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.
“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.”
