I think the bottom line on big Pharma knowing about shedding was the obvious clause about reporting unwanted vaxx trial participants accidental exposure to pregnant women in the Pfizer trials and the already known data on gene therapy. This article recaps it well:
"At the same time however, Pfizer’s protocol for testing their vaccine:
Prohibited pregnant women or those breast feeding from receiving the vaccine (or future doses if they had already received one).
Stated it needed to be reported if a pregnant women (e.g., a healthcare worker in the trials) was exposed to the intervention by inhalation or skin contact from someone who had been vaccinated.
Stated it needed to be reported if someone in the previous category (not vaccinated but exposed to someone who was) then was in close proximity to their wife and their wife was pregnant.
This suggested either that Pfizer knew shedding (and secondary shedding) was a real problem, or that they were following the existing standards—the FDA stipulates that gene therapies need to be evaluated for shedding before being given to humans (and furthermore be subsequently tested for shedding in humans). For context, both the FDA and the EMA (along with Moderna and Pfizer 1,2,3) classify the mRNA vaccines as a gene therapy.
Note: the first approved gene therapy, Luxturna, (which works like the J&J vaccine by using a modified virus to produce a target protein in the patient), is an eye medication (that costs $425,000.00 per eye) that treats a rare form of genetic vision loss (that DMSO also treats). Its prescribing information specifies that Luxturna can be found in a patient’s tears after injection. Hence, for the first seven days after injection, care must be taken to prevent anyone else from coming in contact with those tears and to prevent unintended shedding of the product. Another similar gene therapy, Roctavian was also found to shed (e.g., into semen), and the FDA advises those who receive it not to donate semen or impregnate someone for at least 6 months after administration. Finally, Zolgensma, a gene therapy, utilizing a different virus was also found to shed for a month, and its package insert advises that during this time, to be careful of how feces from the patients are disposed of (so no one else is exposed to it). Additionally, there is one other gene therapy on the market, but due to its design, shedding was unlikely (and hence undetected) so the FDA does not advise special precautions for its recipients. Curiously, the package inserts for all of the American COVID vaccines do not mention shedding.
I think the bottom line on big Pharma knowing about shedding was the obvious clause about reporting unwanted vaxx trial participants accidental exposure to pregnant women in the Pfizer trials and the already known data on gene therapy. This article recaps it well: "At the same time however, Pfizer’s protocol for testing their vaccine:
This suggested either that Pfizer knew shedding (and secondary shedding) was a real problem, or that they were following the existing standards—the FDA stipulates that gene therapies need to be evaluated for shedding before being given to humans (and furthermore be subsequently tested for shedding in humans). For context, both the FDA and the EMA (along with Moderna and Pfizer 1,2,3) classify the mRNA vaccines as a gene therapy.
Note: the first approved gene therapy, Luxturna, (which works like the J&J vaccine by using a modified virus to produce a target protein in the patient), is an eye medication (that costs $425,000.00 per eye) that treats a rare form of genetic vision loss (that DMSO also treats). Its prescribing information specifies that Luxturna can be found in a patient’s tears after injection. Hence, for the first seven days after injection, care must be taken to prevent anyone else from coming in contact with those tears and to prevent unintended shedding of the product. Another similar gene therapy, Roctavian was also found to shed (e.g., into semen), and the FDA advises those who receive it not to donate semen or impregnate someone for at least 6 months after administration. Finally, Zolgensma, a gene therapy, utilizing a different virus was also found to shed for a month, and its package insert advises that during this time, to be careful of how feces from the patients are disposed of (so no one else is exposed to it). Additionally, there is one other gene therapy on the market, but due to its design, shedding was unlikely (and hence undetected) so the FDA does not advise special precautions for its recipients. Curiously, the package inserts for all of the American COVID vaccines do not mention shedding.