What Has to Happen Before mRNA Vaccines Are Pulled: Why RFK Jr. Hasn’t—and Why He Might Soon

by James Lyons-Weiler, PhD, Popular Rationalism, ©2025

(May 12, 2025) — The continued use of mRNA vaccines in the United States remains one of the most politically and medically contentious issues of our time. As public awareness grows around adverse event profiles and the questionable regulatory processes that ushered these products into global use, many are now asking an urgent question: why hasn’t HHS Secretary Robert F. Kennedy Jr. acted to revoke them?

To the untrained observer, Kennedy’s hesitation might appear as political caution or betrayal of his vaccine-critical roots. But the reality is far more complex. Pulling a product authorized under Emergency Use Authorization (EUA) or granted full Biologics License Application (BLA) approval is not a matter of executive decree. It requires a coordinated, multi-agency reckoning with evidence, policy, and law. And the legal scaffolding built to protect vaccine manufacturers—particularly under the Public Readiness and Emergency Preparedness (PREP) Act—was designed precisely to prevent the kind of abrupt retraction the public is demanding.

Yet the fortress is beginning to crumble.

The Nature of the Authorizations

Most Americans believe the mRNA vaccines are “approved.” In fact, the vaccines administered to the majority of the population have remained under EUA, not full licensure. The FDA granted BLAs to Comirnaty (Pfizer) and Spikevax (Moderna), but those exact products are often not available in the U.S. commercial supply chain. This bait-and-switch has significant legal implications, particularly around informed consent and product liability.

Under 21 U.S.C. § 360bbb-3, EUA requires that the Secretary of HHS determine that there is a public health emergency, that no adequate approved alternatives exist, and that the known and potential benefits outweigh the known and potential risks. But what happens when emerging data calls that balance into question?

What It Has Taken to Pull Vaccines Before

History tells us that only under grave circumstances does the FDA pull a vaccine. The Cutter Incident in 1955, in which live polio virus in inactivated vaccine batches caused paralytic disease and death, is one example. RotaShield, pulled in 1999 after being linked to intussusception in infants, is another. Pandemrix, used during the 2009 H1N1 pandemic, was withdrawn in Europe after post-vaccine narcolepsy cases.

But unlike those cases, mRNA vaccine injuries are statistically diffuse, often delayed, and obscured by passive surveillance systems with notorious underreporting.

The Collapse of Confidence: What the Data Are Saying

The CDC’s V-safe program, made public only after legal action, revealed that over 7% of vaccine recipients sought medical care after vaccination. The Vaccine Adverse Event Reporting System (VAERS) has registered more deaths, heart attacks, strokes, and permanent disabilities post-COVID vaccine than all other vaccines combined over 30 years. Independent reanalyses of the original clinical trial data (e.g., Fraiman et al.) have shown more serious adverse events in the treatment group than in the placebo group.

Myocarditis risk in young males, stroke risk in older populations, menstrual disruptions, and autoimmune relapses have all been documented across peer-reviewed studies. A special case involves the discovery of plasmid DNA contamination in mRNA vaccine vials by McKernan et al., raising questions about the adequacy of manufacturing quality control.

The Peter Marks Problem

For years, the man sitting at the nexus of vaccine authorization has been Dr. Peter Marks, former director of the FDA’s Center for Biologics Evaluation and Research (CBER). No individual has done more to uphold the facade of unassailable safety and effectiveness surrounding the mRNA platform. Under his leadership, concerns over myocarditis were minimized, booster authorizations were rushed, biased testing drove us to the brink of collapse, and product labeling was never updated to reflect new risk profiles,

Marks, reportedly resistant to any form of transparency regarding the V-safe and VAERS data, remained a blockade to reform. He was the final bulwark of the pharmaceutical status quo—“the last person on Earth who would ever take action,” as one insider put it.

His resignation earlier this year, amid rising tensions with Secretary Kennedy, was not only overdue—it was pivotal.

Vinay Prasad: The Reform Pivot

In a move that shocked the biomedical establishment, Dr. Vinay Prasad was appointed to replace Marks as director of CBER. Known for his rigorous critique of pharma-captured science and his opposition to the inclusion of COVID-19 vaccines on the routine childhood schedule, Prasad represents a new era.

He has repeatedly challenged the dogma of “safe and effective,” highlighting the need for absolute risk reduction data, transparent trial endpoints, and ethical risk communication. His academic work on overmedicalization and his public opposition to vaccine mandates suggest that, unlike his predecessor, he may not shield mRNA products from scrutiny.

