Is the approved Pfizer jab available?
Pfizer is licensed to market "Comirnaty"; but it's BNT162b2 injection remains available under emergency use authorization.
On August 23, 2021, the FDA announced it “approved the first COVID-19 vaccine,” but that “the vaccine also continues to be available under emergency use authorization (EUA).”
Though Pfizer’s EUA injection is called “Pfizer-BioNTech COVID-19 Vaccine” or “BNT162b2,” the FDA was announcing that Pfizer now has a license to market a similar, non-identical, legally distinct product labeled as “COMIRNATY” (koe-mir’-na-tee). Relevant FDA documents are here.
To recap, emergency use authorization for Pfizer’s BNT162b2 injection is still in place, and Pfizer now has a license to market a similar, non-identical injection called COMIRNATY. Yet, have you seen COMIRNATY on the market?
Is COMIRNATY available?
Based on this, some legal scholars, like constitutional lawyer Robert Barnes, have concluded “There is no *available* FDA approved licensed vaccine.” To Barnes, the FDA’s recent move appears to shield Pfizer from potential product liability claims that could arise for injuries from COMIRNATY (because people will continue using the EUA BNT162b2 injection). I’ll need to look into this.
Others seem to agree that only EUA injections are presently available. For example, Pam Long of Children’s Health Defense believes our military members still have the right to decline all of the available EUA injections.
Legally distinct with certain differences
While some may be skeptical, take a look at footnote 8 on page 2 of the FDA’s emergency use authorization reissue letter (8/23/11) for BNT162b2. There, the FDA states that the licensed injection (COMIRNATY) and EUA injection (BNT162b2) are “legally distinct with certain differences.”
The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.
Of potential relevance also is page 14 of the FDA’s Summary of Regulatory Action, where the FDA identifies that a difference between COMIRNATY and a product termed “BNT162b2 (V8)” is that “COMIRNATY includes the presence of optimized codons to improve antigen expression.”
A few questions are warranted
Perhaps more than a few questions are warranted, but let’s start with these.
Initially, what are the “certain differences”? Is it really the case that these differences have no impact on safety and effectiveness, whether positive or negative? And over what period of time was this determination made?
What if, for example, the mRNA used in COMIRNATY is not the same as the mRNA used in the EUA injection? Does that mean the antigen (spike protein) expressed by COMIRNATY would be different than the antigen (spike protein) expressed by the EUA injection?
Next, what is “BNT162b2 (V8)”? Is this the EUA injection? If so, what was the purpose of altering COMIRNATY to include “codons optimized to improve antigen expression”? Does this or does this not mean that the actual mRNA in COMIRNATY is different than the mRNA in the EUA injection?
Further, what is the legal impact of taking the available EUA injection, rather than waiting for COMIRNATY, which is licensed?
Would the decision impact a person’s ability to sue Pfizer if an injury occurs?
Would the decision impact how a person’s insurance would treat an injury arising from the injection? (Note that a major insurer has indicated they don’t cover expenses related to injuries from an experimental EUA injection.)
In the coming days, I hope to update this post with my findings on the COMIRNATY vs. BNT162b2 issue, and the questions above.
In the meantime, the relevant FDA documents are here, and those listed below are of particular interest.
Approval Letter (8/23/21) (approving biologics license application).
Reissued EUA Letter (8/23/21).
Original EUA Review Memo (12/11/2020).
To be continued…