U.S. Senator Ron Johnson (R-WI) is intensifying his calls for transparency from the Food and Drug Administration (FDA) regarding the safety of COVID-19 vaccines.
In a Friday press release, the senator voiced his concerns through a letter addressed to Robert Califf, Commissioner of the FDA, taking issue with the agency’s reluctance to share requested vaccine safety data.
Sen. Johnson highlighted in his letter that, “FDA’s intentional withholding of information relating to the safety of the COVID-19 vaccines is outrageous and shows a complete disregard for the health and safety of the American people.”
Such strong words underscore the increasing tension between those in Congress and the regulatory agency.
This is not the first time that Sen. Johnson has sought clarity from the FDA.
The press release reveals that since June 2022, he has been aiming to access the “COVID-19 vaccine safety data described in the Jan. 29, 2021 Standard Operating Procedure document.”
This pivotal document outlines the data analysis types that both the Centers for Disease Control and Prevention (CDC) and FDA would perform.
However, it was only in March 2023 that his office specifically requested the FDA to share certain vaccine safety data termed as “empirical Bayesian data mining analyses.”
This request was made following information from the CDC, suggesting that only the FDA could furnish this specific data.
Adding to the senator’s frustration, the FDA formally responded in June 2023, declining to provide any of the sought-after vaccine safety data.
The senator did not mince words in his press release, stating, “The notion that FDA is actively hiding information about vaccine safety signals from Congress and the American people is beyond despicable, particularly given the fact that COVID-19 vaccine adverse events can and do occur.”
With the release of this statement, it remains to be seen how the FDA will respond to such direct criticism from a senior member of Congress.
The safety and transparency of COVID-19 vaccines continue to be a topic of utmost public interest and concern.
