Moderna's Pre-Pandemic Knowledge of Biodistribution in Organs, Brian Simpson

Moderna's scientists, including lead author Staci Sabnis, submitted a study in late 2017 (accepted March 2018, published June 2018) to Molecular Therapy detailing biodistribution of their novel lipid nanoparticles (LNPs) for mRNA delivery. The paper focused on an amino-lipid series for mRNA-1325 (a Zika vaccine candidate), showing LNPs trafficked rapidly (within hours) to liver, spleen, and other organs in rodents and non-human primates, persisting 24–48 hours, with accumulation on repeat dosing. While the abstract emphasises endosomal escape and safety for repeat dosing, the full text and supplements confirm systemic spread beyond injection sites, entering plasma and vital organs like heart, lungs, and kidneys – mirroring the LNP tech (SM-102 ionisable lipid) in Moderna's Spikevax COVID-19 vaccine.

However: The submission was November 2017, but publication followed peer review in 2018, still pre-pandemic (COVID-19 emerged December 2019). The study tracked only up to 48 hours, not longer-term. Informed consent for COVID vaccines? Fact-checks confirm no explicit mention of LNP organ trafficking in standard EUA fact sheets or trial protocols; risks focused on common side effects (e.g., arm pain, fever), not biodistribution details. Preclinical data was filed with regulators (e.g., FDA's 2020 review noted liver accumulation in rats), but not translated to layperson consent forms, a gap critics call "incomplete disclosure." Broader literature corroborates: mRNA LNPs routinely distribute to liver/spleen (21.5% dose in liver at 48h in Moderna rat studies), with trace levels in heart/lungs/kidneys/brain. No evidence of deliberate concealment, but the asymmetry, insiders knew, public didn't, fuels ethical debates.

They Knew: Moderna's Pre-Pandemic LNP Secrets and the Consent Void in COVID's Shadow

Flash back to a sterile Cambridge, Mass., lab in November 2017. Moderna, the biotech upstart bootstrapping mRNA dreams on $2 billion in government seed money, submits a pivotal paper to Molecular Therapy. Authors: Their own team, led by Staci Sabnis. The cargo? Data on proprietary LNPs ferrying mRNA-1325, a Zika shot that never flew commercially but laid the rails for a pandemic juggernaut. Within hours of dosing rodents and primates, these nanoparticles, microscopic fat bubbles cradling fragile genetic code, don't stay put. They surge into the bloodstream, pooling in the liver (21% of dose by 48 hours), spleen, kidneys, heart, lungs. Repeat shots? Accumulation, like uninvited guests overstaying. The paper touts "improved safety" for multi-dosing, but buries the biodistribution bomb: Systemic spread, no firewalls. Fast-forward three years. COVID crashes the world. Moderna pivots, swaps Zika code for SARS-CoV-2 spike, and unleashes Spikevax, same LNP backbone, billions of arms jabbed. No queue-line whisper: "Hey, these lipids will tour your organs." They knew. We didn't.

The 2017 Blueprint: LNPs as Wandering Emissaries, Not Local Messengers

mRNA tech was no overnight miracle. By 2017, Moderna had iterated LNPs for years, tweaking ionisable lipids like SM-102 (debuting in that Sabnis paper) to shield mRNA from immune shredders and ferry it into cells. The goal? Endosomal escape, busting out of cellular jails to crank protein at ribosomes. But delivery's dark side: LNPs aren't taxis to lymph nodes; they're hitchhikers.

Sabnis et al.'s data, gleaned from radiolabelled LNPs in mice and monkeys, paints a migratory map:

Hour 1: Plasma entry, en route from muscle injection.

6–24 Hours: Peak in liver/spleen (immune hubs, but off-target for vaccines).

24–48 Hours: Traces in heart, lungs, kidneys; persistence noted, with repeat doses stacking up.

