TUCSON, Ariz., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Serious but unacknowledged adverse events from COVID-19 vaccines occurred in the artificially foreshortened Pfizer/BioTech and Moderna trials, write Jeyanthi Kunadhasen, M.D., and Corinne A. Michels, Ph.D., in the winter issue of the Journal of American Physicians and Surgeons.
The vaccines received Emergency Use Authorization (EUA) in December 2020 after only 20 weeks of testing, authors write. The highly atypical trial protocol was part of a “declared health emergency,” as defined by the 2005 US PREP (Public Readiness and Emergency Preparedness) Act.
The authors are part of the team that carried out a forensic review of the 38 subject deaths that occurred in the first 6-month period of the Pfizer COVID-19 mRNA vaccine clinical trial. They observe that regulators were not informed of two deaths of vaccinated subjects that occurred during the reporting period. Critically, one subject possibly had an autopsy report of “sudden cardiac death” that could have been made available at the critical junction prior to approval. There were other reporting delays, and had accurate results been presented to the FDA’s Advisory Committee, “it would have been clear that the vaccine did not save lives.” The authors also highlighted that information that would help establish accurate timelines is still withheld.
Dr. Michels and others revealed a multitude of other data discrepancies, including misrepresentations and obfuscations that hid a 3.7-fold increase in cardiac events in subjects who received the BNT162b2 vaccine versus the placebo.
By the time the FDA and CDC reported a “suggested increased risks” of myocarditis and pericarditis and ordered relevant changes to safety labels, thousands of teenagers had been needlessly vaccinated. “Shamefully, the danger was minimized by telling parents that the heart damage was ‘temporary,’” the authors write.
Restoring public trust in regulatory agencies requires significant policy changes, the authors conclude. “The FDA’s clinical review process has many weaknesses. The COVID-19 vaccine emergency ‘countermeasures’ presented a unique problem. Repeal of the PREP Act is the only way to ensure that an inadequately tested treatment of any kind will not be foisted on an unsuspecting population ever again.”
The Journal of American Physicians and Surgeons is published by the Association of American Physicians and Surgeons (AAPS), a national organization representing physicians in all specialties since 1943.
Contact: Jane M. Orient, M.D., (520) 323-3110, janeorientmd@gmail.com
