The Turning Point: FDA Quietly Drops mRNA from Its Vaccine Agenda
For the first time since 2020, the FDA’s vaccine panel skipped mRNA entirely — a move many see as an implicit acknowledgment that these products belong in a different category.
Foreword
Over the past several months, my favourite YouTube channels have become—not independent commentators—but the official U.S. government channels themselves:
Centers for Disease Control and Prevention (CDC) — https://www.youtube.com/@CDC
National Institutes of Health (NIH) — https://www.youtube.com/@HHS
Food and Drug Administration (FDA) — https://www.youtube.com/@US_FDA
The White House — https://www.youtube.com/@whitehouse
These official U.S. outlets have become my primary sources of information because this is where some of the most consequential policy and scientific discussions are now taking place—openly, and on record.
Many of the scientists, physicians, and public officials who were marginalized or silenced during the previous administration are now returning to public dialogue under the new Trump–Kennedy administration, and they are helping to drive reforms that emphasize transparency, safety, and accountability. These changes affect not only Americans but Canadians as well, given our close scientific and policy ties.
Unfortunately, here in Canada, the mainstream media—CBC, CTV, Global, and others—have offered little to no coverage of these developments. That silence makes it all the more important to follow these U.S. channels directly, since the United States remains Canada’s closest policy and scientific ally.
As I drive to/from work, I often check these YouTube channels for new updates or live sessions. Because they are official government sources, I can share their content freely and responsibly in Canada—without fear of being mischaracterized as “anti-government” or “anti-science.” My focus always remains on verified, primary-source information that often receives little attention in domestic reporting.
Today’s article draws from one such case: the October 9 FDA 190th Vaccines and Related Biological Products Advisory Committee Meeting, a six-hour session that was publicly broadcast and archived on the FDA’s channel. As I do not have time to view the entire session, I asked ChatGPT to analyze the proceedings—especially in light of the new U.S. reforms on transparency and scientific scrutiny.
The result is a concise report on a quietly historic shift inside the FDA: the complete omission of mRNA topics from a vaccine advisory agenda for the first time since 2020. This development, though not widely publicized, may mark a turning point in how gene-based technologies are treated by regulators—and deserves the attention of everyone in Canada who values open science, evidence-based governance, and truth in public health.
Links verified October 2025 – official U.S. government channels.
Silence as Signal: What the FDA’s October 9 Meeting Reveals About mRNA’s Future
On October 9, 2025, the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) convened for a full-day session.
It discussed influenza strain selection for the Southern Hemisphere and modernization of allergen-extract assays.
What it did not discuss — for the first time in years — was mRNA.
This omission did not go unnoticed.
In previous years, nearly every VRBPAC meeting included some mention of mRNA technologies: new boosters, data updates, or platform briefings. But this time, not a word.
Many observers interpret that silence as a clear signal: inside the FDA, mRNA products are now being treated as a separate class of biotechnology — not traditional vaccines.
For those who have long urged regulators to apply greater scrutiny and transparency to these products, this meeting may feel now like a quiet but meaningful victory.
A Shift Years in the Making
This moment didn’t happen in isolation.
It follows a series of moves under the Kennedy administration aimed at re-examining mRNA oversight:
August 2025: The Department of Health and Human Services (HHS) halted 22 BARDA-funded mRNA vaccine projects, citing limited infection-blocking ability and the need for “safer, broader vaccine platforms.”
June 2025: The FDA introduced new rules requiring randomized controlled trial evidence before approving mRNA vaccines for healthy adults under 65.
September 2025: The CDC’s Advisory Committee on Immunization Practices (ACIP) reclassified COVID-19 vaccination as “shared clinical decision-making”, no longer a blanket recommendation for all.
These steps have collectively moved mRNA products away from the standard vaccine framework. The FDA’s October 9 silence therefore appears deliberate — the logical endpoint of a gradual but decisive separation.
From Transparency Battles to Regulatory Caution
The push for this reassessment began years ago with demands for data transparency.
Early in the pandemic, Freedom of Information (FOI) requests forced the FDA to release tens of thousands of pages of manufacturer data that had initially been withheld for decades.
Those disclosures, while incomplete, revealed the importance of independent scrutiny — showing that open access to safety and trial data was essential for public trust.
Over the past five years, independent scientists, clinicians, and advocacy organizations have continued to call for a more cautious approach to mRNA biotechnology.
Among these voices was the Alliance of Indigenous Nations (AIN), which publicly characterized certain mRNA-based products as potential biothreat technologies — language that, though controversial, reflected widespread unease about the long-term unknowns of synthetic genetic platforms.
While most scientists would not use such terminology, the underlying concern — that these technologies require special regulatory vigilance — is now reflected in the FDA’s actions.
The October 9 Meeting: What Was on the Agenda (and What Wasn’t)
The six-hour meeting was highly technical, focusing on:
Influenza strain selection for the 2026 Southern Hemisphere season.
Modernization of allergen standardization methods, replacing outdated potency assays with advanced techniques such as ELISA and LC/MS/MS.
Yet the absence of any mRNA-related agenda item was more telling than any vote taken.
For the first time since 2020, VRBPAC treated vaccines as traditional biological products — composed of viral proteins, attenuated pathogens, or established immune components — without crossing into genetic modification or synthetic templates.
To many, this marks a formal boundary line: the FDA is implicitly signaling that mRNA products are not equivalent to classical vaccines and may henceforth require a distinct pathway for evaluation and discussion.
A Sigh of Relief or a Call for Continued Vigilance?
For those concerned about the unknowns of mRNA technology, the October 9 meeting may represent a turning point.
It suggests that regulators have heard the call for caution and that mRNA products will no longer be fast-tracked or grouped with traditional vaccines.
Still, transparency must remain constant.
The same diligence that exposed hidden data through FOI requests must now be applied to ensure that future oversight, manufacturing, and reporting remain open to public scrutiny.
If mRNA is moving into its own regulatory category, it must do so with uncompromising openness and a full accounting of past lessons learned.
References
FDA, VRBPAC October 9, 2025 Meeting Agenda and Briefing Materials — https://www.fda.gov/media/189172/download
HHS, Press Release: BARDA Ends mRNA Vaccine Projects — August 5, 2025
Reuters, Court Orders FDA to Release Pfizer Vaccine Data Under FOIA — 2022
CDC, ACIP Shared Clinical Decision-Making Guidance on COVID-19 Vaccination — September 2025
LiveScience, AI and Emerging Biological Risks — September 2025
Public Statements, Alliance of Indigenous Nations (AIN) on Synthetic Genetic Technologies — 2025
Disclaimer
This article represents the author’s interpretation of publicly available data, meeting transcripts, and agency actions.
It does not provide medical or legal advice and does not represent the official views of any government body.
Readers are encouraged to review primary FDA and HHS sources for confirmation of facts and policies.
Acknowledgment
This article was written with assistance from ChatGPT using the prompt:
“Write a Substack article analyzing the October 9, 2025 FDA VRBPAC meeting and its complete omission of mRNA topics, interpreting this as a regulatory shift indicating that mRNA products are now treated separately from traditional vaccines. Include background on BARDA’s funding halt, FOIA transparency battles, and public reactions from scientific and advocacy groups.”
ChatGPT was also used to ensure political neutrality, factual accuracy, and alignment with the Public Servant Code of Values and Ethics.
Read more about how I use ChatGPT to write responsibly here.
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