The two are identical and interchangeable.
—
The two may be chemically identical, but not from a legal perspective. One is FDA approved, the other is EUA, which shields the manufacturer from liability.
Flick Lives wrote: “The two may be chemically identical, but not from a legal perspective. One is FDA approved, the other is EUA, which shields the manufacturer from liability.”
Two misrepresentation. Here’s the Congressional report that explains why they are legally distinct. They are still chemically identical and interchangeable.
Quotation begin.
Why did FDA refer to Comirnaty and the Pfizer-BioNTech vaccine as “legally distinct”?
In the EUA, FDA states that the Comirnaty and Pfizer-BioNTech vaccines “are legally distinct with certain differences that do not impact safety or effectiveness.”
87 While the Comirnaty and Pfizer-BioNTech vaccines have the same formulation, they are legally allowed to be marketed
and used pursuant to different legal authorities. Specifically, Comirnaty is licensed pursuant to a BLA issued under the PHS Act (42 U.S.C. §262). The Pfizer-BioNTech vaccine is authorized for emergency use pursuant to the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C.
§360bbb-3).
Each product must be manufactured, labeled, marketed, distributed, and administered in accordance with the requirements of the legal regime under which it was approved or authorized. These requirements may differ in a number of ways. For example, under the EUA, the PfizerBioNTech vaccine must be accompanied by fact sheets for the vaccine administrator and recipient informing them, among other things, of the product’s emergency authorization, known and
anticipated risks and benefits, and the right to decline the vaccine. Comirnaty need not be accompanied by this information if it is being administered pursuant to the BLA rather than the EUA; instead, the PHS Act and other FDA regulatory labeling requirements apply.
As another example, the Pfizer-BioNTech vaccine may be manufactured only at facilities identified and agreed upon in Pfizer’s EUA request, must be distributed directly by Pfizer or through authorized distributors to emergency response stakeholders (as defined in the EUA) as directed by the U.S. government, and must be administered by vaccination providers (as defined in the EUA) only to individuals 12 years of age and older in accordance with the uses authorized by the EUA. These limitations do not apply to Comirnaty vaccines manufactured and distributed pursuant to the BLA; instead, the PHS Act and FD&C Act requirements apply.
End Quotation.
https://crsreports.congress.gov/product/pdf/R/R46913
Page 12.
As to liability:
Quotation begins:
Does FDA’s licensure of Comirnaty affect liability protections for COVID-19 vaccines under the PREP Act?
Generally speaking, it does not. Under the PREP Act, “covered countermeasures” include both (1) “qualified pandemic or epidemic products” and (2) biological products authorized for emergency use under an EUA.
Comirnaty is a biological product licensed by FDA to prevent COVID-19 (see “What is the scope of FDA’s biologics license for Comirnaty?”). It meets the definition of qualified pandemic or epidemic product and is thus a covered countermeasure under the PREP Act while the PREP Act
declaration remains in effect. For its part, the Pfizer-BioNTech vaccine is authorized under an EUA to prevent COVID-19 (see “What is the scope of the current EUA for the Pfizer-BioNTech vaccine?”). It, too, meets the definition of covered countermeasure under the PREP Act.
Because Comirnaty and the Pfizer-BioNTech COVID-19 vaccine are both covered countermeasures, the liability protections under the PREP Act apply to both products. That is, assuming that all the other elements for immunity under the PREP Act are met, whether the vaccine’s use is licensed by FDA or authorized under an EUA does not affect the PREP Act’s
liability protections.
Quotation Ends.
https://crsreports.congress.gov/product/pdf/R/R46913
page 14.