It doesn’t matter if the formulation is the same, they are legally distinct products.

Another example:  Army National Guard vs. Active Duty Army Infantrymen.   Essentially the same thing.  They can both get sent to fight terrorists in…wherever, almost interchangeably.  Same training, skill set, etc. for the most part.  But why can only one of those be used for police-actions inside the United States?  Because they are legally distinct.

Double Tap

Except under the EUA, the one you CAN get does not have liability recourse for the labrat recipient.
If you want the one that is labeled FDA approved and gives you legal recourse, that's not available. Only the one that the manufacturer is protected from liability if the worst happens.
But, they get to hand wave and say "See, it's approved! That's what was holding you back, right?"

Nick

Oh I know he's doctor.

ETA: Which is why I'm not arguing medical info with him. Just like I won't argue healthcare statistics with you.

Yeah, the is an FDA approved vaccine, but there's still a huge amount of the "old" vaccines in the supply chain.  

Do you think they're going to let all of those existing vaccines go to waste?

I believe they also have to continue manufacturing the EUA labelled bottles, as Comirnaty is not yet FDA approved for 12-15 year olds or as a third booster.

The FDA approval for Comirnaty also included allowed for it to be used under the EUA for 12-15 year olds and as a booster. The two vaccines are the same and maybe used interchangeably. There is a legal distinction between them but they are interchangeable for medical purposes.

It's unlikely it's a different formulation because they relied on the original vaccine trials as part of the evidence submitted to prove safety and efficacy. If it were different they would have had to restart the entire process. Being unable to use the first six months of data would have been a huge delay.

Depending on how you understand "can be used as if it were Cominarty" the approval included the EUA vaccine. I am not a lawyer and don't know if that "as if" leaves a lot of legal wiggle room. I'm willing to bet even lawyers don't know.

The distinction is that they are shielded from liability as long as they keep doling out the EUA vaccine. Why can't people see through this fucking scam?

Maybe. If you ask for Cominarty, and are told you got Cominarty, but the nurse fulfilled the order by using EUA vaccine "as if it were Cominarty", are they really shielded?

Lawyer time.

From what I've read, both receive the same legal protections.

You can try to dance around and wordsmith all you want, but the facts of the situation as stated by the FDA themselves, is that Comirnaty is not FDA licensed for use in 12-15yr olds

DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19

It's kind of a convoluted mess to read as there is a ton of referencing previous sections, but PREP Act liability immunity was invoked last year and runs until 2024, for just about everything used to treat and prevent COVID/SARS-CoV-2.

But at least Congress set up a fund for compensation. We'll ignore that it's only paid out 29 times in the last decade.

1. I hate the Federal Register as you have to reformat the text. 2. Here is the meat and potatoes if anyone cares.

Section IV. Limited Immunity

The Secretary must also state that liability protections available under the PREP Act are in effect with respect to the Recommended Activities. These liability protections provide that, ‘‘[s]ubject to other provisions of [the PREP Act], a covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure if a Declaration has been issued with respect to such countermeasure.’’
In Section IV of the Declaration, the Secretary states that liability protections are in effect with respect to the Recommended Activities.


Section V. Covered Persons

The PREP Act’s liability immunity applies to ‘‘Covered Persons’’ with respect to administration or use of a Covered Countermeasure*. The term ‘‘Covered Persons’’ has a specific meaning and is defined in the PREP Act to include manufacturers, distributors, program planners, and qualified persons, and their officials, agents, and employees, and the United States. The PREP Act further defines the terms ‘‘manufacturer,’’ ‘‘distributor,’’ ‘‘program planner,’’ and ‘‘qualified person’’ as described below.

A manufacturer includes a contractor or subcontractor of a manufacturer; a supplier or licenser of any product, intellectual property, service, research tool or component or other article used in the design, development, clinical testing, investigation or manufacturing of a Covered Countermeasure; and any or all the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.

A distributor means a person or entity engaged in the distribution of drugs, biologics, or devices, including but not limited to: Manufacturers; re-packers; common carriers; contract carriers; air carriers; own-label distributors; privatelabel distributors; jobbers; brokers; warehouses and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies.

A program planner means a state or local government, including an Indian tribe; a person employed by the state or local government; or other person who supervises or administers a program with respect to the administration, dispensing, distribution, provision, or use of a Covered Countermeasure, including a person who establishes requirements, provides policy guidance, or supplies technical or scientific advice or assistance or provides a facility to administer or use a Covered Countermeasure in accordance with the Secretary’s Declaration.

Under this definition, a private sector employer or community group or other ‘‘person’’ can be a program planner when it carries out the described activities.

A qualified person means a licensed health professional or other individual authorized to prescribe, administer, or dispense Covered Countermeasures under the law of the state in which the Covered Countermeasure* was prescribed, administered, or dispensed; or a person within a category of persons identified as qualified in the Secretary’s Declaration. Under this definition, the Secretary can describe in the Declaration other qualified persons, such as volunteers, who are Covered Persons. Section V describes other qualified persons covered by this
Declaration.

The PREP Act also defines the word ‘‘person’’ as used in the Act: A person includes an individual, partnership, corporation, association, entity, or public or private corporation, including a federal, state, or local government agency or department.


Declaration Part III. Recommended Activities 42 U.S.C. 247d–6d(b)(1)

I recommend, under the conditions stated in this Declaration, the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures.

Declaration  Part VI.
Covered Countermeasures are any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID–19, or the transmission of SARS-CoV–2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product. Covered Countermeasures must be
‘‘qualified pandemic or epidemic products,’’ or ‘‘security countermeasures,’’ or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act.

All vaccines are shielded from liability. You cannot sue Pfizer for Comirnaty unless they have a defective batch, the same as it works for the EUA version. In both cases, you go to one of two federal vaccine court. You can argue that the court used under the EUA is harder to win a case in or that the compensation is less but in neither case does Pfizer pay the claim. For the FDA approved version, Pfizer and any other company that gets approved pays a fixed amount into a fund used to compensate people.

I agree they are legally different, my contention is the liquid in the vial is the same unlike what at least one other person here is claiming.

I don't see how the FDA can be truthful and/or accurate unless the formulations are different. Perhaps some of their statements are erroneous. But, if they are not, then the compounds are not identical. Simple as that.

I think you and I have chased each other around the mulberry bush enough on this issue.

Cheers.

Neither is the vaccine manufactured and placed in bottles labelled with the previous designation.  Neither are "Licensed" for use in children less than 15.  BOTH are "Authorized" for that use, however.

It will be, no chance it won't.

Yep, they would have to start over, even if they removed some impurities that do not affect function.

Vax lovers and sheep hate it when you question the unknown chemicals they so eagerly had injected into their body.