1. Serious adverse events from COVID-19 vaccines were unacknowledged in trials. 2. Clinical trial protocols were atypical, under 20 weeks of testing. 3. Regulators were misinformed about deaths linked to Pfizer vaccine. 4. A 3.7-fold increase in cardiac events was hidden in data discrepancies. 5. Call for policy changes to restore trust in regulatory bodies.
FAQ
Why Very Bearish?
Historical precedents show regulatory scrutiny impacts vaccine stock prices negatively, e.g., J&J's vaccine issues causing plummeting share prices. If public confidence wanes in the safety of Pfizer's vaccine, it could lead to reduced demand and government scrutiny.
How important is it?
Vaccine safety issues directly impact Pfizer’s reputation and market performance. High likelihood that increasing concerns could lead to immediate regulatory responses affecting stock price.
Why Short Term?
Pending investigations or community concern over vaccine safety can trigger immediate market reactions. Historical events, like the early controversies over the AstraZeneca vaccine, show swift investor reactions to safety reports.
Undisclosed Deaths in Pfizer mRNA COVID-19 Vaccine Trial Highlighted in Recent Journal
TUCSON, Ariz., Dec. 09, 2025 (GLOBE NEWSWIRE) — A recent study published in the Journal of American Physicians and Surgeons raises serious concerns about unacknowledged adverse events linked to the Pfizer/BioNTech COVID-19 vaccine trials. Conducted by Jeyanthi Kunadhasen, M.D., and Corinne A. Michels, Ph.D., the study reveals critical issues regarding the safety and efficacy of the vaccine, noted by its stock symbol PFE.
Overview of the COVID-19 Vaccine Trials
The Pfizer/BioNTech and Moderna vaccines received Emergency Use Authorization (EUA) in December 2020 after a mere 20 weeks of clinical testing. This expedited approval process was categorized under a "declared health emergency" by the 2005 US PREP (Public Readiness and Emergency Preparedness) Act. According to Kunadhasen and Michels, this atypical trial protocol has significant implications for public safety.
Forensic Review of Clinical Trial Deaths
The authors conducted a forensic review of the clinical trial data, specifically analyzing the 38 subject deaths that occurred within the first six months of the PFE vaccine trial. Alarmingly, they found that regulators were not informed of two deaths involving vaccinated subjects during the reporting period. One case involved a reported "sudden cardiac death" that may have been pivotal in influencing the vaccine's approval status.
Delayed reporting and withheld information led to a distorted representation of the vaccine's safety, leading the authors to assert: “Had accurate results been presented to the FDA’s Advisory Committee, it would have been clear that the vaccine did not save lives.”
Data Discrepancies and Health Risks
Dr. Michels and her colleagues uncovered multiple discrepancies in the data, including misrepresentations that concealed a significant 3.7-fold increase in cardiac events among subjects receiving the BNT162b2 vaccine compared to the placebo group. The late acknowledgment of increased risks for myocarditis and pericarditis by the FDA and CDC did not mitigate the potential harm caused; thousands of teenagers were vaccinated before these risks were formally recognized.
- 3.7-fold increase in cardiac events with BNT162b2 vaccine compared to placebo
- Regulators initially unaware of certain vaccine-related deaths
- Delayed advisory actions led to thousands of unnecessary vaccinations
As noted by the authors, misleading narratives suggested that resulting heart damage was "temporary," which downplayed the seriousness of the potential health outcomes.
Implications for Public Trust in Regulatory Agencies
The conclusions drawn by Kunadhasen and Michels highlight a pressing need for policy reforms within regulatory agencies. They argue, “The FDA’s clinical review process has many weaknesses,” emphasizing that the emergency measures associated with the COVID-19 vaccine trials present unique challenges for public health.
The authors advocate for the repeal of the PREP Act, asserting that doing so is crucial to prevent inadequately tested treatments from being administered to the public without adequate scrutiny in the future.
About the Journal of American Physicians and Surgeons
The Journal of American Physicians and Surgeons is published by the Association of American Physicians and Surgeons (AAPS), a national organization that has represented physicians across all specialties since 1943. For further information, please contact Jane M. Orient, M.D. at (520) 323-3110 or via email at janeorientmd@gmail.com.