A recent article at American Greatness, “Defense Department Pulls a Bait and Switch on Vaccines” by Benjamin Braddock contained some information that may assist you in your vaccine mandate cases. According to the piece, the formulations of the Comirnaty and BNT162b2 are not the same. I have contacted the author for his source data and have not yet received a reply. However, I felt my additional research in this area may be of interest. (Link to article: https://amgreatness.com/2021/10/19/defense-department-pulls-a-bait-and-switch-on-vaccines/)
According to my review of the the FDA’s BLA rules, it looks to me as perhaps the vaccine dosage could be changed under the EUA extension or the BLA (authorization of Comirnaty) but the formulation cannot be changed or adjusted (all ingredients including the mRNA) without further authorization. This seems to include changes in the mRNA to adjust for variants (which is likely why there has been no media discussion of the need to do so!).
The Comirnaty BLA (https://www.fda.gov/media/151710/download) says in the “Manufacturing Changes” section: “You must submit information to your BLA for our review and written approval under 21 CFR 601.12 for any changes in, including but not limited to, the manufacturing, testing, packaging or labeling of COVID-19 Vaccine, mRNA, or in the manufacturing facilities.”
21 CFR 601.12: “(1) As provided by this section, an applicant must inform the Food and Drug Administration (FDA) (see mailing addresses in § 600.2 of this chapter) about each change in the product…”
The introductory section of the FDA’s “Summary Basis for Regulatory Action” for Comirnaty (https://fda.gov/media/151733/download…) states that Comirnaty is “also referred to as BNT162b2 in this document,” thus making it appear they are identical. (By the way, although the American Greatness piece mentioned a redacted ingredient, this summary doesn’t redact any ingredients other than in specific descriptions of the structure of the mRNA.)
Also all of the subsequent discussion on BNT162b2 trial data furthers the impression that the products are identical.
So if as asserted by Braddock in the article, the product approved by the BLA is different from the product in the EUA, the legal ramifications are (or should be!) huge. This goes well beyond the availability issue, and means that essentially NO clinical trials (even though for BNT162b2 they were inadequate and misleading in the first place) were performed for Comirnaty.
Perhaps the FDA was informed of the specific changes and chose to waive requirement of additional data or trials because they felt they were insignificant etc — but that should have been disclosed to the public, at a minimum. I can find no discussion of these changes anywhere.
It’s too late for my son. He took the jab September 1 which was the deadline for the navy. Jag officers were present to process out any sailor who presented an exemption. 😠
A recent article at American Greatness, “Defense Department Pulls a Bait and Switch on Vaccines” by Benjamin Braddock contained some information that may assist you in your vaccine mandate cases. According to the piece, the formulations of the Comirnaty and BNT162b2 are not the same. I have contacted the author for his source data and have not yet received a reply. However, I felt my additional research in this area may be of interest. (Link to article: https://amgreatness.com/2021/10/19/defense-department-pulls-a-bait-and-switch-on-vaccines/)
According to my review of the the FDA’s BLA rules, it looks to me as perhaps the vaccine dosage could be changed under the EUA extension or the BLA (authorization of Comirnaty) but the formulation cannot be changed or adjusted (all ingredients including the mRNA) without further authorization. This seems to include changes in the mRNA to adjust for variants (which is likely why there has been no media discussion of the need to do so!).
The Comirnaty BLA (https://www.fda.gov/media/151710/download) says in the “Manufacturing Changes” section: “You must submit information to your BLA for our review and written approval under 21 CFR 601.12 for any changes in, including but not limited to, the manufacturing, testing, packaging or labeling of COVID-19 Vaccine, mRNA, or in the manufacturing facilities.”
21 CFR 601.12: “(1) As provided by this section, an applicant must inform the Food and Drug Administration (FDA) (see mailing addresses in § 600.2 of this chapter) about each change in the product…”
https://accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=601.12…
The introductory section of the FDA’s “Summary Basis for Regulatory Action” for Comirnaty (https://fda.gov/media/151733/download…) states that Comirnaty is “also referred to as BNT162b2 in this document,” thus making it appear they are identical. (By the way, although the American Greatness piece mentioned a redacted ingredient, this summary doesn’t redact any ingredients other than in specific descriptions of the structure of the mRNA.)
Also all of the subsequent discussion on BNT162b2 trial data furthers the impression that the products are identical.
So if as asserted by Braddock in the article, the product approved by the BLA is different from the product in the EUA, the legal ramifications are (or should be!) huge. This goes well beyond the availability issue, and means that essentially NO clinical trials (even though for BNT162b2 they were inadequate and misleading in the first place) were performed for Comirnaty.
Perhaps the FDA was informed of the specific changes and chose to waive requirement of additional data or trials because they felt they were insignificant etc — but that should have been disclosed to the public, at a minimum. I can find no discussion of these changes anywhere.
It’s too late for my son. He took the jab September 1 which was the deadline for the navy. Jag officers were present to process out any sailor who presented an exemption. 😠