COVID Booster Can Be Administered To Some Patients. Can Your Doctor Give Informed Consent?

by Chris Bailey

19 September 2021, Ventura County California

Over the course of 8 hours on Friday September 17th medical professionals from throughout the United States participated in a ZOOM conference to discuss the authorization of a booster shot to Pfizer’s COVID-19 vaccine MnRA protocol. For anyone interested it is available here on YouTube.

Much has been written about the result of a dry, self congratulatory 8 hours taken from life to view the conference. There was one overall, clear message that came through the 8 hours of pomposity.

Some of the concern expressed from coast-to-coast by patients about the M-1 Abrams approach to COVID-19 vaccination of the public is pushing up into the clinical areas of our Nation’s Healthcare administrators. Pfizer wasn’t rubber stamped for approval, and the sectors of our Nation’s demographics who truly need to take a gene therapy created under an Emergency Use Authorization will be able to get a booster shot, if they want one.

What I learned from the conference. 

Comirnaty is the clinical, legal name for the Pfizer two shot gene therapy COVID shot. The name was coined with Co- as the prefix, followed with -mirna as a nod to mRNA, and ends in the -ty suffix, representing both the words community and immunity

As of the writing of the article,  there STILL is no Informed Consent 

Informed Consent is a contract, an agreement between a Healthcare provider and a patient where the care provider discusses the options available for treatment, and the patient decides what works for them. This can be as simple as telling you there will be discomfort for a period of time after a procedure, to a clear possibility of death from other procedures or therapeutic protocols. 

The use of the Physicians Desk Reference(PDR).

When you open a medicine container, be it prescription medication or Over The Counter(OTR) a tightly folded multi page piece of paper falls out. It’s not origami. This is called the package insert, and it gives you all the clinical information about the medication you have opened. Uses, precautions, what medicine can be taken with it, whether is should be taken with/without food, etc. Your doctor doesn’t need to read this very small print, as the PDR takes ALL of these little pieces of clinical record and puts it in an easy to read size for your physician to read. The PDR also comes in handy for your pharmacist, who deconflicts every medication you currently take against any new prescription you are written. This last fact is the reason you want to try to keep all your medications coming from the same pharmacy.  

In a nutshell, your physician needs the package insert to provide patients with thorough and complete Informed Consent. Does your physician have the package insert information for any of the currently approved COVID-19 shots?

As the three separate searches show above, there is NO data for Comirnaty provided in the PDR. Some medications have literally pages of reference data for your physician. Aspirin, the most basic of medications, has a page of reference material. This access point can be found here  to look up your prescription and OTC medications. I asked Christopher Rake MD of CuffsUSA if he had an example of the package insert for any of the COVID-19 shots. He stated, “I haven’t been able to put my hands on that yet. Nobody has it”.

All three of the Emergency Use authorization (EUA) vaccines were released under experimental use. That freed the manufacturers from liability in the event of some type of adverse reaction such as cancer or death. the Pfizer vaccine was recently approved by the FDA however it was uncertain how much pressure was applied by the White House. The recent push for the booster shot #3 was definitely pushed by the Biden administration and resulted in 2 senior FDA officials who were involved with vaccine development, to resign. U.S. Food and Drug Administration advisory panel on Friday voted 16-2 to reject use of Pfizer’s booster vaccine in people ages 16 and older.  The major concern for this decision was insufficient evidence regarding the efficacy and safety of the vaccine. Natural immunity has been showing more durable immunity. Despite the millions of dollars the CDC receives in grants, no substantial research has been done to investigate natural immunity. The CDC is relying on Israel to do research to determine the benefit. a recent Israeli study showing natural immunity is superior to the protection provided by COVID-19 vaccines.

The FDA Committee Conference on approval for a Comirnaty booster for the general population did two things. It did not agree to certify Comirnaty as a general population booster, but they did agree the medication could be used on a case by case basis to assist in enhancing the immune systems of persons who need the help to ward off an attack from SARS-COV-2. Patients should consult with their physicians, and with Informed Consent, make that decision. 

Chris Bailey is a reporter-at-large of citizensjournal.us, a business owner, military veteran and longtime resident of Camarillo

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