In a recent letter addressed to President Donald Trump, two experts from the DNA Integrity Project accused Pfizer and BioNTech of manipulating clinical trial data for their Covid-19 vaccine, misleading regulators and the public during Operation Warp Speed. The scathing 17-page document was sent in late October, signed by Eric Feintuch, D.C., C.C.S.D., and Charles Rixey, M.A.

Their letter urgently requests the invocation of the FDA’s Application Integrity Policy (AIP) to audit the trials and possibly revoke approvals, citing incomplete and altered submissions that provided the original emergency use authorization (EUA) and subsequent full biologics license application (BLA) in 2020 and 2021.

The letter claims that data provided to Trump in the fall of 2020 was “incomplete, manipulated, and delayed,” in an effort to paint a rosier picture of the vaccine’s efficacy and safety, than what independent analyses now reveals.

Sifting through FOIA-obtained records, datasets, protocols, and clinical reports, experts argue that these discrepancies undermined the integrity of the trial, which included over 43,000 participants. They point to one post-marketing report of 1,223 deaths within 90 days of vaccination, far exceeding pre-covid annual averages of less than 150 vaccine-related deaths, as an early red flag that should have halted distribution.

Significant failures were identified in trial blinding leading to biased treatment. Further analyses showed significant deviations in protocol and non-random patterns within these variations. Adverse event terms were also found to have been altered, further suggesting manipulation.
Dataset discrepancies raise even graver concerns, with over 300 randomization IDs missing; many of which occurred the same day in 2020 that whistleblower Augusto Roux reported severe adverse effects like pericarditis, which were being criminally misclassified on request.

Additionally, the total randomized subjects dropped by 1,203 without explanation. Cardiac deaths were known but omitted from FDA briefings and publishing’s, delaying recognition of cardiac risks.

The manufacturing process came under fire as well, with the clinical trial primarily using one process while the commercially distributed vaccines employed an alternative process known to have risks, one which had been tested on only 1.2% of participants (252), before emergency authorization. This new process showed significantly higher adverse event rates yet differences in processes and components like DNA templates, purification, and lipid nanoparticle production were not fully disclosed.

The authors also condemn the illegal exclusions from environmental assessments, arguing that synthetic modified RNA disqualified the products from exemptions under FDA regulations. DNA contamination found in commercially produced vials emerged as a major safety hazard, with a peer-reviewed study finding levels 36 to 627 times above permissible thresholds. Additional components went completely undisclosed, despite being known to increase cancer risks.

Data submitted to regulators in the U.S., Canada, and Europe were believed to be edited to hide these elements, and flawed testing underestimated contaminations by up to 100-fold. This, the letter warns, may contribute to rising rapid-onset cancers.

Finally, the experts allege misclassification of the mRNA vaccines as conventional vaccines rather than gene therapies, despite meeting FDA definitions for the latter. This allowed assessments to bypass the gene therapy advisory committee in favor of the vaccine advisory committee, avoiding the required 15-year monitoring for delayed effects like cancers or autoimmune disorders; violations that render approvals “void ab initio.”

The letter justifies AIP invocation under statutes like 21 U.S.C. s355, emphasizing that PREP Act immunity does not shield against FDA probes into fraud. Recommendations include deferring reviews, issuing preservation notices, auditing all trial data and manufacturing sites, conducting digital forensics, and pursuing criminal referrals.

“The coordinated nature of these violations suggests institutional-level decision making to circumvent safeguards,” the letter concludes with a call to action, to restore public trust in regulatory processes.

The truth behind this disastrous push to vaccinate en masse will continue to be spoken by real experts like these, ones who cannot be bought or manipulated. Until these crimes are acknowledged, we will continue to support truth and those who speak it.

To read the 17 page document containing the data, click here