated that none of the safety signals identified for Covid vaccines were considered “unexpected.” Both the CDC and FDA conducted different types of analyses on the reports submitted to VAERS, which are primarily filed by healthcare professionals.
The CDC utilized Proportional Reporting Ratio (PRR) analyses, comparing adverse events reported to those reported after vaccination with other vaccines. The first time this method was applied to COVID-19 vaccines in 2022, hundreds of signals were triggered, according to files obtained by The Epoch Times.
In 2021, the FDA conducted Empirical Bayesian (EB) data mining, a different form of analysis. Dr. Rochelle Walensky, the former director of the CDC, had previously informed Senator Johnson that the PRR results were in line with EB data mining, indicating no additional unexpected safety signals.
Senator Johnson sought further information to support Dr. Walensky’s assertion. However, instead of providing the requested information, the CDC directed Senator Johnson to the FDA.
The FDA has since responded by declining to furnish the requested information.
“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.”
Senator Johnson has previously received documents subject to litigation from the government, including the FDA’s parent agency, the U.S. Department of Health and Human Services (HHS). He has now urged the FDA to provide the Empirical Bayesian (EB) data mining analyses by September 20.
In January, the agency faced a lawsuit for refusing to disclose the results of the EB data mining to The Epoch Times and the nonprofit Children’s Health Defense, citing Freedom of Information Act (FOIA) exemptions. Children’s Health Defense, the litigant, argued that withholding the records was unlawful.
In the latest update on the case, the FDA indicated it possessed 150 responsive pages. However, it explained that it needed to conduct a detailed review of each page to determine if any information should be withheld or redacted, citing an “unprecedented FOIA workload.”
These FOIA requests stem from federal court orders requiring the FDA to release information it had initially claimed would be made public regarding Pfizer and Moderna’s Covid vaccines.
In another recent letter, Senator Johnson pressed the HHS about its compensation program for individuals injured by Covid-19 shots. Despite the shots’ public rollout since December 2020 and over 1.5 million reports filed with the Vaccine Adverse Event Reporting System (VAERS), only four people have received compensation from the HHS, totaling just $8,592. Others have been approved for compensation, but the funds are still pending.
Senator Johnson sought additional details about the program, including potential compensation caps and government advertising. He also demanded communications between the HHS and Covid vaccine manufacturers regarding compensation claims. However, the HHS declined to answer many of these questions in a recent letter.
On September 5, Senator Johnson urged HHS Secretary Xavier Becerra to provide comprehensive responses to all his inquiries, referencing Becerra’s commitment during his Senate vetting process to promptly address questions from 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.”