A petition was filed 1-21-2025 with the FDA by Julian Gillespie, Kevin McKernan, Dr. David Speicher, Dr. Jessica Rose, and L. Maria Gutschi.
I had not examined environmental assessment criteria in any litigation. I look forward to the FDA response in the new administration. This citizen petition was filed January 21, 2025 with the FDA requesting administrative action regarding Pfizer and Moderna’s COVID-19 mRNA vaccines to:
- Revoke or suspend the Biologics License Applications (BLAs) for Pfizer (Comirnaty) and Moderna (Spikevax) COVID-19 vaccines.
- Investigate regulatory processes and decisions.
- Issue public guidance on risks of synthetic DNA contamination.
- Mandate independent testing of existing stocks.
- Establish testing for DNA integration into human cells.
Primary Concerns:
Wrongful categorical exclusions from Environmental Assessments (EAs)
- Excessive synthetic DNA contamination, with multiple studies showing levels 6-470 times above regulatory safety thresholds.
- Presence of SV40 promoter and enhancer sequences.
- Potential risks including genomic integration and cancer.
Legal Arguments:
- The products should have been classified as gene therapies.
- The FDA wrongfully granted categorical exclusions from environmental assessments.
- The BLA approvals were legally void from the beginning due to these failures.
They argue these issues represent significant public health risks requiring immediate regulatory action and investigation.