FOI release

Manufacturing process for Pfizer-BioNTech and Moderna COVID-19

Some or all of the information requested may not have been provided because we required clarification from the requester.

Case reference FOI2025/00359

Received 7 April 2025

Published 6 July 2025

Request

FOIA Request: Full Disclosure of Plasmid DNA Backbone Sequences and Related Studies for Pfizer and Moderna COVID-19 Vaccines Date: April 7 2025 To Whom It May Concern, Under the Freedom of Information Act, I am requesting detailed information regarding the full genetic sequence of the plasmid DNA backbone used in the manufacturing process for Pfizer-BioNTech and Moderna COVID-19 vaccines. Specifically, I seek: 1 Complete Plasmid DNA Backbone Sequence Data: The full genome of any and all plasmid DNA backbones used in the production of mRNA for these vaccines, including: ◦ SV40 promoter/enhancer sequences. ◦ Any additional regulatory elements (e.g., origins of replication, antibiotic resistance genes). ◦ The spike protein gene sequence and any modifications made to stabilize or enhance its expression. ◦ All other genetic elements intentionally included in the plasmid DNA backbone. 2 Purpose and Function of Genetic Elements: Documentation explaining the function and purpose of each genetic element within the plasmid DNA backbone design, including why specific sequences (such as SV40 regulatory elements) were chosen. 3 Safety Assessments on the Full Plasmid DNA Backbone: All studies or analyses conducted to evaluate whether the plasmid DNA backbone is associated with: ◦ Carcinogenesis: Risks of cancer development due to genomic integration or other mechanisms. ◦ Mutagenesis: Risks of inducing mutations in human genomic DNA. ◦ Impairment of Fertility: Effects on male and female reproductive health, including germline cells. ◦ Teratogenicity: Risks of congenital malformations or developmental abnormalities. 4 Batch-Specific Variations: Information on whether different batches of Pfizer and Moderna vaccines used distinct plasmid DNA backbone designs or sequences, particularly between clinical trial materials and commercial production batches. This request is made because it is already known that Pfizer’s COVID-19 vaccine contains residual plasmid DNA, including SV40 promoter/enhancer sequences within its plasmid backbone. However, the full genome of this plasmid DNA backbone has not been disclosed, nor have the results of any studies evaluating its safety. Americans were not informed that these vaccines contain plasmid DNA capable of integrating into human genomic DNA. Such integration could theoretically lead to permanent mutations, genomic instability, activation of oncogenes, or heritable genetic changes. Additionally, Pfizer has documented over 1,200 diseases linked to adverse events following vaccination. Despite this alarming list, these vaccines continue to be widely promoted without full transparency about their contents or risks. Understanding the complete composition of the plasmid DNA backbone and reviewing related safety studies are critical for ensuring public trust in vaccine safety. If any portion of this request cannot be fulfilled due to exemptions under FOIA, please provide a detailed explanation. I look forward to your prompt response.

Response

see attached

Documents

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