Substack – by Peter A. McCullough, MD, MPH
One of the most common questions I am asked from the unvaccinated stems from concerns over “shedding.” Because the mRNA vaccines have been in development by the US Department of Defense DARPA since 2011, one would have expected that all of the necessary preclinical testing would have been completed before Operation Warp Speed was announced. The 2015 FDA guidance on Gene Product Shedding Studies with gene therapies, which are defined as “all products that exert their effects by transcription and/or translation of transferred genetic material and/or by integration into the host genome and that are administered in the form of nucleic acids, viruses or genetically modified microorganisms”.[i] By this statement mRNA vaccines are indeed gene therapy products and should have been submitted to these excretion studies by DARPA funded researchers long ago.[ii] Sadly, these careful development steps were skipped from the beginning in our military-style vaccine development program, and now the public is grappling with the issue of nucleic acid and Spike protein shedding as a potential concern among those who have worked so hard to remain healthy and free of COVID-19 vaccination. In the most comprehensive paper on shedding thus far, former Inserm researcher Dr. Helene Banoun has published the basis for which there is great likelihood that mRNA either on lipid nanoparticles or within exosomes is circulatory in blood and is secreted in every body secretion that would naturally expect to contain particles of this size.[iii]
Fertig et al, have shown mRNA is circulatory in blood for at least two weeks with no reduction in concentration out to that time point.[iv] Likewise, Hanna et al, have found mRNA within breast milk.[v] Less data exist on Spike protein shedding but it is not a far stretch to understand this is well within the realm of reality. The pivotal questions are: 1) for how long is a recently vaccinated person at risk to shed on to others? 2) can shed mRNA be taken up by the recipient and begin to produce Spike protein just like vaccination? 3) can shed Spike protein cause disease as it does in the vaccinated (e.g. myocarditis, blood clots, etc.)? It’s time for the lapses by DOD BARDA and NIH BARDA, to immediately be corrected by those agencies funding the necessary independent shedding studies to ensure the public safety of those who wisely deferred on COVID-19 vaccination. This research should preferably be conducted while the current products are paused and taken off to market to protect others at risk. Until then, we simply cannot answer these questions for those who sacrificed so much to remain “pure-blood.”
[i] Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products Guidance for Industry AUGUST 2015
[ii] Department of Defense Driving Mass Vaccination While FDA and Vaccine Companies are Powerless to Stop It by Dr. Peter McCullough | Nov 8, 2022 | Health, Military, Politics,
[iii] Current state of knowledge on the excretion of mRNA and spike produced by anti-COVID-19 mRNA vaccines; possibility of contamination of the entourage of those vaccinated by these products by Helene Banoun Infectious Diseases Research 2022;3(4):22. https://doi.org/10.53388/IDR20221125022
[iv] Fertig TE, Chitoiu L, Marta DS, Ionescu VS, Cismasiu VB, Radu E, Angheluta G, Dobre M, Serbanescu A, Hinescu ME, Gherghiceanu M. Vaccine mRNA Can Be Detected in Blood at 15 Days Post-Vaccination. Biomedicines. 2022 Jun 28;10(7):1538. doi: 10.3390/biomedicines10071538. PMID: 35884842; PMCID: PMC9313234.
[v] Hanna N, Heffes-Doon A, Lin X, et al. Detection of Messenger RNA COVID-19 Vaccines in Human Breast Milk. JAMA Pediatr. Published online September 26, 2022. doi:10.1001/jamapediatrics.2022.3581
See graph here: Substack