Nemo
Member
- Joined
- Jul 8, 2019
- Messages
- 2,163
Welp, the FDA is worried about shedding from virus gene therapy shots:
"The Center for Biologics Evaluation and Research (CBER)/Office of Cellular, Tissue, and Gene
Therapies (OCTGT) is issuing this guidance to provide you, sponsors of virus or bacteria-based
gene therapy products (VBGT products)1 and oncolytic viruses or bacteria (oncolytic products)2
with recommendations on how to conduct shedding studies during preclinical and clinical
development.
"For purposes of this guidance, the term 'shedding' means release of VBGT [gene therapy products] or
oncolytic products from the patient through one or all of the following ways: excreta (feces);
secreta (urine, saliva, nasopharyngeal fluids etc.); or through the skin (pustules, sores, wounds).
"Shedding is distinct from biodistribution because the latter describes how a product is spread
within the patient’s body from the site of administration while the former describes how it is
excreted or released from the patient’s body.
"Shedding raises the possibility of transmission of
VBGT [gene therapy products] or oncolytic products3 from treated to untreated individuals (e.g., close contacts and
health care professionals)."
There were no shedding studies cited in the vax makers' emergency use authorization applications.
"The Center for Biologics Evaluation and Research (CBER)/Office of Cellular, Tissue, and Gene
Therapies (OCTGT) is issuing this guidance to provide you, sponsors of virus or bacteria-based
gene therapy products (VBGT products)1 and oncolytic viruses or bacteria (oncolytic products)2
with recommendations on how to conduct shedding studies during preclinical and clinical
development.
"For purposes of this guidance, the term 'shedding' means release of VBGT [gene therapy products] or
oncolytic products from the patient through one or all of the following ways: excreta (feces);
secreta (urine, saliva, nasopharyngeal fluids etc.); or through the skin (pustules, sores, wounds).
"Shedding is distinct from biodistribution because the latter describes how a product is spread
within the patient’s body from the site of administration while the former describes how it is
excreted or released from the patient’s body.
"Shedding raises the possibility of transmission of
VBGT [gene therapy products] or oncolytic products3 from treated to untreated individuals (e.g., close contacts and
health care professionals)."
There were no shedding studies cited in the vax makers' emergency use authorization applications.
