Dear Editor:

The sole purpose of this letter is to disseminate vital researched information our rulers are not telling us.

The nation was informed on Aug. 23 that the “Pfizer” vaccine for COVID-19 had just been given full Food and Drug Administration (FDA) approval, having graduated from its initial Emergency Use Authorization (EUA) to full licensing.

Under a government-declared public emergency with PREP Act designation such as the current pandemic, fully licensed vaccines are allowed to be backed by the same limited liability protections as the experimental vaccine that was fast-tracked and first authorized for emergency use only. Consequently, any liability compensation for either vaccine classification is of “last resort” and excludes pain, suffering, emotional distress, or similar damages.

On the day of approval, President Joe Biden singled out the vaccine-hesitant community waiting for what he dubbed the “gold standard of FDA approval” by announcing, “The moment you’ve been waiting for is here. Please get vaccinated today.” 

Then, Dr. Fauci said in a recent television interview, “Now that we have the full stamp of approval for the Pfizer vaccine, we are definitely going to see mandating.” And according to the FDA press release, “The vaccine has been known as the Pfizer-BioNTech COVID-19 vaccine, and will now be marketed as COMIRNATY, for the prevention of COVID-19.”

However, irrefutable official FDA documentation explicitly states otherwise regarding the manufacturing and approval level of the original Pfizer-BioNTech partnership vaccine commonly known to Americans as simply “Pfizer.”

In a 13-page letter exclusively to Pfizer Inc. the FDA in part wrote, “On Aug. 23, 2021, FDA approved the license application submitted by BioNTech Manufacturing for COMIRNATY. FDA is reissuing the Aug. 12 letter of authorization in its entirety to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously authorized indication and uses. COMIRNATY is the same formulation as the Pfizer-BioNTech vaccine and can be used interchangeably with the Pfizer-BioNTech vaccine to provide the COVID-19 vaccination series. COMIRNATY is now licensed. There remains, however, a significant amount of Pfizer-BioNTech vaccine that was manufactured and labeled in accordance with this emergency use authorization. This authorization thus remains in place with respect to that product for the previously-authorized indication and uses.”

This troubling, contradictory disclosure addressed to Pfizer clearly means that the significant remaining amount of experimental “Pfizer” vaccine that first debuted under emergency use authorization in December will continue to be administered uninterrupted even after the same formulation becomes available under the FDA-approved COMIRNATY brand name.

Logically, this then means that the original and current Pfizer-BioNTech’s EUA patient consent form remains unchanged and should equally apply to COMIRNATY since it is admittedly the same product. 

That said, the first paragraph of the consent form states, “The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19.” Later it states, “Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19 Vaccine is still being studied in clinical trials. Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS).”

Yet, what has never been available to the public in an expectedly effortless manner prior to vaccination is vital decision-making information from the VAERS government website that totals such data of reported side effects on a revised weekly basis.

Thankfully, however, there is such an invaluable resource created by a group of selfless concerned citizens that neither accepts donations nor solicits fees: openvaers.com.

Frank Gabl

Prospect Heights, Ill.