University of Illinois Backtracks on FDA Emergency Use Authorization


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The University of Illinois system has recently backpedaled on a previous claim that their saliva-based COVID-19 SHIELD testing was authorized by the Federal Drug and Food Administration (FDA) for emergency use. WCIA broke this news late last month, detailing the announcement of the authorization by Governor J.B. Pritzker on August 19. A spokesperson for the FDA had confirmed that the University of Illinois had never received approval and the university disclosed that this misinformation was due to a mistake regarding a bridge study with Yale University.

The study between the two universities follows the on-campus COVID-19 testing for both campuses, and Yale’s test has been approved by the FDA for emergency authorization, while the University of Illinois’ has not. The federal agency had reached out to the University of Illinois to urge them to quit using terms such as “bridging study” and “umbrella” when describing their saliva-based test. A formal announcement regarding the change was not made to the public and an August 19 online news article by the university announcing the FDA approval was later changed without an editor’s note.

It is important to note that this comes after a surge of positive COVID-19 cases within the U of I system, some occurring here on the UIS campus. The Interim Chancellor, Karen M. Whitney, recently sent out a mass email to all students and staff regarding this uptick:

“Our COVID-19 testing data has revealed some unfortunate and disappointing trends

with our campus positivity rate this week. The first three days of this week, we had 18

students test positive for COVID-19, and many more have been placed in quarantine due

to possible exposure to an infected individual.”

The lack of transparency regarding the validity of the university’s saliva-based COVID-19 test and its authorization by the government is significant, and without a systemic apology to the faculty, staff and students on all campuses, it appears the university is looking to sweep the issue under the rug.