Citizen Petition from PJ O'Brien & Associates on behalf of multiple clients
"Citizen Petition
We request the Commissioner of the FDA and the Secretary of Health and Human Services revoke or suspend by taking administrative actions in respect of the earlier emergency use authorizations (EUAs), biologics license applications (BLAs), and approvals of BLAs for all the modRNA-LNP based Covid-19 products of Pfizer (Comirnaty) and Moderna (Spikevax)...
I. Actions Requested
The undersigned petitioners request that the FDA and the Secretary of Health and Human Services:
1. Revoke or suspend the Biologics License Applications (BLAs) granted to Pfizer-BioNTech (Comirnaty) and Moderna (Spikevax) for their modRNA Covid-19 products, pending investigations into the following grounds:
a. Wrongful and Illegal Categorical Exclusions from Environmental Assessments (EAs): Both Pfizer and Moderna improperly sought and were improperly granted by the FDA categorical exclusions from submitting EAs under 21 CFR 25.31. This exclusion prevented their products from being reviewed by the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC), the appropriate body for gene therapy evaluation.
b. Excessive Synthetic DNA Contamination: Nine independent laboratories, including one supervised by FDA scientists, have confirmed excessive synthetic DNA contamination in the Pfizer and Moderna modRNA products at levels significantly exceeding regulatory thresholds. This DNA has been detected in vials and in the bloodstream of human recipients.
2. Investigate the regulatory processes and decisions that allowed for these violations, including:
a. The illegal classification of these products as non-gene therapies.
b. The failure to ensure public disclosure and transparency about the gene therapy nature of these products, thereby denying legally valid Informed Consent.
3. Issue public guidance regarding the risks posed by excessive synthetic DNA contamination, including its potential for genomic integration, self-replication, and associated health consequences...
II. Statement of Grounds
C. Conclusion to Statement of Grounds
10.0 Protecting Public Health: The overwhelming scientific evidence presented in this petition demonstrates that the Pfizer and Moderna Covid-19 products fail to meet the basic safety and efficacy requirements expected of approved biological products. The risks of synthetic DNA contamination, genomic integration, and SV40 promoter sequences demand immediate regulatory action to safeguard public health. In addition, corroborative evidences from pharmacovigilance databases with respect to increasing rates of cancer reports (including rare cancers), also demand investigation - it is imperative that we determine if these products are causing cancer."
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