Continuing the Crook County News Since 1884

Letter to the Editor

Dear Editor,

People have questioned why so many people are vaccine hesitant, especially here in northeast Wyoming. I think a quick look at a Pfizer vaccine fact sheet available at vaccine distribution outlets will shed some light on why folks are not trusting of the information they are getting on these vaccines. I offer these direct quotes from a revised sheet dated 23 August 2021.

Third paragraph down on page 1: “The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 vaccine under the Emergency Use Authorization (EUA) have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.1”

The footnote at the bottom of page 1 states: “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.”

These two products are the same formulation but have enough “differences” to be legally distinct? How does that work?

Okay, so let’s say the formulas are the same. Then why not give the EUA-authorized vaccine (Pfizer-BioNTech) full FDA approval if they are the same formula?

If you get the Pfizer vaccine, which one are you likely to receive, the EUA (BioNTech) vaccine or the FDA-Approved (COMIRNATY) vaccine? If you get the FDA approved Pfizer vaccine, COMIRNATY then, Pfizer, the company providing the vaccine is liable if something goes horribly wrong. However, my understanding is that Pfizer is not liable for negative outcomes of the Emergency Use Authorized vaccine because it is distributed under the EUA designation.

How many vaccine outlets are providing the FDA approved vaccine vs. the Emergency Use Authorization vaccine? My suspicion would be, the licensed vaccine has not seen a wide distribution. I wonder if it ever will?

The FDA uses BIONTECH and COMIRNATY titles interchangeably and yet maintains a legal distinction between the two products. It appears this legal distinction is maintained to avoid liability on the manufacturer for the vaccine that is actually being distributed.

Are people really going to trust the distributors of these vaccines if they appear deceptive in the presentation of license vs. authorized?

Thank you for your time,

Ted Davis

 
 
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