Covid mRNA defined as genetherapy by FDA and EMA requires testing for shedding in humans

A Midwestern Doctors shows us even more why no one could not trust the medical leaflets concerning the genetic covid injections. The Covid genetic injections were classified as gene-therapy by both the FDA and EMA. This requires testing about shedding for humans when it comes to gene-therapy medical products. This was never done.

Excerps from A Midwestern Doctor:

1. Shedding is very real.
2. People’s sensitivity to it greatly varies.
3. Most of the people who are highly sensitive to shedding have already figured it out, so if you do not already believe it is an issue for you, you probably don’t need to worry about it.
4. There is still no agreed upon mechanism to explain why it happens.

Typically, shedding occurs (e.g., from a live viral vaccine like MMR or polio) because an individual “sheds” a self replicating form of the disease. This results in the low concentration of the pathogen which the shedder expels into their environment then amplifying within the recipient and eventually reaching a comparable concentration to what was found in the “shedder.”

Since I was nonetheless seeing numerous clear cut cases of shedding occurring, this suggested to me that I was missing a huge piece of the puzzle which once known invalidated much of the above logic.

Conversely, I could not help but notice that 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).
  Note: due to the thalidomide disaster, a foundational rule in medical ethics is that you do not experiment on pregnant women due to the potential danger this exposes the fetus to.

• 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 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 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 which treats a rare form of genetic vision loss. Its prescribing information specifies that Luxturna can be found in a patient’s tears after injection and it hence for the first seven days after injection, care must be taken to avoid anyone else coming in contact with those tears to prevent unintended shedding of the product. Another similar gene therapy, Roctavian also was found to shed (e.g., into semen), and the FDA advises those who receive it to not 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 insert for Pfizer’s vaccine does not mention shedding at all (despite the fact it has long since been proven), and likewise J&J’s vaccine (which is very similar to the currently approved viral gene therapies) does not have shedding mentioned in its inserts either.

In short, like the cancer issue, I suspect Pfizer had concerning data on the shedding issue but opted not to disclose it so it could be claimed there was “no evidence” of shedding.

Note: in my eyes, the most unacceptable side effect of a pharmaceutical is if it harms individuals beyond those who received it. This for instance is why the federal government eventually cracked down on opioid prescriptions, as the opioid epidemic has been devastating for the communities affected by it. Similarly, this is why I recently focused on the decades of evidence linking SSRI antidepressants to triggering psychotic violence (e.g., mass shootings).

Article in full: What We've Learned from Over a Thousand Vaccine Shedding Reports