[Pollard]

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.

Approval of BLA(biologics license application) for 16 and older

On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA.

Reauth of EUA for "certain uses that are not included in the approves BLA" eg 12-15 year old

[mewzilla]

Does that letter contain all the fine print?

Just feels like we’re missing something to me...

All that boilerplate about revisions and certain uses...

[rktman]

As well as this first sentence in FDA press release:

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine.