Freedom of Information Act

Defending the Republic Obtains Troubling Moderna

Documents in its FOIA Lawsuit Against the FDA

Defending the Republic has just received thousands of pages of Moderna COVID-19 vaccine documents, including materials relating to serious adverse events and post-vaccine deaths, Moderna responses to FDA concerns, spreadsheets detailing potential vaccine injuries, and summaries of meetings between the FDA and Moderna.

Here are just some of the key findings and takeaways from these records:

*On January 24, 2022 (approximately one week before the FDA announced its approval of Spikevax), Moderna informed the FDA that it had “no plan to produce BLA [biologics license application] SPIKEVAX labelled material.” This is significant for a number of reasons. First, BLA vaccines are subject to stricter testing and safety standards than Emergency Use Authorization (EUA) vaccines. Second, United States armed service members were mandated by Secretary of Defense Lloyd Austin to receive COVID-19 vaccines; he could only issue this order if the vaccines were “FDA approved.” However, the FDA (and the Department of Defense) knew that Moderna would not be providing the “approved” vaccines to the military. Third, it misled the public that they were getting “approved” vaccines while actually receiving EUA vaccines approved under lesser standards.

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Meeting Minutes (includes discussion that Moderna did not plan to produce Spikevax)
           Jan 24 2022 Meeting Minutes from FDA and Moderna Meeting 

Clinical Trial Information (includes information on adverse events and efficacy)
          CBER Requested Tables – Safety and Adverse Events
          CBER Requested Tables Batch 2
          CBER Requested Tables
          Moderna – Mapping
          Tables – Summary of Deep Vein Thrombosis up to 28 days post injection
          Tables – Summary of Dyspnoea up to 7 days post injection
          Tables – Summary of Syncope up to 7 days post injection

Spikevax Inserts (Draft “Highlights of Prescribing Information” including FDA edits)
          Moderna Spikevax Insert Draft – Jan 27 2022
          Moderna Spikevax Insert Draft – Jan 28 2022
          Moderna Spikevax Insert Draft with FDA redlines – Jan 27 2022
          Moderna Spikevax Insert Draft with FDA redlines – Jan 28 2022

Research (Kaiser Permanente Effectiveness Study)  
           Kaiser Permanente – Real-World Study of the Effectiveness of Moderna COVID-19 Vaccine – Sept 2021

          HHS-FDA Certification of Compliance
          HHS-FDA Prescription Drug User Fee Coversheet FY 2021