A Proposal to Repeal PREP Act Liability Immunity for COVID-19 Vaccines

Date: February 24, 2026

Jessica Rose

1. Introduction

The Public Readiness and Emergency Preparedness (PREP) Act was enacted to provide broad liability immunity to manufacturers and administrators of medical countermeasures during a public health emergency. [1] While intended to facilitate a rapid response to the COVID-19 pandemic, the continued application of these protections to COVID-19 vaccines warrants urgent reconsideration. This proposal outlines the case for repealing PREP Act immunity for COVID-19 vaccines, based on emerging scientific evidence of potential long-term adverse events (AEs) and the systemic failure of the designated compensation program to provide justice for the injured.

2. Emerging Evidence of a Cancer Safety Signal

A foundational principle of public health is the continuous post-market surveillance of new medical products. Data from the Vaccine Adverse Event Reporting System (VAERS) reveals a significant and unprecedented increase in cancer-related AE reports following the mass rollout of COVID-19 vaccines. As illustrated below, the rate of such reports per 100,000 total VAERS reports surged dramatically in 2021 and has remained at historically elevated levels.

   Figure 1: Cancer-related VAERS reports per 100,000 total reports. The data shows a dramatic increase in reports of major solid tumors and other specific cancers beginning in 2021, coinciding with the COVID-19 vaccination campaigns..
This statistical anomaly is not an isolated finding. A comprehensive 2026 review by Kuperwasser and El-Deiry published in Oncotarget systematically analyzed the world’s literature and identified a growing number of peer-reviewed publications reporting “diverse cancer types appearing in temporal association with COVID-19 vaccination or infection” [2]. The study documented 69 publications describing 333 patients, with many reports highlighting recurrent themes of:

“(1) unusually rapid progression, recurrence, or reactivation of preexisting indolent or controlled disease, (2) atypical or localized histopathologic findings, including involvement of vaccine injection sites or regional lymph nodes, and (3) proposed immunologic links between acute infection or vaccination and tumor dormancy, immune escape, or microenvironmental shifts.” [2]

The authors conclude that while the evidence is in an “early phase of potential safety-signal detection,” it underscores the urgent need for rigorous investigation, particularly since the vaccine package inserts explicitly state they have not been evaluated for carcinogenicity [2,3].

3. The Inadequacy of the Countermeasures Injury Compensation Program (CICP)

Under the PREP Act, individuals who believe they have been harmed by a COVID-19 vaccine are barred from the traditional court system and the National Vaccine Injury Compensation Program (VICP), which handles claims for most other vaccines. Instead, they are directed to the Countermeasures Injury Compensation Program (CICP), an administrative program with a notoriously high bar for claimants and a near-impenetrable process.

The results have been devastating for those seeking recourse. According to the latest data from the Health Resources and Services Administration (HRSA), of the 14,102 COVID-19 countermeasure claims filed, a mere 44 have been compensated [3]. This represents a compensation rate of approximately 0.3% of all claims filed. Over 6,500 claims have been denied outright, with thousands dismissed for technicalities like missed filing deadlines [3].

This stands in stark contrast to the VICP, which has historically compensated a significant majority of petitions. The CICP’s structure, which does not cover attorney’s fees, places an extraordinary burden on the injured and has proven to be an ineffective and unjust forum, leaving thousands of Americans without a viable path to justice.

4. Conclusion and Recommendation

The PREP Act’s liability shield for COVID-19 vaccines is no longer tenable. The combination of a statistically significant and biologically plausible safety signal for cancer, as documented in VAERS and peer-reviewed literature - including recent publications by Speicher et al. and McKernan et al. that clearly establish high levels of DNA contamination to include SV40 fragments due to RNA:DNA hybrids [4,5] - and the manifest failure of the CICP to provide a fair and accessible compensation pathway, creates an unacceptable situation. Citizens who complied with public health recommendations, and in many cases mandates, are now left without recourse in the face of potential life-altering harm.

Accountability is a cornerstone of public trust and pharmaceutical safety. The broad immunity granted to manufacturers has removed a critical incentive for ensuring long-term product safety and transparency. Legislative efforts, such as the End the Vaccine Carveout Act [6], reflect a growing consensus that this imbalance must be corrected [7].

I strongly urge the repeal of PREP Act liability protections for COVID-19 vaccines. This action is essential to restore the rights of the injured to seek justice through the civil court system, to hold manufacturers accountable for the safety of their products, and to rebuild public confidence in our nation’s health institutions.

References

[1] https://www.federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures

[1] Kuperwasser, C., & El-Deiry, W. S. (2026). COVID vaccination and post-infection cancer signals: Evaluating patterns and potential biological mechanisms. Oncotarget, 17, 1-29. https://www.oncotarget.com/article/28824/text/

[2] Food and Drug Administration. (2021). COMIRNATY Package Insert. https://www.fda.gov/media/151707/download

[3] Health Resources and Services Administration. (2026, February 1). Countermeasures Injury Compensation Program (CICP) Data. https://www.hrsa.gov/cicp/cicp-data

[4] Speicher, D. J., Rose, J., & McKernan, K. (2025). Quantification of residual plasmid DNA and SV40 promoter-enhancer sequences in Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada. Autoimmunity, 58(1). https://doi.org/10.1080/08916934.2025.2551517

[5] McKernan K, Rixey C, Rose J. RNA:DNA hybrids survive digestion in mRNA vaccine manufacturing. J Independent Med. 2026;2(1):31-46. doi:10.71189/JIM/2026/V02N01A04

[6] https://www.congress.gov/bill/118th-congress/house-bill/9828

[7] Lee, M. (2026, February 17). Lee, Paul Introduce End to Vaccine Carveouts. Office of Senator Mike Lee. https://www.lee.senate.gov/2026/2/lee-paul-introduce-end-to-vaccine-carveouts