The FDA information you asked for

I’m not interested in trying to sway anyone’s opinion by putting this info out. I’ll bombard you with whatever I want on instagram, but if we’re going to have an inclusive community on Terminal X, then I think it’s important to observe a more neutral voice on certain topics and deliver the information as honestly as I can.

There may be one or two individuals who read this who can actually speak intellectually about virology and vaccines (I’m not one of them). The rest of us are trying to stitch together whatever information we can cobble together out of a heavily polluted pit of biased conjecture and manipulated information. I’m going to outline everything I’ve put out on social media, and I’m going to do my best to articulate the differing viewpoints I’ve received so you can make your own conclusions.

I’ll start with this write-up here. There was contention that the first slide involving the formulas wasn’t contextual and there were more resources that showed the formulas were the same. I haven’t seen those resources, they weren’t presented to me, and I’m of the opinion the Covid-19 EUA and Comirnaty are different in composition.

The email from Tricare is legitimate, and it’s currently going forward as evidence in an upcoming lawsuit. One of the things I’ll discuss later on is the argument over the wording that states, “… same forulation and can be used interchangeably” and “the products are legally distinct.”

I then posted information regarding the definition of “interchangeable” and the legal hurdles a drug must overcome to achieve an interchangeable status.

Before I discuss, here are some links which the information was pulled from: Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry, Biosimilar and Interchangeable Products, Biosimilar Development, Review, and Approval, Biosimilars, Biosimilar and Interchangeable Products: The U.S. FDA Perspective, Abbreviated New Drug Application (ANDA).

Let’s get Pfizer in here to talk about it themselves really quick:

Very briefly, let’s discuss. I contend the FDA has not cleared the hurdle to say the EUA and Comirnaty are interchangeable. For one, a drug must be biosimilar to be interchangeable. According to the FDA’s purplebook, Comirnaty does not have any biosimilars.

On August 23, the FDA gave full clearance to Pfizer’s brand name drug called Comirnaty. The DOD declared on August 24th that all service-members will receive the vaccine. However, by Pfizer’s own admission (we included the documents in multiple articles now), they will not start producing the FDA approved Comirnaty until the abundance of EUA vaccine has been used. No one, anywhere, is receiving the FDA approved version. This has not stopped medical providers and the DOD from listing Comirnaty on troop’s medical records (of which a number of you have joined the forthcoming lawsuit).

What’s the argument against this? Dustofficers, an account who regularly disagrees with content we post surrounding this topic, wrote:

There are no biosimilars because they’re the same shot, produced by the same company. Both have the research name BNT162B2. They use “comirnaty” to describe it when given to people 16 and older and “Pfizer-BioNTech” when used for people between 12 and 15. If you’re a SM trying to use this argument, you’re wasting your time and opening yourself up to actual repurcussions (GOMOR/general discharge etc).

I won’t argue with his statement, because he’s not on here to defend his position. I’m providing it as one of the more articulate voices speaking in opposition to my viewpoint.

I’d ask a few questions to yourself as you deliberate: why would they say the drugs are legally distinct if they’re the exact same thing and produced under the exact same conditions? If they’re legally distinct, why does that legal rendering not apply to the DOD’s decisions? Why would Pfizer publicly state they won’t produce the Comirnaty until the EUA is used up? That statement doesn’t seem like it would be necessary if they’re the same. I’d simply say production will continue, and the new labels will be added as more is produced in the future. Finally, if they’re legally distinct, then shouldn’t the name on the medical records reflect the legal designator of the specific version? Either they’re all Comirnaty in every use of medical and legal vernacular, or they’re not. You can’t pick and choose what venue they’re given distinction vs. lumping them all together as the same thing.

I obviously have my very strong and researched opinions on this topic. I’ve spoken publicly about my stance on this issue more times than I’d care to. I’m nothing more than a person doing research, receiving information from others, who has a platform with which to distribute my thoughts. My purpose in writing this article is to give you the tools and viewpoints to come to your own conclusion. An echo chamber of thoughts and ideas benefits no one. Arm yourself with knowledge, and act on your convictions. Godspeed.

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2 years ago

There is a large difference between interchangeable and biosimilar. Biosimilars are relatively new territory for drug manufacturers. However, any time the active ingredient is the same, it’s the same drug. The EUA version and the branded version are the same active ingredient, but only legally distinct because you can’t market a product not approved by the FDA. Has one million percent nothing to do with biosimilar products. I can explain this better another time if you can’t figure it out. Look up epogen and biosimilars for instance, a great starting point and one that’s used often in the US market.

Reply to  Josh
2 years ago

You didn’t read anything I put together, did you? It’s obvious with that kind of comment. You browsed through this singular article (written for the many people who requested the documents I was using on Instagram) and somehow thought I was comparing and contrasting biosimilar and interchangeable drugs, as if they’re even comparable at all. An interchangeable drug MUST be biosimilar with the other drug. I’ve put that information out 3 times now, directly from the FDA’s regulations. Comirnaty isn’t currently biosimilar to anything according to their website data base, therefore it can’t be interchangeable with anything either.

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