Pfizer vaccine still NOT fully approved by FDA

[sfs]

If they believe they are receiving Comirnaty and suffer a debilitating blood clot or cardiac condition as a result of the vaccine, then find that they had in fact received the Pfizer-BioNTech COVID-19 product, they have no legal recourse to sue for damages.

But why can they sue for damages from the approved version? The PREP act doesn't limit protection from liability only to unapproved countermeasures.

 

[TLK Valentine]

I have to say, from these posts, I think some here are anticipating a flaw or fault or at least looking for one....only to be pointed out that there isn't one..and they are like "oh".

Some of them seem more like "nuh-uh!"

...which is a thing to be expected, sadly.

 

[ThisIsMe123]

But why can they sue for damages from the approved version? The PREP act doesn't limit protection from liability only to unapproved countermeasures.

I'm starting to think this is turning into a Red Herring argument.

 

[Aldebaran]

Footnote 8 at the bottom of page two of the OP’s link,

“The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness…”

The vaccine that has been in use, is what got the EUA, it now has a Brand Name “COMIRNATY” and a license to market the full approved vaccine.

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

Since they won't tell us what those differences are, I guess we just have to take their word for it.

 

[TLK Valentine]

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

Since they won't tell us what those differences are, I guess we just have to take their word for it.

It would be irresponsible for the FDA to give away Pfizer's trade secrets.

 

[Pommer]

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

Since they won't tell us what those differences are, I guess we just have to take their word for it.

While I do not know what the legal distinctions are, I’m guessing that the vaccine that had obtained the EUA will be covered by a different “adverse reaction” program than the fully licensed version under the brand name COMIRNATY as prescribed by law.

EDIT:

Conditions With Respect to Use of Licensed Product
AA. COMIRNATY (COVID-19 Vaccine, mRNA) is now licensed for individuals
16 years of age and older. There remains, however, a significant amount of Pfizer- BioNTech COVID-19 vaccine that was manufactured and labeled in accordance with this emergency use authorization. This authorization thus remains in place with respect to that product for the previously-authorized indication and uses (i.e., for use to prevent COVID-19 in individuals 12 years of age and older with a two-dose regimen, and to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise).
BB. This authorization also covers the use of the licensed COMIRNATY (COVID-19 Vaccine, mRNA) product when used to provide a two-dose regimen for individuals aged 12 through 15 years, or to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. Conditions A through W in this letter apply when COMIRNATY (COVID-19 Vaccine, mRNA) is provided for the uses described in this subsection III.BB, except that product manufactured and labeled in accordance with the approved BLA is deemed to satisfy the manufacturing, labeling, and distribution requirements of this authorization.

Source, @Page 12

 

[KCfromNC]

While I do not know what the legal distinctions are, I’m guessing that the vaccine that had obtained the EUA will be covered by a different “adverse reaction” program than the fully licensed version under the brand name COMIRNATY as prescribed by law.

EDIT:

Source, @Page 12

I'm not a lawyer, but it sure reads to me like "heads up, the old stuff came in a different box".

 

[Aldebaran]

I'm not a lawyer, but it sure reads to me like "heads up, the old stuff came in a different box".

If someone manages to actually get the COMIRNATY branded shot, I'd love to hear about it. Rumor has it that it won't be available until 2023.

 

[whatbogsends]

While I do not know what the legal distinctions are, I’m guessing that the vaccine that had obtained the EUA will be covered by a different “adverse reaction” program than the fully licensed version under the brand name COMIRNATY as prescribed by law.

EDIT:

Source, @Page 12

Them being "legally distinct" allows the previous vaccine to be used with a liability waiver, while claiming they're "essentially the same" such that it has "full approval", while the one with full approval (Comirnaty) won't actually be administered at this point in time.

It's fully approved without actually being fully approved, and still using an Emergency Use Authorization. Win/win (well, for Pfizer, at least).

 

[Aldebaran]

Them being "legally distinct" allows the previous vaccine to be used with a liability waiver, while claiming they're "essentially the same" such that it has "full approval", while the one with full approval (Comirnaty) won't actually be administered at this point in time.

It's fully approved without actually being fully approved, and still using an Emergency Use Authorization. Win/win (well, for Pfizer, at least).

When they play these kinds of games with wordings and definitions, it just further any suspicions people already had, and may even make those who were on board with the vaccine idea take a step back when it comes to getting a 3rd shot.

 

[Pommer]

Them being "legally distinct" allows the previous vaccine to be used with a liability waiver, while claiming they're "essentially the same" such that it has "full approval", while the one with full approval (Comirnaty) won't actually be administered at this point in time.

It's fully approved without actually being fully approved, and still using an Emergency Use Authorization. Win/win (well, for Pfizer, at least).

Yes, this site covers “adverse effects” of the COVID19 vaccines distributed under the EUA.
The license for the Comirnaty vaccine means it’s adverse effects cases will be handled (I think) by the usual
National Vaccine Injury Compensation Program, though I’ve yet see changes on the second link to confirm that.

 

[Pommer]

When they play these kinds of games with wordings and definitions, it just further any suspicions people already had, and may even make those who were on board with the vaccine idea take a step back when it comes to getting a 3rd shot.

Governing is complicated, yes.
Deal.

 

[Aldebaran]

Governing is complicated, yes.
Deal.

Telling the truth is simple. They should just go that route.

 

[Pommer]

Telling the truth is simple. They should just go that route.

Operation Warp Speed: “Quick big-pharma, save us!”
BPh: Okay try this!
OWS:“What is it?”
BPh: it’s a new type of vaccine that we make from scratch so that we don’t have to grow trillions of SAR-CoV-2 virii to produce the vaccine!
OWS: “Brilliant! What’s it called!?”
BPh: The marketing guys haven’t come up with anything ye, it’s early!
OWS: “Here’s EUAs to cover you!”

And now that the FDA is signing off on “Comirnaty” (as the marketing people finally come up with) and licensed it for use, we get complaints that it’s “too confusing” for people to follow the process.

 

[KCfromNC]

If someone manages to actually get the COMIRNATY branded shot, I'd love to hear about it. Rumor has it that it won't be available until 2023.

Many people are saying...

 

[Aldebaran]

Many people are saying...

If you have a link showing where the great new (or old, but renamed) Comirnaty vaccine is available to be gotten injected with it, I'd love to see it. Otherwise, it's the equivalent of vaporware.

 

[TLK Valentine]

If you have a link showing where the great new (or old, but renamed) Comirnaty vaccine is available to be gotten injected with it, I'd love to see it. Otherwise, it's the equivalent of vaporware.

In whose opinion?

 

[KCfromNC]

If you have a link showing where the great new (or old, but renamed) Comirnaty vaccine is available to be gotten injected with it, I'd love to see it. Otherwise, it's the equivalent of vaporware.

Weird you'd think one would need links and evidence to ignore a retelling of the rumor in your previous post.

 

[Aldebaran]

Weird you'd think one would need links and evidence to ignore a retelling of the rumor in your previous post.

Still awaiting evidence that the Comirnaty vaccine is available so we don't have to keep relying on experimental EUA substances. FDA approval is supposedly important.

 

[KCfromNC]

Still awaiting evidence that the Comirnaty vaccine is available so we don't have to keep relying on experimental EUA substances.

I'm not convinced you're actually waiting for evidence.