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Comment by xienze | Hacker News Reader

> Individuals 18 years of age and older are eligible for a single booster dose of the Moderna COVID-19 Vaccine, Bivalent if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

So if you haven’t had the primary course of shots you can’t take this one? Why not? I’m pretty sure I can take the flu shot even if I didn’t take it last year, or in the last ten years for that matter. So what gives? I thought this was supposed to be a “vaccine” just like any other?

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They only approve that which they've tested for; in this case, they've only tested using this dosage as a booster. If, later, there's more testing on people who have not had any vaccine, they may expand the authorization. It's not a conspiracy.

They've only tested it on mice....

This is a Booster.

I'm sure they could develop a primary vaccine that starts with this strain as the base.

In case you weren't aware, the primary shots and boosters (up until these two) were all the same shot. These also work the same as those.

The only reason it's not being treated as a primary shot is it wasn't tested as such (and probably also marketing purposes).

With most things there's the right way to do something, the wrong way to do it, and the bureaucratic way. Honestly I'm happily surprised that they're going with the Flu system for Covid because the rules for the yearly Flu vaccine are grandfathered in from a time when the vaccine approval process was very different. There were a lot variances in the ways that vaccines can be administered, like "first doses first", that would have made a huge positive difference in our overall response and that other countries like the UK employed successfully but that didn't match existing procedures. Well, except that given years of work the procedures were changed and now we're doing that with Monkeypox vaccination. So yeah, it's stupid but it isn't sinister, it's just a big bureaucracy being a big bureaucracy.

My random guess which should be taken with a grain of salt is there is some kind of workaround based on the fact that the original vaccine and this are both under the EUA.

Context info: FDA approved one of the original vaccines (Pfizer I think?) but the approved version has never hit the market because the approved version comes with liability. Literally no one has access to the approved vaccine, only the EUA one. If the EUA version harms/kills you then you can't sue anyone.

Both Pfizer[0] and Moderna[1] vaccines are full-approved, so your "context info" is absolutely false.

[0] - https://www.fda.gov/emergency-preparedness-and-response/coro...

[1] - https://www.fda.gov/emergency-preparedness-and-response/coro...

The approved versions of the vaccine are not actually being distributed, at least as of a few months ago. Your own FDA article differentiates them.

>The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and the approved vaccine is marketed as Comirnaty, for the prevention of COVID-19 in individuals 12 years of age and older.

The Pfizer-BioNTech version is different than the Comirnaty version. Even if the difference is just the label, we have no way of knowing. The difference is likely the difference between name brand and generic. There's no reason, as far as I know, to believe there's any difference in efficacy or safety. However, the one that is being distributed is still the Pfizer-BioNTech version because that one carries liability immunity for Pfizer due to the EUA. They would be foolish to produce and distribute the approved version. I believe the prevailing narrative that the vaccines are safe enough and effective enough to use.

Edit: I did the OPs homework. The claim about a legal liability difference is false per https://www.washingtonpost.com/politics/2021/08/30/false-cla....

In fact both the eua and fully approved version have the same protection due to the PREP act.

OP please stop spreading false rumors that originated on Steve bannons war room. Now that you know the rumors you posted are false it would be appreciated if you go back to wherever you’ve posted the wrong info and post updates indicating the mistake.

Original post: Please provide a citation for saying the fda approved version is not being distributed because it seems highly illogical that the full approval wouldn’t supersede the eua, with all the legal entailing implications, and the eua would cease to be valid. The fda has done some odd things in the past but a citation is needed on that claim that the approved version is not distributed and that both approvals coexist rather then the eua is superceded.

According to vaccines.gov, I can get COMIRNATY at a number of drugstores near by.

There are subtleties around the precise vaccine series, in that the FDA approved, and COMIRNATY marketed thing is precisely a two dose series for people 12 and up, and there are a bunch of places where only the EUA applies (a three dose, non-booster series for immunocompromised folks, anything for kids 4-12 years old, etc.).

Your claim about the EUA appears to be wholly unfounded, as I don't think there are significant liability differences between an EUA and full FDA approval anyway (you get limited liability with FDA approval normally, the National Vaccine Injury Compensation Program existed pre Covid-19). And there's tons of resources that trivially confirm that the vaccines are identical and that you can even get half COMIRNATY and half not, which makes the whole liability argument even less legitimate looking.

> The Pfizer-BioNTech version is different than the Comirnaty version.

You haven't proved this to be the case. It seems like fearmongering to me.

It's "marketed" differently, not "formulated" differently.

