The “Noise” of mRNA
The FDA’s recent “preferred study design” for certain covid “vaccine” trials states: “The control group could receive a saline placebo, to permit documentation of the full adverse-event profile.” https://www.nejm.org/doi/full/10.1056/NEJMsb2506929
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Yet FDA guidance also states: “The placebo-controlled trial also allows a distinction between adverse events due to the drug and those due to the underlying disease or background noise [bold added].” https://www.fda.gov/media/71349/download
Have we considered that the “noise” of persistent mRNA or vaccine-associated spike protein in some is above “background noise”? While a placebo-controlled trial “[m]easures Absolute Efficacy and Safety,” will not the “noise” of long-lasting mRNA and vaccine-associated spike protein confound these measurements? https://www.fda.gov/media/71349/download
The PK (pharmacokinetic) profile (how the drug moves through the body) of a drug or vaccine involves assessment of ADME (absorption, distribution, metabolism, and excretion). https://www.merckmanuals.com/professional/clinical-pharmacology/pharmacokinetics/overview-of-pharmacokinetics
How do we define a true control group if we still don’t have complete ADME/PK information for the mRNA covid vaccines? What is the timeframe, for those having received mRNA vaccines, to have cleared or “washed out” any “noise” of mRNA?
In the case of Moderna’s Spikevax (mRNA-1273), “[n]o dedicated ADME [absorption, distribution, metabolism, and excretion] studies with mRNA-1273 were conducted…” https://www.ema.europa.eu/en/documents/assessment-report/spikevax-previously-covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf
And, with Pfizer’s Comirnaty (BNT162b), “[n]o traditional pharmacokinetic or biodistribution studies have been performed with the vaccine candidate BNT162b2.” https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf
In May of 2022, the FDA offered some PK information in their response to a clinical pharmacology concern of mine: “Following vaccination, after an immune response is triggered, the body breaks down the components of the vaccine and eliminates them in approximately 36 hours after vaccination [bold added].” I then requested a reference/data for that statement:
https://dailyclout.io/fda-and-pfizer-data-allegedly-missing-important-blood-brain-barrier-data-letter/ https://dailyclout.io/fda-response-to-doctor-raises-new-questions/
Last updated in June of 2022, the CDC had stated that covid vaccine mRNA is degraded and eliminated “within a few days,” while the vaccine-associated spike protein is “estimate[d]” to/”may” “stay in the body up to a few weeks.”
On the same archived CDC page, a link, How Long Do mRNA and Spike Proteins Last in the Body?, takes one to …
… this archived Nebraska Medicine website. The page states:
- “The Pfizer and Moderna vaccines work by introducing mRNA (messenger RNA) into your muscle cells. The cells make copies of the spike protein and the mRNA is quickly degraded (within a few days).”
And
- “The Infectious Disease Society of America (IDSA) estimates that the spike proteins that were generated by COVID-19 vaccines last up to a few weeks, like other proteins made by the body”
The same information above appears on Nebraska Medicine’s current, active website.
https://www.nebraskamed.com/COVID/where-mrna-vaccines-and-spike-proteins-go
The link of “…last up to a few weeks,…” on the current Nebraska Medicine website takes one to the IDSA website where I could not locate information on vaccine-associated spike protein/mRNA duration.
https://www.idsociety.org/ID-topics/infectious-disease/covid-19/
The link of “…last up to a few weeks,…” on the archived Nebraska Medicine website takes one to an archived Vaccines FAQ of a “CDC and IDSA” website, where one can find the following, under mRNA Vaccines…
https://web.archive.org/web/20220629095501/https://www.idsociety.org/covid-19-real-time-learning-network/vaccines/vaccines-information–faq https://web.archive.org/web/20220731034412/https://www.idsociety.org/covid-19-real-time-learning-network/vaccines/mrna-vaccines/
The linked reference, “Pardi, 2018,” is to a 2018 publication on “mRNA vaccines” in general, not specifically on the yet to be developed mRNA covid vaccines.
https://web.archive.org/web/20220801194920/https://www.nature.com/articles/nrd.2017.243
Today, however, the CDC does not cite the time required for degradation and elimination of the vaccine components. Instead, it simply describes elimination of the covid vaccines as: “After the [spike] protein piece is made, our cells break down the mRNA and remove it, leaving the body as waste.”
https://www.cdc.gov/covid/vaccines/how-they-work.html
Yet the published evidence gathered independently contradicts the above CDC statements. Rather, it demonstrates that both the vaccine-associated spike protein and/or mRNA are identified in the body at least months, not days or weeks, post-vaccination:
https://onlinelibrary.wiley.com/doi/10.1002/prca.202300048
https://pubmed.ncbi.nlm.nih.gov/36647776/
https://www.nature.com/articles/s41541-023-00742-7
https://www.cell.com/cell/fulltext/S0092-8674(22)00076-9
https://www.sciencedirect.com/science/article/pii/S096758682500195X
https://www.tandfonline.com/doi/full/10.1080/21645515.2025.2494934#d1e1688
https://bpspubs.onlinelibrary.wiley.com/doi/epdf/10.1002/prp2.1218
https://zenodo.org/records/14559625 (compilation)
Today, I still await a supporting reference for the covid mRNA vaccine pharmacokinetics claim of degradation and elimination in “approximately 36 hours after vaccination.”
It is my opinion that:
- Any persistent “noise” of vaccine mRNA and vaccine-associated spike protein is very much above “background noise” and precludes measurement of “[a]bsolute Efficacy and Safety.” This means that it becomes difficult to accurately determine how effective and safe a test vaccine is because the background presence of these components can interfere with the study results. As there is no normal “background” presence of modified (vaccine) mRNA in our bodies, the presence of any detectable mRNA from a vaccine is, by default, above “background noise.”
- The inclusion of individuals with persistent mRNA and vaccine-associated spike protein in trial control groups complicates the distinction between background noise and the actual effects of the test vaccine. This makes it challenging to establish a true control group, which is essential for gold-standard drug development, and can lead to uncertainties in identifying the true cause of adverse events.
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Dr. Carol Taccetta is a U.S.-licensed physician, board-certified in pathology, with a career in drug development spanning 25 years. Key agency interactions include Dr. Taccetta’s co-drafting of a chapter in the 1989 U.S. Surgeon General’s Report (CDC), as well as serving as Sponsor’s Responsible Medical Officer for a successful New Drug Application (NDA) to the FDA.
Please note: The views expressed are Dr. Taccetta’s personal opinions and do not reflect the views of former or current employers or any professional organizations to which she belongs.
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