What RFK Jr. Can Do—and Why He Hasn’t Yet

Secretary Kennedy does not have unilateral authority to revoke an EUA or a BLA. However, he can:

1. Halt federal contracts for vaccine purchases.
2. Initiate a formal review of existing EUAs through VRBPAC.
3. Recommend CBER reanalyze product safety and efficacy.
4. Publicly support whistleblowers, especially those inside FDA, CDC, and manufacturers.
5. Direct the HHS Office of General Counsel to assess the legality of continued EUA in light of known alternatives (e.g., Novavax).
6. Back legal challenges to the PREP Act’s scope, potentially inviting a Supreme Court ruling that curtails its overreach.

The PREP Act and the Coming Showdown

The PREP Act, passed in 2005, grants sweeping liability protection to manufacturers of medical countermeasures during declared emergencies. But it hinges on the absence of fraud and willful misconduct. If mounting evidence confirms either, PREP immunity collapses.

A constitutional challenge may already be forming behind the scenes—one that claims the Act unlawfully usurps judicial power by shielding corporations from accountability. The Supreme Court could soon be asked whether HHS may revoke these immunities if the product’s risk-benefit profile is no longer defensible.

Kennedy’s strategy may well be to invite that judicial review, rather than act rashly and risk invalidating the entire case through procedural missteps.

The Clock Is Ticking, But It Has Always Ticked

The window is closing to instill reliable predictability and transparent accountability in both biomedical science and public health regulation. For many, each day that passes without decisive action—either from HHS or the courts—erodes the possibility of establishing widespread trust. With Prasad now helming CBER, and Kennedy leveraging the full legal and political weight of his office, the groundwork is being laid.

The end of mRNA vaccines may begin with a press conference. It may end in a courtroom. And when it does, the public will no longer accept “we didn’t know” as an excuse.

For those involved, please do not ignore the Lyons-Weiler/Fenton Effect, which draws claims of efficacy into question in a provable manner (it’s just math). By first estimation, published in 2021 by Lyons-Weiler in Children’s Health Defense’s The Defender (Read it here), the efficacy of these vaccines was never 95%; It as 75%, and thus, the Risk/Benefit consideration given for the EUA was dramatically biased toward optimism. I think we can all agree that the vaccines do not meet the standard used by FDA for the EUA (See Appendix B, below).

The regulators knew. The manufacturers knew. And, in time, the record will show who acted—and who remained silent.

For More Information:

FDA Leadership Profiles

https://www.fda.gov/about-fda/fda-organization/fda-leadership-profiles

FDA Organization

https://www.fda.gov/about-fda/fda-organization

CDC COVID-19 Vaccine Safety (Outdated as of 5/10/2025)

https://www.cdc.gov/vaccine-safety/vaccines/covid-19.html

PREP Act Questions and Answers

https://aspr.hhs.gov/legal/PREPact/Pages/PREP-Act-Question-and-Answers.aspx

PREP Act Guidance (National Guard)

https://aspr.hhs.gov/legal/PREPact/Pages/prep-act-guidance-DoD-COVID.aspx

Barron’s: Moderna, Pharma Stocks Fall as FDA Names Industry Critic as Top Vaccine Regulator

https://www.barrons.com/articles/moderna-pharma-stocks-fda-vaccine-regulator-64d9137d

AP News: Critic of Drug Industry and COVID-19 Measures to Lead FDA Vaccine Program

https://apnews.com/article/8bbdc172215a9ba1cd587733b1732bbf

Axios: RFK Jr. Picks Controversial Doctor as Top Vaccine Regulator

https://www.axios.com/2025/05/06/rfk-jr-new-top-vaccine-regulator

Fierce Pharma: FDA Commissioner Marty Makary Taps Vinay Prasad to Head Up CBER

https://www.fiercepharma.com/pharma/fda-commissioner-marty-makary-taps-vinay-prasad-head-cber

AABB: Peter Marks Resigns as CBER Director

https://www.aabb.org/news-resources/news/article/2025/03/31/peter-marks-resigns-as-cber-director

Fierce Pharma: As FDA’s Peter Marks Resigns, Industry Watchers Size Up Vaccine, Cell and Gene Therapy Hits

https://www.fiercepharma.com/pharma/cber-chief-peter-marks-telegraphs-exit-fda-industry-watchers-eye-vaccine-cell-gene-hits

Academic and Legal Publications

JAMA: Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021

https://jamanetwork.com/journals/jama/fullarticle/2788346

JAMA: Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination

https://pubmed.ncbi.nlm.nih.gov/35076665

ScienceDirect: COVID-19 Vaccine-Associated Myocarditis

https://www.sciencedirect.com/science/article/pii/S2352906723001112

Frontiers in Pharmacology: Profiling COVID-19 Vaccine Adverse Events by Statistical and Ontological Analysis

https://www.frontiersin.org/articles/10.3389/fphar.2022.870599/full

Sci Publ Health & Law (IPAK): A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse Events Reporting System (VAERS) in Association with COVID-19 Injectable Biological Products

