All gene therapy products pose a risk of shedding, according to the FDA. The topic of COVID-19 vaccine shedding has long been controversial, but now, some doctors say even the authorities know about it.
All gene therapy products pose a risk of shedding, according to the FDA. FDA Documents In a 2015 document titled Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products, the FDA defines shedding as "The release of ... from the patient through one or all of the following ways: excreta; secreta; or through the skin."
The FDA denied that the 2015 document applies to COVID mRNA vaccines.
Pfizer Investigators Told to Report 'Environmental' Vaccine Exposures Another piece of evidence resides in Pfizer documents, Dr. Kory added.
In Pfizer's COVID mRNA vaccine protocol, the company instructs investigators to report "Environmental exposures" if trial participants expose people around them to the vaccine through inhalation or skin contact.
In its Periodic Safety Report submitted to the European Union, Pfizer listed several adverse events it deemed not attributable to the vaccine and that should be excluded from discussion.
While another definition of shedding refers to the release of live viruses in people infected or vaccinated with live vaccines, Dr. Kory reiterated that the shedding discussed in the case of COVID-19 vaccines is different from the shedding of live viruses.
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