FILE PHOTO: Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Moderna logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic/Illustration/File Photo

Daily Clout

July 21, 2023

Defending the Republic on Its Historic Win to Require the FDA to Release Moderna’s Spikevax Clinical Trial Documentation

“As a result of Defending the Republic’s (DTR) successful Freedom of Information Act (FOIA) litigation against the Food and Drug Administration (FDA), we are excited to announce that we are releasing nearly 15,000 pages of documents relating to testing and adverse events associated with Moderna’s COVID-19 vaccine ‘Spikevax.’

DTR filed its FOIA lawsuit after the FDA denied the expedited production of Moderna COVID-19 records, stating there was no compelling need or urgency for the public to review this information. This spring, DTR reached an agreement with the FDA for the production of approximately 24,000 pages of some of the most important records submitted by Moderna in support of its Biologics License Application (BLA). This is the first part of that production. Later this year the FDA will produce approximately 8,000 more pages of Moderna documents.

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