FDA Seeks Public Input on COVID Vaccine: Here's How to Comment and What to Say

Comments must be submitted by Wednesday, May 14 at noon ET to be delivered directly to the committee.

This article originally appeared on Jon Fleetwood’s Substack and was republished with permission.

Guest post by Jon Fleetwood

On May 8, 2025, the U.S. Food and Drug Administration (FDA) announced that it is officially inviting public comments from all Americans on the formulation of the 2025–2026 COVID-19 vaccines.

The Vaccines and Related Biological Products Advisory Committee will meet virtually on May 22, 2025, from 8:30 a.m. to 4:30 p.m. ET, to discuss and recommend which COVID-19 vaccine formula should be used in the United States next season.

Only on the market since 2020, Centers for Disease Control and Prevention (CDC) data show 38,541 deaths have been linked to the COVID jab. However, fewer than 1% of vaccine adverse events that do occur are ever reported to the CDC in the first place, according to a 2010 analysis submitted by Harvard doctors to the U.S. Department of Health and Human Services (HHS). If that’s correct, then there may have been closer to 3.8 million deaths linked to the COVID injection in the U.S. For context, the opioid pain medication propoxyphene was pulled from the U.S. market in November 2010 after being linked to 7,109 total reported U.S. deaths since 1981.

Importantly, any member of the public may comment on anything related to the COVID-19 shots, including:

• Demanding that the vaccines be pulled from the market,

• Urging the committee to reject the proposed 2025–2026 formula,

• Calling out informed consent violations,

• And submitting evidence of harm, safety concerns, or lack of necessity.

The public docket is FDA-2025-N-1146 and is open for comment until May 23, 2025, at 11:59 p.m. ET.

• Comments submitted by May 14 at noon ET will be given directly to the committee.

• Requests to speak live during the meeting must also be submitted by May 14 at noon.

Written comments can be submitted at: https://www.regulations.gov/commenton/FDA-2025-N-1146-0001.

This is a rare opportunity to make your voice heard and ensure your objections, data, or concerns about the COVID-19 vaccine program are formally entered into the federal record.

What to Write:

Beware—the FDA warns: anything you write, including your name, email, medical details, or sensitive data, will become part of the public record and published online—permanently:

“Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov,” writes FDA.

When you visit the link to submit a comment, you can either type in a written comment up to 5,000 characters or attach a document that does not exceed 10MB.

You can write whatever you like, but here’s an example of what you can copy/paste into the comment box, under 5,000 characters (I clicked ‘Individual Consumer’ in the “What is your comment about?” selection):

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To Whom It May Concern:

I am submitting this public comment regarding the May 22, 2025 meeting of the Vaccines and Related Biological Products Advisory Committee to formally urge the FDA to halt the authorization of any new COVID-19 vaccine formula for the 2025–2026 season and to re-evaluate the continued presence of these products on the U.S. market.

The public has never been given informed consent about the genetic contents of the current mRNA vaccines. COVID-19 vaccine manufacturers have failed to produce the full plasmid DNA backbone sequences used to produce the shots. Despite independent confirmation of plasmid DNA fragments—including SV40 promoter/enhancer sequences, bacterial origins of replication, and antibiotic resistance genes—neither manufacturers nor federal agencies have released the complete sequences or safety studies evaluating their risk of: Genomic integration, Carcinogenesis, Mutagenesis, Fertility impairment, Teratogenicity.

This is a staggering violation of scientific transparency and medical ethics.

Plasmid DNA is not inert. It can integrate into the human genome via nonhomologous recombination, potentially altering or damaging genes—including tumor suppressors or germline DNA. The inclusion of SV40 elements—a sequence historically linked to oncogenic risk—amplifies those concerns. The FDA has not released any evidence it has conducted safety reviews on this plasmid material.

The FDA’s own permitted residual DNA limit (10 ng per dose) was exceeded by over 500 times in some vials according to independent lab testing. Yet these injections remain authorized.

Compounding this is the gross failure of these products to perform. Peer-reviewed studies have shown: The Pfizer shot has “no significant effect” against infection or transmission (BMC Medicine, 2024); Protection wanes within months, while prior infection provides stronger, longer-lasting immunity (The Lancet, 2023); 1 in 10 recipients suffer vaccine-related injury (Royal Society of Medicine, 2024); COVID-19 vaccines do not protect against Long COVID (Open Forum Infectious Diseases, 2024); Spike protein persists in critical organs long after vaccination (Pathology International, 2024; Biomedicines, 2023).

In fact, vaccine spike protein has been found in the blood up to six months (Proteomics Clin Appl., 2023) and even 709 days (Yale researchers in medRxiv, 2025) post-injection, and is now recognized by multiple studies as a pathogenic factor in myocarditis, neurological damage, and Long COVID-like symptoms.

These are not hypothetical concerns. They are published, peer-reviewed, and growing.

Furthermore, thousands of physicians, scientists, and elected officials around the world have called for a moratorium or full withdrawal of the COVID-19 mRNA vaccines due to safety failures. These include: Florida Surgeon General Joseph Ladapo, who cited DNA integration risks and SV40 contamination in his call to halt mRNA COVID vaccines; The World Council for Health; Over 17,000 doctors and scientists at the COVID Summit; Public Health and Medical Professionals for Transparency; The McCullough Foundation, Research Triangle Park, and MIT affiliates.

Americans were injected with unknown DNA constructs. We still don’t know exactly what was in them. We still don’t have the safety data. That alone is grounds to halt all current and future COVID vaccine approvals until full transparency and rigorous safety reviews are complete.

Respectfully, I urge the committee to: 1) Reject the proposed 2025–2026 COVID-19 vaccine formula; 2) Immediately disclose the full plasmid DNA backbone sequences used by Pfizer and Moderna; 3) Release all safety studies on plasmid integration, carcinogenicity, and reproductive toxicity; 4) Suspend further use of DNA/RNA-based COVID vaccines until these concerns are addressed; 5) Investigate informed consent failures regarding plasmid DNA and SV40 disclosure.

Without this information, it is impossible for the American people to give informed consent—and impossible for the FDA to claim these products meet basic safety standards.

Sincerely,
Concerned American

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Speak now—or the FDA will take your silence as permission to inject the next round of DNA-contaminated, under-tested genetic material into the American people.

This post was originally published by Jon Fleetwood. Please visit his Substack and subscribe to support his work. Follow Jon: Instagram @realjonfleetwood / Twitter @JonMFleetwood / Facebook @realjonfleetwood

Copyright 2025 Jon Fleetwood

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