This article is from a great newsletter I get from a highly recommended website called Just the Inserts. All sources they use are official documents.
It’s been quite the week. You may have heard the FDA approved the first Covid-19 vaccine on Monday. What was known as Pfizer-BioNTech Covid-19 Vaccine will now be marketed as “Comirnaty” (koe-mir’-na-tee). There’s quite a bit of confusion on licensing, tradenames, and lots of legal jargon that I’m not qualified to discuss. The bottom line is that according to the FDA, Comirnaty is approved for individuals 16 years or older and still under Emergency Use Authorization for 12-15 year olds and the administration of a third dose in certain immunocompromised individuals. Until the complexities of the approval are ironed out, this will most likely be the information used to enforce vaccine mandates. So let’s work with what we know so far.
Comirnaty Manufacturer Insert
FDA approval finally initiated a manufacturer insert. I took my time reading through the 20 page insert and will share my initial thoughts below. This is verified information from the FDA website and can be used to engage in fact-based discussion with those in your sphere of influence.
Manufacturer-listed Adverse Reactions (so far)
I received quite a few messages when I posted this on Instagram on why certain adverse reactions were not listed (death, GBS, blood clots, etc). My assumption is that the VAERS reports for these reactions have not initiated “safety signals” for the FDA/CDC for them to investigate and discuss the cause/effect. Unfortunately, there is not enough transparency in the process to state either way.
Let’s look deeper at heart inflammation.
Several news articles have downplayed the implications of these reactions that truly concerns me. I’ve discussed these concerns with several medical professionals that are baffled anyone would consider these reactions as “mild” and something to brush off. If you experience any of the symptoms, please contact your provider immediately.
The following sections from the insert are incredibly important to understand. There are many unknowns even with FDA approval.
Should vaccines be mandated when the FDA discloses the below information on the insert? Should education or the ability to gain/maintain employment hinge on these products? If the initial series is mandated, will the boosters be mandated as well?
For those facing mandates, here is a resource that I’ve been told is successful when trying to gain an exemption. Feel free to use whatever is applicable to your situation.
For those looking to change jobs, there are several job boards of employers that will not enforce a vaccine mandate.
There are many that believe if you are responsible for the outcome of a medical product you should also have authority to accept, delay, or decline it. Stay calm, clear-minded, and strong. Band together with those in your sphere of influence. You have more power than you think.
A word on Censorship
If you’ve been following on Instagram, you know that the platform threatened to delete my account for sharing the information within the manufacturer insert. The .gov information I shared was ironically labeled “harmful false information.” This is a huge red flag that there isn’t open + honest discussion occurring with these products. This is not what informed consent looks like. We should be able to share .gov information about medical products anywhere we please without the threat of account deletion. My hope is this platform will uphold its promise to keep it a safe place for its users. If not, I will create a backup account and email it to subscribers. I currently do not have a backup. If you’re on Telegram, here is my channel.
The CDC has announced an ACIP meeting on Monday to discuss the FDA approval. I assume they will add it to the recommended schedules. Depending on your State legislation, this may make it easier for State government to mandate it. I suggest following your State’s Freedom Keeper United chapter to stay updated on State legislation. They have international chapters as well.
To listen into the ACIP Meeting, follow this link and scroll down to the box with the webcast link. The draft agenda is already loaded and the presentation slides should populate in that same box when the meeting starts.