No long-haul tracking, the study caps at two days, but precedents warned of weeks-long lingers (e.g., 20–30 days half-life in other LNP trials). Why organs? ApoE proteins in blood glom onto LNPs, shuttling them to LDL receptors in hepatocytes. Spleen? Phagocytes gobble them for antigen presentation, boon for immunity, bane for "local-only" myths. Heart/lungs? Capillary leaks and endothelial fenestrations let nanoparticles slip in, sparking debates on myocarditis (spike expression there?) or pulmonary inflammation.

This wasn't fringe. Moderna's pipeline brimmed with LNP intel: Earlier Zika trials (mRNA-1325 Phase 1, 2016) hinted at it; broader lit (e.g., 2013 Onpattro LNPs) flagged liver tropism. Insiders – Sabnis, Benenato, Almarsson – penned it proudly: "Sustained pharmacology... safe repeat dosing." Translation: We engineered wanderers, tested the trails, and deemed them fit for prime time.

The COVID Pivot: From Zika Lab to Global Rollout – Same Engine, Silent Upgrade

December 2019: Wuhan whispers. By January 2020, Moderna's BARDA-backed team splices spike mRNA into those self-same LNPs. Operation Warp Speed greenlights: $955M flows. Trials blaze – Phase 3 efficacy 94% by November 2020. EUA drops December 18. Billions dosed by 2025.

The tech? Identical chassis. SM-102 ionisable lipid, DSPC phospholipid, cholesterol stabilizer, PEG-2000 cloak – all echoing Sabnis's series. Preclinical filings to FDA (June 2020) echo 2017: Rat studies show 21.5% liver dose at 48h, <1% spleen/adrenals/ovaries; plasma peaks early, clears variably. Human autopsies (2023) confirm: mRNA lingers in lymph nodes (30 days), heart (less often), not liver/spleen, but gaps persist (no routine brain/ovary checks).

Yet, the jab line? Crickets on LNPs' road trip. EUA fact sheets list "pain at site, fatigue, headache" – no "nanoparticles may vacation in your liver." Trial protocols (NCT04470427) nod to "biodistribution studies per regulations," but consent forms? Boilerplate: "Unknown long-term effects." Regulators knew – EMA/FDA reviews cite organ data – but waived full disclosure in pandemic haste, prioritising speed over granularity. Critics (e.g., neurorights advocates) cry foul: Informed consent demands material risks, like spike in ovaries (trace, but fertility fears) or brain (stroke risk). Moderna? "Safety profile established" – but buried in fine print.

The Consent Chasm: Innovation's Speed Bump or Ethical Evasion?

They knew, from Zika's cradle to COVID's crescendo. But knowledge hoarded in journals and dockets isn't consent. Nuremberg Code demands "voluntary consent... after explanation of risks." Here? A veil: Public pitched "local muscle action," eliding LNP nomadism. Why? Emergency use sidestepped full trials; "greater good" trumped details. Yet, precedents bite: Thalidomide's limb horrors stemmed from incomplete disclosure; Tuskegee hid syphilis truths.

Post-rollout shadows: Myocarditis (1/5K young males), clotting whispers, fertility panics, some tied to systemic spread. A 2023 autopsy series found mRNA in hearts up to 30 days; critics link to LNPs' cardiac jaunts. Moderna rakes $18B in 2022 sales, but lawsuits mount: "Failure to warn." Ethicists like Marcello Ienca (neuro-rights pioneer) warn: "Neural data as sensitive default" – extend to genetic payloads?

Reckoning: Toward Transparent Trails for Tomorrow's Shots

Moderna's saga? Triumph laced with hubris. They engineered the vax, but skimped on maps. Future mRNA waves – cancer, flu, HIV – demand better: Real-time biodistribution trackers (e.g., radiolabels), consent apps detailing "LNP journeys," and post-market organ scans.

In 2017, Sabnis's team glimpsed the horizon. By 2025, hindsight indicts the haze.

https://jonfleetwood.substack.com/p/moderna-knew-in-2017-that-its-mrna