FDA agrees to release approximately 13,685 adverse event documents from Moderna’s COVID-19 vaccine safety profile submission for emergency use authorization.

Since June 2022, a non-profit organization called Defending the Republic has been involved in Freedom of Information Act litigation to obtain documents from the FDA relating to Moderna's application for emergency use authorization of its COVID-19 vaccine.

According to a motion filed on March 31, 2023, both parties have agreed on the release of the documents.

Within the motion, the FDA agreed to release approximately 23,751 pages related to Moderna’s emergency use authorization application. Of those approximately 23,751 documents, the FDA acknowledges approximately 13,685 pages are adverse event documents.

Both parties have agreed that the approximately 13,685 adverse event documents will be released by July 17, 2023, with 10,000 more documents being released each month after that and to be completed no later then December 2023.

When the documents are released, I will follow up and let you know what I find.