patrick.net

Undoctored says

I thought Biden only (almost) got away with his employee mandates because the Pfizer original two-dose series was FDA-approved. But only for ages 16 and up.

@Undoctored

No, none of the mRNA shots actually given to the public were ever FDA approved, and I'm pretty sure that it's still true that the shots have NOT been FDA-approved. This is so the FDA can protect itself.

Only "Comirnaty", which is NOT available, was approved. This is a legal slight-of-hand that worked on most people get them to believe the shot was FDA-approved.

Yep, and that is one of the reasons that Xi Biden is going to extend the Emergency Declaration. If it lapses, there is no emergency authorization for the Vaxx.

Among other powers granted the Executive Branch for the "Emergency".

Patrick says

Only "Comirnaty", which is NOT available, was approved. This is a legal slight-of-hand that worked on most people get them to believe the shot was FDA-approved.

There seems to be a consensus that you can only have a vaccine mandate in the US if an FDA-approved vaccine is on the list of options.

There’s a line of reasoning that “the Pfizer vaccine” was approved by the FDA and whether it is distributed as “authorized” (unbranded) or “licensed” (Comirnaty) it satisfies that requirement. Same for Moderna and its Spikevax. @Patrick you and many others may disagree but I concede this for the sake of argument.

What I’m saying is even if you take that lenient definition of “approved vaccine” the approvals of Comirnaty and Spikevax were only for the initial two-dose series, not the boosters. The FDA never approved any COVID-19 vaccine for use as a booster.

So how is it that COVID-19 booster shots can be mandated at all? There’s no FDA-approved option, not even theoretically.

Undoctored says

Patrick says

Only "Comirnaty", which is NOT available, was approved. This is a legal slight-of-hand that worked on most people get them to believe the shot was FDA-approved.

There seems to be a consensus that you can only have a vaccine mandate in the US if an FDA-approved vaccine is on the list of options.

There’s a line of reasoning that “the Pfizer vaccine” was approved by the FDA and whether it is distributed as “authorized” (unbranded) or “licensed” (Comirnaty) it satisfies that requirement. Same for Moderna and its Spikevax. @Patrick you and many others may disagree but I concede this for the sake of argument.

What I’m saying is even if you take that lenient definition of “approved vaccine” the approvals of Comirnaty and Spikevax were only for the initial two-dose series, not the boosters. The FDA never approved any COVID-19 vaccine for use as a booster.
<...

You are simply wrong. The FDA has approved the boosters under the emergency.

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use#:~:text=Today%2C%20the%20U.S.%20Food%20and,following%20primary%20or%20booster%20vaccination.

Misc says

Undoctored says

Patrick says

Only "Comirnaty", which is NOT available, was approved. This is a legal slight-of-hand that worked on most people get them to believe the shot was FDA-approved.

There seems to be a consensus that you can only have a vaccine mandate in the US if an FDA-approved vaccine is on the list of options.

There’s a line of reasoning that “the Pfizer vaccine” was approved by the FDA and whether it is distributed as “authorized” (unbranded) or “licensed” (Comirnaty) it satisfies that requirement. Same for Moderna and its Spikevax. @Patrick you and many others may disagree but I concede this for the sake of argument.

What I’m saying is even if you take that lenient definition of “approved vaccine” the approvals of Comirnaty and Spikevax were only for the initial two-dose se...

No, you are wrong. According to your link, the FDA has extended EUA to the boosters. It has not approved them.

You fail at reading comprehension.

stereotomy says

You fail at reading comprehension.

C'mon, that is unnecessarily personal.

No, in the article it states

Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. .

For those with limited English skills:

https://www.thesaurus.com/browse/approved

Misc says

Yep, and that is one of the reasons that Xi Biden is going to extend the Emergency Declaration. If it lapses, there is no emergency authorization for the Vaxx.

There are some rumblings that next week’s public health emergency declaration renewal will be the last and it will expire in January.

https://www.healthcareitnews.com/blog/lose-covid-19-public-health-emergency-keep-progress-says-himss-gr-director

The president’s latest statement indicates that this could be the final renewal, and that the PHE may finally expire in the new year.

https://www.reuters.com/business/healthcare-pharmaceuticals/who-chief-says-end-sight-covid-19-pandemic-2022-09-14/

The U.S. health department is set to renew it again in mid-October for what policy experts expect is the last time before it expires in January 2023.

And yes, this would spell the end of boosters, which are all “emergency use authorized” only. What I keep hearing is that that their spirit will live on with a claim of “latest COVID-19 variant protection” in the annual flu shots.

There is a significant difference between FDA “approved” and “authorized” and unfortunately most people are unaware of this difference. The FDA documents I think intentionally mislead people into thinking they have given approval (found overall safe and effective for the indicated use) for all uses and not mere authorization (found potentially overall safe and effective for the indicated use) by using the word “approved” at the top with reference to the one “approved” use. Then they switch to saying “authorized” for the other uses hoping you won’t notice the difference.

To repeat: no COVID-19 vaccine was ever approved by the FDA for use as a booster.

It appears my English skills are fine, however, in bureaucratese (yes that's a word) there is a difference between authorized and approved.

That the boosters have been authorized by the FDA is correct, but sounds less ominous.

Misc says

That the boosters have been authorized by the FDA is correct, but sounds less ominous.

So that means that the original non-Comirnaty Pfizer and Moderna jabs are still under EUA only, but boosters based on those shots are approved beyond EUA?

Authorized not approved via bureaucratese. Nope they are under EUA.

All COVID-19 boosters available in the US are Emergency Use Authorized only. What happened recently is that Pfizer and Moderna’s “authorizations” were expanded to include the new formulations with the “Omicron” component (so-called bivalent).

To repeat, no “booster” use of COVID-19 vaccines has ever been approved by the FDA; they have only ever been “authorized” to be used as boosters.

And no, authorization is not a kind of approval. Don’t mix these terms. The FDA has no degrees of approval. With approval there’s a declaration that the product works as claimed and is safe. With Emergency Use Authorization there’s only a declaration that the use of the product might have a net positive benefit/risk ratio but it has not been proven, and the product can only be distributed for that use while a certain public health emergency is in effect.

It sounds less apocalyptic to simply say the FDA has authorized the use of the Vaccine boosters.

Your way of phrasing simply sounds like fearmongering.

Misc says

It sounds less apocalyptic to simply say the FDA has authorized the use of the Vaccine boosters.

Your way of phrasing simply sounds like fearmongering.

It's been 2 fucking years. Get the fucking booster if you want. Fuck it. 2 years ago, it was a responsibility to warn you, today, it's your responsibility. If you can't see the obvious in front of your face, well, that's not my fault or anybody else's. People do have a civic duty to inform but if you want to stick your fingers in your ears and scream lalalala - whatever.

We're at the point of diminishing returns. People that still believe this shit, are they worth saving?

Bottom line; our governments tried to lock everyone in the world into a "vaccine passport". They wanted to restrict every movement, every purchase, and every breath we took. They still desperately need their, "great Reset".

Build Back Better!

We're just hanging out waiting for "what's next" knowing November holds the answer as to where we have to go. If they don't nuke us in the meantime.