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Undisclosed excipient

Physicians For Informed Consent (PIC), a large group of doctors and scientists advocating for informed consent when it comes to vaccines, recently posted a document from the Food and Drug Administration via their Instagram profile showing there is an undisclosed ingredient in the Pfizer/Comirnaty COVID vaccine.

PIC explains,

Table 2 shows that 0.45 mL of an undisclosed excipient is part of the composition of the diluted vaccine solution. Because the entire solution in a multi-dose vial measures 2.25 mL, that excipient comprises 20% of the solution and potentially 20% of each vaccine dose. The undisclosed ingredient is also not disclosed in the vaccine package insert. If the American people don’t know the identity of an ingredient in an FDA-approved vaccine, how is informed consent possible?

The document is from August 23, 2021. Perhaps this mystery ingredient is disclosed somewhere else, and just not within this document.

In simple terms, throughout the document “(b) (4)” shows up in a number of areas that are redacted. One of the ingredients has been redacted. Perhaps it has been redacted to protect proprietary processes. But can a company protect ingredients and still offer a product under informed consent?

The Pulse has contacted the FDA to inquire about why this redaction appears. We will update this article when/if we receive a response from them. Perhaps the FDA has a good explanation for lack of transparency, we will see when we receive a response. Be sure to sign up to our email list to be notified as well.

Regardless of what choice you make with regards to COVID vaccines, we all have a right to know what the vaccines are made of and what we are injecting into our own body. This is key in the process of informed consent.


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