They are approved differently, as is detailed further in the article.

I already stated the difference may just be the label. Or perhaps like the difference between name brand and generic. I explicitly stated there's no reason to believe there's any difference in safety or efficacy.

My commentary is about skirting liability laws, not efficacy or safety.

Again, you haven't proved it. Just more fearmongering.

Pfizer themselves prove it for him (https://www.fda.gov/media/150386/download, Page 18):

“The two formulations of the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) differ with respect to certain inactive ingredients only and have been shown to be analytically comparable.”

They go on to explain that the modified formulation uses a different buffer. He is correct at least regarding a formulation difference.

Okay, now the next issue is whether or not they're withholding Comirnaty from the US Market.

Again, no proof of this. Just speculation and fearmongering.

Further they have to show that have potential legal exposure from a fully approved vaccine over an EUA.

From my understanding of the PREP [1] act, Alex Azar declared a public health emergency in 2020. The PREP act gives immunity for all medical companies working on Covid 19 treatments until 2024.

[1] https://crsreports.congress.gov/product/pdf/LSB/LSB10443

I didn’t read fearmongering from OP’s comments, just speculation.

I have no idea about the liability issue. The more interesting one to me was the government vaccine mandates last year (medical vs legal interchangeability, eua vs approved).

Interestingly, according to Pfizer the 08/23/2021 originally approved Comirnaty formulation (PBS buffer) was never available: “… These NDCs will not be manufactured. Only NDCs for the subsequently BLA approved tris-sucrose formulation will be produced” (https://www.cdc.gov/vaccines/programs/iis/COVID-19-related-c...).

The updated Tris buffer Comirnaty formulation was FDA approved on 10/29/2021 (https://www.fda.gov/media/150386/download, Page 8).

As for if its available, I guess you would have to go check a few pharmacies and ask if the Pfizer vaccine they have is labeled ‘Comirnaty.’ Some articles from the end of last year say they couldn’t find it, but who knows now. I have not looked into this at all, and to be honest I’ve already spent too much time searching this stuff up today so I’ll leave that for another person.

At least in the EU, the vaccine that was approved in December 2020 was already called Comirnaty.

I'm less familiar with EU liability laws. In the US the FDA differentiates an EUA version and the regular FDA approved version. The difference may only be the label, but Pfizer would be foolish to distribute a version with liability attached when they could distribute a version without liability attached.

Are you familiar enough with EU drug liability laws to speak to whether Pfizer has any liability?

I hate having these autistic fine detail discussions in this context because people assume I'm anti-vax. I will state here again I believe the vaccines are safe enough and effective enough to justify use.

> The Pfizer-BioNTech version is different than the Comirnaty version.

How do they differ? Aren't they both tozinameran?

As I stated in my comment, the difference may only be the label. But the FDA article clearly differentiates them and explicitly discusses how the approvals vs EUA are different for each.

They are the same. Changing the name of something doesn’t mean anything substantial. https://www.nebraskamed.com/COVID/you-asked-we-answered-are-...

From your source:

The products are legally distinct with certain differences that do not impact safety or effectiveness

I for one do care about legal distinctions. So, what are these differences?

From: https://www.fda.gov/media/150386/download

"The two formulations of the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) differ with respect to certain inactive ingredients only and have been shown to be analytically comparable.35

35 Analytical comparability assessments use laboratory testing to demonstrate that a change in product formulation does not impact a product's safety or effectiveness. For the Pfizer-BioNTech COVID-19 Vaccine, multiple different release parameters were evaluated to assess the comparability of the modified formulation (the formulation with the Tris buffer) to the originally-authorized formulation (the formulation with the PBS buffer). These release parameters ranged from product appearance to size of the lipid-nanoparticle to the integrity of the modRNA in the product. Release and characterization tests include tests for purity, composition, and critical attributes of mRNA associated with the activity of the vaccine. The combination of release testing and characterization testing demonstrated that the modified formulation is analytically comparable to the original formulation."

Changing one buffer to another (to keep the vaccine at a similar pH to the body) isn't likely to have any active effect.

Advil and Motrin are two products with differences in inactive ingredients that are analytically comparable. They are however legally distinct. If Motrin slips on QC, you don't get to sue the manufacturer of Advil.

So, what are the legal distinctions? Is this legally distinct product actually available and what are the distinctions, for instance, regarding liabilities?

> Even if the difference is just the label, we have no way of knowing.

They actually said in the approval document that they're not the same, there were changes to inactive ingredients (to improve shelf life IIRC).

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