“Clinical observations conclude that symptomatic shedding events do occur,” wrote Pierre Kory in a Substack series, indicating more research needs to be done to learn about the potential impacts shedding can have on the population, regardless of COVID-19 vaccination status. The concept of vaccine shedding has been a topic of conversation since the rollout of the mRNA shots, although health authorities have frequently stated that shedding does not occur. 

This CDC article about COVID-19 vaccine myths states as a ‘fact’ that “Vaccine shedding is the release or discharge of any of the vaccine components in or outside of the body and can only occur when a vaccine contains a live, weakened version of the virus.” The post further clarifies that “none of the COVID-19 vaccines recommended for use in the U.S. contain a live virus,” indicating that it is impossible for these vaccines to shed. Note that the nation’s supposed leading “science-based” organization does not provide any scientific literature supporting the position that the COVID-19 vaccines do not shed. 

In a recent interview with Del Bigtree on The HighWire, Dr. Kory referred to a study that found a spike in mortality in unvaccinated children in areas where adults were vaccinated. “It lasted for eight weeks before going back to baseline.” He also indicated that shedding is real, as well as secondary shedding. “You can be exposed to someone who is shedding a lot of spike protein; go home and expose someone else.” 

Kory’s blog post states the FDA definition of gene therapy medicinal products; “Gene therapy products are all products that mediate their effects by transcription and/or translation of transferred genetic material and/or by integrating into the host genome and that are administered as nucleic acids, viruses, or genetically engineered microorganisms.”

Kory states that the mRNA vaccines do fall into the classification the FDA has for Gene Therapy Medicinal Products (GTMP). The FDA states guidance in this 2015 document on how shedding studies should be conducted for GTMPs. This admission is certainly not mentioned anywhere in the CDC’s “debunking” of the “myth” that COVID-19 mRNA vaccines can cause shedding. The same can be said of other “fact checks” that use the same CDC talking point without providing scientific sources to support the claim. 

The FDA guidance document further states, “Shedding studies should be conducted for each VBGT (Virus or Bacteria Based Genetic Therapy) or oncolytic product to provide information about the likelihood of transmission to untreated individuals because historical data alone may not be predictive of the shedding profile.” While the need for adequate shedding studies for gene therapy products was clear in the FDA document 2015, the mRNA vaccines were not regulated as gene therapy products. 

Furthermore, a Pfizer shedding study was referenced in a journal, but the document is nowhere to be found. The journal states, “Pfizer documents obtained by FOIA show that only the excretion of some components of the LNPs (ALC-0315 and ALC-0159) was studied in the urine and feces of IM-injected rats.” Dr. Kory indicated that this document was no longer visible, but the document has since been reposted. 

The Pfizer study uncovered via FOIA request looked at urine and feces excretions of PEGylated lipids in rats. The conclusion of the study states, “The unchanged form of ALC-0315 was almost undetectable in both urine and feces, but monoester metabolites, double transesterified metabolites, and 6-hexyl decanoate were detected in feces and plasma samples collected in the rat PK study, and glucuronide conjugates of the double transesterified metabolite were detected in urine. On the other hand, about 50% of the dose of ALC-0159 was excreted in feces as unchanged drug.”

While this hidden study provides details that support the claim that shedding is happening with the mRNA Pfizer vaccine, there is not enough information or enough studies to determine the potential harm that can be caused. Furthermore, this study only focused on rats’ excretions through feces and urine. Dr. Kory points out that both American and European agencies, based on a classification of the mRNA as gene therapy products, should have required “excretion studies of all secreted fluids (urine, exhaled droplets, saliva, sputum, nasopharyngeal fluids, semen, breast milk, feces, and sweat). Unfortunately, the emergency use authorization removed this part of the regulatory process, while everyone is left asking questions about the potential hazards of shedding.  

This lipid nanoparticle study states, “Hypersensitivity reactions rarely observed upon intramuscular injection of the mRNA-LNP COVID-19 vaccines may be related to the PEG-lipids.” ALC-0159, as studied by Pfizer, is the PEG lipid conjugate that was found to excrete 50 percent in the feces of rats.

Dr. Kory’s blog states, “So, LNPs, naked mRNA, naked spike and spike containing exosomes are disseminated in the bloodstream and to tissues as long as 187 days from vaccination (know this is not a limit, it is just the longest they followed the patient for). The dissemination of spike protein can cause immense organ damage leading to death.”

Dr. Kory cites a study about nanoparticle technology that states, “These ultrafine particles are capable of entering the body through skin pores, debilitated tissues, injection, olfactory, respiratory, and intestinal tracts. These uptake routes of NPs may be intentional or unintentional. Their entry may lead to various diversified adverse biological effects. Until a clearer picture emerges, the limited data available suggest that caution must be exercised when potential exposures to NPs are encountered. These nanosized particles are likely to increase unnecessary infinite toxicological effects on animals and environment, although their toxicological effects associated with human exposure are still unknown.”

Experts think that more safety studies should be implemented on this technology before more boosters are promoted to the general public. In the meantime, people are left to wonder how their health might be impacted by the shedding of the mRNA vaccines. Dr. Kory closes out his blog post by stating, “Thus it is my opinion that based on our clinical observations and treatment of shedding injuries that the lungs would be the primary (but not only) route of transmission (i.e. the inhalation of exhaled breath from a vaccinated person which contains free spike/free mRNA, and/or natural or synthetic LNP/exosomes containing spike or mRNA).”

In another blog post in this series, Dr. Kory states, “My general sense is that it occurs largely in people who have increased physiologic sensitivity to environmental exposures, toxins, or pharmaceuticals and that it is generally transmitted by someone recently vaccinated or someone who is producing a lot of spike protein. Note that is my ‘general sense.’ More studies are required to fully understand both the frequency of and physiologic impacts from such events.”