[EEGator]

My understanding is full approval for 16 y/o and over.
The EUA has been extended for 12 - 15, and for the booster shot.

[Pollard]

My understanding is full approval for 16 y/o and over.
The EUA has been extended for 12 - 15, and for the booster shot.

Exactly. They had to re-auth and rewrite the EAU due to the approval of the shot in certain cases, 16+ etc. Separation of use cases.

[gas_dr]

That is correct. It is licensed for over 16 and fully approved. It can’t have a trade name without official licensing. The EUA was extended for 12-16 and I think the booster is EUA

But we now have a fully licensed vaccine thanks to president trump.

[packagingguy]

“My understanding is full approval for 16 y/o and over.
The EUA has been extended for 12 - 15, and for the booster shot.”

It took me a long time to reconcile the extended EUA with the clearance to market the vaccine. I came to the same conclusion as you did and I believe you are correct.

What concerns me is there are a number of new vaccines in development which may not be as dangerous as an mRNA vaccine. In particular is Novavax which is only the proteinaceous component of the virus. It is due out in the fourth quarter. I am watching this one carefully.

It seems as though the public is being stampeded into one type of vaccine when there are other alternatives that will come to market. Individuals should use their own judgement as to which vaccine they want to take or if they even want a vaccine.

[liberalh8ter]

Reading through the FDA letter is a nightmare. Here's an example:

I. Criteria for Issuance of Authorization

I have concluded that the emergency use of Pfizer-BioNTech COVID‐19 Vaccine for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because:

II.

A. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus;

B. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that Pfizer-BioNTech COVID‐19 Vaccine may be effective in preventing COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of Pfizer-BioNTech COVID‐19 Vaccine when used to prevent COVID-19 outweigh its known and potential risks; and

C. There is no adequate, approved, and available9 alternative to the emergency use of Pfizer-BioNTech COVID‐19 Vaccine to prevent COVID-19.10

Scope of Authorization

I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited as follows:

• Pfizer Inc. will supply Pfizer-BioNTech COVID‐19 Vaccine either directly or through authorized distributor(s),11 to emergency response stakeholders12 as directed by the U.S.

9 Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA. Additionally, there are no products that are approved to prevent COVID-19 in individuals age 12 through 15, or that are approved to provide an additional dose to the immunocompromised population described in this EUA.

So as you can see here, the author keeps saying it's a re-issuance of the EUA.

[Hatteras]

"On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.

Cool! It will now PREVENT Covid instead of just lessening the severity of the symptoms. Says so right there.

[Georgia Girl 2]

That’s the way I’m reading it too.