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Report: Moderna excluded infection data from FDA advisory group during booster approval meetings

"Data that was relevant" was allegedly not presented to officials

Published: January 11, 2023 2:52pm

Updated: January 11, 2023 3:11pm

Bio-engineering company Moderna reportedly withheld important data in meetings with U.S. Food and Drug Administration advisors last year when the agency was debating whether or not to authorize a COVID-19 vaccine booster shot. 

A CNN report on Wednesday claims that a group of doctors that advise the FDA on vaccine matters are "disappointed" that "pharmaceutical company Moderna didn’t present a set of infection data on the company’s new Covid-19 booster during meetings last year."

The data in question indicated that "1.9% of the study participants who received the original booster became infected," while "among those who got the updated bivalent vaccine – the one that scientists hoped would work better – a higher percentage, 3.2%, became infected."

The data were allegedly "included in a preprint study that was posted online in June, again in September in an FDA document and then later that month in a top medical journal," but Moderna apparently did not share the data with advisers when meeting with them. 

The advisers who spoke with CNN told the network that the data "wouldn’t have changed how they voted, because the data had such limitations," but they reportedly argued that it "still should have been presented to them."

Philip Krause, the former deputy director of the FDA’s Office of Vaccine Research and Review, told CNN that he didn't think there was "any excuse for excluding" the data from the full review process. 

“The company’s failure to present this information at the [FDA advisers meeting] and the omission of discussion about the data at that meeting raises questions about the ability of the process to provide a full and transparent review of the data,” he told the network.

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