Report From Europe Raising Eyebrows Over FDA Response To FOIA Request
The official European Union database of suspected drug reactions has posted new data on their website that explains why the FDA is trying to keep Pfizer data under wraps.
The European Medicines Agency reported that as of November 13, there have been 30,551 fatalities and 1,163,356 adverse drug reactions from all four coronavirus vaccines.
All of the data was officially recorded using the ADRreport.eu portal that “allows users to view the total number of individual suspected side effect reports (also known as Individual Case Safety Reports, or ICSRs).”
The data came from individual case report forms taken from EudraVigilance which is “a system designed for collecting reports of suspected side effects, used for evaluating the benefits and risks of medicines during their development and monitoring their safety following their authorization in the European Economic Area (EEA).”
It’s no wonder the FDA is asking to withhold Pfizer data for the next 55 years.
A group of scientists filed a Freedom of Information Act requesting to see the data it used to license Pfizer’s COVID-19 vaccine. The group was shocked to learn the FDA told them the full record won’t be available until 2076.
Federal lawyers representing the FDA said that it would take them 55 years to compile the 329,000 pages of related material they are requesting.
The FOIA request came from a group of 30 professors and scientists representing Yale, Havard, UCLA and Brown. The groups seeks expedited access to the records in order to reassure skeptics the. vaccine is safe. The group wants to use the records to show the vaccine is “safe and effective and, thus, increase confidence in the Pfizer vaccine.”
The FDA requested if they could release 500 pages at a time however plaintiff lawyers said if Pfizer can approve a vaccine in 108 days they should have no problem releasing the records they examined in 108 days.
“This 108-day period is the same amount of time it took the FDA to review the responsive documents for the far more intricate task of licensing Pfizer’s COVID-19 vaccine,” wrote Aaron Siri of Siri & Glimstad in New York and John Howie of Howie Law in Dallas in court papers.
“The entire purpose of the FOIA is to assure government transparency,” they continued. “It is difficult to imagine a greater need for transparency than immediate disclosure of the documents relied upon by the FDA to license a product that is now being mandated to over 100 million Americans under penalty of losing their careers, their income, their military service status, and far worse.”
The plaintiffs are demanding that the FDA be forced to meet their deadline and release 80,000 pages a month.
US District Judge Mark Pittman will be holding a conference on December 14, 2021 to consider a timeline for releasing the documents.