Reports Of Autopsies In VAERS And Associated Adverse Events Linked To Cause Of Death

Vaccine: Fraiman, J. et al. Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults. Vaccine, Volume 41, Issue 10, 2023.

https://doi.org/10.1016/j.vaccine.2022.08.036

Sci Publ Health Law (IPAK): Kammmer et al., BioNTech RNA-Based COVID-19 Injections Contain Large Amounts Of Residual DNA Including An SV40 Promoter/Enhancer Sequence v5.2019-2024

BioNTech RNA-Based COVID-19 Injections Contain Large Amounts Of Residual DNA Including An SV40 Promoter/Enhancer Sequence

McKernan, K. et al. “DNA Plasmid Contaminants in COVID-19 mRNA Vaccine Vials.” OSF Preprints, 2023.

https://osf.io/sgzdb

SAGE OPEN MEDICINE: Hooker, B. & Miller, N. Analysis of health outcomes in vaccinated and unvaccinated children: Developmental delays, asthma, ear infections and gastrointestinal disorders. Journal of Translational Science, 2020.

https://journals.sagepub.com/doi/10.1177/2050312120925344

Sci Publ Health Law. Skidmore, M. 2023. COVID-19 Illness and Vaccination Experiences in Social Circles Affect COVID-19 Vaccination Decision, https://publichealthpolicyjournal.com/covid-19-illness-and-vaccination-experiences-in-social-circles-affect-covid-19-vaccination-decisions/

VAERS Search Interface (CDC/VAERS Wonder Tool)

https://wonder.cdc.gov/vaers.html

BMJ Investigations: Thacker, P. “Covid-19: Researchers blow the whistle on data integrity issues in Pfizer trial.”

https://www.bmj.com/content/375/bmj.n2635

National Vaccine Injury Compensation Program (VICP) Statistics Report (Updated quarterly)

https://www.hrsa.gov/vaccine-compensation/data

U.S. Code Title 42 – The PREP Act (Public Health Service Act § 247d-6d)

https://aspr.hhs.gov/legal/PREPact/Pages/default.aspx

Congress.gov: The PREP Act and COVID-19, Part 2

https://www.congress.gov/crs-product/LSB10730

National Academies Press: “Vaccine Safety Research, Data Access, and Public Trust.”

https://nap.nationalacademies.org/catalog/11234/vaccine-safety-research-data-access-and-public-trust

Supreme Court Docket: No. 23-411 IN THE Supreme Court of the United States Petitioners v. Murthy (AAPS Amicus brief)

Click to access 20240207151527024_AAPS%20amicus%20brief%20Murthy%20v%20Missouri%2023-411.pdf

Appendix B.

The FDA’s standard for issuing an Emergency Use Authorization (EUA) for medical products, including vaccines, during a public health emergency like the COVID-19 pandemic, is outlined under Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The key criteria for granting an EUA are:

1. Serious or Life-Threatening Disease or Condition: The product must address a serious or life-threatening disease or condition caused by a chemical, biological, radiological, or nuclear (CBRN) agent, such as SARS-CoV-2.
2. Evidence of Effectiveness: It must be “reasonable to believe” that the product “may be effective” in preventing, diagnosing, or treating the disease or condition. This is a lower evidence threshold than the “effectiveness” standard required for full FDA approval, assessed through a risk-benefit analysis based on the totality of available scientific evidence.
3. Emergency Declaration: An EUA requires a declaration by the Secretary of Health and Human Services (HHS) that a public health emergency or significant potential for one exists. For COVID-19, this was declared on February 4, 2020, and amended on March 15, 2023.
4. Serious or Life-Threatening Disease or Condition: The product must address a serious or life-threatening disease or condition caused by a chemical, biological, radiological, or nuclear (CBRN) agent, such as SARS-CoV-2.
5. Evidence of Effectiveness: It must be “reasonable to believe” that the product “may be effective” in preventing, diagnosing, or treating the disease or condition. This is a lower evidence threshold than the “effectiveness” standard required for full FDA approval, assessed through a risk-benefit analysis based on the totality of available scientific evidence.
6. Risk-Benefit Analysis: The known and potential benefits of the product must outweigh the known and potential risks, considering the emergency context.
7. No Adequate, Approved, and Available Alternatives: There must be no adequate, approved, and available alternative products for the same purpose.
8. Emergency Declaration: An EUA requires a declaration by the Secretary of Health and Human Services (HHS) that a public health emergency or significant potential for one exists. For COVID-19, this was declared on February 4, 2020, and amended on March 15, 2023.
9. No Adequate, Approved, and Available Alternatives: There must be no adequate, approved, and available alternative products for the same purpose.