Amid Revelations of Contamination, DailyClout Finds: FDA Withheld 16,000+ Pages of Quality Control Documentation for Pfizer mRNA Vaccine, Citing ‘Trade Secrets.’
Multiple independent labs have confirmed that Pfizer’s COVID vaccine is contaminated with DNA fragments, SV40, and plasmids. Given that, surely it is unethical for the Food and Drug Administration (FDA) to withhold the Pfizer vaccine quality data from Americans. Obviously, all eyes are now turning to Pfizer’s manufacturing process. What did Pfizer know about the adulteration, and what did FDA know? With a novel gene therapy drug, such as Pfizer’s COVID-19 vaccine, the public must be confident that manufacturing, batch analyses, and drug stability – indeed all quality control issues – are done appropriately.
The evidence in vials of contaminated COVID vaccine reveals that something has gone terribly wrong. I looked through the thousands of publicly available clinical trial documents for documents related to Pfizer’s manufacturing processes. What I found is that the FDA produced only two meaningless documents (https://www.phmpt.org/wp-content/uploads/2023/10/125742_S5_M3_requirements-travel-belgium.pdf and https://www.phmpt.org/wp-content/uploads/2023/10/125742_S5_M3_guidelines-travel-red-zone-belgium.pdf) related to quality among the over two thousand Pfizer documents it has released to date as a result of Aaron Siri’s lawsuit to release the Pfizer documents. An informed source told DailyClout: “In September’s production, [the FDA] withheld 834 records (16,044 pages) in full pursuant to [Freedom of Information Act (FOIA) exemption] (b)(4) – trade secrets.” The wording implies that what was withheld is related to manufacture or formulation – i.e., ‘Module 3’ Quality documentation.
In order for a drug, such as Pfizer’s mRNA COVID-19 vaccine, to be considered by the FDA for emergency use authorization (EUA) or approval, the pharmaceutical company must submit extensive documentation, defined by the FDA, for the FDA’s review. That documentation, including the Pfizer mRNA vaccine clinical trial documents, are broken down into five “modules” as follows:
- Module 1 (“M1”) – Administrative Information
- Module 2 (“M2”) – Summaries
- Module 3 (“M3”) – Quality
- Module 4 (“M4”) – Nonclinical Study Reports
- Module 5 (“M5”) – Clinical Study Reports.
How can the FDA withhold that documentation when the Court has ordered Pfizer to release its clinical trial documents to the public?
The (b)(4) exemption allows the FDA to conceal companies’ wrongdoing at its discretion. The (b)(4) exemption “…of FOIA permits agencies, as a matter of discretion, to withhold trade secrets and commercial or financial information obtained from a person which is privileged or confidential.” [Emphasis added.] [https://www.acus.gov/recommendation/exemption-b4-freedom-information-act] Is this “trade secrets” carve-out being invoked now that such appalling evidence has surfaced about the drug’s contamination?
Is the (b)(4) exemption being used properly? We would say not. But FDA is exploiting it as a pretext to conceal massive wrongdoing. Examples 1 through 4 paraphrased below show how the FDA can interpret information submitted to it so broadly as to cover up any crime.
- Information can be withheld if it is considered to be the “property” of the submitter, i.e., except for the government’s possession, the submitter has an exclusive right to dispose of the information.
- Information submitted is, in the ordinary colloquial sense, “confidential”. It is held by the government in confidence and is not already in the public domain as a result of lawful disclosure by the government or by others, nor is it required by law to be made public.
- Information can be withheld if it has value to the submitter that disclosure threatens to diminish. It is enough that, without demonstrating the precise manner in which persons receiving access to the information may use the information to cause injury to the submitter, the submitter have a valuable interest in the information, and that disclosure may reasonably be expected to impair that interest. In this respect, due regard should be given both to the probability and to the magnitude of impairment; thus, the greater the harm potentially resulting from disclosure, the less need a showing be made of the certainty of occurrence of the harm, and vice versa.
- In addition to the traditional “commercial” and “financial” interests that may be jeopardized by the disclosure of confidential information, “business” information—a bit of commercially relevant information which alone appears insignificant but which, when combined with other bits, can reveal important business data—should come within the exemption. And “research” information, whether submitted by a commercial or non-commercial person, should be recognized to have value to the submitter and to be deserving of protection. [https://www.acus.gov/recommendation/exemption-b4-freedom-information-act]
However, all of this is game-playing, because the content that (b)(4) protects must be “legitimate.” “The exemption should not be used to shield evidence of unlawful activities, fraud, waste, or government mismanagement. This condition is necessary to insure the availability of FOIA as an effective means of the public’s oversight of government, while protecting those private interests that legitimately are not in the public domain.” [https://www.acus.gov/recommendation/exemption-b4-freedom-information-act]
The FDA’s “Comprehensive Table of Contents Headings and Hierarchy” shows us exactly what the FDA is withholding from public analysis by hiding Module 3 Quality documentation. The FDA is concealing extremely important information by invoking (b)(4) – information that would answer questions in the news right now. It is concealing, for instance, “manufacture,” including “batch formula,” “description of manufacturing process and process controls,” “controls of critical steps and intermediates,” and “process validation” and/or evaluation.” The FDA is hiding “batch analyses” and, shockingly enough given the news headlines about contamination, “characterization of impurities.”
In a seeming contradiction to the FDA’s actions related to Pfizer’s Module 3 Quality documents, its mission statement says the FDA “…is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices…FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products to …improve their health.” The public now knows beyond doubt that Pfizer’s SV40- and DNA-contaminated mRNA COVID vaccine is neither safe nor effective, so the FDA already failed in its mission to protect “public health by ensuring the safety, efficacy, and security of human…drugs.” Yet, the taxpayer-funded agency still chooses to shield Pfizer rather than offer transparency to the American people.